LUnis For MHS: Tomorrow‘s Healthcare Today Analyses and Recommendations by members of the LUnis team (names & university anonymized) Page 0
Agenda
Using the Strengths of American Healthcare for American Healthcare Future
Proposed solutions • The Semantic Web: Revolutionizing Data Management in Healthcare • RFID: Generating new Insights and increasing Supply Chain Transparency • Cyber Security Culture: Enabling Technology usage
Action Plan • Strategy Implementation Process • Roadmap and Timeline • Funding Model and Investment Required
Outlook
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Using the Strengths of American Healthcare for American Healthcare Future
Leverage potential
Strengths
IT & Cyber Security ⚫
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Basic IT infrastructure & IT knowledge available Analysis of consequences of data breaches
Organizational & Data management ⚫ ⚫ ⚫
Comprehensive collection of PHI and PII First Virtual Healthcare Approaches VBP triggering improvements in IT & data collection and management
Supply Chain ⚫
Flexibility − GPOs can freely choose their suppliers − Free movements of goods and patients
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IT & Cyber Security ⚫
Transform awareness into organizational change towards a technically advanced security culture
Organizational & Data Management ⚫
⚫ ⚫
Reorganize available data with Semantic Web technologies Extrapolate new insights from restructured data Feed the system with newly generated data by using RFID technologies
Supply Chain ⚫
Use the data insights to restructure the Supply Chain in a sustainable and transparent way considering both, goods and patient movements
Proposed solutions for MHS
Where we can help you to leverage the potential of your data
The Semantic Web: Revolutionizing Data Management in Healthcare
Three interconnected solutions where LUnis will support you throughout the planning and implementation
RFID: Generating new Insights and increasing Supply Chain Transparency
Cyber Security Culture: Enabling Technology usage
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The Semantic Web: Revolutionizing Data Management in Healthcare
The concept in a nutshell
Current situation: Data stored on separate local servers
Main idea: overcoming the classic hierarchical database model by developing a Semantic “Web of data” More than storing all collected data e.g. on a cloud-based SQL Server The same data as the one in traditional databases is stored
Interservice data transfer on demand sent via mail or fax Attempts for centralized data storage on traditional SQL databases within a single institution exist
- Redundancies - Little information - Not transparent
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The new twist: The “Semantic Web” links data in a secure and interactive matter; Stakeholders/institutions of MHS can create data stores on the Web and write rules for handling data Treatment of data e.g. the data of a traditional patient record (lab values, prescribed medication, personal data etc.) like an html file containing descriptive variables (patient, hospital, age, … = tag) allowing to search, organize and analyze information by tag. Linked data are empowered by technologies such as RDF, SPARQL, OWL, and SKOS to develop systems that can support trusted interactions over the network.
Outcome of this investment Better user experience of “virtual hospital” apps for doctors and patients by integrating facts from several datasets Real-time SPARQL screening is combined with algorithms assuring a high degree of confidence. The output, visualized as meaningful dashboards allows for holistic decision-making in patient-care. Prosperous clinical research, by bridging forms of biological and medical information across institutions leverages huge growth potential of the healthcare market.
Access to data controlled and monitored with access control tools like ones currently implemented for common databases such as SAP (e.g. “AIM” of KPMG)
The Semantic Web: Revolutionizing Data Management in Healthcare
Use cases exemplifying the three return-categories of the complex implementation & investment
Cost Minimizer
Growth Accelerator
Risk Reducer
Avoiding costly medical procedures
Leverage potentials of public health situation awareness and research
Increasing patient safety
Tissue biopsies are currently the only way to properly monitor transplant patients for organ failure related to immune rejection. They are needed to determine drug requirements of every transplant patient. Using the Semantic Web for the detection of patients at risk of organ failure through immune rejection could eliminate about 12 biopsies per heart transplant patients at a composite cost of $5,000- $10,000 each.
Using the Semantic Web technology for the generation of valuable insights by integrating unstructured text such as doctors’ notes into structured electronic medical records. Through a unified query interface the data is stored and contextualized so that it can be used for analysis by developing abstractions and models on top of the integrated data.
Drug safety: Over 200 thousand deaths each year result from adverse drug events, while threequarters of those deaths are believed avoidable if only existing knowledge could be effectively applied. An already existing application based on the Semantic Web solution enables the navigation of the complex interaction of drugs and people to identify the best trade-offs for each patient.
