Information Technology in the U.S. Healthcare System: The Federal Government's Role in Medical IT

Gracin 1 Robert Gracin 12 December 2019 Electronic Hospitals: Who Are They For? For so long, a patient’s health history has traditionally been tracked on paper files written by physicians. Health records often had only one copy, filed securely in the doctor’s office.

Access to these records was limited, even though the information stored within these files is better when accessible to patients and all of their doctors. An article in the ​American Medical Association Journal of Ethics​ describes the medical record in essence as “a communication tool that supports clinical decision making, coordination of services, evaluation of the quality and efficacy of care, research, legal protection, education, and accreditation and regulatory processes” (Harman et al. 712).

Today’s digital age is seeing virtually all aspects of human life moving further into the internet and cloud-based systems. The healthcare industry is no different, with hospitals constantly acquiring and testing the latest technologies for patient services. In the past ten years, U.S. patients have seen a large increase in the amount of ‘patient portals’ enabling them to access their health information and communicate with their doctors online. These portals are just a small user-side glimpse at a larger industrial shift in today’s medical system: the digital aggregation of patient data moving to cloud-based storage systems commonly referred to as electronic health records, or EHRs. A 2017 article in ​The New England Journal of Medicine cited that almost all U.S. hospitals and nearly 80% office-based practices use certified EHRs, and nearly 87% of patients reported having access to their electronic health information (Washington et al. 904). Working thesis: The U.S. federal government, in partnership with Big Tech, have

Gracin 2 developed a digital healthcare system prioritizing the aggregation of patient data; while these strides are noteworthy, patient data and privacy must be more central to digital healthcare moving forward.

21st Century Medicine: It’s All About Data Many are hopeful about the opportunities for innovation that EHR technology promises.

A trio of M.D.s offer their predictions for the future of medical technology in a ​New England Journal of Medicine​ periodical titled “A Glimpse into the Next 100 Years in Medicine.” Kohane et al argue that modern health information technology’s abilities to aggregate large data sets of the human population promises a detailed era of “precision medicine.” Further, treatment innovation will be made possible because “virtually all the data will be in an advanced infrastructure of electronic health records (EHRs) that includes input from physiological monitoring, which is already starting to become part of the management of chronic diseases and of guidelines for prevention and fitness” (Kohane et al. 2538). Technology’s collection of data can create new opportunities for health management solutions and recommendations to patients.

The doctors further touch on the future of machine learning and algorithms, saying that “management algorithms will evolve and be modified continuously in accordance with inputs from ongoing clinical observations and from new research. Clinical decision support algorithms will be derived entirely from data, not expert opinion, market incentives, or committee consensus” (Kohane et al. 2539). Thus, medical professionals are increasingly relying on data stored in EHR systems to make patient care and treatment decisions. Further, doctors themselves

Gracin 3 are enthusiastic about artificial intelligence working with the data they collect to streamline patient care.

The New York Times​ writer Oren Frank builds on the concept of data aggregation’s promise for innovative patient care in his opinion piece “Donate Your Health Care Data Today.”

Frank shares the story of a May 2019 experiment conducted in partnership by Google and Northwestern Medicine that aimed to predict a patient’s likeliness of lung cancer diagnosis. The team applied 42,290 patient CT scans to a deep learning algorithm, which detected and analyzed numerous data variables within the scans. The algorithm’s analysis of the CT scans was compared to a team of six radiologist’s analysis. Results showed that the “​machine-learning model was able to detect cancer 5 percent more often than the radiologists and was 11 percent more likely to decrease false positives” ​(Frank 7).​ Of course, such results and capabilities are not possible without first having large data sets, which are made available by EHR technology.

Frank uses this basis to argue that as a patient, the best thing to do with one’s health data, is not to guard it, but to share it--as health IT innovators can do more good with more data.

