American Hospital & Healthcare Management - Issue 03 by Ochre Media Pvt. Ltd.

I S S U E 03

2024

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Rohan Goswami MD, Director of Heart Transplant Innovation and Research, Mayo Clinic

Caitlyn Luce Research Fellow, Division of Advanced Heart Failure and Transplant, Mayo Clinic

Breaking the Chain in Cardiac Amyloidosis PA G E

The Multifaceted Interactions of the Brain-Heart Interface

PA G E

Cardiovascular Risk Assessment for Comprehensive Healthcare Solutions

21 48

Sponsor

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Exploring Cardiovascular Frontiers, AI Revolution, and Patient-Centric Paradigms It is my pleasure to welcome you to the third edition of AmericanHHM, where we commence a comprehensive exploration of the intricate world of healthcare. In this edition, we present a collection of insightful articles, expert interviews, panel discussions, and opinion pieces shedding light on cutting-edge advancements, critical decision-making processes, and the transformative impact of digital technologies reshaping the global healthcare scenario. As you navigate through the pages of AmericanHHM Issue 03, we invite you to engage with the profound insights shared by our esteemed contributors, whose collective expertise propels us toward a future where healthcare innovation and patient-centric care intersect. It is evident that the healthcare sector is undergoing a remarkable transformation. We hope that the third edition of AmericanHHM Magazine serves as a valuable resource for healthcare professionals globally. Dr. Thomas Bartel, an Interventional Cardiologist from Flexdoc GmbH, takes us through the domain of cardiovascular diagnostics, highlighting the increasing role of personalization in advanced diagnosis. Dr. Bartel describes the various screening methods that have become essential in clinical assessments and diagnostic procedures The issue unfolds with Piyanun Yenjit, Founder and Managing Director of Apuk Co., Ltd, addressing the pressing concern of cardiovascular disease on a global scale. Yenjit emphasizes the importance of skilled risk management and the need for tailored screening methods, recognizing the crucial role they play in early detection and intervention for improved public health outcomes. Contributing invaluable information into the significantly underdiagnosed realm of cardiac amyloidosis, Rohan Goswami, MD, and Caitlyn Luce from Mayo Clinic provide a critical guide for diagnosing advanced heart failure. Their work reveals the complexities of misfolded proteins and the subsequent limitations in cardiac muscle function that can lead to severe heart failure if improperly managed. Thomas N Muziani, President and CEO of HEMOSTAT Blood Management Consulting, presents a comprehensive exploration of cardio-protective strategies. His discussion on the myriad options available for cardiac programs provides a detailed understanding of the evolving nexus between empirical trial-and-error and contemporary solutions.

Directors Aniruddha Singh and Shilpi Mittal share an insightful opinion, reflecting on the negotiation inherent in critical decision-making within the complex realm of healthcare. They challenge traditional perspectives, bringing forth a detailed exploration of how negotiation principles intertwine with medical decision-making, especially in high-risk care situations. Nataliia Lopina, Director and Founder of ClinCaseQuest, discusses the pivotal role of simulation in healthcare platforms for advancing patient safety and improving care quality. She emphasize the importance of immersive, lifelike experiences in refining the skills and decision-making of healthcare practitioners. Finally, we are honored to present an expert interview with Anitha Chandrasekhar, Clinical Lead at Northwestern Medicine. She provides a captivating overview of the latest innovative technologies in heart and lung transplantation. She narrates the changing role of artificial intelligence and machine learning in patient management strategies portray a field prepared for a new era of intelligent scientific applications. Thank you for being a vital part of the AmericanHHM community. We eagerly anticipate the continued exchange of ideas and knowledge, as together, we are navigating the ever-evolving global healthcare landscape. If you have a perspective, an idea, or a story to share, we welcome your voice in our upcoming issues. Whether it's an article that sheds light on emerging trends, an interview with a thought leader, or a unique insight into the healthcare ecosystem, your wisdom can be a beacon guiding others in the healthcare journey. We want to hear from you via email: editorial@americanhhm.com Thank you for joining us on this exploration of healthcare innovations in AmericanHHM. Wishing you continued success and innovation in your future endeavours. Stay tuned for more in upcoming editions!

N D Vijaya Lakshmi Editor

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CONTENTS

HEALTHCARE MANAGEMENT 06 Personal Health Data Asset innovation in the Digital Economy Era Lu Yimin, President, China General Technology (Group) Holding

MEDICAL SCIENCES 21 The Multifaceted Interactions of the BrainHeart Interface Benjamin Wai Yue Lo, MD PhD FRCSC, Queen Mary Hospital, Hong Kong Hospital Authority

26 Remote Monitoring and Telehealth in Chronic Disease Care Dr. Sony Prabowo, MARS Acting Hospital Director, Ciputra Mitra Hospital

SURGICAL SPECIALITY

CoverStory

Breaking the Chain in Cardiac Amyloidosis Rohan Goswami MD, Director of Heart Transplant Innovation and Research, Mayo Clinic

Caitlyn Luce Research Fellow, Division of Advanced Heart Failure and Transplant, Mayo Clinic

40 Re-Imagining Myocardial Reanimation Ensuring a Successful Operative Outcome Thomas N Muziani, President and CEO of HEMO-STAT Blood Management Consulting

INFORMATION TECHNOLOGY 61 Artificial Intelligence (AI) Automation of Diagnostic Image Acquisition Reza Forghani, MD, PhD, Prof of Radiology & Artificial Intelligence (AI) and Vice Chair of AI, Director, Radiomics & Augmented Intelligence Laboratory (RAIL), Department of Radiology, University of Florida College of Medicine

EXPERT TALK DIAGNOSTICS

68 AI in Digital Transformation

48 Cardiovascular Risk Assessment for Comprehensive Healthcare Solutions Piyanun Yenjit, Founder & managing Director, Apuk Co., Ltd

Dipu Patel, Vice Chair for Innovation and Professor, University of Pittsburgh’s DPAS program

73 Improving Patient Safety and Quality of Care Nataliia Lopina, Director and Founder, ClinCaseQuest

81 Recent Innovative Technologies in Heart and Lung Transplantation

54 Patient-Centered Cardiovascular Diagnostics Thomas Bartel, MD, PhD, Interventional Cardiologist, Flexdoc GmbH

Anitha Chandrasekhar, Clinical Lead- Lung Bioengineering and Organ Procurement, Northwestern Medicine

89 THROUGH THE HOURGLASS 93 INDUSTRY SENSE 99 EVENTS LIST 102 EVENT PREVIEW 110 NEWS 4

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Advisory Board

Andrey Andreevich Kapitonov CEO Oxygen Technologies LLC Belarus

Aung Pyae Kyaw Executive Director Asia Royal Hospital Myanmar

EDITOR Vijaya Lakshmi N D EDITORIAL TEAM Sarah Richards Debi Jones Harry Callum Supraja B R ART DIRECTOR M Abdul Hannan

Eiman Shafa

PRODUCT MANAGER Jeff Kenney

Medical Director, Spine Surgery Abbott Northwestern Hospital USA

SENIOR PRODUCT ASSOCIATES John Milton Peter Thomas

Gabe Rijpma

BUSINESS EVENTS Sussane Vincent

CEO Aceso Health New Zealand

James Doulgeris Chairman Population Health Advisory Board, RSDSA United States

Likaa Najuib

PRODUCT ASSOCIATE Ethan Wade CIRCULATION TEAM Sam Smith SUBSCRIPTIONS IN-CHARGE Vijay Kumar Gaddam HEAD-OPERATIONS Sivala VNR

Medical Marketing Operational Officer, Alfa Cure Oncology Center Egypt

Pinheiro Neto Joao

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Chief Executive Officer Meu Doutor Angola

Piyanun Yenjit Managing Director APUK Co.,Ltd Thailand

Thitisak Kitthaweesin Chief of Phramongkutklao Center of Academic and International Relations Administration, Thailand

Ochre Digi Media www.ochre-media.com ©Ochre Digi Media Private Limited. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying or otherwise, without prior permission of the publisher and copyright owner. Whilst every effort has been made to ensure the accuracy of the information in this publication, the publisher accepts no responsibility for errors or omissions. The products and services advertised are not endorsed by or connected with the publisher or its associates. The editorial opinions expressed in this publication are those of individual authors and not necessarily those of the publisher or of its associates. Copies of American Hospital & Healthcare Managemen can be purchased at the indicated cover prices. For bulk order reprints minimum order required is 500 copies, POA.

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Wanita Ramnath CEO International Pharmacy and Health Care Suriname

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Personal Health Data Asset innovation in the Digital Economy Era This article delves into the significance of personal health data within the digital economy, emphasizing its pivotal role in revolutionizing health management and medical services. It covers the sources and diversity of personal health data, discusses the transformation of health services due to the digital economy, explores the value of a personal health data asset management platform, and highlights associated risks, including privacy and security concerns. In summary, personal health data plays a crucial role in reshaping healthcare, but it also necessitates addressing privacy and security challenges. Lu Yimin President China General Technology (Group) Holding 6

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he two strategies of "Healthy China" and "Digital China" have formed an important intersection in China's development, and together they have built a new era with digital economy characteristics. The 20th National Congress of the Communist Party of China provided further guidance for this intersection in the new development concept. From the "Healthy China 2030" planning outline to the implementation of the "Healthy China Action", the Chinese government has continuously strengthened the construction of the health service system, focusing on intervening in factors affecting health, maintaining health throughout the life cycle, and preventing and controlling major diseases, etc., and promoted the rapid development health service industry.

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The "Healthy China" strategy and the "Digital China" strategy blend with each other in the new era of digital economy. "Healthy China" emphasizes health management as the core impetus and promotes a much wider healthcare management scope, while "Digital China" emphasizes the goal of comprehensive digitalization and applies digital technology to various fields. The intersection of these two strategies is that digital technology offers new ways to achieve health goals. Digitalization has promoted innovation in health services, such as Internet medical care and health data analysis, to provide people with more efficient and high-quality health services. At the same time, the digital transformation in the healthcare field has also injected vitality into the digital economy, accelerated the rise of the digital industry, and built a digital health industry ecosystem. In the new era of digital economy, the characteristics of these two strategies are revealed. The "Digital China" strategy uses informatization, intelligence, networking and other means to promote industrial upgrading and innovative development, with the digital economy becoming a key driving force. In the healthcare field, digital transformation has brought new business model, such as telemedicine and health data management, injecting new impetus into the sustainable growth of the health industry. The "Healthy China" strategy emphasizes the construction of a full life cycle health service system. Digital means make health management

more accurate and convenient, and meet diverse health needs. At the same time, the application of digital technology in health data management, disease prevention and other aspects also provides important support for achieving national health goals.

1. The Upcoming Changes in the Healthcare market 1.1 Consumer demand for health management shows obvious diversification characteristics The consumption concept has been upgraded to "health management-centric", and different groups of people require different health services. With the improvement of social and economic levels and people's increasing emphasis on healthcare, consumer demand for health management has shown a diversified trend. Different groups of people have different health needs. For example, the elderly pay more attention to maintaining quality life standards, patients with chronic diseases require professional rehabilitation services, and young people may pay more attention to fitness and body shape management. At the same time, people's demand for health management has gradually shifted from simple treatment to prevention and early intervention, focusing on health management throughout the life cycle. In order to meet the needs of different groups of people, health management services should provide diversified products and services, including health consultation, customized health w w w. a m e r i c a n h h m . c o m

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plans, health testing and evaluation, etc. Health services have different overall demands for different people. "Thousands of people with thousands of faces" means providing targeted health management services based on each person's individual needs and characteristics. Everyone’s health status, lifestyle habits, genetics, etc. are different, so the same health management plan does not apply to everyone. Through personalized customization, we can better meet everyone's needs and provide more effective health management services that are more in line with individual characteristics. This requires health management institutions or service providers to master a large amount of personal health data and use advanced technologies and algorithms to analyze and mine this data to generate personalized health management plans. Big health services require big data to drive precise services. The application of big data technology makes health management more accurate and intelligent. Big data can collect and organize huge amounts of health information from multiple dimensions, including disease data, health habits, environmental factors, genetic data, behavioral data, etc., to better understand the health status and development trends of the population. Through big data analysis, potential health risks and problems can be discovered, and early warning and intervention can be carried out to reduce the occurrence and exacerbation of diseases. 8

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At the same time, big data can also support health management decisions and program formulation, optimize the allocation of medical resources and the provision of health services.

1.2 The current rights and interests of Personal Healthcare Data are ambiguous and permissions are undetermined, and urgent changes are needed. The rights and interests of personal health data in China are still subject to some unclear issues and yet-to-determine factors over permissions. Most of the existing laws are from the perspective of protection and supervision, regulating the use of data through the Cybersecurity Law, Data Security Law, Personal Information Protection Law, etc. However, there is no law that regulates the ownership of data in various scenarios. Who owns it is clearly defined, and current laws rarely involve other rights and interests carried by the data itself. In the judicial process, the "Anti-Unfair Competition Law" and other laws are currently mainly used as an expedient to protect data rights and interests, recognizing that data has competitive interests. However, there is no consensus on the specific rules for demarcating rights, and there is great uncertainty. Operators are still prone to frequent disputes caused by unclear ownership. First, data ownership is undetermined: In China, personal health data involves multiple departments and institutions, such as medical institutions, health insurance companies,

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scientific research institutions, government departments, etc. Due to the lack of clear legal and policy provisions, it is difficult to establish clear ownership of personal health data, which leads to problems in data being obtained, used and shared by multiple parties. Current thinking is to focus on the rights of use and control rather than ownership. Second, there is a lack of clear data protection laws: Although China implemented the Personal Information Protection Law in 2020, it mainly focuses on the protection of personal information and does not have detailed regulations on the protection of personal health data. This puts the rights and interests of personal health data at greater risk and may be abused or improperly used. Third, data sharing between medical institutions and Internet companies: As Internet companies enter the medical field, data sharing becomes a problem. Data sharing between medical institutions and Internet companies may involve personal health data, but during the sharing process, individuals' rights to use and control the data are not clear, which can easily lead to risks of data privacy leakage and abuse. Fourth, ambiguity over permissions for scientific research and commercial use: Personal health data has important value in both scientific research and commercial use. However, in both areas, permissions for data use and sharing are not clearly defined, which can lead to abuse, unfair competition, and unauthorized use. 10

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Fifth, lack of data standards and norms: In the process of collecting, storing and using personal health data, the lack of consistent standards and norms makes it difficult to share data between different institutions and increases the risk of data misuse.

2. The changes in business formats brought about by the Digital Economy have also brought new thinking about Personal Health Data. 2.1 Diversified health needs will lead to comprehensive, life-cycle health and medical services The transformation of health and medical services from the current fragmented and independent form to a comprehensive, full life cycle, and all-scenario model is driven by multiple factors. At the same time, this transformation is also an inevitable and inevitable trend.

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This transformation is first driven by technology and supported by data. With the rapid development of information technology and digitization, the data acquisition, transmission and analysis capabilities in the medical field have greatly improved. Through smart devices, sensors and other tools, people can collect a large amount of personal health data in different scenarios and at various times, thereby building a more comprehensive and accurate health profile. These data provide scientific basis to enable medical services to better meet individual needs and realize the transformation from passive treatment to active prevention. Secondly, the all-round, full life cycle, and all-scenario medical service model is more in line with personalized health needs. Everyone's health needs vary with age, lifestyle and genetic factors. The traditional medical model cannot fully grasp the medical care required at each stage of an individual's life cycle. However, from a full life cycle perspective, medical services can manage and intervene in health problems in a more refined manner, achieving continuity and collaboration in health management. In addition, the all-scenario model helps improve the efficiency of medical services and avoid repeated examinations and waste of resources. The interconnection of medical data enables information sharing between different medical scenarios, and doctors and professionals can work better together to provide individuals with more accurate and

timely medical advice. At the same time, for emerging fields such as telemedicine and health consultation, the all-scenario connection model provides the possibility of cross-regional and cross-time medical services.

2.2 In the future, Personal Health Data will inevitably move towards the form of convergence, all-round multi-scenario coverage, and the entire life cycle. In the future, it is an inevitable development trend that personal health data will be integrated, with all-round multi-scenario coverage and the entire life cycle. There is inevitability and important value behind it. This trend aims to achieve more refined health management and promote the development of the digital economy, in which the elementalization of data assets will play a key role. The inevitability lies in the fact that the rapid development of science and technology in modern society has made data acquisition, transmission and storage more convenient than ever. It has become normal for people to record various data such as health indicators and living habits through smart devices. Gathering these scattered data can build a more comprehensive and accurate personal health portrait, providing data support for medical treatment, disease prevention, health management, etc. At the same time, as medical services transform from passive treatment to active prevention and personalized management, comprehensive w w w. a m e r i c a n h h m . c o m

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and multi-scenario health data coverage will better meet the diversity of individual health needs. This trend also brings significant value. First, the aggregation and elementalization of personal health data can promote the development of precision medicine. By analyzing data such as individual genes, physiological indicators, and living habits, medical and health services can more accurately predict disease risks and formulate personalized prevention and treatment plans, thereby improving medical effects. Secondly, the elementalization of data assets makes personal health data a valuable digital asset. Individuals can authorize the use of their own data, obtain benefits, and at the same time better protect personal privacy. In addition, comprehensive analysis of data helps advance scientific research and

Digital Era's Impact on Health Data: Transforming health management, emphasizes the pivotal role of personal health data while addressing privacy and security concerns.

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promotes breakthroughs in medical research and technological innovation.

2.3 Forming a Digital Twin Healthcare Ecosystem Under the new business format, big health service companies will realize the big health ecosystem of digital twins, forming a close twin relationship between business and digital dimensions, achieving comprehensive health service coverage and intelligent operation management. Specifically reflected in the following aspects: Digital twin relationship in the business dimension: The big health ecosystem will gather all personal big health data through the digital platform to form a full life cycle and multi-dimensional personal health data assets. This will allow personal health information to be comprehensively and accurately assessed and customized services. At the same time, the ecology will expand its product system to provide full-scenario product services such as healthy living, diet, sports, health care, finance, tourism, real estate, insurance, and cultural creativity to meet the health needs of different groups. Business development will be closely integrated with digital platforms to realize the mutual empowerment of data and services and improve the quality and efficiency of health services. Digital twin relationship in the digital dimension: The digital platform will make full use of technologies such as intelligence and blockchain to ensure the security and

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privacy of personal health data. Through data aggregation and analysis, digital twin technology will provide comprehensive business insights and decision-making support for the ecosystem, and promote the construction of a group operation system. The digital platform will achieve multiinstitutional coverage, realize cross-sector collaboration, and improve the collaborative capabilities of various business sectors within the ecosystem. At the same time, the digital platform will establish unified ecological service capabilities, covering individuals, groups, institutions and regions, create a unified cloud network security system, and promote the integration and sharing of ecological capability resources.

3. The value and connotation of Personal Health Data Asset Management Platform In this new health ecosystem, the comprehensive collection of personal health data assets will be the engine and value accumulation of the entire ecosystem. By giving personal health data assets control and usage rights, the data asset resource layer returns data initiative to individuals, promoting a virtuous cycle of user participation, data security and health innovation. This value not only meets the rights and needs of individuals, but also provides the group with a broader space for business expansion and innovative development, and promotes the realization of the comprehensive value of the digital architecture. At the same 14

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time, the data asset resource layer is also interconnected with other sectors, Internet application systems and ecological resource integration capabilities to form a collaborative and complete digital ecosystem.

3.1 The value of Personal Health Data In the digital era, the application of health data is increasingly becoming the key to achieving personalized health management and highquality medical services. For different types of applications, such as value discovery, medical empowerment, health risk control and personal data services, the integration of digital capabilities has injected new vitality into the health field. Through value discovery, personalized health care and intelligent customer service become possible, bringing medical services closer to user needs. In terms of medical empowerment, digital support for early intervention and cost control can effectively improve medical quality and reduce costs. The health risk control application achieves early identification and intervention of disease risks through full life cycle portrait warning. Personal data services provide users with data privacy protection and authorization management, enabling safe sharing and migration of data. However, this is only an initial attempt at health data applications. With the continuous advancement of science and technology and the promotion of innovation, more diversified applications will appear in the future. From more sophisticated life and health data collection to the popularization of smart

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medical equipment, from the application of genomics to in-depth analysis of medical images, digital capabilities will continue to expand the boundaries of the health field. At the same time, cross-field data integration and analysis will lead to more accurate medical predictions and treatment plans to protect everyone's health. These innovations will further promote the vigorous development of the health industry and bring more benefits to individuals and society as a whole. Therefore, the digital capabilities of health data applications have not only shown great value in the early stages, but will also continue to evolve in the future, bringing revolutionary changes to our health and medical experience. The first category of applications, value discovery, plays a key role in the application

of health data. Through customer value discovery and evaluation, the system can gain an in-depth understanding of the user's personal health situation, thereby accurately customizing personalized health management plans. Based on the user's health data, the system can identify the user's health needs and risks, and provide users with targeted product recommendations and health advice. As an interactive platform, intelligent customer service can answer users' health questions in real time, provide professional medical advice, and help users better understand their own health conditions. This kind of application not only enhances users' awareness of personal health, but also provides customized health plans, thereby increasing users' enthusiasm and participation in health management. Through digital w w w. a m e r i c a n h h m . c o m

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capabilities, the system can quickly analyze large amounts of health data, mine valuable information, provide users with accurate health advice and services, and achieve the goal of personalized health care. The second type of applications, clinical empowerment, is of great significance in health data applications. By in-depth analysis of users' health data, the system can identify potential health needs and risks, thereby achieving the goals of early intervention and long-term cost control. The system can track changes in users' health data, detect signs of health problems early, and take appropriate treatment measures before the disease worsens. In addition, digital capabilities can help the system detect ineffective treatments, avoid unnecessary medical behaviors, and reduce medical costs. By connecting with medical databases, the system can obtain rich medical information, provide users with scientific and reasonable medical advice, and improve medical efficiency and treatment effects. Digital analysis and prediction capabilities enable the system to more accurately predict patients' disease development trends, achieve precision and personalization of health management, and provide users with better medical empowerment services. The third category of applications, health risk control, plays an important role in early warning and risk control in health data applications. By comprehensively analyzing an individual's life-cycle health data, the 16

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Shaping the Future of Healthcare: Personal health data emerges as a catalyst in the digital economy, revolutionizing health management.

system can identify people with potential long-term symptoms or latent symptoms, detect health risks in advance, and take appropriate intervention measures. Digital capabilities enable the system to build a personal health portrait and comprehensively consider various factors, including genes, living habits, medical history, etc., to more accurately predict individual health risks. The system can discover potential correlations and patterns through data mining and model analysis, and provide timely warning information to medical institutions and individuals so that appropriate intervention measures can be taken to reduce health risks and medical burdens. Digital capabilities also enable the system to achieve real-time monitoring and tracking, detect health abnormalities early, and provide users with more comprehensive and accurate health risk control services, thereby improving the user's overall health level.

