On May 13, 2025, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) announced a request for information seeking stakeholder input on the market of digital health products for Medicare beneficiaries, as well as the state of data interoperability and broader health technology infrastructure (the “RFI”).  Per the RFI, responses “may be used to inform CMS and ASTP/ONC efforts to lead infrastructure progress to cultivate this market,” increasing access to digital health tools and availability of health data.

The “Why”

In the RFI, CMS and ASTP/ONC recognize the promise of digital health products to enhance healthcare experiences, reduce costs, increase access to care, enable chronic disease prevention, and improve patient outcomes, but they acknowledge that the current digital health ecosystem is not optimally designed to fully unleash these benefits.  Based on stakeholder feedback, ASTP/ONC seek to “drive large-scale adoption of health management and care navigation applications, reduce barriers to data access and exchange, realize the potential of recent innovations in healthcare . . ., and accelerate progress towards a patient-centric learning health system.”

Of note, this RFI is on the heels of a request for information issued by the Food and Drug Administration (FDA) to “identify and eliminate outdated or unnecessary regulations,” which FDA Commissioner Makary said is intended to “lower costs, increase access to innovation, and let clinicians spend more time with patients—not paperwork.”  The goals of both RFIs appear consistent with the broader HHS-wide interest in advancing the development and adoption of digital health tools and removing barriers that could stifle innovation.  Indeed, the CMS announcement emphasizes that the “government must be a catalyst, not a barrier, to unleashing American innovation in healthcare.”

The “Who”

Although the RFI invites feedback from all stakeholders, the RFI poses specific questions to patients and caregivers, providers, payers, technology vendors and data providers (including digital health product developers), and value-based care organizations. 

The “What”

The questions in the RFI seek feedback on which elements of the existing digital health ecosystem are or are not working, policies that would ease health data exchange and promote innovation in digital health products, and ways HHS can encourage consumer engagement with digital health products.  The RFI also requests feedback on how current requirements around the use of technology by healthcare providers—such as certified electronic health record technology (CEHRT)—can enable value-based care while meeting other program objectives. 

For technology vendors and data providers, the RFI tees up several questions about digital health product innovation and accessibility, including questions about the health technology ecosystem in general, as well as questions about digital identity, technical standards and certification, data exchange, and compliance.  For example, one question asks how CMS can better encourage use of “open, standards-based, publicly available APIs over proprietary APIs.”  Another asks whether CMS should “endorse non-CMS data sources and networks, and if so, [which] criteria or metrics” it should consider.  CMS and ASTP/ONC also ask about information blocking practices and price transparency implementation.

The “When”

The public comment period will be open through June 16.  Stakeholders should consider providing comments to inform this evolving landscape.