Frank’s opinion piece explores the nuanced arguments about health data and privacy. On one hand, patients have much to fear about their sensitive health data being stored online, hiding in digital corners that may be inaccessible to patients, even if they are skilled with navigating online database systems. However, patients can also envision themselves as part of something larger: the first wave of digital health information that could help spur new methods for screening, diagnosis, and treatment recommendations. Frank says that ​“the vast amount of information each of us possesses is far too important to be left under the control of just a few entities — private or public. We can think of our health care data as a contribution to the public

Gracin 4 good and equalize its availability to scientists and researchers across disciplines” (Frank 12). On a micro level, Frank’s idealistic view of how aggregated health data can advance medical research is reliant upon how well patients and healthcare providers utilize EHR systems.

Further, the promises of health data aggregation can only be realized if there is cooperation and regulation of the many EHR technologies on the market on the macro level.

The Federal Government: Architect of the Digital Healthcare Revolution This digital healthcare revolution consists of a complex web of relationships between the United States government and the Big Tech industry. It is important to understand that the widespread adoption of EHR technology across U.S. healthcare has been encouraged by numerous federal policies enacted over the past ten years. The 2009 American Recovery and Reinvestment Act of 2009 was President Obama’s economic stimulus legislation package in response to the 2009 financial recession. A part of this legislation titled the Health Information Technology for Economic and Clinical Health (HITECH) Act provided financial incentives for hospitals to purchase EHR systems to replace traditional paper files (Washington et al. 904).

HITECH has been effective in motivating the nation’s health systems across specialties to implement EHR technology, with the goal of reducing health care costs through the sharing of more readily accessible data (Washington et al. 906). Digitized information can be shared between separate healthcare facilities with the click of a button, giving providers a more comprehensive overview of a patient’s health history. In this way, EHR systems are created for communication across healthcare providers to aggregate public health data, and the federal

Gracin 5 government has aided healthcare professionals and digital vendors alike in collecting this data through policy incentives.

Long before the HITECH Act when the internet’s use for medical innovation was in its infancy, President George W. Bush made the first step to establish regulatory power over health information technology in 2004 by signing Executive Order 13335, which established the Office of the National Coordinator for Health Information Technology (ONC). The HITECH Act “statutorily authorized the ONC and called for establishing the Health IT Certification Program to set health IT standards and implementation specifications” (Washington et al. 904). Thus, HITECH made the Office of the National Coordinator responsible for certifying new health IT software and IT systems, boosting the federal agency’s profile as a stakeholder in the health informatics landscape.

With federal encouragement of EHR technology, many government agencies began collaborating to develop a risk-based regulatory framework for health IT. Throughout the 2010s, the Food and Drug Administration, the Department of Health and Human Services, and the Office of the National Coordinator for Health IT have all been consistently reviewing best practices for regulating digital health technologies. With new technologies being developed every year, federal agencies have experienced regulatory overlap and loopholes when determining responsibilities. Historically, the FDA has been responsible for pre-market approval and testing of medical devices. The Food and Drug Safety and Innovation Act of 2012 (FDASIA) clarified that the FDA was responsible for ensuring the safety and effectiveness of medical products. FDASIA enhanced the FDA’s power to review new medical IT developments with the goal of streamlining pre-market approval (Slight and Bates 181). After four years of

Gracin 6 unclear regulatory overlap between the ONC and the FDA on the topic of health IT certification, regulatory matters were split into two areas: ​software certification​ and physical device pre-market approval​ with the 21st Century Cures Act of 2016, which removed “electronic medical records, decision-support software, and related stand-alone software from the FDA’s regulatory jurisdiction” (Ronquillo et al. 540). This legislation is also making way for the increased developments of AI and machine learning within medical IT previously mentioned by Kohane and Frank.