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The fourth category of applications, personal data services, has important privacy protection and data controllability functions in health data applications. This application focuses on the authorized management and use history tracing of personal health data. It not only enables individuals to fully control their own health data and decide how to share and utilize this data with all parties, but also provides the inheritability of personal data assets through digital capabilities. It gives a new dimension and lays a solid foundation for building a credible and efficient digital health ecosystem. As a valuable asset, personal data can be better managed, inherited, shared and applied, creating multiple values for individuals and the entire health ecosystem. In this type of application, data privacy protection and authorization management are still the core. Digital technology provides more secure and intelligent storage, transmission and access methods for personal data to meet users' needs for data security. Users can share data with medical institutions, insurance companies, research institutions, etc. according to their personal wishes to achieve safe sharing and effective application of data. Digital capabilities give the system a high degree of security and credibility, ensuring the security of personal health data during transmission, storage and processing through encryption technology and access control. The system can record authorization records of personal health data, including which institutions or individuals were granted access to the data,

and when and how the data was used. Users can view and manage these authorizations at any time, ensuring personal privacy while also achieving reasonable sharing of data. Digital capabilities also enable the system to transfer data across agencies. When users need to share health data between different service agencies, the integrity and consistency of the data can be ensured through secure data transmission and sharing mechanisms. At the same time, digital capabilities also give personal data assets the property of inheritability. By establishing a clear data inheritance mechanism, individuals can choose to pass on their health data assets to relatives or trustees, thus ensuring the sustainable use of data assets. This digital capability not only helps to continue to provide health management support to the individual's family after his death, but also provides longer-term and continuous health services to the individual himself. In general, the digital capabilities of the fourth category of applications not only strengthen the individual's control over data and realize the safe, efficient and reasonable use of data, but also focus on the inheritability of data assets, creating benefits for individuals and the entire society. Greater value the continuous development and innovation of this digital capability will provide more possibilities for the reasonable use and inheritance of personal data, further promoting the intelligent and humanized development of health management. w w w. a m e r i c a n h h m . c o m

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3.2 The connotation of Personal Health Data Assets In the construction of the personal health data system, the construction of the data asset platform emphasizes partition construction and isolation of risks, and realizes the safe and efficient use of big health data through three clear steps. First, the diversified data collection model ensures the coverage of various health data sources, from clinical to scientific research, from individuals to governments, ensuring data diversity and integrity. At the same time, data areas are strictly divided by region to prevent the risk of data leakage. Secondly, the data processing stage covers the establishment of unique identification, data cleaning, annotation, valuation, confirmation of rights and other processes to complete the data processing and set up security barriers at every step to ensure data accuracy and compliance. Finally, in the application output stage, diversified health services and applications are provided on demand. Through clear permission control and isolation mechanisms, the safe flow of data is ensured and the potential risk of cross-border spread of data is reduced. This digital architecture based on partition construction and risk isolation not only enhances the value of data in the general health field, but also provides security guarantees for personalized health management and services, providing a solid foundation for the sustainable development of the health ecosystem.

4. Risks of building a personal health data asset platform Building a personal health data asset platform 18

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is an important step in the context of realizing all-round, full life cycle, and all-scenario medical services. However, it is also accompanied by a series of risks and challenges. Among them, risks in privacy protection, data security, and ethical considerations are particularly prominent. First of all, privacy protection issues are one of the main risks faced in building a personal health data asset platform. Personal health data involves extremely sensitive private information, such as disease conditions, genetic information, etc. In the process of data sharing and exchange, how to protect personal privacy from being abused or leaked is a very challenging issue. Without an effective privacy protection mechanism, the platform may cause users to worry about data security, and even cause users to be reluctant to share data. Secondly, data security risks cannot be ignored. Personal health data faces the risk of hacking, data leakage or misuse during the process of transmission, storage and processing. Once data is illegally obtained, personal privacy and rights may be seriously violated. Therefore, it is crucial to establish a solid data security system and strengthen encryption and protection measures to deal with potential security risks. In addition, moral and ethical considerations are an important risk. In the process of building a personal health data asset platform, how to balance the relationship between the value of data and personal autonomy is a complex issue. The collection, sharing and

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use of data must follow ethical principles to ensure that the rights and dignity of individuals are not violated. Otherwise, it may cause moral disputes and social dissatisfaction, affecting the sustainable development of the entire platform.

5. Conclusion In the digital age, the intersection of "Healthy China" and "Digital China" strategies presents an exciting prospect. "Healthy China" emphasizes comprehensive health services, from the policy level to regional implementation, and continuously strengthens the status of the health industry. "Digital China" popularizes digitalization in various fields, proposes to build a comprehensive digital society, and provides strong support for the development of the health industry. The intersection of the two strategies highlights the importance of factoring data assets in the health field.

In the era of digital economy, the value of personal health data has become increasingly prominent, becoming a key element in building comprehensive, full life cycle, and all-scenario medical services. Through diversified data collection and comprehensive data applications, personal health data is expected to achieve breakthroughs in precision medicine, personalized health management, and scientific research. However, in the process of building a personal health data asset platform, it also faces many risks and challenges such as privacy protection, data security and ethical considerations. The diversity and comprehensiveness of personal health data provide a more accurate scientific basis for medical services, prompting the medical model to shift from passive treatment to active prevention and personalized management. The development of the digital economy has significantly improved data acquisition, transmission and analysis capabilities, supporting a comprehensive, full life cycle, and full scenario medical service model. This trend emphasizes the integration of personal health data, all-round multiscenario coverage, and the entire life cycle, creating inevitability and value for achieving refined health management and promoting the development of the digital economy. The application potential of personal health data covers value discovery, medical empowerment, health risk control and personal data services. These applications not only enhance users' awareness of personal health, w w w. a m e r i c a n h h m . c o m

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personal health data need to be guaranteed. In addition, the reasonable use of data also needs to follow ethical principles to ensure a balance between the value of the data and individual rights and interests. To sum up, personal health data will lead the innovation and innovation of medical services in the context of the digital economy, and have a profound impact on health management and the medical industry. However, when building a personal health data asset platform, it is necessary to fully understand the risks and challenges and take effective measures to ensure privacy protection, data security and ethical compliance in order to realize the maximum value and social benefits of personal health data. This combination enables digital medicine, driven by data, to better meet the diverse health needs of individuals and promote medical services into a new era that is more personalized and intelligent.

Lu Yimin, is the President of China General Technology (Group) Holding. Established in 1998, China General Technology (Group) Holding Co Ltd, commonly known as Genertec, is a centrally administered State-owned enterprise, which is directed by the State-owned Assets Supervision and Administration Commission of the State Council (SASAC). It was approved by the government as a pilot enterprise of State-owned capital investment in December 2018.

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AUTHOR BIO

but also improve the quality of medical care, reduce costs, and will usher in more diversified applications with continuous technological advancement. However, building a personal health data asset platform also faces risks in privacy protection, data security and ethical considerations. The protection of personal privacy is a key issue, and the security and compliance of

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The Multifaceted Interactions of the Brain-Heart Interface

The brain-body interface comprises many physiological interactions which can go awry in disease states. This article discusses the brain-heart interface and its interactions with the autonomic nervous system under conditions of normal homeostasis and in cerebrovascular disorders. Benjamin Wai Yue Lo MD PhD FRCSC, Queen Mary Hospital, Hong Kong Hospital Authority

he brain-body interface comprises many physiological interactions which can go awry in disease states. This article discusses the brain-heart interface and its interactions with the autonomic nervous system under conditions of normal homeostasis and in cerebrovascular disorders.

The Brain-Heart Interface and the Autonomic Nervous System Direct and indirect projections of the autonomic nervous system control the cardiovascular system. These projections act via the parabrachial nucleus of the midbrain and pons (Figure 1). The parabrachial nucleus is w w w. a m e r i c a n h h m . c o m

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a relay station that transmits signals between the cerebral cortex (especially limbic cortex), amygdala, hypothalamic paraventricular nucleus, vasomotor area of the lower brainstem (including the ventrolateral medulla, medullary raphe, nucleus of the solitary tract), and the thoracolumbar intermediolateral gray column of the spinal cord. Autonomic visceral afferents from the thoracolumbar (sympathetic) and craniosacral (parasympathetic) levels ascend to the nucleus tractus solitarius. In addition, afferents from arterial baroreceptors in the aortic arch and carotid bodies also reach the nucleus tractus solitarius. This nucleus of the solitary tract also receives information about humoral (such as plasma electrolytes) and cerebrospinal chemical information from the area postrema (a circumventricular organ). Autonomic efferents include the anterior cingulate

gyrus, amygdala, insula, hypothalamus, periaqueductal gray matter within the diencephalon, locus ceruleus, parabrachial nucleus of pons before final pathways within the medulla and interomediolateral spinal cord (Figure 1). Arterial baroreceptors in the carotid sinus and aortic arch send information about arterial wall stretch to the nucleus tractus solitarius via the glossopharyngeal and vagal nerves. In so doing, the autonomic nervous system mediates heart rate (chronotropy), rate of nervous impulse transmission through the cardiac conduction tissue (dromotropy), and force of contraction (inotropy). Blood vessel diameter and tone are also mediated via the autonomic nervous system. Nucleus tractus solitarius inhibits the rostral ventrolateral medulla, excites the nucleus ambiguus and dorsal motor nucleus of vagus, producing a

Figure 1. Structures involved in the central autonomic nervous system.

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Figure 2. Inter-relationships between the nervous system and other body organ systems.

reduction in sympathetic tone and increase in vagal activity (including negative inotropic effects via the sinoatrial node as well as vasodilatory effects). Adrenergic neurons originating between T1 and L2 synapse with the entire arterial tree (Figure 2). Counter-regulatory feedback with the sympathetic nervous system predominates. An example of such counter-regulatory feedback is the Cushing reflex. Increase in intracranial pressure from disease states, such as intracerebral hemorrhage, leads to decreased levels of oxygen and increased local levels of hydrogen ions and carbon dioxide around the vasomotor regions of the lower brainstem secondary to anaerobic

metabolism. As a counter-regulatory measure, the systemic blood pressure is elevated in an attempt to increase blood flow to the brain. With this increase in blood pressure, heart rate is reflexively decreased via the arterial baroreceptors. Other factors also affect the amount of autonomic nervous output from the vasomotor regions of the brainstem, including: 1. Blood oxygen level, 2. Blood carbon dioxide level, 3. Pain stimulus, 4. Chemoreceptors and baroreceptors in the carotid, pulmonary and aortic vessels sense corresponding changes, 5. Nerve impulse feedback from the lungs w w w. a m e r i c a n h h m . c o m

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secondary to lung inflation and deflation, and 6. Regulatory signals between the cerebral cortex and brainstem

Heart Rate Variability & Baroreceptor Activity Heart rate variability can reflect the balance of sympathetic and parasympathetic nervous activity. The QRS complex's RR interval time series reflect heart rate variability, sensing changes in atrioventricular conduction affecting cardiac output and stroke volume. Low frequency power (0.05-0.15 Hz) of heart rate variability is under the combined influence of sympathetic and parasympathetic tones, with sympathetic modulation by the sinus node. Increases in low frequency power represent decreased vagal activity. High frequency power (0.15-0.4 Hz) of heart rate variability reflects parasympathetic modulation of cardiac activity, a measure which is influenced by respirations. In respiratory sinus arrhythmias, heart rate oscillations are caused by ventilation with slight heart rate increases with each inspiratory cycle due to transient decreases in parasympathetic tone. Therefore, the high frequency to low frequency ratio can be regarded as a measure of sympathovagal balance. As described, the autonomic nervous system adjusts blood pressures by adjusting heart rate, cardiac contractility and peripheral vascular resistance, where the baroreceptors measure blood pressure by sensing blood vessel stretch located in the aorta, carotid 24

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Exploring the brain-heart interface: Unraveling physiological interactions from normal homeostasis to cerebrovascular disorders.

arteries and large veins. Baroreceptor activity sends afferent activity to regulate blood pressure through: (1) Baroreflex - with systolic blood pressure as inputs and RR interval changes as outputs through the sinoatrial node, and (2) Sympathetic vasomotor tone with diastolic blood pressure as inputs and outputs through muscle sympathetic nervous activity to control blood vessel constriction and peripheral vascular resistance. Baroreceptor sensitivity reflects the capability of the baroreflex to adjust heart rates to changing conditions. The baroreceptor sensitivity can be regarded as the ratio of heart rate changes in response to fixed changes in blood pressure.

Interplay between Sympathetic and Parasympathetic Nervous System Innervation of Cerebral Vasculature Parasympathetic innervation includes pterygopalatine ganglion (vasoactive

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may be used to partially overcome both primary and secondary injury cascades in stroke and brain hemorrhage patients.

Conclusion Increase basal sympathetic discharges and disrupted autoregulation of sympathetic outflow, as observed in conditions including hypertension, ischemic and hemorrhagic strokes, renal insufficiency, heart failure, and liver dysfunction, result in vicious cycles of increased catecholamine release, increased activation of renin-angiotensin-aldosterone system, shunting of blood from venous to arterial system with resultant vascular congestion, predisposing to cerebral edema formation and hemorrhage. Targeting autonomic interactions in both vasculature and end organs such as the heart, liver, kidney and spleen, one can investigate for better ways of controlling autonomic nervous system responses in both states of health and disease.

Benjamin W Y Lo is a Neurosurgeon and Neuro-ICU specialist. His clinical focus is cerebrovascular disorders. His research focus characterizes brain-body interactions in neurocritical care patients with cerebrovascular disorders. Dr. Lo’s qualifications include FRCSC certification in neurosurgery (2009), FRCSC certification in critical care medicine (2011), MSc and PhD degrees in clinical epidemiology and biostatistics from McMaster University, Canada. His clinical experience includes working as a licensed neurosurgeon and neuro-ICU specialist at St. Michael’s Hospital, University of Toronto, Canada; Montreal Neurological Institute & Hospital, McGill University, Canada; Northwell Health Lenox Hill Hospital, Manhattan, New York; and Queen Mary Hospital, Hong Kong Hospital Authority. He is licensed to practise medicine in these locations as well as the United Kingdom.

AUTHOR BIO

intestinal peptide), otic ganglion (peptide histidine methionine) and carotid ganglion (nitric oxide). Cholinergic innervation is most densely distributed at cerebral vessel branching points, especially pial vessels. Sympathetic innervation includes the superior cervical ganglion (norepinephrine, neuropeptide Y) with neuronal synapses in the loop from hypothalamus, intermediolateral cell column of the spinal cord to superior cervical ganglion. Sympathetic nerve terminals are found in the outer media layer of cerebral vessels, most densely distributed in the anterior circulation with autoregulatory and chemical contributions from both the superior cervical ganglion and pontine locus ceruleus. Finally, sensory innervation is noted with transmitters from the trigeminovascular system (substance P, calcitonin gene related peptide, neurokinin A). Vasodilatory, antiinflammatory and parasympathetic nitric oxide mediated effects of therapeutic agents

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Remote Monitoring and Telehealth in Chronic Disease Care Remote monitoring and telehealth have a crucial role in transforming and improving chronic disease care through: remote vital sign monitoring, education and support, remote alerts, medication tracking, reduced hospital visit, complications prevention, and efficient resource utilization. In summary, remote monitoring and telehealth contribute to proactive, patient-centered, and cost-effective healthcare delivery. Dr. Sony Prabowo MARS Acting Hospital Director, Ciputra Mitra Hospital

hronic disease management involves a comprehensive and coordinated approach to prevent, monitor, and control conditions that persist over an extended period. Chronic diseases are often characterized by their long duration, gradual progression, and the need for ongoing medical care. Common examples include diabetes mellitus, hypertension, heart disease, chronic respiratory diseases, and cancer. Remote patient monitoring and telehealth play a crucial role in transforming and 26

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improving chronic disease care. These technologies leverage digital communication and information technologies to provide healthcare services remotely. Here are several ways in which remote patient monitoring and telehealth is being utilized in chronic disease care:

Continuous Monitoring: • Wearable Devices: Remote monitoring allows patients to track vital signs such as blood pressure, blood glucose levels, heart

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rate, and more from the comfort of their homes. Patients can use wearable devices to monitor their health continuously. • Activity Tracking: Many chronic diseases, such as diabetes and obesity, benefit from regular physical activity. Wearable devices equipped with accelerometers can monitor a person's daily activity levels, encouraging them to meet specific goals and maintain a healthy lifestyle. • Blood Glucose Monitoring: For individuals with diabetes, wearable devices can provide continuous glucose monitoring. This allows for better management of blood sugar levels, reducing the risk of complications associated with fluctuating glucose levels. • Sleep Tracking: Many chronic conditions are linked to sleep quality. Wearables with sleep tracking capabilities can help individuals monitor their sleep patterns and make lifestyle adjustments to improve overall health. • Stress Management: Wearables can include features such as heart rate variability monitoring to assess stress levels. Individuals with chronic stressrelated conditions can use this information to practice stress reduction techniques or seek appropriate support. • Fall Detection and Prevention: Elderly individuals and those with certain chronic conditions are at an increased risk of falls. Wearable devices with built-in accelerometers and gyroscope sensors can

detect falls and send alerts to caregivers or emergency services.

Early Detection and Intervention: • Alerts and Notifications: Remote monitoring systems can generate alerts for healthcare providers when there are deviations from normal health parameters. This allows for early intervention, preventing complications and hospitalizations. • Regular Screening and Monitoring: Establishing routine screening programs for high-risk populations can help detect chronic diseases at an early stage. Monitoring key health indicators, such as blood pressure, blood glucose levels, cholesterol levels, and body weight, can identify abnormalities before symptoms appear. • Public Health Education: Promoting public awareness about the risk factors, symptoms, and importance of early detection can encourage individuals to seek medical attention promptly. Education campaigns can also focus on lifestyle factors, such as diet, exercise, and smoking cessation, to prevent the development of chronic diseases. • Use of Technology: Leveraging technology, such as wearable devices and health apps, allows individuals to track their health metrics and share data with healthcare professionals for early intervention. Telemedicine and remote w w w. a m e r i c a n h h m . c o m

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monitoring can facilitate regular check-ins, making it easier for healthcare providers to identify potential issues early. • Genetic and Molecular Testing: Genetic testing can help identify individuals at a higher risk of certain chronic diseases, allowing for personalized preventive measures and early intervention. Molecular testing, such as biomarker analysis, can provide insights into disease progression and guide targeted therapies. • Integrated Healthcare Systems: Coordinated and integrated healthcare systems enhance communication and collaboration among different healthcare providers, leading to more effective early interventions. Electronic health records

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(EHRs) help in tracking a patient's health history and enable timely interventions based on the individual's health data. • Behavioral Interventions: Behavioral changes, such as adopting a healthier diet, increasing physical activity, and managing stress, can have a significant impact on preventing and managing chronic diseases. Early identification of risk factors allows for targeted behavioral interventions and support.

Improved Patient Engagement: • Education and Support: Telehealth platforms offer educational resources and support for patients managing chronic conditions. Patients can access educational

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materials and self-management tools through telehealth platforms, empowering them to take an active role in managing their chronic conditions. • Remote Coaching: Health coaches can remotely guide patients in making lifestyle changes, such as adopting healthier diets and incorporating physical activity into their routines. • Virtual Care Teams: Telemedicine facilitates collaboration among healthcare providers, allowing specialists, primary care physicians, and other members of the care team to coordinate and share information seamlessly. • Virtual Consultations: Telehealth facilitates regular virtual consultations between patients and healthcare providers, eliminating the need for in-person visits. This is particularly beneficial for individuals with mobility issues or those living in remote areas. This regular communication helps build a strong patient-provider relationship, leading to better adherence to treatment plans. • Telephone Consultations: For patients without access to video technology, telephone consultations can still provide a means of communication and monitoring. • Virtual Mental Health Services: Telemedicine is valuable in delivering mental health services, which are often integral to managing chronic conditions. Patients can access counseling and support remotely.

Transforming Chronic Care: Remote monitoring and telehealth enhance patientcentered, cost-effective healthcare by enabling vital sign monitoring, education, medication tracking, and reducing hospital visits.

Enhanced Access to Care: • Geographical Accessibility: Telehealth eliminates geographical barriers, allowing patients in remote or underserved areas to access specialized care without the need to travel long distances. • Convenience: Patients with chronic diseases often require ongoing care. Telehealth provides a convenient way for patients to consult with healthcare professionals without the need for frequent in-person visits. • Integrated Care Models: Coordinating care across different healthcare providers and specialties to ensure a comprehensive approach to managing chronic conditions. Team-based care involving physicians, nurses, pharmacists, and other healthcare professionals can improve communication and collaboration. w w w. a m e r i c a n h h m . c o m

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• Patient Education and Empowerment: Empowering individuals with chronic diseases through education on selfmanagement strategies, lifestyle modifications, and medication adherence. Providing resources and tools to help patients actively participate in their care and make informed decisions. • Flexible Scheduling and Extended Hours: Offering flexible appointment scheduling, including evenings and weekends, to accommodate individuals with chronic conditions who may have busy schedules or transportation challenges. • Community Outreach and Support Groups: Engaging community resources and support groups to provide additional assistance and encouragement for individuals managing chronic diseases. Establishing partnerships with community organizations to address social determinants of health that may impact chronic disease management. • Financial Support and Insurance Coverage: Addressing financial barriers to healthcare access by advocating for affordable insurance coverage and exploring financial assistance programs. Reducing out-of-pocket costs for medications and medical services can enhance access to essential care.

Medication Management: • E-Prescriptions: Healthcare providers can electronically prescribe medications, 30

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improving efficiency and reducing the need for physical prescriptions. • Medication Adherence Apps: Healthcare providers should ensure that patients understand the importance of adhering to their prescribed medication regimen. Provide clear and concise information about each medication, its purpose, and how and when to take it. Work with healthcare providers to simplify medication regimens when possible. This may involve consolidating doses, selecting medications with longer durations of action, or using combination medications. Apps can help patients adhere to their medication schedules by sending reminders and providing educational resources. • Regular Follow-up and Monitoring: Schedule regular follow-up appointments to monitor the patient's progress, adjust medications as needed, and address any concerns or side effects. Depending on the chronic disease, regular lab tests may be necessary to monitor the effectiveness and safety of medications. • Medication Reviews: Periodically review the patient's medication list to assess the ongoing need for each medication. This is particularly important if the patient is on multiple medications. Consider deprescribing when appropriate, especially for medications that may no longer be necessary or when the risks outweigh the benefits. • Technology Integration: Ensure that

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healthcare providers have access to up-todate medication information through electronic health records, facilitating better coordination of care. • Lifestyle Management: Emphasize the importance of lifestyle modifications (e.g., diet, exercise, stress management) in conjunction with medication management to optimize overall health and disease management.

Cost Savings: • Reduced Healthcare Costs: By leveraging telehealth platforms, healthcare providers can offer virtual consultations, monitoring, and follow-ups, reducing the need for in-person visits. This can lead to cost savings for both patients and healthcare systems by minimizing travel expenses and operational overhead. Telehealth allows for proactive management of chronic diseases

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Remote monitoring and telehealth enhance patientcentered management, optimizing resource utilization and fostering proactive healthcare.

through regular check-ins, education, and early intervention. This preventive approach can help avoid costly emergency room visits and hospitalizations. • Improved Chronic Disease Management: Telehealth solutions can include remote monitoring devices that allow healthcare providers to track vital signs and other relevant health metrics in real-time. This helps in early detection of potential issues and enables timely interventions for patients with chronic diseases. • Telehealth platforms can be used to educate patients about their medications, provide reminders, and monitor adherence. This can result in better management of chronic conditions, reducing the likelihood of complications and hospitalizations. • Reduced Travel and Time Expenses: 32

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Patients with chronic diseases often require frequent check-ups. Telehealth eliminates the need for patients to travel long distances for routine appointments, saving time and transportation costs. Telehealth allows patients to attend appointments without taking extended time off work, reducing lost productivity for both patients and their employers. • Policy and Regulatory Considerations: Healthcare systems need supportive reimbursement policies for telehealth services to encourage providers to adopt and sustain these technologies. Ensuring seamless integration of telehealth platforms with existing healthcare systems and electronic health records is crucial for efficient and coordinated care.

