On May 13, 2021, MITRE Corporation, a non-profit that provides engineering and technical guidance for the federal government, published a long-awaited report proposing a National Strategy for Digital Health (the “Report”).  The proposed strategy provides a framework and prescribes tangible action items in order to revolutionize the American healthcare system through digital tools and technology.  The underlying premise is that harnessing the power of research, data, and innovation can further shared goals and accomplish priority outcomes to transform not only the digital plane of the healthcare system, but every facet of modern American healthcare.

At the outset, the Report highlights the shortcomings of the United States healthcare system: its cost, inequity, and relatively poor health outcomes.  In part, the Report commends recent efforts to shift from a volume-based to a value-based system that recognizes the impact of social determinants of health (“SDOH”) on individuals and communities.  The significance of the SDOH and rife inequity in the current system was on full display this past year as certain communities bore disproportionately large burdens of the COVID-19 pandemic.  The Report argues that the shift toward a more equitable, efficient, and value-based healthcare system will only be possible in tandem with a digital revolution in the healthcare industry.

The strategy outlined in the Report is founded upon identifying and implementing a set of national priorities that can steer government and industry toward common goals.  Beyond identifying shared priorities, the Report argues that meaningful change requires more than simply adopting and implementing new technologies.  Instead, the change must be seismic and alter every facet of the current system—from government programs to private payors, from exam rooms to classrooms, and from smart phones to off-site servers.

The Report offers six strategic goals:

1. Access, affordability, and utilization of universal broadband for all Americans.

“[T]ens of millions of Americans do not have access to or cannot afford quality internet service.”[1]  In the COVID-19 pandemic “new normal,” many are expected to work, learn, connect, and seek healthcare from home, making access to quality, affordable internet necessary to succeed and realize basic human rights.  The Report highlights President Biden’s plan to “expand broadband, or wireless broadband via 5G, to every American,” and mandates that this goal be accomplished by 2025.

Achieving accessible broadband for every American will require creating a national broadband plan, enabled by accurate mapping of broadband availability and speed, and engaging historically disadvantaged communities.  Failing to involve historically overlooked communities, the Report says, will magnify health disparities.

2. A sustainable health workforce that is prepared to use new technologies to deliver person-centered, integrated, quality care.

Today’s healthcare workforce does not have the necessary skills to take advantage of the tools currently at its fingertips, let alone to embrace a comprehensive digital overhaul.  In fact, 30-70% of the healthcare workforce reports that they lack the skills to effectively utilize digital technology and fully engage with digital information.[2]  To address this issue, the Report recommends “upskilling” current employees in the short run; investing in education and resources to train the incoming workforce over the next four to six years; integrating data scientists and digital experts in to the folds of the healthcare workforce over the next four to six years; and, in the long run, developing opportunities for early exposure to concepts of digital health in K-12 education for all socioeconomic groups.

The Report calls upon higher education institutions and professional associations to lead the workforce overhaul, but warns that rote implementation of the Report’s recommendations must be accompanied by more profound cultural shifts.  Professional and ethical paradigms must shift to recognize and incorporate the utility of digital tools, and the workforce must not only learn to use the new tools, but to trust and value the technology.

3. Digital technologies that empower individuals to manage their health and well-being safely and securely.

The COVID-19 pandemic catapulted the expansion of digital health services.  In the first months of the pandemic, in-person medical visits dropped by 23% in March and 52% in April, in turn, telemedicine services grew by more than 1000% in March and more than 4000% in April.  However, this dramatic increase in telemedicine usage only offset about 40% of the decline in-person visits.[3]  As digital devices become more and more necessary to benefit from the new digital standard in the delivery of care, it is imperative that individuals have data ownership—control over data—and digital health literacy—the “ability to seek, find, understand, and appraise health information from electronic sources and apply the knowledge gained to addressing or solving a health problem.”[4]

The Report calls for policy and legal changes to implement strong patient data privacy and innovative data governance, as well as coordinated action to improve digital health literacy that includes engaging stakeholders to identify key pain points.  As we move to a post-pandemic world and return to in-person activities, it is important to find the right mix of virtual and traditional in-person care to improve quality and outcomes while reducing cost, which the Report refers to as the “reasonable use of digital health.”  The Report also addresses the need to break through current barriers to digital health that include moving away from fee-for-service models, addressing state law restrictions on the use of telemedicine, and improving precision medicine capability.

4. Data exchange architectures, application interfaces, and standards that put data, information, and education into the hands of those who need it, when they need it, reliably and securely.