USA p.a.: 2,200 heart transplant patients; thus $198.000.000 savings (assuming biopsies: $7.5k)
Retrieval of all information which can be used for holistic research.
133,000 lives worldwide can be saved per year by avoiding adverse drug events.
The broad applicability to various use cases leverages the potential of secure and collaborative use of data. It allows to generate a holistic data management enabling effective patient-centric care.
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RFID: Generating new Insights and increasing Supply Chain Transparency
Real Time Tracking
Application Area ⚫
People: patients (especially elderly patients, physically or cognitively impaired patients and infants) and staff
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High-value portable medical equipment
What is needed?
How does it work? ⚫
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Active RFID tag wristband for each patient and employee
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Active RFID tag on each equipment item
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RFID readers throughout the hospital or clinic buildings
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Active RFID tag transmits a short-range radio signal Reader picks up the signal and measures the received signal strength through a trilateration between multiple readers to get the location for the RFID tag Reader sends data to the Semantic Web which analyses the data in order to provide valuable insights
Outcome ⚫
Driving patient safety: e.g. protect patients from the risks associated with injuries due to falls, wandering and elopement
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Reducing time-to-treatment: e.g. prioritize patients with critical needs through analysis of transfer times between departments
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Optimizing patient flow & Reduce waiting time: e.g. through higher transparency for patients and staff in the surgical trajectory
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Enhancing tracking of the treatment process: e.g. remind patients of upcoming scheduled events such as screening appointments
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Overcoming gaps in the internal workflow process: e.g. through analysis of staff locations throughout the day
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Ensuring availability of & Reducing capital expenditure for medical equipment: e.g. through reduction of misplacement
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RFID: Generating new Insights and increasing Supply Chain Transparency
Patient Identification
Application Area ⚫
Patients
What is needed?
How does it work? ⚫
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RFID tag wristband for each patient
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Handheld reader for nurses & doctors
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Nurse or doctor verifies patient identify with handheld reader Patient records are associated with the tag’s ID through the Semantic Web Reader provides information retrieved from the Semantic Web & stores newly entered information to the Semantic Web
Outcome ⚫
Driving Patient Safety: e.g. improvement of patient medication accuracy through access to accurate patient records
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Increasing quality & efficiency of anamneses: through immediate access to and update of patient records → Reducing labor costs → Increasing patient throughput
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No additional investment in tags: due to usage of same tags as for real time tracking
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RFID: Generating new Insights and increasing Supply Chain Transparency
Inventory & Sterilization Management
Application Area ⚫
Medicine
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Surgical instruments: e.g. scalpels, scissors, clamps and retractors
What is needed? ⚫ ⚫
How does it work? ⚫
Passive RFID tag inside or on each bottle or box of medicine
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Passive (on-metal) RFID tag embedded in or applied on each surgical instruments
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Fixed shelf readers and antennas to enable smart shelving
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Handheld reader for nurses & doctors
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Reader and antennas read what is on the shelf at pre-set intervals Reader within autoclave-sterilization device ensures that surgical instruments went through the disinfecting process Reader sends the data to the Semantic Web Nurses & doctors can check disinfection status of surgical instruments with their handheld reader
Outcome ⚫
Improving forecast accuracy: correct types and amounts of drugs & surgical instruments can be forecasted and ordered
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Improving inventory visibility: real time medicine & instrument availability check
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Reducing human error: associated with manual inventory counts
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Avoiding labor costs in the inventory process: through automated and smart shelving
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Improving Patient safety: through assurance of proper autoclave disinfection specified by the manufacturer
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RFID: Generating new Insights and increasing Supply Chain Transparency
Medicine Authentication
Application Area ⚫
Medicine
What is needed?