Data Analytics and Decision Support: • Predictive Analytics: Predict the likelihood of exacerbations or complications in chronic conditions, allowing healthcare providers to intervene proactively. • Decision Support: Clinical Decision Support Systems (CDSS): Implement CDSS to assist healthcare professionals in making informed decisions. It can provide evidence-based recommendations and alert providers to potential issues or interventions. Use decision support tools to create personalized treatment plans based on individual patient data and preferences. • Integration of Systems: Ensure

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seamless integration of various healthcare systems to enable the flow of information between electronic health records (EHRs), data analytics platforms, and telehealth solutions. Unified Patient Records: Create a unified patient record that encompasses data from different sources, providing a comprehensive view for healthcare providers. • Continuous Improvement: Establish a feedback loop to gather input from healthcare providers and patients, allowing for continuous improvement in the integration of data analytics, decision

support, telehealth, and chronic disease management.

Security and Compliance: • HIPAA Compliance: Ensure that your telehealth platform adheres to the Health Insurance Portability and Accountability Act (HIPAA) regulations, or equivalent regulations in other countries, which govern the security and privacy of patient information in the United States. Implement secure communication channels, encryption, and access controls to protect patient data during transmission and storage.

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• End-to-End Encryption: Use end-to-end encryption to secure the communication between healthcare providers and patients during telehealth consultations. This helps prevent unauthorized access to sensitive health information. • Access Controls: Implement robust access controls to ensure that only authorized individuals have access to patient records and telehealth sessions. This includes user authentication and authorization mechanisms. • Data Storage Security: Safeguard patient data by employing secure data storage practices. Utilize encrypted storage solutions and regularly audit and monitor access to stored health records.

Dr. SONY PRABOWO is currently an Acting Hospital Director at Ciputra Mitra Hospital in Indonesia. He took Pediatric residency at Davao Doctors Hospital Philippine and obtained his Master of Hospital Administration from Esa Unggul University – Indonesia. In addition to his academic career, Dr Sony is the author of several health-related books in Indonesia.

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• Secure Telehealth Infrastructure: Regularly update and patch the telehealth platform and associated infrastructure to address vulnerabilities and ensure a secure environment. • Patient Consent and Education: Obtain informed consent from patients regarding the use of telehealth services and the storage of their health information. Educate patients about the security measures in place to protect their data. • Integration with Electronic Health Records (EHR): Ensure seamless integration between telehealth platforms and EHR systems while maintaining the security and integrity of health records. In summary, remote monitoring and telehealth in chronic disease care contribute to proactive, patient-centered, and cost-effective healthcare delivery. They empower patients to actively participate in their care while enabling healthcare providers to deliver timely interventions and personalized treatment plans

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Breaking the Chain in Cardiac Amyloidosis Cardiac amyloidosis is a significantly underdiagnosed disease that is a large contributor to poor prognosis of heart failure in the elderly population. As a result, the following information is crucial to consider when diagnosing a patient with advanced heart failure. Rohan Goswami MD, Director of Heart Transplant Innovation and Research, Mayo Clinic

Caitlyn Luce Research Fellow, Division of Advanced Heart Failure and Transplant, Mayo Clinic

What is Cardiac Amyloidosis? Cardiac amyloidosis is the buildup of misfolded proteins in cardiac muscle, known as amyloid fibrils. Amyloid fibrils are an umbrella term for any misshapen proteins. As a result, several types of cardiac amyloidosis result in the heart muscle's thickening and stiffening. This limitation of cardiac muscle function can result in advanced forms of heart failure when treated improperly.

Under Recognition of Cardiac Amyloidosis Studies using the 2019 Medicare database have shown that an alarming number of autopsy reports of heart failure patients presented with w w w. a m e r i c a n h h m . c o m

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undiagnosed amyloid built up in heart muscle, which may have contributed to worsening heart failure symptoms with improper treatment (Gilstrap et al, 2019). Further studies found that there was a median 22-month delay of diagnosis for cardiac amyloidosis following the initial hospitalization of heart failure patients (Bishop et al., 2018).

Prevalence Trends The figure above represents the increasing prevalence rates of cardiac amyloidosis from 2004 to 2018, with a significant increase

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following 2006 (Gilstrap et al., 2019). As more individuals are diagnosed with cardiac amyloidosis, there are more individuals with restricted heart muscle movement. Hence, the increase of chains around the heart.

Diagnosing Cardiac Amyloidosis The underlying cause of the underdiagnosis of cardiac amyloidosis is the overlapping of signs and symptoms of several other cardiovascular myopathies. Recent technologies, such as cardiovascular MRI (CMR) have allowed for the noninvasive detection of amyloid buildup

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in heart muscle. Other diagnosing modalities include low QRS voltages in electrocardiograms (ECG), cardiac biomarkers in blood tests, diastolic dysfunction in echocardiograms, and fibril detection in endomyocardial biopsy. Awareness of risk factors, such as male gender, African American ethnicity, elderly age, and genetic risks, along with these modalities hold the potential to enhance early detection, prevent plaque accumulation, and lower the severity of heart disease.

Timeline The buildup of plaque in cardiac muscle is an irreversible process. Early diagnosis and treatment are essential to slowing the progression of this fatal disease. Figures 2 and 3 represent the multisystem clinical signs and symptoms that in conjunction with cardiomyopathic and neurologic symptoms give rise to further amyloid evaluation (Nativi et al., 2021).

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Following the recognition of multidisciplinary symptoms and signs from the various diagnostic modalities, the diagnostic pathway below represents an algorithm to confirm the diagnosis of cardiac amyloidosis and identify the correct type of amyloid depositions (Kittleson et al., 2023).

Novel therapies Though there are few treatments for cardiac amyloidosis, recent therapy developments hold promises for preserving the functional capacity of patients with various forms of this fatal cardiomyopathy. Tafadamis remains one of the only U.S. Food and Drug Administration medications approved for the treatment of amyloid transthyretin cardiac amyloidosis (ATTR). This therapy slows the formation of transthyretin (TTR) fibril and cardiac plaque formation (Kittleson et al., 2023). Patisiran is a novel drug that is currently in the third phase of clinical trials and functions to inhibit the production of TTR via RNA interference (Maurer et al., 2023). The first human trial for in vivo gene editing took place in 2021 for single intravenous infusion of NTLA-2001. The gene editing therapy shows consistent reduction in serum TTR and indicates a potential therapeutic option for amyloid cardiomyopathy (Gilmore et al., 2021).

Healthcare costs The high medication cost and limited access to amyloid specialists pose an economic burden w w w. a m e r i c a n h h m . c o m

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Cardiac

Heart failure

Musculoskeletal

Carpal tunnel syndrome

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Polyneuropathy

Autonomic Dysfunction

Painful neuropathy in hands and feet

Orthostatic hypotension/ intolerance to blood pressure meds

Back pain/ lumbar spinal stenosis Atrial fibrillation

Chronic diarrhea/ constipation/ weight loss

Ruptured distal biceps tendon/ Popeye sign

Shoulder, knee and hip pain or surgery

Bradyarrhythmias/ conduction abnormalities/ pacemakers

Muscle weakness, difficulty walking, and falls

Erectile dysfunction Trigger finger

to the healthcare system. Not only do patients experience a variety of financial implications, such as high out-of-pocket expenses and difficulty in prescription authorization. Our healthcare system misevaluates amyloidosis as a rare disease and thus mispriced several therapeutic drugs. If all ATTR cardiomyopathy patients were treated, annual healthcare spending is estimated to increase by over $30 billion (Kittleson et al., 2023). Given the effectiveness of such recently discovered therapies and increasing prevalence of amyloid cardiomyopathy, it is imperative to reconsider 38

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pricing and lower the burden on the economy and patient.

Conclusion Cardiac amyloidosis is one of the most overlooked, undiagnosed, and treatable cardiovascular diseases (Rubin & Maurer, 2020). Despite its ability to be treated, it still serves as a common preexisting condition for heart failure patients that rarely gets discovered before it is too late. With the recent development of noninvasive diagnostics and physician awareness of the disease, the inclusion of

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Continued heart failure management

Heart Biopsy

Positive Diagnosis of amyloid light chain cardiomyopathy

Positive Recognized multidisciplinary signs and symptoms from risk factors, ECG, echocardiogram, and CMR

Monoclonal protein screening

Negative

Plasma cell therapies in collaboration with hematology

Cardiac amyloidosis unlikely

Wild-type tranthyretin amyloid cardiomyopathy

Negative Technetium-based Positive compound cardiac scintigraphy

Amyloid transthyretin cardiomyopathy

Tafadamis medication

Genetic Testing

Variant transthyretin amyloid cardiomyopathy

AUTHOR BIO

cardiac amyloidosis in the initial workup of heart failure hospitalizations over the age of 65 could potentially revolutionize the heart failure mortality rate. The pathway for treatment is constantly evolving and shifting towards a

more multidisciplinary approach, making the common goal of improving patient outcomes more attainable. References are available at www.americanhhm.com

Dr.Goswami is a Transplant Cardiologist practicing at Mayo Clinic in Florida. He is a graduate of the American University of the Caribbean School of Medicine and completed his internal medicine residency at Columbia University College of Physicians and Surgeons – Stamford Hospital, a cardiology fellowship at The University of Tennessee Memphis, and a Transplant Fellowship in 2017 at Mayo Clinic in Florida. He has a keen interest in clinically focused artificial intelligence research to improve outcomes in patients with advanced heart failure. He has published articles in the field of both heart transplantation and artificial intelligence, as well as presented at Ai4 in 2020 on the future impact of AI in healthcare and invited lectures at the International Society of Heart and Lung Transplantation in both 2021 and 2022. He looks forward to one day utilizing AI integration to prevent organ failure. Caitlyn Luce recently graduated from the University of Florida with a degree in Biology and a minor in Health Science. She is currently applying to medical school while working as a Research Fellow in the Division of Advanced Heart Failure and Transplant at the Mayo Clinic in Jacksonville, Florida. My goals in research include embracing lifelong learning, providing holistic healthcare, minimizing health disparities, and contributing to humanity in medicine. I am eager to meet these goals as I continue to grow my research throughout medical school and future training.

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Re-Imagining Myocardial Reanimation Ensuring a Successful Operative Outcome The evolution of cardio-protective strategies, through numerous years of empirical trial-and-error, has evolved to the nexus of: utilizing cardioplegia that one trained with vs. a cardioplegia that displays superior protection capabilities. It is necessary to discuss the myriad of present day cardioprotective strategies available to all Cardiac programs in order to effectively provide a “menu” of options. The fascinating cornucopia of cardioplegia solutions literally runs the gamut. From all crystalloid, pink tinged crystalloid, crystalloid with blood to all blood with no crystalloid. Then there are ratios of delivery: 4:1 (4 parts blood, 1 part crystalloid), 1:1, 1;4,8:1...all the way to 66:1. Then you have frequency of delivery: Every 10 to 20 minutes, after every graft, after one hour to one hour 30 minutes.

Thomas N Muziani President and CEO of HEMO-STAT Blood Management Consulting

he evolution of cardio-protective strategies during “Open Heart” surgery, through numerous years of empirical trial-and-error, has evolved into two primary factors: utilizing cardioplegia (to quiet a beating heart) that one trained with in medical school vs. a cardioplegia solution with demonstrated superior global protective qualities.

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It is necessary to discuss the myriad of present day cardio-protective strategies available to all Cardiac programs in order to effectively provide a “menu” of available options. The fascinating cornucopia of cardioplegia solutions literally runs the gamut. From all crystalloid solution, pink tinged crystalloid, crystalloid with blood to all blood with no crystalloid. We have ratios of delivery: 4:1 (4 parts blood, 1 part, crystalloid), 1:1, 1;4, 8:1...all the way to 66:1. You have frequency of delivery: Every 10 to 20 minutes, after every graft, after

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one hour to one hour 30 minutes and longer to just one large dose. The benefits conferred by either warm or cold blood cardioplegia (or any compounded formulation) are viable only if solutions are delivered to all myocardial regions in sufficient amounts to exert their desired effects. Maldistribution of flow unfortunately is commonplace with patients experiencing coronary artery disease when principle reliance is solely placed upon antegrade delivery of perfusion. This is especially true when arterial conduits are utilized,

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and precluding delivery from the newly constructed vein grafts. Retrograde cardioplegia has neutralized this limitation. This is due to excellent left ventricular protection following coronary sinus or right atrial perfusion. The development of transatrial coronary sinus cannulation techniques has provided simple, safe and rapid access to the coronary sinus utilizing antegrade/retrograde technique. Of paramount importance and never to be confused: Simplicity and Safety are not synonymous. w w w. a m e r i c a n h h m . c o m

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A cogent analysis: arterial conduits such as internal mammary artery (IMA) or gastricepiploic artery, along with mitral valve repair have now reached a nexus where they are superior to implanting all saphenous vein grafts or routine mitral valve replacement. Once again, time thereby longevity, will provide validation into the advantages and limitations from various operations. A similar situation now exists regarding methods of intra-operative global myocardial reanimation. Longevity of patency is a key indices in determining whether or not you have achieved superior repair and/or replacement on the Cardiac muscle. As of this writing, a Starr/ Edwards Aortic Ball Valve is still operating flawlessly after sixty years implanted. During the 1970’s an explosion of interest in different methods protecting the Heart evolved across the Planet. From the introduction of multi-dose crystalloid cardioplegia in 1976. Cold blood cardioplegia in 1977, warm blood cardioplegic reperfusion and warm induction in 1977 and 1983. Alternating between antegrade and retrograde delivery in 1989...and the most recent technique of antegrade/retrograde delivered simultaneously in 1994. During this same time period, the concept of continuous cold non-cardioplegic blood perfusion was introduced. Primary endpoint: Full restoration of Normal Sinus Rhythm; without impeding surgical progress. Of paramount importance, seldom appearing in print- extreme diligence in providing global myocardial protection is to ensure your 42

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surgeon repeatedly has uneventful spontaneous conduction into NSR when the cross-clamp is removed. To that end, the onus is upon Perfusion to become creative enough and “tailor” the appropriate myocardial protection strategy to the particular dynamics of the surgical procedure.

Normothermic Ischemia: Pioneered by Norman Shumway at Stanford University in 1957, “normothermic ischemic arrest” became standard arresting practice for myocardial management prior to the acceptance of intra-cardiac cardioplegia solutions. This moment in history is well documented due to the robust political rancor from two distinct camps that emerged with Cardiac Surgeons Worldwide over how best to “quiet” the beating human heart. One vocal group of Surgeons maintained that “normothermic ischemic arrest” should be the primary technique when striving for total quiescence of the heart. The second group believed empirically that normothermic arrest did not provide a “safety valve” to guard against the onset of ischemia. They preferred a cold water solution, either circulating or static, or an ice-slush filling the pleural cavity. The major proponent of this technique was Stanford with Dr. Norman Shumway...and he maintained a very large coterie of disciples. With the advent of electro-chemical arrest utilizing high doses of potassium, it seemed only natural for topical ice-slush to coalesce with potassium cardio manifesting a quiescent heart. This technique radically reduced the metabolic

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Revolutionizing myocardial reanimation: A strategic menu of cardioplegia options, from crystalloid to all-blood solutions, sets the stage for operative success

uptake, allowing for approximately two hour window to complete the necessary operation. Unfortunately, it was discovered that it was not uncommon with ice-slush remaining in the pleural cavity for two hours plus the lungs would not tolerate extreme cold very well and periodically developed atelectasis. Of note; during the 1960’s, 70’s and 80’s it was not unusual for individuals to smoke unfiltered cigarettes. From air pollution to self-abuse, our lungs took quite a beating. At this moment in time there is a plethora of varied compounded compositions achieving electro-chemical arrest of the myocardium. This is an updated sample: 1. Hypothermia: First viable and reproducible method of preservation 2. Hypothermia with fibrillation 3. Only fibrillation 4. Pure crystalloid solution 5. Crystalloid solution w/ “pink tinge” (small

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amount of whole blood) 6. High K+ or Low K+ delivery 7. Warm vs. Cold, intermittent and/or continuous, with or without substrate enhancement 8. Warm, Cold, Warm, with or without substrate enhancement 9. Continuous vs. Intermittent perfusion 10. Flowing through vein grafts 11. Antegrade and/or Retrograde delivery 12. Pure whole blood (cold and warm) w/ micro titrations of drugs (microplegia) 13. del Nido single dose low K+ with Lidocaine and Magnesium 14) Bretschnider single cross clamp The results from a recent survey of more than 1800 surgeons in the United States indicated that blood cardioplegia emerged as the preferred cardio-protective strategy due to its versatility. This directly correlates with voluminous research indicating blood cardioplegia blends onconicity, buffering, rheology plus antioxidant benefits. It has also been established to augment oxygen delivery and its ability to “resuscitate the heart” plus attenuate ischemic injury, “limit reperfusion injury” and the potential to reverse “ischemic/reperfusion injury”. “One shot” non-blood cardioplegia, by its delivery time-frame and composition cannot provide the same assurance. Over the last several years, cold crystalloid 1:4 (one part blood, 4 parts crystalloid) cardioplegia has gained widespread favor. Primarily this is due to the advocacy of giving one large (1000ml +) cardio and then w w w. a m e r i c a n h h m . c o m

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zero replenishment for over an hour. Since the surgical team is not required to stop the procedure to periodically replenish the heart, they are free to continue the operation un-tethered by periodic administration of cardioplegia. In a perfect World scenario, this technique would be the panacea to all cardioplegia drawbacks. However, “a heart knows what a heart wants”. And a Heart that has endure years of less-than-ideal blood flow and oxygen is by far less tolerant than a young vibrant virgin baby heart. Therefore, it is not unusual for surgeons to experience a heart that refuses to spontaneously conduct when the cross clamp is removed It is questionable if the route response to a heart that does not conduct is to just say: “Oh, we just start the pacemaker”. Becoming reliant on artificial electrical excitation to establish a rhythm would not be considered “Best Practices”.

Multidose Cardioplegia: The logic behind multi-dose blood cardioplegia derives from the occurrence of non-coronary collateral flow in all in-sit u hearts. This non-coronary collateral flow rewarms the heart by replacing any carefully formulated cardioplegic solutions with systemic (non-cardioplegic) blood at the temperature prevailing in the extracorporeal circuit. It enters the heart via open mediastinal connections and becomes evident as blood fills the coronary arteries or the coronary ostia while the aorta is cross clamped and the heart decompressed. 44

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Rewarming can be circumvented by topical hypothermia. However, voluminous evidence has proven this technique is not only a cumbersome adjunct...but may well create pulmonary complications without supplementing the cardio-protective effect of multi-dose cold cardioplegia with warm induction and reanimation. To clarify another misconception that should be easily rectified: Routine use of Cold Induction. Cold induction has gained widespread acceptance Worldwide. The reasoning behind it

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is multifaceted and held onto tenaciously. And yet, the logic behind the technique is not only counter-intuitiveit is also counter-productive. Cold creates constriction! Anyone who has fallen into snow or ice is familiar to what extreme cold is like on your bare skin. Constriction, when coupled with severe coronary disease makes it extremely difficult to adequately flow cardioplegia past blockages down to the myocyte. In essence, you are creating precisely what you should be preventing; that is the inability to flow cardioplegia adequately down to the myocyte.

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Warm induction is nature’s wondrous dilator, opening the coronaries and periphery to facilitate adequate flow. Finally: In defense of multi-dose administration versus single “one shot”: Lab testing has not been able to quantify a scientific model nor gather empirical evidence as to a time point when exactly ischemia begins in human hearts. It is noted that some patients display signs of ischemia at three minutes. While other patients show signs of ischemia at one hour. Oxygen demands rise rather quickly if electro-mechanical activity (ie. beating or fibrillating) recurs in the under-perfused right ventricle. The use of cold blood, therefore, provides for the shifting of high K+ to Low K+ to No K+ during the same procedure while maintaining an arrested state.

Intermittent-continuous Infusion: In order for an operation to be considered a success, one must maintain a quiet, dry operative field. A prerequisite ensuring a precise cardiac surgical procedure. Unfortunately, most surgeons create “intentional ischemia” during non-delivery of any form of adequate protection. All in-sit u hearts derive some non-coronary unpredictable flow that will effectively “wash away” cardioplegic solutions. Therefore, intermittent replenishment is mandatory to restore washed out metabolites, counteract acidosis and edema, and restore a cardioplegic composition to attenuate reperfusion injury prior to the next period of planned ischemia. w w w. a m e r i c a n h h m . c o m

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With every occurrence of “breakthrough beats”, unintended electro-mechanical activity while the aorta is clamped and cardioplegic administration has ceased; is not only a surgical nuisance, but signifies the retained capacity of producing sufficient ATP to allow robust contractility to resume. Coronary artery bypass grafting is the most frequently performed procedure in the United States. The issue of intra-operative cerebral atheroemboli is becoming ever more evident as the patient population exceeds 70 years of age and undergoing revascularization. The atherosclerotic process in the aorta may lead to potential cerebral atheroemboli when the aorta if clamped. This potential is compounded if the aorta is repeatedly clamped tangentially to construct proximal anastamosis.

Warm Reperfusion: Anticipating infusing the final cardioplegic dose; delivery temperature is set at 37 degrees C, essentially to correspond when all anastomoses are complete. This provides for warm reperfusate, both antegrade and

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retrograde to be delivered without stopping the continuity of the operation. This will also avoid needless delays waiting for rewarming prior to terminating bypass. The final cardioplegic dose is delivered warm with or without K+. This should be followed immediately by warm blood with zero cardioplegia, zero K+. This provides administration of warm blood while checking for any leaks, de-airing of grafts and washing out metabolites and any extraneous potassium. Please keep in mind; there is zero downside to replenishing the heart with as much oxygenrich blood as you deem feasible. Studies have indicated this whole blood washout procedure enhances the recovery period, dilating the heart and vasculature thereby replenishing any energy stores down to the myocyte. In the 1970’s we had a rather macabre expression: “Surgery was a success. But the patient died”. This was in reference to utilizing a patient and family member who would act as the heart-lung machine. It has been the goal since this forgetful period in time to strive for any patient in any condition to undergo revascularization and never look like they endured surgery.

AUTHOR BIO

Thomas Muziani began his career in medicine in 1968. In 1970 he entered military service with the United States Army, attending Physician’s Assistant training in 1974. Mr. Muziani is the author of: “The Utah Protocol”, a syllabus for providing micro-doses of cardioplegia for extremely ill adults. The protocol has been utilized in over 100,000 patients. Mr. Muziani is the author on a continuing series entitled: “Standing on Tall Shoulders; The History of Cardiac Surgery”.

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Cardiovascular Risk Assessment for Comprehensive Healthcare Solutions Cardiovascular disease looms as a prominent global health concern. Successfully tackling this challenge depends on skilled risk management. Tailoring screening methods to local population traits and the competence of those conducting screenings are crucial. Integrating and simplifying multiple screening tools can enhance effectiveness and minimize variations among screeners.