Thus, in just seven years, many changes have been made to the regulatory landscape surrounding health information technology. As it stands, the FDA is responsible for ​safety evaluations o​ f medical IT, while the ONC is responsible for ​certification​ of software before it is implemented in healthcare practices. “The ONC Certification Program set the standards, implementation specifications, and certification criteria that EHRs must meet, at a minimum, to support the achievement of meaningful use. To qualify for the financial incentives offered under the Medicare and Medicaid EHR Incentive Programs, healthcare professionals and hospitals must both adopt certified EHRs and demonstrate meaningful use of this technology” (Slight and Bates 183). In partnership, the ONC and the Center for Medicare and Medicaid Service (CMS) have made ‘meaningful use’ central to the implementation of EHR. As discussed, the technical skills and practices of the healthcare professionals utilizing the EHRs feeds into ‘meaningful use,’ but how exactly does the federal government measure it?

Centers for Medicare and Medicaid Services leads the way

Gracin 7 The Centers for Medicare and Medicaid Services (CMS) is perhaps the most influential stakeholder leading the way for the digital revolution of healthcare in the United States. The agency administers the Medicare EHR Incentive Program, the vessel that disburses federal funds to healthcare facilities to purchase EHR software through the HITECH Act. CMS plays an active role in determining which “eligible professionals (EPs), eligible hospitals (EHs), and critical access hospitals (CAHs)... are meaningful users of EHRs'' (“CMS Finalizes Requirements for Electronic Health Record (EHR) Incentive Program 1”). ‘Meaningful use’ requirements have been released in waves by the CMS. Stage One in 2011 set goals for data capture and sharing, Stage Two in 2014 aimed at “advanced clinical processes,’ and Stage Three in 2016 aims for improved outcomes (Slight et. al 30.) The goal of meaningful use, again, is to ensure accurate and intentional data collection to advance science and data-based decision making.

Recently, the agency has leveraged its power in processing over $500 billion of claims each year to shape the framework for health IT companies to develop best practices and uniform standards across EHRs and other health IT systems (U.S. Digital Service 1). Because 57 million Americans rely on Medicare for healthcare payments, CMS is in an influential position to coordinate health insurers, hospitals, and other stakeholders active in the payment process. The Blue Button Initiatives demonstrate the CMS’s efforts to establish interoperability across a variety of stakeholders in the health IT arena. Blue Button 1.0 was released in 2012, and was essentially a program pushing IT companies and healthcare providers to enable their EHR systems with the ‘blue button’ downloading feature, so patients could download their medical records stored by hospitals. With the goal of empowering patients with their own health records,

Gracin 8 Blue Button 1.0 was the first step to establishing standards for patient access to EHR data. The Blue Button 2.0 Initiative conducted by the CMS is a strong partnership between CMS and the nation’s largest tech companies. The initiative essentially aims to encourage seamless interoperability for data storing and transferring technologies. At the heart of this movement is a desire for all computers and health IT systems to have some uniformity, and be able to work together. An API is essentially a set of functions that allow computer software to access data in other computer applications, other times referred to as ‘open source.’ At the first Blue Button 2.0 conference in July 2018, tech giants Amazon, Google, IBM, Oracle, and Salesforce pledged to work with CMS to begin reporting all medical payment data in a uniform, “open source format,” enhancing interoperability between digital health systems (Sullivan 8).

IBM Head of Global Product and AI Mark Dudman commented at the event that “patients should have access to their data and have the flexibility to use products and services across different systems to work seamlessly for their care” (Sullivan 9). “In a meeting of the digital service, which helped CMS develop the Blue Button 2.0 API, USDS Deputy Administrator Edward Hartwig said that Blue Button is a broad effort and not an "if you build it they will come"-type initiative – because the government also has to get the word out so people know about it and, in turn, use the API.” (Sullivan 7). Thus, the CMS has assumed a very active role in developing technical blueprints that encourage Big Tech companies to prioritize interoperability across all health IT developments. CMS Administrator Verma commented that “we are leading by example and calling on all insurers to release data in an API format… You'll see through our regulatory process that we're very serious about that” (Sullivan 6). Thus, the Blue Button Initiatives conducted by the CMS have effectively brought together Big Tech and

Gracin 9 insurers for advancements of medical data processing. As discussed, the technical skills and practices of the healthcare professionals utilizing the EHRs feeds into ‘meaningful use,’ but what exactly does the federal government do with all of this data?