How does it work? ⚫
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Authenticated RFID tag inside or on each bottle or box of medicine
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Fixed authenticated RFID shelf readers and antennas
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Manufacturer encrypts Unique Item Identifier (UII) and Product Manufacturer Identifier (PMID) on the tag with reader MHS hospitals & clinics verify that the medicines they sell are genuine by authenticating the tag with reader Reader communicates result to the Semantic Web
Outcome ⚫
Driving Patient Safety: through reduction of counterfeit medical products
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Increasing upstream supply chain visibility
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Assuring high-quality standards for medicine
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Elevating confidence: in the security of the MHS pharmaceutical supply chain
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No additional investment in infrastructure needed: due to usage of same tags and readers as for inventory management
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RFID: Generating new Insights and increasing Supply Chain Transparency
Medicine Authentication Process
Message digest UII* & PMID** Message
Hash Algorithm
100011010
Digital signature
Encryption 100011010
Private Key
Pharmaceutical Manufacturer
Write & Lock
Write & Lock RFID Tag
Message digest
Digital signature
Decryption 100011010
Read
100011010
Public Key
=
RFID Tag
Hash Algorithm
MSH UII* & PMID** Message
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*UII: Unique Item Identifier ** PMID: Product Manufacturer Identifier
100011010
Message digest
Signature is valid when message digests match
Cyber Security Culture: Enabling Technology usage MHS‘s Value Proposition: Identification of sustainable MHS core values, translated into a value proposition
MHS’s activities are centered around providing personalized, safe and innovative care of the highest quality to our patients.
We guarantee controlled, legal and traceable access to our patient's data as well as product and medication traceability and visibility.
MHS focusses on setting new industry standards to improve healthcare worldwide.
MHS: Tomorrow‘s Healthcare Today Page 11
Cyber Security Culture: Enabling Technology usage
Cyber Security Objectives and Culture
CORE VALUES High Quality Care | Safety | Improving Healthcare Worldwide OBJECTIVE: Redefine cyber security in healthcare by creating and implementing a cyber security culture enabling the most secure, transparent and innovative patient care.
CYBER SECURITY CULTURE Collaboration
Prevention
Work together with external partners such as DHS Cyber Hunt and Incident Response Teams, community representatives and partners for advanced healthcare and technologies Exchange with internal partners such as physicians and clinic chefs within multifunctional teams
Monitoring of evolving cyber attack techniques Supervising of changes in the legal system Frequent training to internal and external stakeholders Implementation of measurers to guarantee information and knowledge sharing Establishment of a cybersecurity dashboard to make current status visible
Data Management (Semantic Web) & Generation (RFID)
Protection Establishment of an emergency process: React faster when detecting breaches
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Cyber Security Culture: Enabling Technology usage
Cyber Security Culture and Action
Action 1: Create Transparency − Stakeholder mapping − System landscape analysis − Data management
Cyber Expert Team • Team of ten IT, healthcare and cyber security specialists • Focal Point for all cyber security regards • Process owner in case of cyber incidents
Action 2: Find the Security Gap − Root cause analysis − Risk assessment Action 3: Build Cyber Capabilities − Cooperate with research institutions − Best practice development, training definition and knowledge sharing Action 4: Prepare for Cyber Incidents − Fill gaps along the supply chain − Definition of emergency cyber incident process
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Goals • Implement the cyber security culture throughout the whole supply chain • Assure, control, maintain and measure cyber security
Cyber Security Culture: Enabling Technology usage
Action 1: Create Transparency
Stakeholder Mapping All different supply chain parties (E2E) require reliable high-quality data and information which are easily as well as in-time accessible. Therefore, they need an integrated and secure platform for cooperation and coordination of these data to ensure best healthcare services with the common overall goal: Patient satisfaction and trust
Measurement of Integration Status and Collaboration
•
•
System Landscape Analysis The System landscape in the healthcare sector is manifold and characterized by a lack of harmonization, integration and transparency. Different types of systems, system providers and APIs to interconnect these are one reason for cyber insecurity. Integration through the Semantic Web aims to overcome this fragmentation.
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Sources: Beyer et al. (2004) Scott Clark Medical (2018)
Stakeholder Coverage: #Stakeholders analyzed/Total # Stakeholders
Integration Ratio: #Stakeholders integrated/Total Number of Stakeholders*
Cyber Security Culture: Enabling Technology usage
Action 2: Find the Security Gap
Risk Assessment
Further Expected Findings
Possible Cyber / Information Security
Top 7 causes for security breaches)
− − − − − −
Application Security Data Protection Identity & Access Management IP Protection Physical Security Vulnerability Management
Measurement of Risk Reduction ⚫
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Sample Key Risks: − Lack of encryption systems − Inadequate cyber security capabilities causing high cost and image losses Implement Risk Assessment according to common leading standards such as COBIT, NIST or ITIL.