Piyanun Yenjit Founder & Managing Director, Apuk Co., Ltd

ardiovascular disease represents a major issue in public health, affecting both immediate and long-term health outcomes. Early detection and management of risk factors is crucial for effective intervention. Multiple cardiovascular risk assessment tools are available, each designed to use specific information like medical conditions, family health history, and laboratory test results. However, it's important to recognize 48

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that each tool has its limitations. Therefore, how effectively these tools are used in realworld scenarios depends greatly on the skill and knowledge of the person conducting the evaluation, as well as the specific circumstances in which the assessment is being made. To make cardiovascular risk assessment more accessible and user-friendly, combining various screening tools into a unified system

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with a coherent logic for their collective use is beneficial. This integrated approach removes the necessity of choosing a specific tool, as the system would automatically evaluate risk factors based on the inputted information and select the most appropriate and detailed results for the user. Such a system can be utilized across various settings, from community screenings by individuals with basic medical training and without lab

results to in-depth assessments in medical facilities by doctors and nurses with access to comprehensive lab data. This inclusive strategy aims to enhance the availability and effectiveness of cardiovascular risk assessments for the wider public in diverse healthcare environments. This article will demonstrate a methodology to integrate and simplify five prominent cardiovascular risk assessment tools. The process will involve streamlining these tools into a singular, user-friendly framework that can be easily employed in various healthcare settings. 1. The Framingham Risk Score (FRS) is a tool used in medicine to estimate an individual's risk of developing cardiovascular disease within a specific period, usually over the next 10 years. This risk assessment model was developed based on data from the Framingham Heart Study, a long-term cardiovascular cohort study that began in Framingham, Massachusetts in 1948. The Framingham Risk Score considers several risk factors, which typically include age, gender, and smoking status, history of hypertension, blood pressure, and lipid profile. However, FRS may not be fully accurate for all populations, as it was developed based on a specific cohort. 2. The ASCVD Risk Estimator tool is a clinical tool used by healthcare providers to estimate a patient's 10-year and lifetime risk of developing atherosclerotic cardiovascular disease (ASCVD). This tool is based on guidelines from the American College of w w w. a m e r i c a n h h m . c o m

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Cardiology (ACC) and the American Heart Association (AHA). The primary purpose of the ASCVD Risk Estimator is to assist clinicians in identifying individuals at higher risk of ASCVD so that preventative measures can be discussed and implemented. 3. QRISK is a clinical algorithm used in the United Kingdom to assess the risk of developing cardiovascular disease (CVD) over the next 10 years. It was developed to provide a more accurate and tailored assessment for the UK population, considering specific factors that may influence CVD risk in this group. The strength of QRISK is its consideration of different ethnic groups, which can have varying risks of CVD. This

tool also includes a broader range of medical conditions in its assessment compared to some other risk calculators, such as atrial fibrillation, chronic kidney disease, and conditions like systemic lupus erythematosus. 4. The Reynolds Risk Score is a risk assessment tool designed to predict the 10-year risk of developing major cardiovascular events, such as heart attack, stroke, or cardiovascularrelated death. It was developed as an enhancement to traditional risk assessment tools like the Framingham Risk Score by including additional risk factors. Unlike the traditional risk scores, the Reynolds Risk Score includes measurements of C-reactive protein (CRP) and family history of heart disease.

Input

FRS

ASCVD

QRISK

REYNOLD

WHO/ISH

Age & gender

Yes

Race Smoking

Yes

Diabetes Mellitus Hypertension

Yes

Others underlying disease *

Yes Yes

Yes

Statin/ aspirin

Yes

Anti-psychotic medication

Yes

Family history of heart disease

Yes

Weight and Height

Yes

Yes Yes

Blood pressure

Yes

Total Cholesterol

Yes

HDL

Yes

LDL

Yes

HsCRP

Yes

Table 1: Other underlying diseases * are chronic renal failure, atrial fibrillation, migraine, rheumatoid arthritis, SLE, mental illness, and erectile dysfunction.

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5. The WHO/ISH (World Health Organization/International Society of Hypertension) risk prediction charts are a cardiovascular risk assessment tool developed to estimate an individual's risk of developing cardiovascular disease (CVD) over the next 10 years. This tool is particularly useful in primary care settings, especially in low and middle-income countries where resources for detailed risk assessments might be limited. Compared to other tools, these charts are designed for use in different geographic regions, with specific versions tailored to different parts of the world and simple to use, requiring only basic clinical measurements like blood pressure, age, gender, smoking status, and presence or absence of diabetes. The primary challenge users often face is determining which risk assessment tool to use and managing situations with limited resources, such as when blood pressure levels, medication details, and laboratory results are unknown. Although each cardiovascular

risk assessment tool requires different data for its calculations, there are common data domains that most of these tools consider essential. These include age, gender, smoking status, blood pressure, and total cholesterol level as Table 1. The input elements will be divided into seven categories: demographic data, health risk, underlying disease, medication, family history, basic measurement, and laboratory. To proceed with the implementation of the form, either in an offline or online format, it is necessary to establish which fields are mandatory and to set default values for them, sample as Table 2. In online settings, it is necessary to have the calculation logic either embedded in the form or connected to external microservices. However, this article does not provide specific details regarding this type of logic. After conducting tests using the scenario of a 48-year-old male with underlying hypertension and dyslipidemia in various settings as described

Input group

Required

Default

Input

Patient demographic

Yes

Age, gender, race

Health risk

Yes

“No”

Smoking

Underlying disease

Yes

“No”

Diabetes mellitus, Hypertension, Chronic renal failure, Atrial fibrillation, Migraine, Rheumatoid arthritis, SLE, Mental illness, Erectile dysfunction

Medication

Yes

“No”

Statin, aspirin, anti-psychotics

Family history

Yes

“No”

Family history of heart disease

Basic measurement

Yes

Weight, height, blood pressure

Laboratory

Total cholesterol, HDL, LDL, HsCRP

Table 2: In the screenshot provided as an example, all necessary data for these five tools is present. However, certain fields are obligatory, and some have been assigned default values.

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below. The result eliminates the need for the user to select the tools as Table 3. 1. Self-assessment: The general population can perform this on their own. If blood pressure measurement is not available, the options for blood pressure values are either unknown or normal. 2. Basic assessment: The assessment conducted by non-healthcare professionals, blood pressure measurement is available and able to identify which medication is statin group. 3.Advanced: The assessment conducted by healthcare professionals with available laboratory results; lipid profile and hsCRP is optional. The final outcome presents a range of risk values, from minimum to maximum, which varies between each setting and the available inputs.

Age Gender

Male

Smoking

Underlying disease

Diabetes mellitus Hypertension Chronic renal failure Atrial fibrillation Migraine Rheumatoid arthritis SLE Mental illness Erectile dysfunction

Medication

Statin Aspirin Anti-psychotic

Family history

Heart disease

Weight Height Blood pressure

Total cholesterol HDL LDL CRP Self-assessment

Basic assessment

Patient demographic Health risk

No smoking

Underlying disease

Hypertension with dyslipidemia

Medication Family history

Advanced setting

Male 48 years old

N/A

Statin

Body measurement

Weight 80 kg, Height 175 cm.

Blood pressure

N/A

Cholesterol

N/A

Normal

145/91 mmHg 250 mg/dL

HDL

45 mg/dL

LDL

120 mg/dL

HsCRP

N/A

1.2 mg/L

Assessment result FRS

N/A

ASCVD

N/A

5.5%

QRISK

N/A

5.3%

REYNOLD

N/A

WHO/ISH

N/A

Final display to user

Table 3: 52

N/A

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5% 6%

5.3-8%

5-8%

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This article presents a methodology for integrating the top five cardiovascular risk assessment tools to enhance user convenience. This integration caters to a wide range of settings, from basic self-assessments with limited clinical data to comprehensive evaluations conducted by healthcare professionals with access to detailed clinical information. The steps for this integration are outlined below: 1. Choose the suitable Tool 2. Compile inputs required by each tool 3. Group similar inputs together 4. Establish standard codes, default values, and mandatory status for each input 5. Link to relevant microservices logic to calculate the risk This form is designed to be applicable to every user and patient in all settings. While the results may not be perfect, owing to the variability of available data and other unknown factors, it will undoubtedly enhance the accessibility of risk assessment and reduce discrepancies across different users and settings.

Piyanun Yenjit is a Founder & Managing Directo of APUK, a healthcare digital transformation consultant and micro services provider, focusing on improvement in patient safety, process efficiency, and business growth. She is also experienced in electronic medical records with structured data implementation compatible with various quality assurance standards.

AUTHOR BIO

Cardiovascular disease is becoming an increasingly significant concern. Despite advancements in treatment technology, prevention and early risk management remain the most effective methods for addressing this issue. Various risk assessment tools are available, but each has its limitations. Furthermore, these tools require different types of input, some of which can be quite complex. The accuracy of these tools also depends on the user's competence and the appropriateness of the tool selection.

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Patient-Centered Cardiovascular Diagnostics Cardiovascular diagnostics can be coarsely divided in clinical assessment, electrocardiographic methods, laboratory diagnostics, imaging approaches and special invasive procedures. Some are considered screening tests, e.g. clinical examination, surface ECG and transthoracic echocardiography, which has widely replaced chest x-ray as a basal approach. Personalization of advanced diagnosis has an increasing role. Thomas Bartel MD, PhD, Interventional Cardiologist, Flexdoc GmbH

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Clinical Assessment Exploration of case history also known as anamnesis as well as clinical examination represent the classic first steps into any diagnosis. Examination starts with the vital signs also called ‘vitals’ usually collected by nursing staff include ISSUE 03 - 2024

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body temperature, respiration rate (rate of breathing) and pulse rate, which mostly but not always represents heart rate (HR). Blood pressure (BP) and oxygen saturation (SO2) are not considered vital signs but are often measured along with them. Clinical examination includes auscultation of heart, lung and vessels as well as qualitative and quantitative assessment of pulses, search for edema and other signs of congestion, skin color and some specific signs, e. g. clubbing of nails also called ‘hippocratic nails’ being indicative of chronic oxygen deficiency and often caused by congenital heart diseases. These findings are not trivial but reveal important information enabling subsequent set up of dedicated plans for stepwise laboratory and instrument-based cardiovascular diagnostics. Having said this, anamnesis and clinical examination can be considered crucial for patient-centricity of the whole diagnostic process in cardiology and angiology.

Laboratory Diagnostics In cardiovascular medicine, laboratory testing can be employed for direct diagnosis of particular pathology, e.g. troponin-I is increased if the heart muscle has been acutely damaged after myocardial infarction or myocarditis. Cardiac biomarkers, e.g. NT-proBNP, are sensitive and specific in congestive heart failure (CHF) and help estimating severity of the same. Other tests are routinely done for screening purposes and cardiovascular risk profiling, e.g. lipid panel, blood sugar,

renal functional markers or blood uric acid level. Cardiovascular risk assessment has a lot of therapeutic and preventive implications as are changes in lifestyle or targeted medical therapy. Some screening tests are used to exclude particular organ dysfunction, which may interfere with the cardiovascular system, e.g. serum electrolytes and thyroid stimulating hormone may be indicative of adrenal or thyroid dysfunction, which can cause several cardiac symptoms up to life-threatening conditions.

Instrument-based Cardiovascular Diagnosis A distinction is made between functional and morphological diagnostics. Electrocardiographic (ECG-based) as well as electrophysiological methods, exercise tests, hemodynamic testing and measurements fall under functional diagnostic approaches. Imaging techniques are predominantly used for morphological evaluation, although they are often combined with functional testing, e.g. echocardiography always includes qualitative and quantitative Doppler assessments, which enable physicians to draw conclusions about valvular dysfunction, intracardiac shunts as well as systolic and diastolic left ventricular function. All instrument-based procedures have to be performed in a strictly standardized way in order to ensure comparability and appropriateness. That is way personalization in medicine does not include this level. w w w. a m e r i c a n h h m . c o m

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ECG-based Diagnostic Approaches Surface ECG is considered a mandatory screening test and does not require special indication. It shows various kinds of dysrhythmia, conduction abnormalities, signs of myocardial damage and ischemia (hypoxia of the myocardium). Even though some diagnoses can be directly made from surface ECG, e.g. conduction blocks, the method has two major limitations: 1. Many ECG abnormalities are nonspecific. 2. ECG just registers abnormalities occurring at a moment and at rest. Arrhythmias and other changes not occurring permanently or just under physical challenge remain undetected. That is why, long-term ECG also known as Holter-ECG is much more sensitive in terms of arrhythmias occurring intermittently. Alternatively, long-term ECG registration

Patient-Centered Cardiovascular Diagnostics: From basic screenings to personalized advanced approaches, embracing a comprehensive spectrum of assessments for individualized care.

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can be provided by telemetry. Sometimes, implantable devices for long-term monitoring are used in order to detect arrhythmias which are experienced seldom but may explain symptoms like sudden loss of consciousness which is also called ‘syncope’. Ergometry includes ECG-registration at different stress levels and can be combined with various imaging techniques as are echocardiography, nuclear medicine imaging (nuclear stress test) and magnetic resonance imaging (MRI) in order to improve sensitivity and specificity in terms of myocardial ischemia, which is a typical dysfunctional result of coronary artery disease (CAD).

Cardiovascular Imaging Echocardiography, vascular ultrasound, computed tomography (CT), and MRI reveal acquired and congenital morphological abnormalities of all cardiac and vascular structures, e.g. valvular or coronary calcification (Figure 1). These imaging modalities also enable measurement of dimensions, e.g. vessel diameters, cardiac chamber sizes and valve opening areas. They visualize and determine flow and flow velocities inside the heart and the vasculature. Important hemodynamic parameters, e.g. left ventricular ejection fraction (LVEF), pressure gradients across stenotic valves, pulmonary artery pressure, regurgitant orifice areas at leaking valves can be calculated or reliably estimated. Thus, these imaging approaches provide with a lot of functional parameters, too.

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Figure 1: two cases of CAD with main stem stenosis (arrows) due to calcification of the central left coronary artery. By courtesy of G. Feuchtner, MD, PhD.

Ultrasound based methods, CT and MRI have their own sensitivity, specificity and accuracy in terms of detecting designated abnormalities and diseases. They entail different costs, e.g. personnel expenditures and costs for equipment. Transthoracic and transesophageal echocardiography (TTE and TEE) are provided by cardiology staff. MRI and CT are established in radiology and vascular ultrasound may be offered by angiology or radiology staff. TTE has replaced traditional chest x-ray as a first line approach in (Figure 1) Cardiology. TEE, CT and MRI are more expensive and are therefore considered second line approaches, which require specific indication. For example, cardiac CT is indicated to show or exclude CAD and TEE

is known to be very sensitive and specific for endocarditis (destructive bacterial infection of heart valves). With an increasing number of surgical and catheter-based therapies both techniques are also used as preoperative or periinterventional guiding tools. All imaging approaches have special features to be used for specific questions and tasks, e.g. threedimensional TEE for post-interventional assessment of the mitral valve (Figure 2). Beside specific indications and diagnostic questions, other criterions exist to choose the optimal diagnostic approach for an individual. Of course, guidelines and professional recommendations preset which imaging modality might be used for distinct scenarios. However, all approaches have w w w. a m e r i c a n h h m . c o m

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Figure 2: mitral valve after implantation of a MitraClip® device (arrows) for treatment of mitral valve insufficiency; left side – valve from above; right side – valve from below.

downsides, e.g. CT entails radiation exposure and usually requires application of a contrast agent. Echocardiography does not require radiation exposure and ultrasonic contrast agents do not interfere with renal function. On the other hand, TEE is a semi-invasive approach and requires the patient to swallow a probe under mild sedation. Standard MRI may be contraindicated in patients with metallic implants or claustrophobia. That is why informed consent needs to be obtained from patients for all instrumental diagnostic modalities except for ECG approaches and TTE. Beside modalities mentioned, there are other imaging approaches, which are established under nuclear medicine, e.g. single-photonemission-tomography (SPECT) and positronemission-tomography (PET), both of which use radioactive tracers. In cardiology, SPECT is performed as a stress test and shows myocardial perfusion. Baseline measurement is followed by another reading after physical 58

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of pharmacological stress. Perfusion defects at rest are indicative of myocardial scars after infarction whereas reversible perfusion defects under stress are indicative of ischemia due to coronary stenoses in patients with CAD. In contrast to SPECT, there are just a few and very specific indications for PET in cardiology, e.g. inflammatory spots inside the heart can be detected in endocarditis. Generally, SPECT and PET should just be employed if other approaches mentioned above do not provide with sufficient information.

Other Non-invasive Testing Diagnosis of heart failure (inability of the heart to pump sufficient amounts of blood) cannot be imagined without spiroergometry, which is a cardiopulmonary exercise test using respiratory gas exchange analysis for the assessment of functional capacity and prognosis of individuals with CHF. It can be beneficially used for follow-up, detection of poorest prognosis and optimal timing of heart

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transplantation. Together with heart failure biomarkers, spiroergometry helps a lot to guide any heart failure therapy throughout the whole spectrum of severity. The tilt table test is another functional diagnostic approach, which is used to evaluate the cause of unexplained dizziness and fainting. The health care provider watches how heart and nervous system respond on changes in position of the human body. Several conditions potentially causing orthostatic hypotension include Parkinson’s disease, postural orthostatic tachycardia syndrome (POTS) and other neurally mediated conditions.

Invasive Diagnostic Approaches Invasive diagnostics require strong indication and informed consent by the patient. Coronary angiography (CAG) represents the most frequently used diagnostic method in order to demonstrate coronary stenoses in detail. It can be combined with ad hoc therapy, namely percutaneous coronary intervention (PCI). However, CAG just shows coronary stenosis but does not provide with functional information. With other words, CAG is not very much specific regarding pathophysiological relevance of stenoses. As a result, moderate coronary stenoses require additional diagnostic efforts for final assessment and therapeutic decision-making. Intravascular ultrasound and measurement of fractional flow reserve (FFR) are considered much more specific and are often used to specify CAG findings prior to final assessment.

Comparable to the relation between CAG and PCI, there is a relation between intracardiac electrophysiological study (EPS) and electrophysiological ablation. EPS reveals pathophysiological background of arrhythmias and can be combined with ablation therapy as needed. The option of immediate therapy is advantageous for patients and may reduce costs, since double procedural preparation and aftercare are dropped. Consequently, invasive diagnosis might be favored if the need for therapeutic consequences is likely.

Individualization vs. Standardization of Diagnostics Guidelines released by European, American and other cardiac societies have been considered having force of law for decades. That widely led to strict standardization of diagnostics and subsequent therapy. However, pure standardization does not live up to current medical, ethical and social requirements anymore but represent a kind of averaging and does hardly cope with individual conditions. Guidelines and current recommendations are usually based on the outcome of trials, which explicitly disregard certain comorbidities, very old and young age, sometimes even gender and other individual conditions, e.g. genetic predispositions, history of cancer or mental illness. That is why, guidelines just provide medical community with a rough orientation regarding strategy of diagnostics, since each patient is unique. Optimal therapy requirs a personalized approach in terms of diagnosis w w w. a m e r i c a n h h m . c o m

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In summary, aspiration of patientcentered cardiovascular diagnostics requires conceptualization of a personalized diagnostic path along individual needs and health conditions. At this point, wheel turns full circle: just thorough exploration of case history and in-depth clinical assessment provide physicians with all information within and beyond cardiovascular medicine, which is needed for what can be called “patientcentricity”. Patient-centered diagnostics require more time, knowledge and personal engagement by physicians compared to standardized diagnostic paths, which just follow presets. Finally, it’s worth it to make these efforts because to current knowledge, it represents the best way to avoid misdiagnoses on the one hand and diagnostic overkill on the other hand. Patient-centered diagnosis can be considered the entrance into patient-centered care at all. It also helps to improve patient’s compliance and may counteract skyrocketing costs in healthcare.

Dr. Thomas Bartel is an interventional cardiologist with about 35 years of professional experience. He finished Charité Medical School in Berlin in 1987. He worked at different academic institutions in Germany, the United States, Austria and the United Arab Emirates. In that regard, he was confronted with a broad spectrum of healthcare conditions and systems.

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as well as therapy rather than standardized but average handling. As an example, diagnostic methods based on radiation or radio contrast exposure might be avoided in cancer patients and individuals with renal failure. In contrast, diagnostic cascade should be tailored along individual needs and risks as well as the likelihood of positive findings. For example, if CAD needs to be excluded in an individual, cardiac CT is considered optimal, since it is very sensitive. In comparison, ergometric approaches followed by CAG are expedient in symptomatic or high-risk subjects in order to unequivocally prove CAD, since these tests are sensitive and very specific.

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Artificial Intelligence (AI) Automation of Diagnostic Image Acquisition

The potential of artificial intelligence (AI) to enhance healthcare extends far beyond diagnostic interpretive tasks. One area of great potential is automation of scan acquisition. In radiology, AI is already showing great potential in enhancing and streamlining acquisition of scans such as CT and MRI, aligning quality and cost-efficiency.

Reza Forghani MD, PhD, Prof of Radiology & Artificial Intelligence (AI) and Vice Chair of AI, Director, Radiomics & Augmented Intelligence Laboratory (RAIL), Department of Radiology, University of Florida College of Medicine

Introduction Artificial Intelligence (AI) has the potential to transform the healthcare industry of the future, although there are unique challenges in healthcare, including patient privacy and related ethical considerations, highly regulated nature of the healthcare industry, and the human element and w w w. a m e r i c a n h h m . c o m

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trust that need to be addressed for successful AI implementation in health care practice. In the field of radiology, also known as medical imaging, numerous research studies have used AI to perform various diagnostic tasks, with an increasing number being developed as commercially available clinical tools regulated by the US Food and Drug Administration (FDA). These are important and highly relevant applications of AI with unique opportunities and challenges for safe and effective implementation in clinical practice. However, one should not lose sight of the many other potential applications of AI that are not primarily focused on a diagnostic scan interpretation task, and instead focus on optimizing and enhancing various healthcare processes. Such tasks have great potential to improve healthcare delivery in the near to

KEY POINTS • AI is increasingly used to support the scan acquisition process and image quality in CT and MRI. • These technological advancements can improve patient care and satisfaction, address practical challenges such as manpower shortages, improve diagnostic quality, and increase productivity, with a tangible return on investment. • Decision makers need to be aware and can leverage these technological advances to ensure a competitive, state of the art practice.

Table 1: 5-Year Relative Survival Rates by Cancer Staging and Type of Cancer 62

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intermediate term, and depending on the specific task, they may be technically less complex and have a lower regulatory burden, with a clear positive impact for patients and return on investment for healthcare organizations. In this article, AI applications for enhancement and semi-automation of diagnostic cross sectional medical imaging scans such as CT (computed tomography; also commonly referred to as CAT scans) and MRI (magnetic resonance imaging) are discussed.