The FDA: Aggregated Health Data In May 2008, the FDA launched the Sentinel Initiative, which it describes as ‘large scale electronic safety surveillance’ that protects the privacy of individual health care records. ​The FDA Voice​, a blog from the agency, describes its goals for the Sentinel Initiative to be the FDA’s extensive tool that analyzes the safety of new medical products, including hospital system IT. The tool is integral to helping both healthcare providers and patients assess new technologies that are the best for treatment, giving both stakeholders more choices when considering new healthcare technology solutions (Gottleib 8). Essentially, the Sentinel Initiative is a step toward cooperation between the stratified field of health IT stakeholders, with the goal of data aggregation for the medical research and innovation that many see EHR technology as a gateway for. The 21st Century Cures Act also discusses the FDA’s plans to “exercise its enforcement discretion by not actively regulating software that does not perform clinical analysis, such as medical device data systems that exchange or display medical data, medical image storage and communications devices, and low-risk general wellness software focused on maintaining a healthy lifestyle” (Ronquillo et al. 539). This connects back to Kohane and Frank’s prophecies for artificial intelligence’s use of diagnosing medical conditions.

While the Sentinel Initiative could be effective, the FDA’s role in regulating health IT is still a bit blurry, and shows there is some regulatory overlap between the various agencies

Gracin 10 monitoring health IT. Examining the impact of HITECH Washington et al. argue that “going forward, the National Coordinator for Health IT will continue to bring together stakeholders in areas where collaboration wouldn’t naturally occur and federal regulation is not desired. The ONC also has an essential role in coordinating federal agencies in developing guidelines for technology deployment — collaboration that must be complemented by private-sector– led innovation. Federal partners, especially the Veterans Health Administration and the Department of Defense, can model new innovations that promote the seamless flow of information for care delivery” (Washington et al. 906). Thus, roles between the ONC and FDA must be clarified and hone in on who monitors data.

Health IT Stakeholders Big Tech and Silicon Valley are a vital set of stakeholders making this digital healthcare revolution possible. The U.S. Department of Health and Human Services is yet another federal agency vital to providing blueprints to tech developers. The agency’s website page “Resources for Mobile Health Apps Developers” outlines regulations that Big Tech must follow when creating apps that will store sensitive patient data, and introduces a toolkit that the Federal Trade Commission has created as a framework for developers. This source adds the FTC to the long list of regulatory agencies participating in the health informatics jurisdiction arena. The page asks software developers and stakeholders to use the FTC’s portal tool to submit recommendations for how the agency can make compliance literature more comprehensive for the private sector. This page serves a similar purpose as the ​FDA Voice ​blog post does, as a public-facing resource explaining the HHS and FTC’s activities working with health IT that will

Gracin 11 be accessible to the public. The HHS explains its coordination with the ONC, FDA, and FTC to develop a resource with the goal of creating safe systems for patients to use (“Resources for Mobile Health Apps Developers”). Here, the DHHS is providing clarity to the private sector on how they can best be in compliance with HIPAA regulations. While it is great that HHS is creating resources for the stakeholders of the health IT industry, where are the resources for patients concerned about their data stored in the IT? Natasha Singer’s September 2019 ​New York Times​ article “When Apps Get Your Medical Data, Your Privacy Might Go With It” discusses the challenges of the public-private challenges that mobile health apps introduce. While they have the goal of putting health data into the hands of patients, there are many privacy concerns surrounding the issue. According to Singer, the Department of Health and Human Services is drafting regulations requiring healthcare providers to share patient’s health data with tech companies who develop applications for patients to view their health information (Singer 10). However, both the American Medical Association and the American Hospital Association have voiced concern that loose legislation could create loopholes for tech companies to abuse and sell this data once retrieved from healthcare providers. The National Coordinator for health IT says that this push will allow patients more autonomy over their health data, allowing them to make more decisions for themselves (Singer 12). Thus, the DHHS, ONC, and Big Tech demonstrate efforts to make EHR technology more useful for patients, pushing the agenda to empower patients with their own data. While the DHHS has the same agenda of putting health data and decision-making into the hands of patients, their methods for achieving this are different. Overall, this article reveals that policy efforts for patient access are being made, and may be happening almost too fast. Quick

Gracin 12 policymaking without proper research into how tech companies will use patient data could lead to data abuse in the future.

