WEDI Responds to the ASTP/ONC HTI-5 Proposed Rule and AI RFI

3/2/26

As an advisor to the Secretary of the Department of Health and Human Services, WEDI provides comments and recommendations to the Department and relevant agencies on a regular basis when opportunities are presented. Two recent actions by the Assistant Secretary for Technology Policy (ASTP)/Office of the National Coordinator for Health Information Technology (ONC) meant that WEDI could act in its advisory role yet again.

The first action by ASTP/ONC was the release of the Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Proposed Rule. The proposed rule focuses on deregulatory actions to update the ONC Health IT Certification Program (Certification Program) with the intent to reduce burden on health information technology (IT) developers by removing redundant requirements, better promote electronic health information access, exchange, and use to prevent information blocking, and advance artificial intelligence (AI)-enabled interoperability solutions.

The second action was the release of the Accelerating the Adoption and Use of AI in Clinical Care Request for Information (AI RFI) in which ASTP/ONC sought public comments on how HHS can accelerate the adoption and use of AI in clinical care. The RFI specifically requested feedback from those who are developing, evaluating, using, and receiving care from AI tools that are part of clinical care. The questions centered around how modifications to regulation, reimbursement policies, and research and development could drive forward change.

WEDI deployed its Member Position Advisory (MPA) process to review and develop comments for both the proposed rule and RFI. The MPA is WEDI’s process to gather widespread, stakeholder feedback from its members to ensure a collective and thoughtful response from our organization. MPAs involve a review of the regulatory proposals or questions led by subject matter experts. MPA attendees have the opportunity to share their perspectives, experiences, ask questions, and offer recommendations. Other methods in the MPA process for collecting member feedback can be used, including surveys, focus groups, interviews, etc. Only WEDI members can participate in the MPA process since the output represents the WEDI organization’s comments and recommendations.

For the HTI-5 proposed rule, WEDI assembled a brilliant lineup of experts to facilitate the two-hour virtual event on February 3. We wish to give a special thanks to these facilitators who made the MPA event so successful – Merri-Lee Stine (Aetna, a CVS Company, WEDI Board Chair), Denny Brennan (Massachusetts Health Data Consortium, WEDI Board Chair-Elect), Pam Grosze (PNC Bank, WEDI Policy Vice Chair), Gail Kocher (Blue Cross Blue Shield Association, WEDI Board Director), Samantha Meklir (Medical Group Management Association, WEDI Board Director), Samantha Burch (AHIP), Jen Holloman (American Hospital Association), Michelle Knighton (NextGen), Ross Martin, MD (Point of Care Partners), and Matt Reid (American Medical Association).

Facilitators and attendees discussed the potential impacts of removing certain Certification Program criteria, emphasizing the need to ensure that removing burden from one stakeholder does not place additional burden on another, the importance of privacy and security measures, and overall assurance needed by end users that technology will work as expected. You can read WEDI’s comment letter here.

For the AI RFI, WEDI again brought together an expert group of facilitators for another two-hour virtual MPA on February 12. Our special thanks goes to Merri-Lee Stine (Aetna, a CVS Company, WEDI Board Chair), Denny Brennan (Massachusetts Health Data Consortium, WEDI Board Chair-Elect), Pam Grosze (PNC Bank, WEDI Policy Vice Chair), Matthew Albright (Zelis, WEDI Board Director), Terry Cunningham (American Hospital Association, WEDI Board Director), Michael Pattwell (Edifecs, a Cotiviti Business, WEDI Board Director), Shannon Curtis (American Medical Association), Jen Holloman (American Hospital Association), and Cara Wahmann (Health Care Service Corporation).

This MPA, again, produced very thoughtful discussion about the use of AI, not just in clinical care, but in health care delivery overall. The attendees coalesced around the themes of ensuring transparency, establishing trust, maintaining privacy and security, defining the role of regulation vs. innovation, and enhancing education for clinicians, health care staff, and patients. WEDI’s comment letter is available here.

Being the moderator for both MPAs gave me a front row seat to the thoughtful and engaging discussion. WEDI will continue to use its MPA process to review any new proposed rules, RFIs, or other applicable inquiries. If you are a WEDI member, please plan to attend and share your perspectives. If you are not a WEDI member, join now so you can be a part of this important work to shape the future of health care delivery.