Artificial Intelligence Applications for Computed Tomography Scanning CT is the workhorse of cross-sectional imaging technology, used for the evaluation of a wide range of urgent and non-urgent medical conditions. CT scans are acquired very rapidly, with a single body part scanned within seconds. This is one among other reasons why they are widely used in the emergency setting. There has been a steady increase in the utilization of CT scans. However, the constantly increasing demand and ensuing high volumes, coupled with other pressures such as rapid turnaround requirements in hospital emergency settings and at times very ill or unstable patients, poses unique challenges for CT operations. This has been compounded by a shortage of radiology technologists – the healthcare professionals who operate and perform the patient scans that are subsequently interpreted by expert doctors, i.e. radiologists. The technologist shortage is not new, but exacerbated by increased demand

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for diagnostic imaging services. In addition to having a core operational impact that in the worse case scenario could be to limit the operational time of a scanner, there is also a quality impact. An indirect effect of this shortage is to have CT scanners staffed by technologists that are not specialized or less familiar with CT, or outside locum technologists who may not be familiar with the scanners at a particular institution. This can sometimes result in a less than optimal operation and quality of the scans obtained. These challenges can at least partly be addressed using current technology and AI. There is a movement among different major CT scan vendors in automating parts of the technologists’ workflow, freeing them up to perform other pertinent tasks such as patient facing tasks with an overall positive impact on operational efficiency and quality. Some CT scanners are now equipped with cameras and other technology that can assist in optimal positioning of a patient. Increasingly, the scan acquisition process is being automated, making it simpler to operate with a few clicks. These processes, in addition to their potential for increasing operational efficiency, make scanning less operator dependent can standardize and improve the quality of scan acquisition using machine intelligence. Technology enhancements, including AI, can also assist by helping standardize and optimize patient positioning and acquisition parameters. As such, scans are increasingly personalized, optimizing radiation exposure to

the minimum required for a diagnostic quality scan. The improved quality and consistency of the examinations will also result in better quality scans, which in turn, can enable a better diagnosis at the time of scan interpretation by radiologists. Beyond the operational optimization of CT scanning, AI is increasingly used for improving the diagnostic quality of images by incorporation of AI algorithms into the image reconstruction process. After a patient is scanned in CT, the X-Ray attenuation data are used to make the CT images that the expert radiologists will look at, a process referred to as CT image reconstruction. Increasingly, AI algorithms are being used in this process by different scanner manufacturers. Currently, a major focus of such algorithms is to reduce image noise and increase image quality. Through this process, the algorithms can also enable the acquisition of a diagnostic quality scan with less patient radiation exposure. Such AI-assisted image reconstruction technology is already available to various degrees on many current commercially available CT scanners. In the future, the image reconstruction realm is likely to further expand, with potential for incorporation of some diagnostic interpretive tasks at the CT console or suite. First, it is possible that AI may enable significantly enhanced or novel types of reconstructions that can further improve and assist in diagnostic interpretation, especially with certain types of advanced CT referred to broadly as spectral CT. On the direct AI-assisted interpretation w w w. a m e r i c a n h h m . c o m

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side, one potentially impactful area is the immediate screening of acquired scans for quality and urgent conditions. Pertaining to scan quality, one can envision the machines increasingly analyzing and alerting the technologist at the time of scanning whether the scan is of good diagnostic quality or not. This would enable immediate mitigation and repeat scanning if necessary, avoiding a non-diagnostic scan or need for patient callback and associated patient inconvenience. AI software, either third party software or that provided by a scanner manufacturer, can also be used to screen for unexpected urgent and or potentially life-threatening conditions, particularly in outpatient settings. This does not necessarily have to be done on the scanner console, but in the most impactful scenario, it would be done and the results available 64

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near-simultaneously and as soon as a scan has been obtained. This way, the technologist can be alerted before the patient has left the scanner suite and the Department. Flagging an unexpected urgent finding would enable immediate routing of the patient to their treating physician or the emergency department if necessary. At a minimum, this will reduce patient inconvenience and in certain cases, it could make the difference between timely diagnosis and potential prevention of an ensuing adverse or catastrophic event.

Artificial Intelligence Applications for Magnetic Resonance Imaging MRI is another commonly used advanced cross sectional imaging technique. MRI provides excellent soft tissue contrast and is used for the diagnosis of a variety of oncologic and

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non-oncologic conditions. A detailed discussion and comparison of MRI and CT is beyond the scope of this article but on the practical and technical side, it’s important to remind the reader of a few things. Operationally, MRI scans take much more time than CT scans to acquire. An average MRI scan can easily take 15-30 minutes, depending on the specific indications and body part examined. In certain practices, MRI scans may on average be longer than 30 minutes, and occasionally some scans may take longer than 1 hour to complete. As a result, there is great opportunity for improving patient comfort and operational efficiency and revenue through reduction of scan times, with an additional associated quality enhancement opportunity. On the patient comfort side, it is needless to say that remaining motionless on a scanner table for long periods of time is not the most desirable or comfortable experience for anyone, but even more so for a patient who is ill, in pain, or has trouble breathing. Claustrophobia can also be a major issue for MRI scans. In that sense, accelerating and having significantly lower scan times can directly benefit the patient by making the process more comfortable for the patient. There is furthermore a secondary quality impact to reducing scan times in MRI is that sometimes is overlooked or not sufficiently emphasized. It is not easy for any patient to remain motionless for long periods of time and the longer the examination time, the more the likelihood of having some

sequences motion degraded which in turn can compromise diagnostic quality and interpretation. Reducing overall scan times can therefore indirectly benefit image quality and diagnostic interpretation. The other potential significant impact of reducing MRI scan times is increased productivity and revenue, particularly because MRI is typically a largely fixed cost operation. This can also have the benefit of reduced wait times, especially when capacity is an issue. In the emergency and inpatient setting, this has the potential to reduce length of stay with a positive impact across the enterprise. Similar to what was discussed for CT, there are an increasing number of AI algorithms used for reconstructing or enhancing MRI images. In the image reconstruction space, AI has shown the potential to both improve image quality and shorten MRI sequence acquisition time. It is important to be aware of these tools and get specifics from a scanner vendor during purchase of a new scanner, since these can have significant productivity and return on investment. Decision makers also need to be familiar with the potential and multi-faceted benefits of such technology, and in certain cases, an upfront investment in a more sophisticated technology could yield significant long term benefits, both from a patient care and an institutional productivity and financial perspective. In addition to the above, an interesting category of AI tools have emerged that typically w w w. a m e r i c a n h h m . c o m

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are vendor neutral and work on the images after the initial image reconstruction. These can improve quality and through the process, enable shortening acquisition time (while preserving image quality). To get the associated efficiency, sequence acquisition parameters are changed that reduce scan time. Without AI algorithm assistance, these change would reduce signal and increase image noise and could make the quality less than desired or unacceptable, but the AI algorithm makes up for the image quality and signal to noise on the shortened sequence yielding images of similar quality while enabling shortened scan times. Because these are applied after the original image reconstruction, some refer to this process as image enhancement. Nonetheless, they also have demonstrated gains in quality and increasing productivity. One particularly attractive feature of vendor neutral MRI enhancement software is that they can be applied to different scanners, including older scanners, and do not require a hardware upgrade. This widens the potential use and benefits to various scanners within an institution that are not yet planned for an upgrade or replacement. They also require much less upfront capital investment. While the data is preliminary, such tools have been shown to increase productivity and can have a significant return on investment, especially in practices where capacity is limited. Some of the other operational benefits of technology and AI discussed for CT also apply to MRI. MRI is also impacted by the technologist shortage, and perhaps even more 66

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susceptible given the specific and complex expertise required for optimal acquisition of MRI scans. Similar to CT, MRI vendors are increasingly using different technologies to streamline the scanning process. There is furthermore other promising developments in this domain, including one approach where a technologist with a high degree of expertise, sometimes referred to as a superuser, can monitor multiple scanners from one location. In the future, this model is likely to expand and be further enhanced with AI, dealing with the practical challenges of manpower shortage and expertise in MRI operations. Similar to what was discussed for CT, AI-assisted image reconstruction may eventually lead to new or enhanced sequences beyond those focused on image quality and noise alone, helping improve diagnosis. There is also potential for the scanners of the future to monitor the quality of sequences, automatically adjust parameters, and suggest repeat sequences when key MRI sequences are suboptimal, avoiding patient callbacks and improving diagnosis. In the future, AI may also be used to match the scan to a patient's prior examinations, optimizing follow-up, and provide a preliminary image analysis including flagging of potentially urgent or unexpected abnormalities as was discussed in the earlier section on CT scans.

Conclusion There have been impressive advancements in CT and MRI scan technology, increasing

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of their technology roadmap, with ultimate benefits to the patients they serve and the healthcare institution.

Selected review of the use of AI for operational streamlining in radiology Pierre K, Haneberg AG, Kwak S, Peters KR, Hochhegger B, Sananmuang T, Tunlayadechanont P, Tighe PJ, Mancuso A, Forghani R. Applications of Artificial Intelligence in the Radiology Roundtrip: Process Streamlining, Workflow Optimization, and Beyond. Semin Roentgenol. 2023 Apr; 58(2):158-169. doi: 10.1053/j.ro.2023.02.003. Epub 2023 Mar 23. AUTHOR BIO

automating and enhancing the process. These have benefits for patients and also can have significant operational benefits by addressing practical challenges such as manpower shortages, increase productivity, and provide a tangible return on investment for healthcare institutions. It is important for decision makers to be aware of these advancements in order to ensure an optimal and competitive operation. In certain cases, upfront investments in technology may yield substantial long-term return on investment. Decision makers in leading healthcare practices will be well served by familiarizing themselves and considering current and upcoming advancements as part

Dr. Reza Forghani is a radiologist and researcher with medical Artificial Intelligence (AI) expertise. He is Professor of Radiology & AI and Vice Chair of AI at the Department of Radiology, University of Florida College of Medicine where he is also the director of Radiomics & Augmented Intelligence Laboratory (RAIL).

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EXPERT TALK

AI in Digital Transformation

Digital transformation in healthcare leverages AI, telemedicine, and data analytics to enhance patient care, improve operational efficiency, and foster innovation. This abstract explores the critical role of healthcare organizations, clinicians, and educators in embracing digital technologies such as AI to meet evolving patient needs and reshape the future of healthcare. Dipu Patel Vice Chair for Innovation and Professor University of Pittsburgh’s DPAS program

1) How can organizations ensure that their AI initiatives align strategically with broader digital transformation goals and objectives? Organizations should start by establishing a clear vision for digital transformation that reflects their core values and objectives. AI initiatives must then be clearly mapped to this vision; this may be done annually at a department level or as part of a larger strategic plan at an organizational level. For instance, if a healthcare organization's 68

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goal is to improve patient outcomes, AI projects should be directly tied to metrics related to patient care, such as predictive analytics for patient risk stratification. Engage stakeholders from departments at all levels (clinical, support staff, operations, etc.) as part of the initiative.

2) In the context of digital transformation, how do you recommend organizations integrate AI with their existing data infrastructure, and what challenges might arise in this process? Integration should be approached in a systematic manner, starting with a data audit to understand the current infrastructure and its capabilities to support AI. It's vital to ensure data quality and governance before layering AI on top of existing infrastructure. Potential challenges that might be encountered are data silos, integration complexity, and ensuring privacy and security compliance, which are critical in healthcare settings. These need to be part of the AI solution as much as patientfacing solutions.

3) What steps should organizations take to embed ethical considerations into the development and deployment of AI technologies during a digital transformation journey? Establishing ethical guidelines for AI use, such as fairness, transparency, and accountability, which are of utmost importance in healthcare for maintaining patient and provider trust.

Aligning the guidelines with industry standards and societal and cultural values requires a diversity of perspectives, including those of the community the organization serves. Involvement of ethicists or an ethics committee during development and deployment can help embed these considerations into AI systems. Asking community members, patients, providers, and other stakeholder to participate on committees can provide a valuable perspective and voice.

4) How do you foresee AI influencing the workforce structure and skill requirements during a digital transformation, and what strategies can organizations employ to manage this transition effectively? AI will automate certain tasks, that will lead to a shift in workforce needs from; a clerical and repetitive tasks towards more analytical and technical skills. Organizations can manage this by investing in training and development programs to reskill and upskill employees. They can also cultivate a culture that values continuous learning and adaptability. Creating new roles for AI oversight, learning, and management can help with both the transition and maintenance phases of the digital transformation journey. Transformation is not a single endpoint, rather a journey with iterative phases of continuous improvement in the delivery of quality of care for patients while striving for a balance of quality of life and reducing burnout for the entire healthcare workforce. w w w. a m e r i c a n h h m . c o m

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Furthermore, cross-functional and crossprofessional collaboration will take on a whole new meaning during the digital transformation process. Regular interdepartmental communications and sharing of resources, knowledge, and platforms can encourage interprofessionalism leading to success for all teams and departments. Facilitating communication, whether it be via regularly scheduled meetings for specific projects, or electronic announcements at a particular cadence, can increase trust and improve efficiency.

5) What key performance indicators (KPIs) would you prioritize when assessing the success of AI-driven components within a digital transformation initiative? Success metrics should reflect the organization's strategic goals. In a healthcare context, KPIs might include improved diagnostic accuracy, reduction in hospital readmission rates, or increased patient engagement rates or improved patient satisfaction through AI-powered platforms. Setting organizational KPIs can help departments set their own KPIs. Aligning KPIs that speak directly to the organization’s mission and values can guide what might be a tumultuous journey towards a smoother path. If there is agreement of KPIs by the people who will do the work, then operationalizing the KPIs will become more efficient. No matter the KPIs, engagement of the stakeholders should be the starting 70

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point. No digital transformation journey is perfectly smooth; there will always be shifting landscapes and competing viewpoints. The role of leadership is to lead by example. Leadership should communicate the context of the digital transformation, develop KPIs that are mission aligned, and be open to feedback on an ongoing basis. This models openness a culture of transparency, innovation, and agility.

6) When selecting the technology stack for AI implementation in digital transformation, what criteria should organizations consider to ensure scalability, flexibility, and compatibility with existing systems? When selecting AI technology, compatibility with existing systems is key. Organizations should also look for solutions that can scale with growth and adapt to changing healthcare

AI drives healthcare transformation, enhancing patient care and operational efficiency.

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regulations and standards. Although there is not perfect way to align all aspects of scale, flexibility, and compatibility, there are several factors that should be considered in the context of the overall strategic plan. Select technology that will align the goals of the organization while keeping in mind data governance and the shifting regulatory landscape. This may require upfront investment in updating IT infrastructure such as serverless architecture or a newer cloud-based service before new AI-based technology can be implemented. As AI evolves, so must organizational infrastructure and the workforce.

7) What are the primary risks associated with AI implementation in digital transformation, and how can organizations proactively manage and mitigate these risks? Primary risks include data breaches and biases in AI algorithms. Organizations can mitigate these risks by implementing robust cybersecurity measures and continuously monitoring AI decisions for unintended biases, especially in diverse patient populations. For example, if an organization implements an AI system for patient diagnosis, they will need to ensure that AI system’s decisions are explainable to both clinicians and patients (this is sometimes difficult as some AI systems are “black boxes” and lack transparency of how it made the decision). Transparency in the AI systems used in healthcare is crucial to improving adoption and trust.

8) How can AI be leveraged to enhance the customer experience and satisfaction as part of a customer-centric digital transformation strategy? AI can personalize patient interactions and streamline care processes. Although still in the early stages of implementation, chatbots can provide immediate responses to common inquiries, and AI can tailor health plans based on individual patient data, enhancing satisfaction. Similarly, AI can be leveraged to analyze realtime data from wearables to identify and deliver personalized healthcare interventions leading to improved patient outcomes and engagement. Another example of utilizing AI is in cancer care. In this instance, AI can assist in integrating diverse clinical data (radiology and pathology reports in EHRs), providing a more holistic view of patient health enabling more informed decision-making.

9) Considering the rapid pace of technological advancement, how should organizations stay abreast of and prepare for integrating emerging technologies with AI in their ongoing and future digital transformation initiatives? Incorporating AI into digital transformation requires a nuanced strategy to ensure that the technology is not only implemented but is also effective and adds value to the organization. It involves developing a foundational competence in AI across all sectors. A portfolio approach is recommended, treating AI implementation as a collection of projects, rather than a single w w w. a m e r i c a n h h m . c o m

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must bolster their technological foundations, ensuring that their infrastructure can support sophisticated AI applications. Embracing a culture of continuous innovation will be crucial, as will the ability to quickly adapt to and integrate new AI-driven methodologies. Forming strategic partnerships with leaders in AI development will provide access to the latest advancements and insights. By doing so, organizations will position themselves to take full advantage of AI's transformative power in enhancing operational efficiency, customer experience, and personalized services.

AUTHOR BIO

goal. This allows for a diverse investment in AI, spreading both the potential benefits and the risks. Reskilling and investing in talent are also essential, as AI will reshape job roles and require new skill sets. An organization must take an agile, iterative approach to digital transformation, enabling a flexible and responsive adaptation to new AI technologies as they emerge. As AI redefines processes from predictive analytics to customer service, organizations must embed change management to smoothly integrate these advanced systems. This multifaceted approach ensures that AI becomes a transformative force within the digital landscape of an organization, reshaping it for the better.

10) Looking ahead five years, how do you envision the landscape of digital transformation, specifically in terms of the role AI plays? What major shifts or transformations do you anticipate, and how should organizations prepare for these changes? In the next five years, the role of AI in digital transformation is expected to become even more pivotal. AI will likely be at the heart of clinical decision-making systems, providing support that ranges from diagnostics to treatment options, and evolving administrative processes to be more efficient. Personalized patient care, powered by AI's ability to analyze large data sets, will become the norm, making healthcare more tailored to individual needs. To successfully navigate this shift, organizations 72

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With over 23 years of experience, Dipu Patel, is deeply committed to medical education. Her leadership extends from academia to healthcare tech startups, where she led provider-driven, patientcentered clinical pathways. As Vice Chair for Innovation and Professor at the University of Pittsburgh’s DPAS program, she focuses on quality improvement, innovation, and digital health. Her passion lies in merging clinical expertise with technology to enhance patient care and education while maintaining the importance of a human touch.

EXPERT TALK

Improving Patient Safety and Quality of Care

Nataliia Lopina Director and Founder, ClinCaseQuest

Simulation in healthcare platforms stands as a pivotal tool in advancing patient safety and care quality. Recreating real-world scenarios empowers healthcare practitioners to refine their skills and decision-making. Through immersive, lifelike experiences, this innovative approach accelerates skill development and bolsters clinical competence. 1. How do you envision the integration of simulation technology with real-world healthcare settings to enhance patient safety and quality of care? Medical errors, ranking as the third leading cause of death in the US and frequently reported in EU data, might be more pervasive

than our records indicate. Underreporting is a concern, and the true scope of the issue remains elusive. A contributing factor could be inadequate practical training for both practicing physicians and students, often overshadowed by theoretical lectures and a lack of active learning approaches. w w w. a m e r i c a n h h m . c o m

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The global surge in simulation training reflects a collective acknowledgment of the need for hands-on, experiential learning in healthcare. Active learning strategies, particularly through simulation, play a pivotal role in fostering competency development among medical professionals. Our approach involves creating lifelike simulation experiences that closely mimic the complexities of actual clinical environments. Simulation training offers a controlled environment for physicians and students to immerse themselves in realistic clinical scenarios, mitigating the risk of errors in actual patient care. By addressing the deficiency in practical training, simulation becomes a catalyst for improving the quality of healthcare delivery. It not only equips practitioners with the skills needed to navigate complex medical situations but also contributes to a culture of continuous learning and improvement in healthcare practices globally. In essence, our vision is to make simulation an integral part of healthcare education and training, ensuring that every practitioner has the opportunity to engage with realistic scenarios, learn from mistakes, and ultimately contribute to a safer, higher-quality healthcare landscape.

2. In what ways can immersive simulation experiences contribute to the refinement of healthcare practitioners' decisionmaking skills and clinical competence? Table 1: 5-Year Relative Survival Rates by Cancer Staging and Type of Cancer 74

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Students engage with clinical scenarios mirroring real-world practice, honing their decision-making skills. This exposure fosters the development of action patterns, ensuring that when faced with similar situations in actual clinical settings, they possess a foundation of theoretical and practical knowledge acquired during training. For physicians, simulation training serves as a means to augment clinical experience and sustain knowledge retention effectively. The realism of clinical situations during simulation directly correlates with the training's efficacy. The closer the simulation mirrors real clinical practice, the greater the benefits for the learner. Crafting realistic clinical case scenarios is, however, a formidable task demanding substantial effort to ensure the simulation aligns seamlessly with authentic clinical settings. Drawing from personal experience, our approach involves utilizing real patient data obtained ethically and rigorously. Simulation preparation necessitates a comprehensive strategy, involving an in-depth analysis of analogous clinical cases from medical literature, an extensive literature search for nosology data, and a thorough review of clinical recommendations. Only after this meticulous process do we prescribe a practical counseling algorithm tailored to patients with similar nosology. Each project demands an exhaustive effort, but this commitment is pivotal in maintaining the quality of simulation training content at a commendable level.

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This dedication to excellence forms the basis of the serious games concept, presenting a promising avenue to mitigate the global prevalence of medical errors. The thoroughness applied to simulation training creation emerges as a robust strategy with far-reaching implications for enhancing patient safety and care quality worldwide.

3. What specific challenges or barriers exist in the widespread adoption of simulation-based training programs for healthcare professionals, and how do you propose to overcome them? It's noteworthy that simulation training stands as the fastest-growing sector in medical education, marked by the establishment of numerous universities and hospital simulation centers worldwide. The global impact of the COVID19 pandemic has underscored the imperative to develop online simulation training methods for educating students and enhancing the skills of healthcare professionals. However, the widespread implementation of online learning simulation technologies faces certain limitations, primarily the associated development costs. Overcoming this challenge poses a significant hurdle for the development team to ensure that training remains both accessible and of high quality. I aspire to automate various development tasks, leveraging artificial intelligence technologies. This, I believe, will contribute to making simulation training universally accessible and easily scalable for every healthcare professional.

Elevating Patient Safety: Healthcare simulation enhances skills and decisionmaking through immersive experiences, accelerating competence development.

4. How do you measure the effectiveness of simulation-based training in improving patient safety and care quality, and what key performance indicators do you consider essential in this evaluation process? In the realm of assessing the effectiveness of simulation training, the widely recognized Kirkpatrick model plays a prominent role. This model is instrumental in gauging the acquisition of competencies through simulation. The Kirkpatrick model, with its multi-level evaluation approach, provides valuable insights into the tangible outcomes of simulation-based learning. In addition, we employ a comprehensive set of key performance indicators (KPIs) to gauge the impact of training interventions. Our evaluation process encompasses both quantitative and qualitative measures. Quantitatively, we analyze performance metrics such as response times, accuracy in diagnosis and treatment, and adherence to established protocols. These quantitative w w w. a m e r i c a n h h m . c o m

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indicators offer tangible insights into the practical application of skills acquired during simulation training. On the qualitative side, we incorporate feedback from participants, considering their perceived confidence, communication skills, and overall competence. This qualitative assessment provides a nuanced understanding of the training's influence on the practitioners. Drawing from personal experience, I have been actively exploring ways to enhance the assessment of simulation training results. Currently, I have developed a specialized mathematical model for simulation scenarios, employing a stratification the severity of medical errors. This model not only facilitates the evaluation of training effectiveness but also enables meticulous modeling of events within the simulation. Our assessment strategy encompasses diverse indicators, including the number of hours and trainings completed in online simulation. We also track the usage of our online resource, completed scenarios, and competencies acquired during simulation training. This wealth of data can be seamlessly integrated into a comprehensive portfolio spanning a healthcare professional's entire career. Moreover, addressing the challenge of reporting medical errors requires a concerted effort. Implementing region-specific improvements in reporting mechanisms and establishing automated, globally unified data registries are essential steps. These measures aim to provide specialists with actionable 76

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insights into the most critical areas that demand focused attention, fostering continuous improvement in patient safety and care quality.

