The U.S. Department of Health and Human Services (HHS) started the new decade by keeping up its momentum to encourage patient engagement and support the secure expansion of digital health by releasing proposed rules and policy initiatives. On January 15, 2020, the HHS Office for the National Coordinator for Health Informational Technology (ONC) released a draft of its 2020-2025 Federal Health IT Strategic Plan (Plan). The outcomes-driven Plan, which ONC collaboratively developed with 25 federal organizations, aims to promote a health IT economy that balances increased transparency, competition, and consumer choice with privacy and security of patient health information. The Plan reflects HHS' ongoing efforts to create pathways for patients to actively engage in their health outcomes and navigate personalized care alternatives.
The Plan is intended to serve as a five-year roadmap for federal health IT initiatives and activities, and to function as a catalyst for streamlined activities in the private sector. In particular, the Plan highlights four key goals with supporting objectives, all focused on meeting the needs of patients, caregivers, health care providers, payers, researchers, developers, and innovators by increasing access to health information, emphasizing product and pricing transparency, and encouraging interoperability.
Goal 1: Promote Health and Wellness
Objective 1a: Improve individual access to health information
Objective 1b: Advance healthy and safe practices through health IT
Objective 1c: Integrate health and human services information
Goal 2: Enhance the Delivery and Experience of Care
Objective 2a: Ensure safe and high-quality care through the use of health IT
Objective 2b: Foster competition, transparency, and affordability in health care
Objective 2c: Reduce regulatory and administrative burdens on providers
Objective 2d: Enable efficient management of resources and a workforce confidently using health IT
Goal 3: Build a Secure, Data-Driven Ecosystem to Accelerate Research and Innovation
Objective 3a: Advance individual- and population-level transfer of health data
Objective 3b: Support research and analysis using health IT and data at the individual and population levels
Goal 4: Connect Health Care and Health Data Through an Interoperable Health IT Infrastructure
Objective 4a: Advance the development and use of health IT capabilities
Objective 4b: Establish transparent expectations for data sharing
Objective 4c: Enhance technology and communications infrastructure
Objective 4d: Promote secure health information that protects patient privacy
ONC's goals and objectives echo the digital health framework previewed by the rulemakings and enforcement actions that dominated 2019. For example, last year HHS' Office for Civil Rights (OCR) settled its first two cases with health care providers who allegedly failed to uphold the patient right to access health information mandated by the Health Insurance Portability and Accountability Act (HIPAA). The patient access enforcement trend gives teeth to Goal 1 of the Plan. Further, in line with Goal 2, the Anti-Kickback Statute Safe Harbors and Stark Law Exceptions proposed by HHS' Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services (CMS), respectively, aim to modernize these federal fraud and abuse law protections by removing barriers that currently thwart the efforts of health care providers to engage patients and coordinate care. The proposed Safe Harbors and Exceptions could greatly streamline the care coordination spectrum by giving patients the tools and technologies to actively engage in their own health care. If finalized, patients could have access to additional tools that encourage health care competition and transparency, and the optimal use of health IT. Finally, CMS and ONC released companion rulemakings in 2019 that provide a basis upon which Goal 4 and its objectives could be achieved. Specifically, the rulemakings are intended to (1) increase innovation and competition by giving patients and their health care providers safe and secure access to health information, encouraging choice in care and treatment, (2) advance interoperability through the use of the United States Core Data for Interoperability standard, new application programming interface (API) requirements, and electronic health information export capabilities, and (3) prohibit information blocking.
The digital health progress we observed in 2019 only scratches the surface of ONC's Plan. The Plan emphasizes that in order to address increases in health spending, poor health outcomes, increased rates of mental illness and substance use disorders, and inadequate access to care and technology, patients must be empowered, value-based care prioritized, interoperability achieved, and health information secured. To achieve these priorities, the Plan acknowledges the critical role of all players across the care continuum:
- Consumers must be educated on the availability of quality and price information, and how to utilize that information to shop for value-based care.
- Researchers must focus on targeted therapies by using real-time data and machine-learning intelligence, which will require integrated networks for sharing data safely and securely.
- Electronic health record developers must develop methods for capturing and integrating health and human services data to properly account for social determinants of health.
- Regulators must remove barriers that prevent new health IT developers from entering and competing in the marketplace.
- Private sector stakeholders must develop and promote access to new technologies – such as new algorithms, analytic capabilities, remote patient monitoring techniques, and other technology tools such as smartphones and broadband internet – to improve access to care and health information.
Accordingly, the Plan addresses both the technological and strategic health IT developments on the horizon, as well as the cultural and regulatory shifts necessary to achieve desired outcomes. We can expect all stakeholders across the public and private sectors who are actively participating in the health IT economy to be impacted by the Plan, once finalized, and the policy initiatives that follow in the next five years and beyond.
ONC is accepting public comment on the draft Plan until March 18, 2020.
This article is presented for informational purposes only and is not intended to constitute legal advice.