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Source: KPMG (2018)
Intrusion Attempts: #Times that actors tried to breach the network Insecurity Rate: #Security incidents Incident Trend: Total #Previous Incidents/ Total #New Incidents Cost of Incidents: Financial breach damage (direct/indirect/opportunity cost in) USD
Cyber Security Culture: Enabling Technology usage
Action 3 & 4 : Build Cyber Capabilities // Prepare for Cyber Incidents
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Action 3 Build Cyber Capabilities
Collaborate with research institutions such as leading universities in the field of cyber security (Georgia Institute of Technology, Virginia Tech, etc.)
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Cooperate with institutions such as HITRUST / NHISAC for best practice and knowledge sharing
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Define safety requirements for stakeholders such as suppliers
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Understand user behavior leading to security traps
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Introduce internal guidelines and certification of devices and training
Measurement of Effective Cyber Capabilities ⚫
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Training Status internal: #Employees trained/Total #Employees
Training Status external: #External stakeholders trained /Total #Stakeholders SC Certification Ratio: #Certified SC participants/Total #SC participants Device Certification Ratio: #Certified Devices/ Total #Devices
Supplier scoring system and development of supplier progress and rating over time
Measurement of Effective Cyber Capabilities
Action 4 Prepare for Cyber Incidents
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Process definition in reparation for major cyber incidents
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Implement tools to fill gaps along the supply chain (RFID, Anti-Virus software, firewall)
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Establishment of an emergency process: React faster when detecting breaches
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Mean Time to Identify (MITTI): Time to detect breach (in hrs) Mean Time to Resolve (MTTR): Time to respond to breach (in hours)
Patient Impact of breach: #Patients affected, Confidentiality level of data (high/medium/low) Devices & Goods Track and Trace Dashboard including RFID technology
Cyber Security Culture: Enabling Technology usage
Action 3 & 4: Possible Training Content for Employees which can be adapted for different stakeholders Security Education Training and Awareness Introduction: Overall Culture, Objective and Action − Increase in breaches − Cost per breach and image losses − Threats (reason for training and campaign)
Consequences of Cyber Breaches Clean Desk/Workplace Policy
− No sensitive/confidential patient information left without observation − Removed and kept locked after use − 5s implementation for lean working method
Bring-Your-Own-Device (BYOD) Policy
− Use of private devices restricted (all mobile devices cause security gaps) − Devices checked before allowance to use. All other devices prohibited − BYOD Monitoring to be aware of used devices − Password protection and latest antivirus update necessary
Policies and Procedures
Data Management
− Information about forms, differences and priority of data − Harmonized backup devices (e.g. encrypted hard disk) − Communication of Backup policy (automated backup by CET and individual backups buy employees)
Removable Media
− Prohibited use of unauthorized removable media such as external hard drive − Awareness for malware infection, hardware failure, and copyright infringement
Safe internet habits
− − − −
Inform about access restrictions Awareness for phishing attracts, malicious attachment and suspicious links Disable pop-up windows No installation of unauthorized/checked software such as security software
Physical Security and Environmental Controls
− − − −
Being aware of patients and visitors watching passwords or stealing materials, devices, information Leaving sensitive information (such as passwords) unobserved (e.g. on paper on desk) Giving sensitive information to inspectors Leaving devices unprotected within breaks
Email Scams, Malware and Hoaxes
Collaboration and Innovation
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Source: IMAM 2020
Information on: − Untrustworthy harming mails − Identification of adware, spyware, viruses, trojans, backdoors, rootkits, ransomware, botnets, logic bombs and armored viruses − Falsehood or deception that is fabricated deliberately to subterfuge and victimize users − Helping other employees to stick to the rules − Contact CET in case of questions/concerns/incidents − Introduction in latest cyber security trends and RFID
Strategy Implementation Process circle
Time 1
Knowledge Formulation Phase: Prepare Vision, Objective, Actions, KPIs
Measure risk Identify Market conditions (SWOT), Stakeholders and Weakness
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Time Q1-Q4 each year
Strategy Implementation Phase 8. Culture Highlighting success stories and increases in: Efficiency, effectiveness and cyber security. Show applicability to other countries.
