CMS and ASTP/ONC Seek Input on the Future of the Digital Health Ecosystem

The RFI focuses on advancing “a seamless, secure, and patient-centered digital health infrastructure,” with specific attention to digital health products, data interoperability, and health technology infrastructure. CMS and ASTP/ONC invite feedback from a broad range of stakeholders—including patients, providers, payers, health IT companies, and others—on how to shape federal policy in these areas. The public comment period will be open through June 16, 2025. On May 20, 2025, CMS will host a webinar to inform comments on the RFI.

In particular, the RFI solicits input from stakeholders on:

• Data Access and Integration: The RFI seeks feedback on identifying critical data types and sources to inform CMS and ASTP/ONC priorities. CMS and ASTP/ONC are particularly interested in recommendations on improving accessibility, interoperability and integration of clinical data both within existing frameworks of data exchange, such as TEFCA and HIEs, and Fast Healthcare Interoperability Resources (“FHIR”), among other initiatives to develop common standards and link patients to their data. Certain requests for input specifically solicit comments on stakeholders’ experiences with implementation of tools based on the FHIR Application Programming Interfaces (“APIs”), which support commonly used APIs like patient access, provider access, and others.  Notably, the agencies also signal potential interest in increased scrutiny and enforcement of the federal information blocking rules in their requests for input, for example, around what disincentives may be most effective to deter information blocking and whether any of the information blocking exceptions should be revised or removed altogether to further access, exchange, and use of electronic health information.
• Patient Care Needs: Numerous questions in the RFI invite stakeholders to provide input on digital tools that help patients navigate care, including viewpoints on usability, efficacy, desired functions, included data, regulatory obstacles, and incentives to encourage developers to fulfill unmet patient needs.
• Provider Tools: The RFI makes clear that CMS and ASTP/ONC are also examining ways to encourage provider adoption of health IT tools to increase efficiency, including in electronic health record workflows that measure quality, document care, support billing, and combine clinical data from multiple systems. Specific questions from CMS and ASTP/ONC address tools used by value-based care organizations and other alternative payment models.
• Payer Analysis: The RFI also seeks perspectives on how to expedite appropriate access to patient-specific information, complete provider directories, and data that bears on quality and efficiency.
• Barriers to Innovation: Finally, the RFI invites developers to comment on obstacles to implementing new solutions effectively, including data missing from data formatting standards, deficiencies in current CMS APIs, shortcomings in current certification standards for electronic health records, and the potential utility of enhanced systems to verify patient identities.

According to CMS and ASTP/ONC, input from this RFI will help inform a federal policy framework “intended to promote the seamless and secure flow of health information between patients, providers, and payors, enabling digital workflows supported by smartphone applications and other modern tools.”[1] The resulting administrative actions may include updates to the federal information blocking rules, modification of requirements for providers that use digital platforms to coordinate care (e.g., Accountable Care Organizations), and potential new incentives for the development and adoption of digital health tools.

This RFI presents a significant opportunity to advocate for priorities and submit feedback to new leadership within the Administration before certain proposed rules and guidance are drafted. Note that other RFIs remain pending on broader topics, including general deregulation by CMS.

[1] RFI at 6.