Privacy Concerns With many technical advances being made by both public and private actors, concerns rise over the security of patient data being stored in cloud systems. The complex web of regulatory actors shows that much attention is placed on patient data privacy, however it is also the responsibility of healthcare systems to secure their EHR data. Harman et al personify the risks of the 21st century of data and hacking that threaten patients. “In 2011, employees of the UCLA health system were found to have had access to celebrities’ records without proper authorization. UCLA failed to ‘implement security measures sufficient to reduce the risks of impermissible access to electronic protected health information by unauthorized users to a reasonable and appropriate level.’ The health system agreed to settle privacy and security violations with the U.S. Department of Health and Human Services Office for Civil Rights (OCR) for $865,000. Controlling access to health information is essential but not sufficient for protecting confidentiality; additional security measures such as extensive training and strong privacy and security policies and procedures are essential to securing patient information” (Harman et al. 714). With the migration of sensitive patient health data into online systems comes increased risk of data breaches and privacy debates. These have consequences for the regulatory and industry stakeholders identified, and even larger consequences for the patients described by this data. While the Sentinel Initiative is effective for monitoring the data disclosed by health IT companies and delivery systems, it does not necessarily provide support and

Gracin 13 training for people on the frontlines of patient data collection: doctors and healthcare professionals.

Doctors: Integral for Meaningful Use Sensationalized headlines and thought pieces like those authored by Kohane and Frank show that there are many advantages and promises of EHR technology, machine learning, and aggregated patient health data. Further, the federal government prioritizes as central to U.S. healthcare through many incentive programs and developments. Of course patients are central to the process of sharing this data, and must be able to advocate for their own health data access and privacy. Patient portals are the patient-side of this large EHR system that has been created by large IT stakeholders and regulators. “These portals give patients one access point through which they can view their information and interact with all of their providers in the system. Due to this comprehensiveness and integration, these portals can trigger mechanisms such as enhanced patient insight into their complete health information, interpersonal continuity of care, and patient convenience, which are instrumental to achieving the outcomes listed above” (​Otte-Trojel et al. 285).

So, what does patient access to data look like in realistic terms of the current healthcare delivery system? An article in ​Family Practice Management,​ a journal publication by the American Academy of Family Physicians (AAFP) discusses the Medicare EHR Incentive Program’s meaningful use stage 2 requirements, and offers providers tips on how to best engage patients for meaningful use. “CMS will soon penalize providers unless they can provide the following: more than half of patients can view, download, or transmit to a third party their health

Gracin 14 record within four business days of being updated, at least 5 percent of patients actually view, download, and transmit their information, and more than 5 percent of patients actually send secure messages through the portal” (Twiddy 27). Twiddy further explores the barriers to patient engagement with the portal systems. The journal cites a 2013 study revealing “a third of respondents who were already online said they were open to asking their physicians questions, making appointments, and getting lab results through their smartphone or tablet. However, many haven’t heard about portals or don’t want to change how they communicate with their physician.

Those who have spent a lifetime communicating with their doctor’s office on the phone may find it a hard habit to break” (Twiddy 29). Thus, there is a large gap to close between disengaged patients and the technical abilities of today’s hospitals. CMS’s meaningful use requirements are a policy effort to engage patients, and healthcare providers are a vital bridge between this gap.