− − Anchor new approaches in the culture
7. Further Change After prof of concept stepwise rollout (ordered downwards by degree of collaboration).
6. First Wins Step by step data integration and alignment after prof of concept with one representative from each internal stakeholder group. First internal alignment (one hospital, physician group, clinic at a time). Thereafter, stepwise external alignment.
5. Broad Action − Encourage risk taking through joint innovation process (IP right sharing) and governmental support (explained later in funding model) − Cyber Expert Team will have the main lead and will be focal point for all ideas, barriers, problems that may arise
Sources: Kotter’s Eight-Step Process for Implementing Change cited in Luenenburg (2010) Aladwani (2001)
Establish a sense for urgency
8 Consolidate gains and produce more change
6
Generate short-term wins
1
7
Kotter’s Change Implementation Process
5 Empower broadbased action
−
Create the guiding coalition
2 3
4 Communicate the change and vision
Develop a vision and strategy
1. Urgency Unfreeze stakeholders by addressing the consequences of cyber breaches (cost, image, loss of sensitive data etc.) Communicate patient expectations: Growing digitalization increases expectations in terms of data sharing and security Showing benefits of joint innovation and risk sharing to redefine cyber security in the whole industry
2. Guideline Create internal and external cross-functional working group: Internal: Representative for Cyber Expert Team, physicians, hospitals and clinics External: Representatives for outpatient clients, government, rural hospitals, suppliers, insurances 3. Vision / Strategy Vision: High quality, Patient Data Safety, Improving Healthcare Worldwide
Strategy: 4 Pillar Action Plan 4. Communication Communication of vision and action plan to all stakeholders: 1. Written Announcement 2. Step by step workshops and trainings with all involved target groups
Status Evaluation Phase
Roadmap and Timeline The creation and stepwise implementation of the cyber security culture within the internal and external MHS network will take one year. As soon as the implementation of the culture has started, quarterly performance measurements and ongoing change management is performed.
Continuous Change Management, Knowledge update and Sharing Unfreezing Culture Formation and Implementation Action 1 Action 2
Moving
Semantic Web : Stepwise introduction and continuous connection to more and more types of data sources as well as institutions of MHS. Pace and range of implementation highly depend on the speed of the linked research. Goal is to fully digitize MHS data in a Semantic Web version within the four years of the project. RFID: Stepwise implementation regarding location and area of application. For example, initially deploying the RFID authentication model at one manufacturer and one hospital. Use of best practices and insights arising throughout the implementation process in order to optimize implementation smoothness and pace. Full deployment of RFID in all 4 areas of application and institutions of MHS within four years.
Action 3 Action 3
Year 1
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Refreezing
Lewin’s Three-Step Change Model Process for Implementing Change cited in Luenenburg (2010)
Year 2
Year 3
Year 4
Funding Model and Investment Required
I.
Labor - Employment of Cyber Security Experts from Healthcare Industry to work with external researchers - Labor hours for trainings of staff
II.
Hardware & IT - RFID tags - RFID readers - RFID Software & License
III.
Services - Consulting Services
IV.
Facilities - Rooms for Employee – Training - Meeting rooms for project meetings within MHC facilities
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MHS
I.
Required Resources
Funding partner
IV.
Labor - Cyber Security Expert Team members with Research Background - Academic Researchers for Support and Innovation Tracking - IT-experts and software developers II.
Hardware & IT - Newly developed Software for the Semantic Web - IT-Hardware of researchers
III.
Services - Software development for the Semantic Web - Applicability research within the MHS landscape - Outcome measurement of RFID implementation - Continuous research in RFID-technology
Facilities: - Research space on institution ground - Public spaces (libraries‌)
Funding Model and Investment Required
MHS Investments to cover the project scope
I
Hardware & IT
Labor cost
II
RFID tags: depending on functionality - passive:~$0,10/tag, active: ~$30/tag
MHS Cyber Security Experts: $94,000/ year
RFID readers: ~$1,500/reader RFID antenna: ~$200/antenna RFID software & license
Cyber Security Trainings for MHS staff ½ day per year per employee *
→ For upscaling see (Bendavid, Boeck & Philippe, 2010)
MHS Cost Categories 1 Project manager: $2,300/day 2 Senior manager: $1,700/day 2 IT specialists: $1,300/day → Project Team $8,300/day
For qualitative support throughout the full 4-year project scope: $8,632,000
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Cost for Services *payroll information of MHS needed for exact value of average income
Facility prices vary from chosen geographic strategic starting point of the project. Exact cost can only be evaluated after MHS accepted the proposal and the exact project scope has been defined.