5. Could you elaborate on any specific ethical considerations or concerns that arise when implementing simulation-based training programs in healthcare, and how do you address these concerns within your institution? In the realm of simulation-based training, realism is a key factor in enhancing learning and competency development. However, achieving realism raises ethical considerations that must be diligently addressed. Our approaches converge on a commitment to upholding the highest ethical standards. In our institution, we follow a robust algorithm for constructing simulation scenarios, drawing inspiration from the real clinical cases. This involves a comprehensive package of ethical documents signed with patients and their healthcare providers. All patient data transferred to the simulation platform is anonymized and blinded, ensuring strict adherence to privacy and confidentiality. Obtaining informed consent is a fundamental step in our ethical framework. Patients are fully informed about the purpose of data utilization, the simulation process, and any potential implications. This approach mirrors the principles of Good Clinical Practice (GCP) observed in clinical trials. Moreover, we share a commitment to transparency and ethical considerations

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in the design of simulation scenarios. Our ethics documents mandate that all drugs within clinical case scenarios are referred to as active substances rather than trademarks. This underscores our dedication to demonstrating medical care based on evidence rather than engaging in pharmaceutical marketing. The ethical principles of the Declaration of Helsinki and GDPR standards are foundational to our simulation training platforms. Patient data protection and privacy are paramount, and we continuously align our practices with evolving ethical norms. By fostering an environment of transparency, informed consent, and alignment with global ethical guidelines, we ensure that our simulation-based training programs not only enhance learning but do so with the utmost respect for ethical considerations. Our commitment to ethical standards in simulation training is embedded in our institutional policies. Regular ethics training for simulation facilitators and ongoing dialogue with stakeholders, including patients and healthcare professionals, ensures that our simulation programs align with the highest ethical standards. We view ethical considerations not just as a compliance requirement but as a fundamental aspect of delivering responsible and effective healthcare education.

quality through simulation-based learning experiences? The collaborative and team-based approach is pivotal in enhancing patient safety and care quality through simulation-based learning experiences. This approach aligns with both of our perspectives. Simulation scenarios often mirror realworld clinical situations that demand interdisciplinary collaboration. In our training programs, we emphasize team-based scenarios where healthcare professionals from different disciplines work together to manage complex cases. This not only reflects the reality of healthcare delivery but also cultivates effective communication and teamwork. Interdisciplinary collaboration allows healthcare professionals to understand and appreciate the unique contributions of each team member, fostering a holistic approach to patient care. It helps break down silos,

6. What role do interdisciplinary collaboration and team-based training play in enhancing patient safety and care w w w. a m e r i c a n h h m . c o m

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Simulation platforms provide lifelike experiences, propelling skill development and refining decision-making for heightened patient safety and care quality.

promoting a shared understanding of roles and responsibilities, which is crucial in critical situations. Moreover, simulation-based team training provides a safe space for professionals to practice not only clinical skills but also teamwork, communication, and decisionmaking. It offers an opportunity to identify areas for improvement in team dynamics without compromising patient safety. As a doctor, I am always happy when I see when different societies of doctors write joint recommendations to answer questions that arise in real clinical practice in order to minimize the unsolved clinicacal questions, for example, very often recently the Society of Cardiologists and the Society of Hematologists write joint recommendations, and so on. Our joint emphasis on interdisciplinary collaboration recognizes that patient care is multifaceted and requires a collective effort. 78

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By simulating scenarios that necessitate collaboration among diverse healthcare professionals, we ensure that our training programs contribute to a healthcare workforce that works seamlessly together for the benefit of patient safety and care quality.

7. How do you ensure the translation of skills acquired through simulation training into real-world clinical practice, and what strategies do you employ to maintain the continuity of learning and skill retention among healthcare practitioners? Monitoring the implementation of skills in a real clinical setting poses a challenge for us, given that we operate as an online simulation training platform accessible globally. The assessment you're referring to aligns with the highest tier of the Kirkpatrick model, which necessitates ongoing improvements in evaluation methodologies and data collection during health professional assessment in the workplace area. At present, our platform evaluates the mastery of competencies achieved during simulation training. Each training module encompasses a specific set of competencies at any convenient time. To support continuous engagement, we employ reminder systems and regular email communications with our students. In a bid to motivate participants, we are actively integrating gamification elements into our platform. This approach fosters a more interactive and engaging learning experience.

EXPERT TALK

Additionally, our system maintains a comprehensive record of all acquired competencies, allowing participants to revisit and reinforce their skills as needed. Crucially, our flexible training structure permits participants to complete each training module multiple times, ensuring a thorough understanding of the content. Collectively, these strategies converge toward a singular goal: influencing real clinical practices and establishing simulation training as an indispensable tool in the professional journey of healthcare practitioners.

8. Considering the rapid advancements in simulation technology, what future trends do you foresee in the field of healthcare simulation, and how do you plan to stay abreast of these developments to continuously enhance patient safety and care quality? As technologies advance rapidly, the active development of simulation training continues. I envision the future of simulation training prominently featuring augmented reality technologies. Additionally, the widespread integration of artificial intelligence will play a crucial role in enhancing the construction and delivery of simulation training programs. These innovations are poised to revolutionize the learning experience for healthcare practitioners, ensuring they are wellequipped to provide high-quality patient care in evolving clinical landscapes.

9. Could you share any specific success stories or case studies highlighting the positive impact of simulation-based training on patient outcomes and the overall quality of healthcare delivery within your institution or practice? ClinCaseQuest has witnessed impactful success stories that underscore the positive influence of simulation-based training on patient outcomes and overall healthcare quality. One noteworthy example involves an ambulance doctor who engaged in our clinical case simulator during a break between calls. The skills acquired in the simulation proved instrumental when providing assistance to a patient in a real clinical emergency. Subsequently, the doctor advocated for the expansion of clinical scenarios within our platform, emphasizing its direct applicability to his professional duties. This real-world application of simulation training directly translates to improved emergency response and patient care in dynamic healthcare settings.

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In our endeavors, we've pioneered a methodology for simulation training that enables us to encompass clinical situations previously untouched by traditional simulation programs. Notably, our recent focus includes the development of simulation training in oncohematology, addressing intricate nosologies and sophisticated decision-making algorithms. Moreover, our proactive efforts extend to the active development of simulations with a core emphasis on ensuring equitable access to highquality medical education. This commitment reflects our dedication to making advanced medical training universally accessible.

11. In conclusion, what key strategies or initiatives do you believe are crucial for the sustained integration and advancement of simulation-based training in healthcare, ultimately leading to improved patient safety and enhanced quality of care in the future? Effective collaboration among patient care institutions, medical educational bodies, simulation centers, governmental agencies, and grant support programs is imperative to construct a globally robust strategy for the practical training and retraining of doctors. This strategy should be rooted in a comprehensive quality control framework for medical education, ensuring the highest standards in healthcare delivery and patient safety. Such concerted efforts aim not only to elevate the competence of healthcare professionals but also to establish a global benchmark for the quality and safety of patient care.

Nataliia Lopina, ClinCaseQuest's CEO and Founder, is a distinguished Clinical Simulation Training Platform Director and Specialist with a decade of impactful experience. Her expertise in simulation-based training, leadership, and business management has driven innovation in medical education. As a Simulation Center Director, she excels in management and strategic planning, ensuring adherence to industry standards. Nataliia's groundbreaking contributions include a Mathematical model for clinical case scenarios and a novel debriefing model, "A Staged Defragmented Simultaneous Debriefing Model." Committed to patient safety, she addresses drug toxicity in oncohematology. Her academic journey encompasses postgraduate studies, a PhD, cardiology fellowship, and a master's degree, showcasing her dedication to advancing medical education and improving patient outcomes.

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AUTHOR BIO

10. How do you tailor simulation-based training programs to address the specific needs and challenges of diverse patient populations and healthcare settings, ensuring inclusivity and equitable access to high-quality healthcare training for all?

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Recent Innovative Technologies in Heart and Lung Transplantation Transplantation is a highly specialized area of medicine and often the only treatment option to improve the quality of life for individuals with serious and complex terminal organ failure. It is an ever-evolving field and the technological advancements made in the field of heart and lung transplantation have been phenomenal over the last 50 years. Artificial intelligence and machine learning are increasingly being used to assist clinicians in decision-making for the care of these high-risk transplant patients. This field is tantalizingly poised to enter a new era of smart science applications where sensational expert systems and staggering expert minds would co-create the patient management strategy. Anitha Chandrasekhar Clinical Lead- Lung Bioengineering and Organ Procurement, Northwestern Medicine

1. Can you provide an overview of the most significant technological advancements in heart and lung transplantation over the past decade? During the past decade, transplantation has undergone significant developments, including the expansion of donor criteria, changes in allocation systems, and implementation of novel therapeutic interventions, leading to broader indications and improved long-term

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survival. There has been a mammoth evolution of every aspect of transplantation including surgical techniques, mechanical circulatory support, organ preservation and perfusion, organ transport devices, immunosuppression, personalized medicine via pharmacogenomics, non-invasive biomarkers, use of artificial intelligence in prognosticating outcomes, monitoring of allograft function and rejection surveillance. The use of extended criteria donors, donation after circulatory death (DCD), and assessment and optimization of previously unsuitable donor hearts and lungs using ex vivo perfusion have revolutionized thoracic organ transplantation.

2. Organ preservation and perfusion technologies have seen substantial advancements. Could you explain the latest techniques and their impact on transplant success rates? The heart and lung perfusion systems offer extended preservation of the respective organs and have reshaped the transplantation domain. The heart perfusion system helps shorten the heart waitlist by increasing the donor pool and translates to better outcomes and fewer patient deaths while awaiting a heart. Recently, there has been a substantial increase in the number of heart transplants due to machine-perfused hearts. These were more commonly allocated to lower urgency status patients, indicating improved access to transplantation with the Organ Care System. 82

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Similarly, EVLP technology has led to an increase in transplantation numbers, with comparable allograft survival and no significant difference in chronic lung allograft dysfunction compared to standard donors.

3. What are the key developments in mechanical circulatory support devices for transplant patients, and how have they improved patient outcomes? Mechanical circulatory support (MCS) devices are innovative treatment options designed to re-establish systemic perfusion and support heart/ lung in terminal organ failure patients. MCS can be used as a bridge to transplant, bridge to decision, bridge to recovery, or in some cases as destination therapy. They can be broadly classified into short-term support devices such as Intra-aortic Balloon Pump (IABP), Extra-corporeal Membrane Oxygenation (ECMO), and Impella or longterm support devices such as Ventricular Assist Device (VAD) or Total Artificial Heart (TAH). These devices are proven to improve survival to hospital discharge in end-stage heart failure patients. Their use has expanded beyond short-term prophylactic support to include procedures in the catheterization laboratory, electrophysiology suite, operating room, and intensive care unit. As the waiting time for heart transplantation has increased, ventricular assist devices have become critical for “bridging” patients with end-stage heart failure. In recent times, increased use of biventricular

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assist devices has led to the survival of the sickest of patients, and the outcomes have been compelling.

4. The use of AI and machine learning in transplant medicine has been mentioned. Can you elaborate on how these technologies are being utilized in prognosticating outcomes and decision-making for transplant patients? Artificial intelligence (AI) and machine learning (ML) can enhance a patient's transplantation journey by predicting the potential benefits of transplantation based on initial lab investigations and imaging. They also help identify potential graft failure and mortality after transplantation, assist patients with medication adherence, and encourage positive behavioral changes to minimize further cardiovascular risk. The use of ML models in cardiac transplantation has allowed clinicians to explore a greater number of variables, including those that were previously thought to be of limited use. By analyzing these variables, clinicians can accurately predict the prognosis of patients after transplantation, quantify the risk of rejection, and estimate waitlist mortality for those who may not survive long enough to receive an organ.

5. Personalized medicine through pharmacogenomics is becoming increasingly important in transplantation. How is

Heart and Lung Transplantation Innovations: Artificial intelligence and machine learning revolutionize patient care, ushering in a new era of smart science applications in this highly specialized field.

genetic information used to tailor immunosuppressive treatments for individual patients? Pharmacogenomics is the practice of creating personalized pharmacological therapy with the highest therapeutic index, based on an individual's genomic composition. In transplantation, pharmacogenomics allows immunosuppressive drug therapy to be specifically tailored to each patient. By matching the drug to the individual's genomic makeup, clinicians can choose the best immunosuppressive drug for any given clinical condition, thereby reducing morbidity and prolonging survival. The idea behind "personalized medicine" is that each patient is unique and should receive treatment that is tailored to their specific needs, based on factors such as their medical history, metabolism, genetic background, and epigenetic w w w. a m e r i c a n h h m . c o m

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factors. The ultimate goal of precision medicine for immunosuppression in transplantation is to optimize drug effectiveness and minimize negative side effects for each patient. This means avoiding overdosing that can lead to serious problems like infections, organ toxicity, or nephrotoxicity, as well as underdosing which can result in graft rejection.

6. Non-invasive biomarkers have gained attention in monitoring allograft function and rejection surveillance. Could you discuss the latest advancements in this area and their clinical applications? There is an increased use of non-invasive biomarkers to predict rejection due to the limitations of endomyocardial biopsy. The allograft injury is characterized by two biomarkers. Troponin and donor-derived cell-free DNA (dd-cfDNA). Additionally, two circulating biomarkers, AlloMap, and microRNA (miRNA), reflect the inflammatory and alloimmune processes associated with allograft rejection. Out of these, the two most promising non-invasive alternatives that are in clinical use in North America include assessment of peripheral gene expression profiling and dd-cfDNA. Gene-expression profiling (AlloMap assay) involves the quantification of 11 genes in peripheral blood mononuclear cells that are involved in various pathways such as lymphocyte activation, cell migration, T-cell priming, hematopoietic proliferation, steroid sensitivity, 84

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and platelet activation. There is a significant and growing body of literature that supports the use of dd-cfDNA as a reliable marker of cardiac allograft injury. Not only is there a clear biological rationale for this, but the test is also highly reproducible, with wellknown kinetics following transplantation, and has been linked to allograft rejection in both case-control studies and multicenter crosssectional studies.

7. Organ transport devices play a critical role in transplantation. What innovations have been introduced to enhance organ transportation safety and efficiency? Rapid advances in organ preservation and transport technologies make it possible for organs to travel further to reach the sickest patients in need of a transplant. The transport system can monitor the heart's hemodynamic parameters every 15 to 30 minutes as if it were a patient in the ICU. The advantages of transport devices are that they allow a heart to travel distances up to 1,000 miles or six hours and enable the use of hearts from older donors and those that would have been rejected. During organ transport, various parameters are closely monitored to ensure the organ's viability such as oxygen levels, temperature, pH, perfusion pressure, and organ function. Perfusion systems provide optimized preservation conditions and extended preservation time, allowing for greater flexibility in logistics.

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8. How do you envision the future of heart and lung transplantation in terms of smart science applications and expert systems collaborating in patient management strategies? Medical decision support systems have become increasingly important in healthcare in recent years. Expert systems have three main applications in the treatment and management of heart failure patients namely classification of various stages of heart disease, early detection, and patient surveillance after heart transplantation. AI is employed effectively in chronic care management, which is paramount in dictating the outcome and quality of life of high-risk patients undergoing heart and lung transplantation. Clinical applications include the detection of acute cellular rejection in heart and lung biopsies, prediction of post-heart transplant graft function, re-transplantation, graft survival, cardiac allograft vasculopathy, and assessment

of blood levels of immunosuppressive medications. Digital therapeutics is another smart science application wherein a ‘virtual doctor’ with an interactive physician avatar interface is being created for self-care at home to guide the safe prescribing of medications and management of co-morbidities in heart failure patients.

9. Are there any ethical or regulatory challenges associated with the integration of advanced technologies in heart and lung transplantation, and how are they being addressed? The development and implementation of AI and Bio-printed organs raise important regulatory and ethical considerations. AI has the potential to exacerbate existing inequalities if not appropriately designed and implemented. It is crucial to ensure that AI systems used in

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healthcare are accurate and reliable. When AI is used for diagnosis or treatment without robust validation, ethical concerns arise as errors can result in incorrect medical decisions. A distinct challenge in the field of AI ethics is the need for constant monitoring, review, and auditability to ensure that the systems perform impartially and reliably. Regulatory bodies are being formed to establish guidelines and standards to ensure the safety, efficacy, and quality of these innovations for clinical use. Effective governance of organ procurement and bio-printing requires legal frameworks and regulations. Achieving a balance between innovation, patient safety, and ethical concerns is crucial for the responsible advancement and adoption of these technologies in transplantation.

10. Can you provide examples of successful cases or outcomes where these innovative technologies have made a significant difference in the lives of transplant patients? The EXPAND trial, which is a prospective, multi-center trial to evaluate the effectiveness of the Organ Care System, assessed high-risk transplants with prolonged ischemic times (>4 hours) or marginal donor heart features such as left ventricular hypertrophy, an ejection fraction of 40-50%, donor downtime >20 minutes, and donor age >55 years, and found excellent shortterm outcomes. Ex vivo heart perfusion can thus expand the donor pool by using hearts 86

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that are otherwise considered unsuitable for transplantation. Clinical trials have conclusively demonstrated that Ex-Vivo Lung Perfusion (EVLP) is a reliable and beneficial technology. The INSPIRE trial conducted for TransMedics OCS recruited standard donor lungs for bilateral lung transplant and showed a 50% lower cumulative incidence of primary graft dysfunction. The HELP trial, which evaluated the XVIVO system, showed a 15% incidence of primary graft dysfunction at 72 hours, compared to 30% in the non-EVLP group, with no significant difference in survival. The NOVEL trial studied EVLP for extended criteria donors and revealed that 50.9% of initially unsuitable grafts were successfully transplanted.

11. What ongoing research and development efforts are taking place in the field of heart and lung transplantation technology, and what breakthroughs can we anticipate in the near future? Presently, the major hurdles in transplantation are devising personalized approaches, which can potentially eliminate the need for lifelong immunosuppression, and expand the pool of donors feasible for human transplantation. Three emerging technologies tackle these challenges. Single-cell RNA sequencing technology is evolving rapidly and has revealed new molecular signatures involved in alloimmune responses. Sophisticated nanotechnology platforms enable the delivery

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of immune-modulating agents that can precisely target the host immune response, leading to donor-specific tolerance. CRISPR/Cas9 gene editing technology has the potential to remove immunogenic molecules while inserting desirable regulatory ones with great precision. This technology can generate genetically modified pigs for xenotransplantation, which can solve the issue of the shortage of human organs. Another futuristic ground-breaking innovation in the field of organ transplantation is bioprinting. Bioprinting involves creating three-dimensional structures using living cells, which can be used to generate functional organs and eliminate the shortage of donor organs. By using a patient's cells, organs can be created in the lab, making transplants more readily available and reducing the risk of rejection.

12. How do you see the collaboration between healthcare professionals, engineers, and data scientists evolving to further advance the field of heart and lung transplantation? With AI assuming a pivotal role in the coming years in heart and lung transplantation, the importance of collaborations between clinicians, system experts and data scientists cannot be overstated. Partnerships allow for the exchange of expertise, resources, and technologies. Engineers bring real-world applications, commercialization capabilities, and funding, while healthcare professionals contribute

Key challenges of incorporating Artificial Intelligence into the transplantation domain are the development of effective regulatory frameworks and ensuring responsible innovative practices.

clinical knowledge, specialized facilities, and research capabilities. Data scientists develop algorithms to learn patterns from clinical data to generate predictive models using AI. These collaborations foster the translation of clinical research into practical solutions, accelerating the development of innovative technologies and their applications.

13. Are there any specific challenges or limitations that you foresee in the continued adoption of these technologies in heart and lung transplantation? The key challenges of incorporating AI into transplant include obtaining relevant data with good quality, incorporating algorithms into decision-making processes, and identifying criteria for adoption. Collaboration among organizations, cross-functional teams, and international partnerships are crucial for driving innovation in organ care technology. Such partnerships help in sharing knowledge, resources, and expertise, leading to the w w w. a m e r i c a n h h m . c o m

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development of effective regulatory frameworks and responsible innovation practices. It can help overcome challenges, improve outcomes, address organ shortages, and transform healthcare.

It has been estimated that the implementation of AI across healthcare could result in savings of around $200 billion to $360 billion per year, equivalent to a 5-10% reduction in healthcare spending.

14. Could you share insights into the cost-effectiveness and accessibility of these advanced technologies for patients in need of heart and lung transplants?

15. Finally, what advice or recommendations do you have for healthcare institutions and practitioners looking to incorporate these innovations into their transplantation programs effectively? For implementing any new technology into clinical practice, it is imperative to have thorough training, structured protocols, robust validation, and regulatory checks to avoid causing harm to patients and to effectively advance the standard of care. Maintaining safe, reliable systems and infrastructure, enhancing oversight and increasing transparency of the peer-review process can help effective implementation of newer technology into clinical practice.

Dr. Anitha Chandrasekhar is a Cardiothoracic surgical professional with over 2 decades of involvement in cardiac surgeries including the entire spectrum of congenital, coronary, valvular, aortic, heart and lung transplantation, and ventricular assist device implantation procedures. She has presented scientific papers extensively in national and international surgical conferences and published articles in indexed journals. She has held leadership positions in various associations and carved a unique pathway in the cardiac surgical domain. As a passionate ‘Surgical Scientist’, she is currently serving a hybrid surgical plus research role as a Clinical Lead- Lung Bioengineering and Organ Procurement at Northwestern Medicine, Chicago, IL, USA.

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AUTHOR BIO

AI techniques can reduce inaccuracies in data, resulting in reliable outcomes and reduced expenses associated with errors. It can be cost-effective as hospitals can reduce the time and resources spent on manual processes by automating repetitive tasks and freeing employees to focus on more strategic objectives. Automation also helps minimize errors and increase consistency, leading to improved decision-making and better patient experiences.

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NEGOTIATING THE TIGHTROPE

Am I a Dictator in the Realm of Critical Decision-Making?

Navigating the complex world of healthcare often places us, as physicians, at the crossroads of critical decision-making. Traditionally, these decisions are viewed through a medical lens, focusing on diagnosis, treatment options, and clinical outcomes. However, my recent journey through a negotiation course illuminated a different perspective, revealing the intricate negotiations inherent in patient care. I aim to explore how the principles of negotiation intertwine with the decision-making processes in a medical setting, particularly in critical care situations where there is significantly high-risk care associated with a high degree of uncertainty. The Revelation and Integration of Negotiation in Medicine

Shilpi Mittal Teleneurology and Telestroke Medical Director, Thomas Jefferson University Hospital

The realization dawned during my course in negotiation. The daily interactions with patients, the discussions of treatment plans, and the decisions made in critical care settings closely mirrored the dynamics of negotiation. This epiphany was transformative, almost like my own “eureka” moment. Medicine, I realized, is not just about clinical expertise; it's a delicate balance of understanding patient needs, negotiating treatment options, and aligning these with medical best w w w. a m e r i c a n h h m . c o m

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practices. This transformative realization reframed my perception of patient care. Each discussion about treatment options, each decision about a patient's care plan, was not merely a medical judgment; it was, in essence, a negotiation with various stakeholders: the patients, their families, and the medical team. These negotiations, however, were distinct from conventional business negotiations; they were imbued with ethical considerations, emotional undercurrents, and the critical importance of life and health. In the realm of critical care, where decisions often have life-altering consequences, the negotiation process takes on a unique form. It requires a delicate balance between imparting medical expertise and respecting the patient's autonomy and values. This balance is critical in creating a shared decision-making process, a fundamental aspect of patient-centered care. We need to present the best evidence from scientific research in the most neutral manner possible, while still staying on track as a guide to help patients make the best clinical decision. Our years of experience and learning help us devise the strategy to provide key insights to the patients so that we can collaboratively create value in this very crucial clinical decisionmaking negotiation process.