Healthcare professionals have implemented many creative solutions to encourage patient engagement with portals and health information management. For example, Harman et al. say that when working with EHRs as a team, “the process of controlling access—limiting who can see what—begins with authorizing users. In a physician practice, for example, the practice administrator identifies the users, determines what level of information is needed and assigns usernames and passwords. Basic standards for passwords include requiring that they be changed at set intervals, setting a minimum number of characters, and prohibiting the reuse of passwords” (Harman et al. 713). The AAFP publication illustrates this in the article’s story of Jennifer Brull, MD, a solo family physician in rural Kansas who struggled to get patient participation with the portal above 30 percent, even after several years of implementation. Once she gave her nurses more access and tasks within the EHR system, the entire family practice staff was encouraging

Gracin 15 patients to utilize the patient portal, and they saw portal account registrations surge to 60 percent (Twiddy 29). Healthcare professionals agree that their enthusiasm and use of patient portals ideally reflects on their patients, helping all parties to get the most out of the technology.

Other best practices have included having the patient login on their personal device with the doctor present to reduce uncertainty around new technology, and hopefully spur patient desire to take full advantage of the portal’s features. Perspectives from the ​Family Practice Management​ article as well as the ​American Medical Association Journal of Ethics​ article show how physicians and practitioners are central to meaningful use of EHR systems; training providers on best practices within these systems not only helps the practice reap all the technology’s benefits, it also helps educate patients on how to take control of their health information and communicate with their providers. While healthcare professionals have made great strides to encourage patient engagement with portal features of EHRs, further research suggests that a patient’s knowledge of their portal systems is an after-thought of the larger EHR movement in U.S. healthcare.

With the migration of sensitive patient health data into online systems comes increased risk of data breaches and privacy debates. These have consequences for the regulatory and industry stakeholders identified, and even larger consequences for the patients described by this data. Harman et al. discuss the importance of auditing and reporting who has accessed health records in the past, to ensure that patient data is being protected. “Audit trails track all system activity, generating date and time stamps for entries; detailed listings of what was viewed, for how long, and by whom; and logs of all modifications to electronic health records.

Administrators can even detail what reports were printed, the number of screenshots taken, or the

Gracin 16 exact location and computer used to submit a request. Alerts are often set to flag suspicious or unusual activity, such as reviewing information on a patient one is not treating or attempting to access information one is not authorized to view, and administrators have the ability to pull reports on specific users or user groups to review and chronicle their activity” (Harman et al.

715). Further, “the HITECH Act of 2009 requires health care organizations to watch for breaches of personal health information from both internal and external sources. As part of the meaningful use requirements for EHRs, an organization must be able to track record actions and generate an audit trail in order to qualify for incentive payments from Medicare and Medicaid.

HIPAA requires that audit logs be maintained for a minimum of 6 years. As with all regulations, organizations should refer to federal and state laws, which may supersede the 6-year minimum” (Harman et al 715). These measures are somewhat illustrated by the FDA’s Sentinel Initiative, however Sentinel does not necessarily have penalties for mishandling of patient data. While HITECH’s regulations are useful and necessary to protect patient information, patients and doctors alike must be educated on how to self-monitor these tools, and know where to report data breaches when they are detected.

Patients: a low priority in health IT development?

The complex web of federal actors encouraging EHR technology that is developed by the private sector paired with the healthcare professionals that handle the health data in question, a moral question arises: who owns the data stored in EHR systems? Harman et al’s ​American Medical Association Journal of Ethics​ article asserts that when it comes to ownership of health records and data, “the physician, practice, or organization is the owner of the physical medical

Gracin 17 record because it is its business record and property, and the patient owns the information in the record” (Harman et al. 713). However, there is no explicit legislation governing a patient’s rights to their electronic data in the case of bureaucracy disputes, data breaches, or negotiations between the federal government and the tech industry. Between the ONC, CMS, FDA, DHHS, and other actors building this framework, there are little patient resources addressing the skills gap between computers and patients. Particularly, Slight et al analyze the effectiveness of meaningful use of EHR technology requirements as they pertain to rural populations interacting with increasingly-high tech hospitals. After interviewing doctors in rural hospitals about their experiences with EHRs and engaging patients to take control of their own data, Slight et al concluded the following challenges in rural settings: “Despite the initial HITECH funding for training, the needs of the HIT workforce in rural areas across the country have not been met.