Cost for facilities
IV
Funding Model and Investment Required Our main collaboration partners providing funding for research and thus allowing MHS’ costs to be extremely low
I
Tec & IT Focus
Academic Research Institutions
II
Funding Partners and Expertise
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Healthcare Industry Focus
Result based Sponsoring
IV
Outlook
The journey has just begun! Exploit advantages arising from combining RFID & Semantic Web
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Restricted areas: enhance security through restricted areas for patients and staff
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Access control: medicine access control for smart shelving
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End-to-end item-level authentication: integration of other points in the chain of custody
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Predictive Analytics: e.g. analyze data about past incidents to detect dangerous areas within the building or patient flow predictions
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RFID for visitors: equip visitors with RFID in order retrace contact points with infectious persons
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Blood transfusion monitoring systems: patient the blood bag data must be matched before blood can be used
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Patient Medication compliance: connecting medicine tag with patient tag
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Collection and analysis of sensor derived data: e.g. from tattoo-like thin surface electronic devices (bio-compatible & self-dissolvable)
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RFID at home:
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Home robots: human face detection and RFID tagged tablet dispenser to improve drug compliance & monitor intake
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RFID-enabled smart bandages: controlled drug delivery for after-surgery patients based on their wound monitoring data
Scope: RFID inlays for single use items
Roll out RFID & Semantic Web Internationally with the help of National Cyber Security Teams adapted to local Culture & Regulations Revolutionize Cyber Security & Data Management in Healthcare Worldwide!
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Bibliography
Apart from the provided reading and its references in the bibliography KLUnis used information from the following sources
Aladwani A. (2001): Change management strategies for successful ERP implementation, Business Process Management Journal (vol. 7), 3, 2001, p.266-275. Bendavid, Y., Boeck, H., & Philippe, R. (2010): Redesigning the replenishment process of medical supplies in hospitals with RFID, Business Process Management Journal, 16(6), 991–1013, doi: 10.1108/14637151011093035.
Beyer M., Kuhn K., Meiler C., Jablonski S., Lenz R. (2004): Towards a Flexible, Process-Oriented IT Architecture for an Integrated Healthcare Network, ACM Symposium on Applied Computing, p.264-271, Magdeburg, Germany. Buyurgan, N., Landry, S., & Philippe, R. (2012): RFID Adoption in Healthcare and ROI Analysis. The Value of RFID, 81–96, doi: 10.1007/978-1-4471-4345-1_7.
IBM (2017): Healthcare Suffers the Most Cyber Attacks, URL: https://www.ibm.com/industries/healthcare/resources/spot-cybersecuritythreats/ [Access 27/02/2020]. IMAM F. (2020): Top 10 Security Awareness Training Topics for Your Employee, URL: https://resources.infosecinstitute.com/top-10security-awareness-training-topics-for-your-employees/#gref [Access 27/02/2020]. Indeed (2019): IT Manager Salary US, URL: https://www.indeed.com/career/it-manager/salaries [Access 27/02/2020].
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Bibliography
Apart from the provided reading and its references in the bibliography KLUnis used information from the following sources
KPMG (2018): Cyber Security & Threats, URL: https://chapters.theiia.org/milwaukee/News/ChapterDocuments/Cyber%20Security%20and%20Insider%20Risk%201.17.18.pdf [Access 27/02/2020]. Lunenburg F. (2010): Approaches to Managing Organizational Change, International Journal of Scholar Academic Intellectual Diversity (vol. 12), 1, 2010. Pearson,J. (2005): Securing the Pharmaceutical Supply Chain with RFID and public-key infrastructure (PKI) technologies, Texas Instruments. Scott Clark Medical (2018): Types of Information Systems Used in Healthcare Facilities, URL: https://www.scottclark.com/2018/10/01/types-of-information-systems-used-in-healthcare-facilities/, [Access 27/02/2020]. Smiley, S. (2019): 7 Things You Can Track in Hospitals Using RFID, URL: https://blog.atlasrfidstore.com/7-things-can-track-hospitalsusing-rfid, [Access 27/02/2020].
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