A Night of Decisions: The Case Study One stark example of this negotiation process in action occurred on a late December night. I received an urgent call about a 92-year-old patient who had suffered a mild stroke. Such 90

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patients are often dismissed as insignificant cases, as they are most likely to recover without any intervention, but these same patients may end up having devastating or life-changing clinical outcomes without thoughtful, timely treatments. As I interacted with the patient and her family through a telemedicine robot, I was keenly aware of the negotiation process that was about to unfold. The patient's condition presented a complex decision: whether to administer a life-saving but highly risky medication. This decision is not only high risk but also highly time-sensitive, as our brain loses millions of neurons every minute. In discussing the treatment options with the patient's family, I found myself utilizing key negotiation concepts. The approach was reminiscent of integrative negotiation, where the goal is to find a mutually beneficial solution – a win-win situation. I offered the aggressive treatment to minimize any risk of future worsening of existing symptoms and also discussed the possible significant side

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effects of the medication with the patient and her family. Information about the medication's benefits and risks was presented carefully, ensuring clarity and transparency. This approach was akin to establishing the ZOPA (Zone of Possible Agreement) in negotiation terminology. The ZOPA in this context was the range of treatment options that would be medically sound and acceptable to the patient and her family. On one end of the ZOPA was taking this medication and getting the full possible chance of recovery from stroke while carrying a potential risk of bleeding, and at the other end was the risk of having incomplete stroke recovery with potentially zero risk of bleeding. Risk always remains in the actual imprecise unpredictability of the outcome, for which I presented the updated details of research from the last two decades related to the medication. Throughout the discussion, I employed various negotiation strategies. I also presented the Best Alternative to a Negotiated Agreement (BATNA), which in this scenario, was opting for conservative management without the medication. Conversely, the Worst Alternative to a Negotiated Agreement (WATNA) – the possibility of severe deterioration without the drug – was also discussed. These concepts were crucial in laying out the entire spectrum of choices to the family. After a thorough discussion, the family decided against the use of the medication. Initially, I was disappointed in myself for not being able to communicate the importance of the medication effectively, perhaps, and I was also underwhelmed by the

lack of medical understanding by the family. I curiously asked the family, with a learning mindset, about their rationale for not taking the medicine, and they expressed that my patient, who was aphasic and could not express her own decision, would not have wanted any aggressive treatment based on her legal will and the family was respecting her wishes. I immediately felt relief that this decision, while not aligned with my initial best medical opinion, was very important to my patient who could not speak up for herself. This outcome highlighted the importance of patient autonomy in medical negotiations. It was a clear demonstration of the principle that in healthcare, the success of a negotiation is not measured by persuading the other party to accept one's point of view or opting for the best possible treatment, but rather in reaching a decision that respects the patient's values and wishes, while also being medically sound.

Reflections on Personal Negotiation Style – Lessons Learned and Future Directions This experience was introspective, prompting me to reflect on my negotiation style. In a medical setting, the negotiation is not about winning or losing but about finding the best path forward for the patient. It requires empathy, active listening, and the ability to present information in a balanced and unbiased manner. This situation also highlighted my tendency to lean towards a decision that “I” professionally deemed medically optimal, which could w w w. a m e r i c a n h h m . c o m

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inadvertently influence the patient's personal choice. It was a reminder of the importance of maintaining neutrality and allowing the patient and family to arrive at a decision that they deemed best. The experience with the stroke patient and her family was a significant learning curve. It taught me the importance of integrating negotiation skills into medical practice, especially in critical care settings. In future scenarios, I aim to focus more on facilitating patient autonomy and ensuring that every decision is a collaborative process. This incident has also emphasized the need to continually refine my communication skills, ensuring that I can convey complex medical information in an understandable and non-coercive manner. I am slowly but constantly working on curtailing my inherent competitive bargaining negotiation style, especially in highly emotional patient care situations, and building on a more collaborative and accommodating negotiation approach. I also realized that sharing multiple clinical offers/options with patients helps them understand that I value their input and signals my flexibility and willingness to accommodate their needs in this process, which is of utmost priority to me as a physician. It is extremely important for me to “Create value” rather than “claim value” in the world of healthcare. For the most effective negotiation with patients and their families, I need to be an active listener, make a genuine effort to understand their perspective, build trust, and explain my thought process rooted in science. 92

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Conclusion In conclusion, this case study underscores the intricate role of negotiation in the field of medicine. It highlights the unique challenges and responsibilities of healthcare providers in navigating these negotiations. The lessons learned from this experience are invaluable, not only in enhancing my approach to patient care but also in understanding the broader implications of negotiation in the medical field. In the end, the true measure of success in medical negotiations is not in the outcome itself but in the process of reaching a decision that is based on mutual trust and upholds the principles of patient autonomy, medical ethics, and compassionate care.

AUTHOR BIO

Shilpi Mittal serves as the Teleneurology and Telestroke Medical Director at Thomas Jefferson University Hospital. In this role, she oversees and directs medical services related to neurology and stroke through telehealth technologies. With expertise in leveraging remote healthcare solutions, Shilpi Mittal contributes to advancing neurological care and stroke management at Thomas Jefferson University Hospital Acknowledgement: The author would like to extend sincere gratitude to Dr. Aniruddha Singh for his invaluable assistance in proofreading and editing this manuscript.

INDUSTRY SENSE

Innovations in Digital Health

Transforming Patient Care *This is 3 part series. Episode 2 will be published next month on our website.

Welcome to our panel discussion on "Innovations in Digital Health: Transforming Patient Care." Our questionnaire is divided into three series, each exploring different facets of the transformative landscape of digital health.

OUR PANELISTS INCLUDE

Series 1: Introduction to Digital Health Journeys Piyanun Yenjit Founder & Managing Director at APUK Co., Ltd., is a visionary leader driving innovation in healthcare.

In Series 1, our experts shared their stories and knowledge, giving you a sneak peek into the world of digital health innovations. Get ready for a captivating journey through the evolving landscape of healthcare innovation.

Dr. Vicknesh Krishnan Vice President, Healthcare at Malaysia Health Tourism Council; bridges traditional healthcare with cutting-edge technologies. Dr. Dipu Patel Digital Health Thought Leader, Educator, and Healthcare Start-Up Advisor, guides the next generation and fosters innovation. Dimitrios Kalogeropoulos CEO of the Global Health & Digital Innovation Foundation, brings a multifaceted perspective with expertise in AI, healthcare, and global health initiatives.

PIYANUN, as the Founder and Managing Director at APUK Co., Ltd., can you share your journey into digital health and highlight any specific projects or initiatives that define your commitment to transforming healthcare through innovation? Sure thing! My journey into digital health started when I was working as a nurse. I first recognized how Technology could be in supporting clinical operations. This insight sparked my transition into the IT domain, leading me to the role of IT Director. In this capacity, I played a pivotal role in helping the hospital achieve the HIMSS EMRAM Stage 6 Standard which was a

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significant milestone to measure the effective use of IT and management outcomes in clinical. Understanding the critical importance of IT in hospitals, my focus shifted to integrating technology with business processes. This was not just about adopting new technologies, but ensuring they seamlessly supported patient safety and streamlined processes. It also involved leveraging technology to drive business growth. In my current position as Founder and Managing Director at APUK Co., Ltd., I've carried forward this philosophy. We've initiated various projects and initiatives aimed at transforming healthcare through innovative technology. Each project is a step towards enhancing patient care and operational efficiency, reflecting our commitment to innovation in healthcare.

Dr. VICKNESH, with your role in medical devices and technology industry, could you provide insights into how digital health innovations are being integrated into large-scale medical care facilities, and what impact they are having on patient outcomes? Integration of digital tools to improve overall patient experience, which eventually is aimed at building more trust, confidence and retain loyalty. Digital health tools are also incorporating preventive measures, where consumers’ state of health is assessed to understand the needs before a care can be delivered, before and after discharge. This gives a personalized touch to patients to improve outcomes

Digital Health Evolution: Experts explore AI, collaboration, and patient empowerment in reshaping healthcare globally. Join the journey through transformative innovations.

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and at the same time build their trust and improve satisfaction. The buzz now is all about the patient journey and how this is reimagined to accommodate the needs and demands of care in healthcare. Seamless integration for eg telehealth to remote monitoring is turning heads to embrace new-age care. The eyes are on digitalfirst health systems which is the platform to improve and enhance patient outcomes and sustainability with quality of care.

Dr. PATEL, as a Digital Health Thought Leader and Educator, how can education play a role in overcoming challenges related to user adoption and ensuring healthcare professionals are well-versed in leveraging digital health tools effectively? Education is crucial to overcoming challenges related to user adoption. There are several ways this can be accomplished. First, offering continuing education courses focused on digital health tools and technologies can promote lifelong learning while ensuring they remain current with new technologies. Second, providing research and development opportunities can help clinicians better understand the value of these innovations and aid in a hands-on experience in the development of the tools while meeting the needs of the users (clinicians) and patients. Third, preparing leaders to manage transitions to digital health systems is essential. Education can empower leaders to drive adoption and shape organizational culture to be accepting of the shifting landscape of healthcare. Finally, overarching policy and interprofessional education can prepare the entire healthcare team to learn from each other.

DIMITRIOS, with your extensive background in AI and medicine, where do you see the most promising opportunities for AI-driven digital health solutions to improve patient outcomes and healthcare delivery?

INDUSTRY SENSE

While research publications continue to grow exponentially in the digital health space, implementation and evaluation of digital technologies that use AI functionalities to support patient-centric care are lagging. Relatively few follow the path to regulatory approval and market validation. Most startups that make it to the clinical setting support clinical workflows and augment the field of applications and efficacy of radiology. Remote patient monitoring is also a promising field of application for AI; one which can revolutionise precision medicine and individualise access to care for patients with suboptimal outcomes with current standards of care, for example many oncology patients. AI applied to precision medicine and individualised evidence-based medicine emerged twenty years ago a few years apart and against a background of systems biology. The combined application of the disciplines aims to improve clinical research, translation and healthcare delivery, addressing disease heterogeneity and genetic variability that leads to the poor efficacy of one-size-fits-all health care. AI helps with drug-diagnostic co-development and the use of predictive safety and efficacy biomarkers. Deep learning further evolved the field with the aim to individualise the practice of evidence-based [stratified] medicine and eventually led to numerous meaningful modern day large language model (LLM) applications. Among other things, LLMs are being applied to the interpretation of digital pathology images or in research data curation, to discover biomarkers in electronic health records and to alert clinicians about hidden comorbidities. An important goal for AI has been to accelerate personalised knowledge mobilisation for secondary uses in research and health care without the need for human supervision during multimodal learning. To have such a transformational impact, AI needs access to real-world population-level outcomes to deal with variability and bias impacting treatment outcomes negatively or when using foreign data sets to train clinical translation models. The challenge for researchers is that despite the many notable efforts to strengthen the role of primary care in health systems, silos and fragmentation in health informatics and digital innovation persist. AI holds the potential to address this adaptive challenge by empowering a workforce adept to collaborative leadership and innovation and with that to change the tide of personalised medicine further upstream. This opportunity is offered by LLMs as foundation models that shift the overarching digital health adoption paradigm from offline fit-forpurpose innovation to adaptive continual learning AI for upstream innovation that is underpinned by downstream market validation.

Today’s healthcare setting is a highly complex and comorbidity challenged ecosystem. Demographics and climate impact add complexity and limit treatment options for many patients. Drug repurposing, biomarker discovery and precision treatment selection offer important solutions for rational use of drugs and targeting defined subsets of patients for patient-centric outcomes. To be able to respond, health systems need to evolve to support adaptive innovation that factors in individuals’ social, genetic and digital determinants of health. AI is uniquely positioned to access that evidence dynamically and to identify interactions and pathways to predicted outcomes. With connected health and adoption of telehealth technologies there is a unique opportunity to bridge the growing innovation divides to address the gaps in data and reciprocally knowledge, to deliver upstream AI solutions that weave clinical and research decision streams into patient-centric care delivery models. This leads to meaningful evidence; AI uses and innovation that incrementally drive improved outcomes with timely and targeted prevention. Future improvements in health care will come from AI innovation that resists the ephemeral and reductionist view of siloes, in favour of scalable, transformational and sustainable innovation, equity and inclusion. Empowering patients with new forms of participation will lead to collaborative innovation ecosystems. At the current pace of progress in conversational and generative AI, soon, if one can describe a concept in natural language, AI will be able to unpack it and predict alternative futures based on the concept structure and past evidence; futures that we simply cannot see at the current level of disease detection enabled by standard-of-care medical devices. To get to such a capacity responsibly, it is critical that we carefully consider the quality of used evidence with digital inclusion. For that we must couple AI capabilities with the reach and ecological validity offered by telehealth innovation and robust industry standards for governance in addition to market regulation.

PIYANUN, how can digital health innovations be designed to empower patients, especially in regions where access to healthcare may be limited?" Nowadays, with the advancement of telemedicine technology, distance has become a less significant

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barrier in healthcare. But it's essential to have a reliable IT infrastructure in place to support effective two-way communication. We can innovate in this space by integrating our clinical knowledge and experience apply with technology to create interactive tools for patients. These tools empower patients, especially in regions with limited healthcare access, by allowing them to perform symptom-checker, self-assessments, and monitor their health with key data elements like blood glucose levels, systolic and diastolic blood pressure, and pulse rate can be tracked. This approach not only empowers patients by giving them tools to manage their health but also allows for close monitoring by healthcare providers. It bridges the gap in healthcare accessibility and ensures continuous patient care, regardless of geographical limitations. Through these innovations, we're striving to make healthcare more inclusive and patient engagement.

Dr. VICKNESH, within the context of your previous industry experience, how do you see personalized medicine evolving with the integration of digital health technologies, particularly in the realm of renal care? It is as rapid as one can imagine – digital technology is revolutionizing renal care by enabling a more personalized, data-driven and patient-centric approach to diagnosis and treatment. A few key trends can be named to have fueled this transition, namely genomic and biomarker profiling, precision diagnostics, data analytics, patient engagement and education AND the need for and importance of an integrated health system. The ultimate aim is for early patient involvement, empowering them to make informed + shared decisions and enabling them to have quality of care.

Dr. PATEL, what guidance can you provide to emerging digital health startups navigating the complex regulatory landscape, ensuring compliance while fostering innovation?

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Navigating the regulatory landscape is important for the success of digital health startups. Startups should familiarize themselves with the relevant regulations based on their region, sector, and type of technology. For example, understanding the specific requirements of ISO 13485 if it applies to your product, is important for scalability. Furthermore, proactively reaching out to regulatory bodies can provide valuable insights into compliance requirements and can save time by navigating the regulatory hurdles early in the development process. Additionally, it is important to build an interprofessional and cross-functional team with expertise in healthcare, technology, and legal compliance. This approach allows for the consideration of diverse perspectives and assure that regulatory requirements are integrated into the product development of the lifecycle. Throughout the process, patient privacy and data security should be kept at the forefront, with a focus on aligning valuebased care principles and patient outcomes. Finally, transparent communication with stakeholders and partners will aid in maintaining a healthy balance of growth, scalability, and trust.

DIMITRIOS, how can global collaboration and standardization efforts in digital health contribute to addressing both regulatory and ethical considerations on an international scale? The pressures applied to health and healthcare systems during the Covid-19 pandemic exposed global health systems lacking in fundamental resilience. Most of the world’s population was neglected or underserved regarding their fundamental needs. In response, international development, regulatory agencies, and normative organizations, realigned their strategies and policies with the need for collaboration. The United Nations, the World Health Organization, the Organization for Economic Cooperation and Development, the World Economic Forum have all published relevant approaches. The many challenges facing health systems and technology adoption require a new culture of adaptive leadership. Regulatory agencies need to adapt and to embrace continual learning, providing improved support for participatory care. With that, digital health technologies aim to disrupt the standard of care; however the industry has

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been focused on point measurements of health services access and utilisation not on the integrated patient experience. The advent of generalpurpose AI challenges this practice and necessitates changes in evidence-based medicine, to no longer aggregate data on disease trajectories but to dynamically interpret an individual’s experience and to answer new research questions that challenge traditional care models. In this context, transparency can no longer be pursued solely as an ethical consideration at the level of leadership and decision-making regarding AI governance but to also deliver meaningful patient-centred uses of AI. Transparency must be a cross-cutting regulatory and standards-setting consideration on an international scale. Transparency leads to clinically robust collaboration and the mitigation of underrepresentation in AI uses that entrench healthcare disparities. There are numerous good startups out there that respond to unmet patient needs and to then need to improve and personalise the standard of care. The question is how we can enable collaboration between those startups globally with competitive-collaborative shared-value ecosystems to tackle transparency collectively and to address the data asymmetries and innovation disparities that undermine global health. For that we need integrative international standards that raise the bar for digital innovation.

PIYANUN, could you share examples of successful collaborations or partnerships within the digital health ecosystem that have driven positive outcomes or innovations? In my view the digital health ecosystem, which encompasses 3Ps Patients, Providers, and Payors, we've seen some dynamic collaborations that have driven positive outcomes and innovations. The rapid growth of healthcare technology has been instrumental in improving operational flow and patient safety. However, a major challenge in this ecosystem is the financial support from payors, such as health insurance companies. One key strategy is embedding data science with medical logic into the system to support patient financing. This approach not only benefits patients by making healthcare more affordable but also aligns

Innovations transforming patient care, where AI, collaboration, and patientcentric solutions shape the future of healthcare.

the interests of providers and payors. By integrating financial considerations with medical logic, we ensure that patient care is not compromised due to financial constraints. This approach not only streamlines the process for patients and providers but also allows payors to make informed decisions based on medical necessity and cost-effectiveness. Such collaborations are essential in creating a more efficient, equitable, and patient-centric healthcare system.

DIPU PATEL, how can startups and established corporations collaborate effectively to accelerate the adoption of digital health solutions, ensuring a balance between innovation and scalability? This is something that all corporations struggle with in different ways. One way to begin is to define common goals and cultural alignment while moving together towards a shared vision; this can be improving patient outcomes, increasing accessibility, or even reducing costs. Whatever the goal, leveraging the strengths of each corporation can help effectively scale digital health solutions. Another way to scale, is by implementing pilot programs. This can help test solutions in beta and get quick feedback to improve, pivot, or adapt

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from real-world users. This can help in continuous improvement for both the startup and the established corporation. Furthermore, established corporations can provide resources and access to networks that can be mutually beneficial, allowing for knowledge sharing and mentorship. In sum, the alignment of overarching goals and culture can go a long way in creating synergy for both startups and established corporations.

DIMITRIOS, which emerging technologies do you believe will play a crucial role in shaping the future of digital health, and how might they redefine the patient experience?" There is an array of innovative digital health solutions and devices out there, many supporting new virtual care models and already transforming healthcare access, quality and outcomes. As market approval can be complex and expensive, the majority are supported in this regulatory path to commercialisation and health reimbursement by private equity and venture capital, as well as national and international grants and public-private accelerator programmes. They include numerous innovations in remote care, treatment personalisation and intelligent automation. Invariably they aim to expand access to care, to redefine the patient experience, and hold the potential to improve equity in universal health coverage. An impediment is that the traditional concept of access to care on which they focus – that of service availability and utilisation, is no longer sufficient. The question is how these technologies can be operationally connected to expand access to care in a patientcentred manner to deliver the hospital at home and to improve the patient experience in both chronic and acute care. We are not short of innovative ideas that enhance the patient experience leading to opportunities for participation and collaboration. What we consistently fail with is to scale innovation and for that we need a new culture of open collaboration. Creating an inclusive and trusting health care environment in which everyone can contribute fully is critical. So is strengthening connections between organisations for more coordinated primary care and public health services. However, introducing

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processes that create a more open and participatory environment can be a challenge. This is where emerging technologies come in. The power the development of new industry standards that are fit-for-purpose to change ecosystem building and enable a connected health paradigm that spans the entire ecosystem, from services that monitor and respond to climate-induced comorbidity and social determinants of health, to shadow prevention, a more cost-effective referral system, and disease management with individualised treatment targets, precision care plans and improvements in patient outcomes. Redefining the patient experience requires connecting these dots with data repurposing/ recycling.

Dr. VICKNESH, how do you foresee the continued evolution of telehealth services within the broader landscape of digital health, especially in the context of patient care in Malaysia? Gaining popularity during the COVID-19 pandemic, the utilization of telehealth services in Malaysia has increased over the past several years, with 88.8% being assisted consultations with e-prescriptions and 11.2% being direct consultations. This is already showing us that what’s going to brew further is enhanced telehealth services that will aim to improve access and fill existing gaps in the healthcare system. The need for remote monitoring is rising within the country where early intervention is a key element to seek greater outcomes. The future looks bright with the emergence of health technology startups and the promising adoption (which is about 50%) of teleconsultation in public primary care clinics. What’s notable to say here is also that the first connected healthcare service (which includes telehealth and remote monitoring) was launched by a private hospital in Malaysia in 2023, spelling further growth of this need in the country? Thank you all for the invigorating & gripping session. Your insights contribute to both a concise magazine feature and in-depth online discussions! I am sure there is a lot for our readers to take back home.

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International Conference on Surgery and Surgeons 15 - 16, February 2024 Rome | Italy About the Event: Surgeons Meet 2024 is designed to provide a diverse and current education that will keep medical professionals up to date on issues affecting the diagnosis, treatment of surgical disorders, and prevention. The main emphasis and theme of the conference are “Surgery Horizons: Exploring Innovations, Enhancing Outcomes”. URL: https://www.meetingsint.com/conferences/ surgeons

Medlab Middle East 2024

Listed Under: Surgical Speciality

5 - 8 February 2024

CDO Healthcare Exchange

Dubai

21 - 22 February 2024

About the Event: Medlab Middle East 2024 is a symphony of cutting-edge breakthroughs, a canvas of limitless networking possibilities, and a gateway to the future of medicine.

Fort Lauderdale| USA

URL: https://www.medlabme.com/en/home.html Listed Under: Technology, Equipment & Devices

SPIE Medical Imaging 2024 18 - 22 February 2024 California |United States

About the Event: The data community event exclusively for the healthcare industry with ever changing FDA regulations, Value-Based Care, huge competition from new players such as Amazon and CVS Health as well as a harsh employment and financial market, it’s a tough but exciting time in healthcare. Data and data leaders are sure to play a key role in ensuring companies navigate these challenges successfully URL: https://www.iqpc.com/events-cdo-healthcareexchange/index

About the Event: SPIE Medical Imaging is the internationally recognized forum for reporting state-of-the-art research and development in medical imaging. The event focuses on the latest innovations found in underlying fundamental scientific principles, technology developments, scientific evaluation, and clinical application. The symposium covers the full range of medical imaging modalities focusing on image acquisition, display, processing, analysis, perception, decision support, and informatics. URL: https://spie.org/conferences-and-exhibitions/ medical-imaging#_=_

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Healthcare CNO Summit 22 - 23 February 2024 Dallas | USA About the Event: The Healthcare CNO Summit is an invitation-only, premium Summit bringing leading Nursing Officers and innovative suppliers and solution providers together. The Summit’s content is aligned with key clinical trial challenges and interests, relevant market developments, and practical and progressive ideas and strategies adopted by successful pioneers. URL: https://www.feb24.nhcno.marcusevanssummits.com/?utm_source=website&utm_ medium=banner&utm_campaign=ochremediabanner#/BackToTop Listed Under: Healthcare Management

Digital Health 28 - 29 February 2024 Stanford | US About the Event: Life science, NGOs and academia in the research and development of digital health solutions to improve global health outcomes. The evolution of digital health solutions is creating new opportunities to transform patient care and personal health outcomes. From remote monitoring and wearable’s to artificial intelligence and machine learning, digital technologies are enabling health data collection and analysis and offering new insights, diagnosis and therapies. URL: https://www.timeshighered-events.com/digitalhealth-2024 Listed Under: Information Technology

Healthcare CMO Summit

International Conference on Nuclear Cardiology and Cardiology

22 - 23 February 2024

25 - 26 March 2024

Dallas | USA

Boston | USA

About the Event: The Healthcare CMO Summit is an invitation-only, premium Summit bringing Chief Medical Officers and innovative suppliers and solution providers together. The Summit’s content is aligned with key clinical healthcare challenges and interests, relevant market developments, and practical and progressive ideas and strategies adopted by successful pioneers.