Patient engagement is likely to be challenge going forward with rural residents, considering unreliable Internet connections, low health literacy, and lack of resources. Although MU requirements currently set a low percentage of patients who are expected to use the portals, systems must be scalable if more patients are to benefit, which will likely entail use of novel technologies such as mobile devices” (Slight et al. 30).

Thus, while doctors can be equipped with EHR technology and data solutions, digital literacy gaps are a barrier to patient engagement that neither the HITECH Act nor CMS meaningful use requirements can fix. There is such a large emphasis on access to data, but at the end of the day, humans must be able to interpret this data and advocate for their own health. In his glimpse into the future of medicine, Kohane predicts that “therapeutic and monitoring instruments will continue to become smaller, smarter, more interactive, and more connected to

Gracin 18 the health information infrastructure. However, the quantum leaps will come not from the devices but from inferences drawn from the data” (Kohane et al. 2539). While policy efforts and technological innovation are pushing for patients to take control over their own data, a reality is that some patients prefer to talk with their doctor face to face, or may not have internet access.

Recommendations Across the academic, medical, and regulatory fields, many agree that patient health data should be accessible across many platforms and used for whatever purposes patients wish. In their observations of healthcare professionals working with EHR technology, Washington et al. conclude that“both patients and providers want health information to be shareable between systems” (Washington et al. 905). While this research has shown that there is strong coordination between federal actors and the private sector, it is also clear that not all efforts to access patient data may be the same. Patient portal interfaces vary depending on the EHR that a hospital chooses to purchase. Further, if the hospital is not receiving Medicare EHR Incentive funds, they may not purchase a ONC-certified software. Large inequalities exist on the patient level when it comes to accessing data.

While federal agencies like the CMS and the FDA have played active roles in building the nation’s health IT infrastructure, the system that exists could be more patient-centered.

Applying designs like Blue Button API and EHR applications built by IBM could result in a comprehensive universal health record system. The stratified system that exists now leaves patients navigating multiple different patient portal/EHR software between different healthcare practices. Creating a universal EHR maintained by the Office of the National Coordinator for

Gracin 19 Health IT would eliminate many issues highlighted in this research. First, it would help close technical skill gaps for doctors and providers, because they would not continuously need to learn new software uses if their practices switch systems. Second, having more skilled doctors would ideally lead to more patient education and engagement with the systems as both parties make the health record central to their experience. Third, this would combine the existing efforts of the FDA and the CMS in both aggregating data and monitoring it. The FDA’s Sentinel Initiative gathers data from across a variety of different EHR systems that are not entirely compatible. A universal health record could streamline this data collection process as it would all come from one source. Washington et al predict this to be the next frontier in health informatics, commenting “market innovations and government policies should soon allow patients to combine information from various sources to create a single resource with their current and historical health information” (Washington el al. 906).

Another solution to this issue is digital literacy training for doctors and medical professionals. The traditional model of patient-centered care is shifting, with new EHR features allowing patients and providers to message each other back and forth. This disrupts the usual model of a patient strictly having contact with a doctor only if an appointment is made. Twiddy explores how this changes compensation factors for some doctors: “Joseph R. Scherger, MD, vice president of primary care for Eisenhower Medical Center in Rancho Mirage, Calif., acknowledges that the predominantly fee-for-service payment system must change to reward nontraditional practice, including non-face-to-face care, before portals see widespread adoption” (Twiddy 28). With the introduction of a universal health record, federal agencies and developers could create more informational resources, and conduct trainings for doctors on best practices.

Gracin 20 Of course, EHR-trained doctors should ideally increase digital literacy for patients to be able to advocate for their own health. Doctors must make the patient portal central to their approach, explaining to patients what information is stored there, why, and how both can use it for the best healthcare choices and outcomes. A universal health record should come with many patient resources to aid in the navigation process, fitting the current agenda of the CMS to put the data in control of the patients. Patients should be assured that wherever they seek medical treatment, their data is available to them and providers for the best care possible.