Cultivating interoperability across the healthcare system is critical to realizing the benefits of technology and innovation.  The Report commends recent efforts to promote interoperability such as the passage of the CURES Act, which penalizes entities for blocking access to patient information and encourages the standardization of health information technology (“IT”).[5]  However, the Report blames incrementalism and special interests for preventing a whole-hearted commitment to and achievement of interoperability, yielding significant gaps in scale and efficiency.  One large barrier is creating a consensus on how to implement practices and standards that facilitate and encourage the exchange of information.

The Report identifies several areas in which standardization would be particularly impactful, including data capture at the points of care, application programming interfaces, common performance metrics at the patient and system levels, algorithms (e.g., eligibility determinations, prior authorization determinations, clinical decision support systems, etc.), and the use of a National Patient Identifier system.  Standardization in these areas, the Report argues, would break down barriers to information, ensuring that data is both discoverable and accessible at all times.

5. A digital health ecosystem that delivers timely access to information to inform public health decision making and action.

The American digital health information ecosystem is decentralized and fragmented, leading to a public health ecosystem that is unprepared and slow to respond to public health events and emergencies.  The Report cites the federated nature of public health governance and program implementation as a barrier to public health decision-making and action, and despite the amount spent on healthcare, many federal and local jurisdictions lack resources necessary to improve their digital health technologies.  The federated system further results in differing standards that are difficult to integrate.  We have diligently monitored the regulatory telehealth landscape here, including in our “State of Telehealth” series, which dives into telehealth rules state-by-state.

The Report calls for a future with an integrated systems approach that relies on collaboration between integral industry stakeholders to innovate and improve digital health ecosystems.  It points to training, data sharing, and governance opportunities around data sharing as key to a healthy digital health ecosystem that can effectively monitor the health and well-being of all community members “to ensure everyone is moving toward a healthier and safer state of being.”

6. Integrated governance designed for the challenges of a digital health ecosystem.

In the Report’s final and most ambitious goal, the Report calls upon all levels of government, industry, stakeholders, and consumers to collaborate and develop unified, comprehensive policies to guide and support the digital transformation.  Currently, governance and oversight has been fractured and ill-equipped to make the investments and decisions necessary to implement meaningful change.  The current complex and convoluted legal and regulatory landscape overseeing health information and IT has siloed useful information, stunted moves towards interoperability, and has failed to appreciate the “complex intersection of sensitive data, electronic records, information security, system interoperability, patient rights, user responsibilities, contractual provisions and arrangements, and accepted risks.”  We recently discussed the tug-and-pull between care coordination, interoperability, and privacy concerns in connection with a proposed modification to the HIPAA Privacy Rule here.

The Report demands comprehensive policies that both encourage interoperability and the free-flow of data through standardization and transparency, while also protecting and promoting data privacy, information security, and patient rights.

Further, the Report acknowledges industry’s hesitation to embrace, and even seek out, greater regulatory burdens.  However, it argues that actively engaging in this effort and this process will produce more practical, more comprehensive, and clearer regulations that enable and incentivize compliance and good business practices.

A Path Forward

The COVID-19 pandemic has put a spotlight on many of these issues, but it is important to note that these problems have burdened the healthcare system for decades.  Thus far, digital technology and innovation has not delivered on its promises to deliver efficiency, reliability, and interoperability.  Renewed efforts and significant investment will be necessary to accomplish our shared goals, chiefly quality and affordable healthcare.  Digital tools will be a significant component of any meaningful efforts to revitalize the American healthcare system at every step of the way.

*Jarrod Brodsky is a Healthcare Intern at Sheppard Mullin

This article is not an unequivocal statement of the law, but instead represents our best interpretation of where things currently stand.  This article does not address the potential impacts of the numerous other local, state and federal orders that have been issued in response to the COVID-19 pandemic, but which are not referenced in this article.

[1] Brookings Institute, 5 Steps to get the internet to all Americans (2020).

[2] Stanford Medicine, “Ride of the Data-Driven Physician,” Stanford University, Palo Alto, 2020.  Qlik, “Data Literacy Index Results Summary,” [Online]. Available: https://thedataliteracyproject.org/files/documents/Qlik%20-%20The_Data_Literacy_Index_October_2018.pdf.

[3] Whaley CM, Pera MF, Cantor J, et al., “Changes in Health Services Use Among Commercially Insured US Populations During the COVID-19 Pandemic.” JAMA Network Open. 2020;3(11):e2024984. doi:10.1001/jamanetworkopen.2020.24984

[4] WHO, “Digital Health Literacy,” 27 February 2017. [Online]. Available: https://www.who.int/global-coordination-mechanism/working-groups/digital_hl.pdf.

[5] Follow updates on health IT developments here and on healthcare legislation and rulemaking here.