About the Event: The central aim of the Conference is to share knowledge and to enlighten about novel advancements, anticipate problems in the field of Business Management and Social Innovation from Emeritus Professors, Eminent Scientists, Faculties like Directors, Senior Professors / Assistant Professors / Associate Professor, Experts in the field of Business Management and Social Innovation, Research Scholars, Industrial Delegates and Student Communities in the relevant fields.

URL: https://www.feb24.nhcmo.marcusevanssummits.com/?utm_source=website&utm_ medium=banner&utm_campaign=ochremediabanner

Listed Under: Medical Sciences

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European Medical Device Summit 30 - 31 May 2024 Berlin, Germany About the Event: The European Medical Device Summit sets the benchmark for industry collaboration and idea exchange. This event offers valuable insights and tactics to enhance the professional growth of executives engaged in medical device aspects such as design, product development, innovation, technology, and quality/ regulatory matters.

Clinical Advances in Heart Failure, Arrhythmias and Cardiogenic Shock Symposium

URL: https://emdsummit.com/ Listed Under: Technology, Equipment & Devices

Date: 26 - 27 April 2024 San Diego | California About the Event: This conference will cover a wide range of topics including the diagnosis, management, and state-of-the-art treatment for heart failure, cardiac arrhythmias, cardiomyopathies and cardiogenic shock as well as a variety of co-morbid and chronic conditions patients with heart disease may face. URL: https://www.scripps.org/events/clinicaladvances-in-heart-failure-arrhythmias-andcardiogenic-shock-symposium-april-26-2024 Listed Under: Medical Sciences

International Conference on Emerging Nuclear Medicine and Radiology 23 - 24 May 2024 Denver | USA About the Event: International Conference on Emerging Nuclear Medicine and Radiology strives to serve all those engaged in the discipline of Emerging Nuclear Medicine and Radiology as an avenue for growth and community-building. URL: https://asar.net.in/event/index. php?id=2270945 Listed Under: Medical Sciences

12th World Congress on Nursing & Health Care 24 - 25 June 2024 Valencia, Spain About the Event: World Nursing Congress 2024 brings together individuals who have an interest in different fields of nursing like psychiatric, cancer, cardiac, critical care, adult & women health, legal, pediatric and emergency nursing, midwifery, public health, healthcare and medicine from practice, research, administration, policy and education. It is a forum to explore issues of mutual concern as well as exchange knowledge, share evidence and ideas, and generate solutions. URL: https://nursing-conferences.org/ Listed Under: Medical Sciences

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Experience the Pinnacle of Healthcare Advancements at Arab Health 2024: A Global Summit of Innovation and Collaboration Embark on a transformative journey at Arab Health 2024, the foremost gathering for the global healthcare community, taking place from January 29 to February 1, 2024, at the prestigious Dubai World Trade Centre. In a commitment to fostering excellence, Arab Health introduces an enhanced visitor experience with a new ticketing system. Seize the opportunity to secure your complimentary access by registering before January 4, 2024, and become a part of shaping the future of healthcare.

Anticipate a Glance into the Future: • Professional Visits: Over 68,000+ healthcare professionals immersing themselves in the latest advancements. • Exhibiting Companies: Connect with 3,450+ trailblazing companies driving innovation in healthcare. • Participating Countries: Immerse yourself in a truly global event with representatives from 180 countries. • Conference Delegates: Engage with 3,600+ conference delegates at the forefront of shaping healthcare's future.

Why Attend Arab Health 2024? • Networking Extravaganza: Meet and connect with influential leaders in the global healthcare community. • Future Insights: Gain invaluable perspectives through curated features and dynamic live sessions.

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• Unveiling Innovations: Explore groundbreaking solutions from 3,450+ visionary manufacturers. • Interactive Spectacle: Witness live demonstrations and directly engage with global healthcare innovators. Don't miss out on this exclusive opportunity to be an integral part of shaping the future of healthcare. Register now for Arab Health 2024 and elevate your understanding of the latest trends, innovations, and collaborations in the dynamic world of healthcare. Your journey into the future of healthcare starts here.

About Arab Health: Arab Health stands as the epicenter for addressing global healthcare challenges. Beyond being an event, it's a dynamic platform where regional and international policy drivers, thought leaders and healthcare professionals converge to explore groundbreaking solutions, share insights, and foster collaborations. The event serves as a spotlight for the progress and achievements of the healthcare sector, facilitating networking with industry leaders from across the globe. Join us at Arab Health 2024 for an unparalleled experience at the forefront of healthcare innovation and collaboration.

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Medlab Middle East 2024: Shaping the Future of Laboratory Excellence Igniting Progress in Laboratory Medicine, February 5-8, 2024, Dubai World Trade Centre In its 23rd year, Medlab Middle East takes center stage in propelling laboratory medicine forward, fostering growth, and catalyzing innovation. Set against the backdrop of the Dubai World Trade Centre from February 5-8, 2024, this event promises to be a transformative hub where challenges metamorphose into opportunities, customized solutions emerge, and strategies unfold to redefine the landscape of medical laboratories, not only in the Middle East but globally.

Global Impact, Local Precision: Redefining the Landscape of Healthcare Growth Medlab Middle East is evolving by adopting a paid visitor ticketing system starting from January 8, 2024. However, you have an exclusive opportunity to secure complimentary registration before this date. This strategic shift underscores our commitment to sustaining and elevating the quality of business and learning opportunities within the industry.

Key Event Highlights: A Glimpse into 2024 • Venue: Dubai World Trade Centre • Floor Space: 15,000 sqm • Attendees: 30,000+ • Exhibitors: 900+ • Visiting Countries: 180+ • Exhibiting Countries: 40+ • Country Pavilions: 12

Why Attend Medlab Middle East 2024? Embark on a dynamic convergence of knowledge, networking, and business-building opportunities.

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With an anticipated attendance of over 30,000, Medlab Middle East 2024 is positioned as a transformative journey, fostering connections and pioneering advancements in laboratory medicine. Dedicated Product Categories: Elevating Your Business Value Explore a rich spectrum of products at Medlab Middle East, meticulously curated to bring maximum value to your business, including Disposables, Healthcare/ General Services, Imaging, Infrastructure, IT, Laboratory, Medical Equipment, and Pharma/ Nutrition.

Why Exhibit? • Build Relationships: Forge connections with the entire spectrum of medical laboratory professionals, propelling existing relationships forward and unlocking new networks and channels. • Professional Engagement: With over 20,000 professional visits and 3,700+ delegates, seize the opportunity to engage with representatives from 180+ countries. • Showcase Innovations: Be at the forefront of the industry by presenting your products and latest innovations, benefitting from face-to-face networking, live product demos, and the chance to seal deals during the show. As Medlab Middle East 2024 marks a pivotal moment in the industry's evolution, seize the opportunity to be part of this transformative experience. Register for your complimentary visitor badge before January 7, 2024, and join us in Dubai for an event that is poised to shape the future of medical laboratories worldwide.

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Fuelling medical laboratory growth across the Middle East region and beyond

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5-8 Feb 2024 | Dubai World Trade Centre medlabme.com

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National Healthcare Chief Medical Officer (CMO) Summit – Hosted by Marcus Evans Welcome to the National Healthcare CMO Summit, an exclusive and invitation-only event that brings together Chief Medical Officers, innovative suppliers, and solution providers. This premium Summit is designed to address key clinical healthcare challenges, keeping pace with market developments, and showcasing practical and progressive ideas and strategies embraced by successful pioneers in the industry.

Distinguished Speakers Include: • Mark Olszyk, CMO – Carroll Hospital • Jason Globin, System CMO – Catholic Health • Jeetu Nanda, CMIO – Cone Health • Salim Saiyad, VP and CMIO – UPMC Central PA

Event Details:

• Theodore Glasser, Chief Medical Officer – Baptist Medical Center – Jacksonville

• Date: February 22 - February 23, 2024

• And many more.

• Location: The Las Colinas Resort, Dallas, TX, USA

Establish Connections, Foster Collaborative Efforts, and Drive Innovation in Healthcare Leadership.

Key Topics for 2024: The Role of Hospital Leadership: Strategizing with the healthcare triad to create resilient, highfunctioning hospital teams. Healthcare Access and Equity: Addressing healthcare disparities for quality care delivery and improving access to healthcare. The Workforce Crisis: Developing strategies to drive retention, engagement, and well-being among hospital staff.

Jason Golbin Chief Medical Officer, Catholic Health

Salim Saiyad VP and CMIO – UPMC Central PA

Healthcare Technology Integration: From integrating AI in hospital workflows to tackling digital health and telemedicine challenges. Driving Quality Care Delivery: Navigating the return to value-based care in the post-pandemic era. Healthcare Policy Updates: Evaluating the impacts of current and pending regulatory updates for physician leaders.

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Jeetu Nanda Chief Medical Officer, Cone Health

Theodore Glasser Chief Medical Officer – Baptist Medical Center – Jacksonville

Mark Olszyk Vice President of Medical Affairs, Carroll Hospital

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National Healthcare Chief Nursing Officer (CNO) Summit – Presented by Marcus Evans Join us at the National Healthcare CNO Summit, an exclusive and by-invitation-only event that brings together prominent Nursing Officers and forward-thinking suppliers and solution providers. This premium Summit delves into key challenges in clinical trials, market trends, and progressive strategies employed by successful pioneers in the field.

Event Details:

Chief Nursing Officer – Glen Cove Hospital • Devin Carr, DNP, RN, RRT, ACNS-BC, NEABC, CPPS, Regional Chief Nursing Officer – MainHealth • Julie Mirkin, Senior Vice President/Chief Nursing Officer – Geisinger • Wendi Goodson-Celerin, DNP, APRN, NE-BC, CNO – Alameda Health System

Date: February 22 - February 23, 2024

• Anne Marie Watkins, SVP/Chief Nursing Executive – UCI Health

Location: The Las Colinas Resort, Dallas, TX, USA

• And many more!

Key Focus Areas for 2024:

Connect, Collaborate, and Innovate at the Forefront of Healthcare Leadership.

Nursing Workforce Development: Cultivating a skilled, diverse, and resilient nursing workforce. Redesigning Nursing Care: Rethinking nursing practices and models. Digital Innovation in Nursing: Leveraging digital innovation to enhance nursing practice. Optimizing the Patient Experience: Exploring innovative approaches and best practices to improve patients' perception of care. The Multigenerational Nursing Workforce: Promoting intergenerational integration and collaboration. Navigating Financial Headwinds: Examining strategies for achieving and maintaining financial stability.

Distinguished Speakers Include: • Theresa A Dillman, MSN, MHA, RN, NE-BC,

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"41% of event professionals have put in on more events in 2023 than they originally planned."

Don't be left behind... We are here to help!

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FDA Gives Green Light to Butterfly iQ3: Next-Gen Handheld Ultrasound Unveiled

Butterfly Network, Inc., a pioneering digital health company at the forefront of revolutionizing healthcare with portable, semiconductor-based ultrasound technology and user-friendly software, has recently received FDA clearance for its cutting-edge handheld point-of-care ultrasound (POCUS) system, the Butterfly iQ3. This marks the third evolution of the world's premier semiconductor-based single-probe, whole-body ultrasound platform. The Butterfly iQ3 distinguishes itself with a fresh ergonomic design and boasts a doubled data processing speed, enhancing overall image resolution, sensitivity, and penetration capabilities. Additionally, the device accelerates 3D functionalities, introducing innovative automated image capture modes: iQ Slice and iQ Fan. This next-generation POCUS system is poised to redefine point-of-care ultrasound with its advanced features. The ergonomic design not only enhances user experience but also ensures optimal functionality for healthcare professionals. The doubled data processing speed represents a significant leap forward, promising heightened precision in imaging and diagnostic capabilities. Furthermore, the Butterfly iQ3's accelerated 3D capabilities open the door to novel automated image capture modes. The iQ Slice and iQ Fan features empower users with efficient and automated image acquisition, streamlining the diagnostic process. Butterfly Network continues to lead the charge in transforming healthcare through innovation, and the FDA clearance of the Butterfly iQ3 underscores the company's commitment to advancing portable ultrasound technology. With its groundbreaking features, this latest iteration promises to elevate pointof-care ultrasound to new heights, reinforcing Butterfly Network's position as a trailblazer in digital health.

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Paige's Virchow AI: Transforming Cancer Detection across Tissues Paige, a global leader in comprehensive digital pathology solutions and clinical AI applications, has unveiled a revolutionary product derived from its groundbreaking Paige Pathology Foundation Model, named Virchow. This innovative solution, empowered by access to one of the most extensive libraries of digitized images and unique computational resources from Microsoft Research, represents a significant leap forward in cancer detection.

Virchow, a pioneer in the field, stands out by detecting cancer across an impressive array of more than 17 tissue types, spanning skin, lung, and the gastrointestinal tract, as well as various rare tumor types and metastatic deposits. Unlike traditional methods that require months or even years to develop AI applications for cancer detection on a single tissue type, Paige's unique Foundation Model has shattered these constraints. Drawing insights from an extensive dataset of over 4 million digitized slides, Paige has achieved an unprecedented ability to efficiently create AI applications for cancer detection across a diverse range of tumor types - a remarkable achievement in the realm of AI-based cancer diagnosis. The outstanding performance of Paige's multicancer application across diverse tissue types has positioned it at the forefront of cancer pathology AI. Emphasizing their commitment to clinicalgrade accuracy, Paige is dedicated to seeking FDA regulatory oversight for products developed using the Foundation Model technology. This breakthrough heralds a new era in the efficiency and scope of AI applications for cancer diagnosis, marking Paige as a trailblazer in advancing healthcare technology.

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GE Healthcare to Acquire MIM Software for Advanced Medical Imaging Solutions

GE Healthcare has announced its acquisition of MIM Software, a prominent global provider of medical imaging analysis and artificial intelligence solutions. This strategic move positions GE Healthcare to leverage MIM Software's cutting-edge imaging analytics and digital workflow capabilities across various medical domains, from radiation oncology to molecular radiotherapy, diagnostic imaging, urology, and more. The collaboration aims to accelerate innovation, offering differentiated solutions for the benefit of patients and healthcare systems worldwide. As the healthcare industry undergoes a digital transformation, GE Healthcare is committed to developing intelligent devices aligned with specific disease states, enabled by digital technologies. The company's mission is to enhance hospital efficiency, empower clinicians, improve therapy precision, and ultimately contribute to patients' overall well-being. MIM Software's innovative imaging solutions bring valuable features to the table, such as the integration of diagnostic images from multiple modalities, task automation, quantitation, and advanced processing in diagnostic imaging and nuclear medicine. GE Healthcare plans to seamlessly integrate these solutions into its advanced visualization offerings, facilitating AI-based segmentation, contouring, and dosimetry analysis across various treatment journeys. This integration is crucial for supporting precision care in areas like oncology, radiation therapy, radiology, and molecular imaging. The acquisition aligns with GE Healthcare's focus on bolstering its offerings to meet the evolving demands of healthcare, especially in novel therapies. The company aims to provide critical information through advanced imaging, workflow solutions, and digital innovations, catering to diverse disease states and imaging practices. This includes addressing Theranostics in oncology, streamlining workflow solutions in radiation oncology, beta-amyloid imaging in neurology for Alzheimer's diagnosis, and myocardial perfusion for diagnosing coronary artery disease.

Medtronic's MiniMed™ 780G: World's First with Simplera Sync™ Disposable Sensor Medtronic plc, a leading global healthcare technology company, has announced the CE (Conformité Européenne) Mark approval for its revolutionary MiniMed™ 780G system, now equipped with the innovative Simplera Sync™ disposable continuous glucose monitor (CGM). This cutting-edge technology eliminates the need for fingersticks or overtape, providing users with a hassle-free experience. The Simplera Sync™ sensor, featuring a streamlined twostep insertion process and a compact size that is half that of previous Medtronic sensors, enhances user convenience. Scheduled for a limited release in Europe in spring 2024, the MiniMed 780G system with Simplera Sync™ sensor will undergo a phased commercial launch in the summer of 2024. This system represents Medtronic's pinnacle in insulin delivery, automatically adjusting glucose levels every 5 minutes. It boasts the exclusive Meal Detection™ feature designed to mitigate post-meal hyperglycemia by anticipating insulin needs when users forget or miscalculate carb intake. The system's unique 7-day infusion set and one of the lowest glucose target settings (as low as 100 mg/dL) distinguish it as a trailblazer in automated insulin delivery, closely mimicking non-diabetic glucose levels. Both the Simplera Sync™ sensor and the Guardian™ 4 sensor eliminate the need for fingersticks, providing a more seamless experience for users. Approved for ages 7 and above, the MiniMed™ 780G system with Simplera Sync™ is compatible with iOS and Android. While the Simplera Sync™ sensor is not yet FDA-approved and limited to investigational use in the U.S., its integration with Medtronic's advanced AID algorithm showcases a promising future in diabetes management. This announcement follows the CE Mark approval of the Simplera™ CGM for use with the InPen™ smart insulin pen in September 2023. Medtronic continues to spearhead innovation in healthcare technology, offering enhanced solutions for individuals living with

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Medical Milestone: Edison® Histotripsy System Unveils World's First Patient Treatments

HistoSonics, the pioneering manufacturer behind the groundbreaking Edison® Histotripsy System, has marked a historic milestone with the successful treatment of the world's first targeted liver tumor utilizing their cutting-edge technology. This achievement follows the recent FDA De Novo clearance for the Edison System, opening new frontiers in non-invasive medical interventions. A patient at the University of Rochester Medical Center was the fortunate recipient of this revolutionary treatment, while simultaneously, Cleveland Clinic initiated treatments for liver tumor patients in the same week. The Edison System, a marvel in image-guided sonic beam therapy, boasts proprietary technology and advanced imaging capabilities, enabling the delivery of precise and controlled non-invasive treatments. Leveraging the science of histotripsy, the system utilizes focused sound energy to induce controlled acoustic cavitation, effectively mechanically destroying and liquefying targeted tissue at subcellular levels. Specifically designed for the non-invasive mechanical destruction of liver tumors, the Edison System offers a solution for both partial and complete destruction of unresectable liver tumors through histotripsy. It's important to note that while the FDA has granted clearance for the Edison System, its evaluation for the treatment of specific diseases or conditions is pending. Additionally, federal law restricts the use of the Edison System in kidney applications for investigational purposes. HistoSonics' groundbreaking technology signifies a paradigm shift in the realm of medical interventions, ushering in an era of personalized, non-invasive treatments with unparalleled precision and control.

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Nanowear's SimpleSense-BP Secures FDA Nod for Revolutionary Blood Pressure Monitoring Nanowear, a pioneering force in healthcare-at-home remote diagnostics, has achieved a significant milestone with FDA 510(k) clearance for its innovative AI-enabled Software-as-a-Medical Device (SaMD) embedded in the SimpleSenseTM wearable platform. Boasting a cutting-edge nanotechnology-enabled design, SimpleSense-BP stands out as the first noninvasive, cuffless, continuous blood pressure monitor and diagnostic tool. This breakthrough is set to revolutionize the clinical diagnostic management of hypertension, complementing the platform's existing FDA-cleared cardiopulmonary diagnostics. With a total of four FDA 510(k) clearances, Nanowear's SimpleSenseTM holds a unique position in the market, supported by an impressive portfolio of 13 awarded and 12 pending patents. The patents cover a spectrum of areas, including nanotechnology, scaled nanosensor manufacturing, multi-parametric wearables, software platforms, ingestion pipelines, and AI algorithms, all seamlessly integrated into a closed-loop ecosystem. Versatility is a key strength, as SimpleSenseTM is designed for use in various settings, from the comfort of home to healthcare facilities and clinical research environments. The groundbreaking SimpleSense-BP introduces a 4-decision tree algorithmic model, validated thorough rigorous testing in three study arms. Both training and validation stages were conducted across independent geographies and demographic populations reflecting the latest US census data, ensuring generalizability to the entire hypertensive population. SimpleSense-BP's credibility is underscored by its validation to accurately track changes of > +/- 15mmHg systolic and +/10mmHg diastolic blood pressures over a continuous recording period. This capability is facilitated through the integration of a wearable undergarment and the AI platform, marking a significant leap forward in remote diagnostics and personalized healthcare.

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K Health Teams Up with Mayo Clinic for Cardiac AI Breakthrough

In a groundbreaking move, K Health, the AIdriven Primary Care Company, has announced a strategic collaboration with Mayo Clinic to pioneer advancements in the prevention and treatment of heart-related conditions. The collaboration will involve Mayo Clinic cardiologists, Dr. Francisco Lopez-Jimenez and Dr. Amir Lerman, who bring their expertise to the development of a cardiac clinical AI solution aimed at preventing premature deaths caused by heart disease and stroke. The cardiac program is set to leverage K Health's proprietary algorithms to fuel cutting-edge AIenhanced electrocardiography (AI-ECG) technology, conduct risk assessments, and implement remote patient monitoring. These innovative tools will empower physicians to personalize treatment for conditions like hypertension and high cholesterol or even prevent them altogether. Dr. Lopez-Jimenez and Dr. Lerman, as leaders in their field, will play a pivotal role in overseeing the development and applying their real-world insights to assess the accuracy and effectiveness of the solution. Since 2020, K Health has been refining its AI models and developing new algorithms using deidentified patient data licensed from the Mayo Clinic Platform. The AI models are designed to predict risk and optimal treatment by considering specific factors such as gender, age, medical history, and ethnicity. Scheduled to kick off in early 2024, this collaboration signifies a significant stride toward revolutionizing cardiac care through the fusion of AI technology and medical expertise. The initiative not only holds promise for more personalized and effective treatments but also underscores the importance of synergistic partnerships in driving healthcare innovation.

SimBioSys and Mayo Clinic Unite for AI-Powered Cancer Precision Medicine

SimBioSys, a pioneering TechBio company specializing in spatial biophysics powered by artificial intelligence (AI), has announced a strategic collaboration with the prestigious Mayo Clinic to advance digital precision medicine solutions for breast cancer patients. The collaboration focuses on the development of cutting-edge cloud-based clinical software tools designed to guide the entire decisionmaking process for early-stage breast cancer patients. This encompasses individualized surgical planning, treatment strategies, drug selection, and risk assessment, addressing the evolving landscape of breast cancer care. In a landmark move, SimBioSys is leveraging its AI and biophysical modeling expertise to analyze data from participants in the Mayo Clinic-led BEAUTY clinical trial (NCT02022202). The objective is to unlock spatial biophysical insights that enable clinicians to tailor personalized treatment plans. SimBioSys is actively engaged in the development of TumorSightTM, a cloud-based platform functioning as software as a medical device. Currently, under FDA review, TumorSight's initial product transforms a patient's standard of care DCE-MRI imaging into a bespoke 3D digital model of their tumor. This innovative tool empowers surgical oncologists with clear 3D visualizations, facilitating more effective surgical planning and patient consultations. Mayo Clinic, recognized as a Comprehensive Cancer Center by the National Cancer Institute, underscores its commitment to advancing patient care, education, and research through this collaboration. As part of the partnership, Mayo Clinic has shared valuable data, contributing to the refinement and validation of SimBioSys's groundbreaking platform. This strategic alliance marks a significant step toward redefining precision medicine for breast cancer patients, ultimately enhancing individualized care and optimizing treatment outcomes.

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