In conclusion, the U.S. healthcare landscape is increasingly reliant on digital technology, literacy, and data-driven decision making. Many federal agencies have influenced the current state of health IT infrastructure in combination with medical software developers. While the efforts for data portability and access have made immense progress toward data-driven care, the challenge now turns to helping patients take control and advocate for their data. In a world where many components of life are moving deeper into the internet, the security of medical data must be prioritized for policymakers in many spaces.

Gracin 21 Works Cited “CMS Finalizes Requirements for Electronic Health Record (EHR) Incentive Program.” ​Center for Medicare & Medicaid Services. ​16 July, 2010. https://www.cms.gov/newsroom/fact-sheets/cms-finalizes-requirements-medicaid-electro nic-health-records-ehr-incentive-program​.

Frank, O. “Donate Your Health Data Today.” ​The New York Times. 2​ October 2019. Web. Access 19 October 2019.

Harman, L., Flite, C., Bond, K. “Electronic Health Records: Privacy, Confidentiality, and Security.” ​AMA Journal of Ethics. ​Vol. 14, Iss 9 (2012): 712-719. Web. 19 October 2019.

Kohane Isacc S., Drazen Jeffrey M., Campion Edward W. “A glimpse of the next 100 years in medicine.” ​New England Journal of Medicine. ​Vol 367. Iss. 26 (2012): 2538-2539.

Web. Accessed 5 October 2019.

“Medicare Payment System Modernization.” ​U.S. Digital Service​. (2018). https://www.usds.gov/projects/medicare-payment-program​. Web. Accessed 9 December 2019.

Otte-Trojel, Terese et al. “Characteristics of patient portals developed in the context of health information exchanges: early policy effects of incentives in the meaningful use program in the United States.” ​Journal of medical Internet research​ vol. 16,11 e258. 21 Nov. 2014, doi:10.2196/jmir.3698 “Resources for Mobile Health Apps Developers.” U.S. Department of Health and Human Services. (2017). https://www.hhs.gov/hipaa/for-professionals/special-topics/developer-portal/index.html#​.

Web. Accessed 5 October 2019.

Ronquillo, Jay G., Zuckerman, Diana M. “Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.” ​Milbank Quarterly, V ​ ol. 95, No. 3, (2017). Web. 26 September 2019.

Slight, Sarah P, Bates, David W. “A risk-based regulatory framework for health IT: recommendations of the FDASIA working group.” ​Journal of the American Medical Informatics Association​: JAMIA Vol. 21, (2014): 181-4. Web. 5 October 2019.

Slight, Sarah P. et al. “Meaningful Use of Electronic Health Records: Experiences From the Field and Future Opportunities.” ​JMIR Medical Informatics​ Vol. 3, No 3, (2015): e30. Web. Accessed 9 December 2019.

Sullivan, Tom. “Amazon, Google, IBM, Oracle, and Salesforce Team Pledge to Remove

Gracin 22 Interoperability Barriers.” ​HealthcareITNews.​ 13 August 2018. https://www.healthcareitnews.com/news/amazon-google-ibm-microsoft-oracle-and-salesf orce-pledge-remove-interoperability-barriers​. ​Web. Accessed 7 December 2019.

Sullivan, Tom. “CMS Administrator Seema Verma Calls on Payers to release claims data in API format.” ​HealthcareITNews.​ 13 August 2018. https://www.healthcareitnews.com/news/cms-administrator-seema-verma-calls-payers-rel ease-claims-data-api-format​. Web. Accessed 7 December 2019.

Twiddy, David. “Removing Six Key Barriers to Online Portal Use.” ​Family Practice Management.​ January 2015. ​https://www.aafp.org/fpm/2015/0100/p26.html Washington, V., DeSalvo, K., Mostashari, F., Blumenthal, D. “The HITECH Era and the Path Forward.” ​The New England Journal of Medicine. V ​ ol. 377, Iss. 10 (2017): 904-906.

Web. 16 October 2019.