This week, Health-ISAC®‘s Hacking Healthcare® shines the spotlight on two U.S. Department of Health and Human Services (HHS) actions that might have flown under the radar during the busy holiday period at the end of December. Join us as we break down two opportunities for the health sector to provide input to HHS related to AI adoption and use in clinical care, and deregulation related to health data, technology, and interoperability.
As a reminder, this is the public version of the Hacking Healthcare blog. For additional in-depth analysis and opinion, become a member of H-ISAC and receive the TLP Amber version of this blog (available in the Member Portal.)
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Welcome back to Hacking Healthcare® in 2026!
U.S. Department of Health and Human Services Ends 2025 with AI RFI and Tech Deregulation Proposal
In the days leading up to the new year, the HHS published a request for information (RFI), Accelerating the Adoption and Use of Artificial Intelligence as Part of Clinical Care,[i] and a proposed rule notification, Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity.[ii] Both of these HHS efforts contain elements related to privacy and security and are open to public comment until late February.
Request for Information: Accelerating the Adoption and Use of Artificial Intelligence as Part of Clinical Care
In alignment with the Trump administration’s goal of pushing the development and adoption of AI as outlined in prior executive orders and last July’s AI Action Plan,[iii] HHS published an RFI on December 23 “to seek broad public comment on what the HHS can do to accelerate the adoption and use of AI as part of clinical care.”[iv]
HHS describes the RFI as intended to assess “actions it can take to establish a forward-leaning, industry-supportive, and secure approach to accelerate the adoption and use of AI as part of clinical care.”[v] In particular, HHS “[seeks] concrete, experience-based feedback from those building, buying, evaluating, using, and receiving care from AI tools that are part of clinical care as well as from those who wish to do so but face barriers.”[vi]
Feedback is requested for three general issue areas (Regulation, Reimbursement, and Research and Development) and for 10 specific questions that cover a wide range of issues. The solicitation for feedback on regulation may be among the most important for Health-ISAC members to engage with as HHS “seeks to establish a regulatory posture on AI that is well understood, predictable, and proportionate to any risks presented to enable rapid innovation while protecting patients and the confidentiality of their identifiable health information, and maintaining public trust.”[vii]
HHS is accepting comments on this RFI until February 23.
Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity
with the RFI above, and consistent with the Trump administration’s stated policy goals to revise the regulatory environment, HHS published this proposed rule on December 29. HHS summarizes the intent of the proposed rule as “[focusing] on deregulatory actions identified in HHS regulations regarding Health information technology standards, implementation specifications, and certification criteria and certification programs for health information technology, and information blocking.”[viii] It proposes to remove or revise numerous certification criteria and regulatory provisions related to the ONC Health IT Certification Program and also “seeks to address reported misuse and abuse of information blocking definitions and exceptions.”
At 208 pages, the proposed rule covers a large number of proposed changes to existing programs and regulations, including the removal of all the privacy and security certification criteria in § 170.315(d) and the associated Privacy and Security Certification Framework under § 170.550(h). The totality of the proposed changes is too numerous to list comprehensively, and we invite Health-ISAC members to review the document summary itself to ascertain which proposals may have relevant security and privacy implications.
HHS is accepting comments on this proposed rule until 5:00 pm ET on February 27.
Action & Analysis
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[i] https://www.federalregister.gov/documents/2025/12/23/2025-23641/request-for-information-accelerating-the-adoption-and-use-of-artificial-intelligence-as-part-of
[ii] https://www.federalregister.gov/documents/2025/12/29/2025-23896/health-data-technology-and-interoperability-astponc-deregulatory-actions-to-unleash-prosperity
[iii] https://www.whitehouse.gov/wp-content/uploads/2025/07/Americas-AI-Action-Plan.pdf, https://www.whitehouse.gov/presidential-actions/2025/01/removing-barriers-to-american-leadership-in-artificial-intelligence/, https://www.whitehouse.gov/presidential-actions/2025/12/eliminating-state-law-obstruction-of-national-artificial-intelligence-policy/
[iv] https://www.federalregister.gov/documents/2025/12/23/2025-23641/request-for-information-accelerating-the-adoption-and-use-of-artificial-intelligence-as-part-of
[v] https://www.federalregister.gov/documents/2025/12/23/2025-23641/request-for-information-accelerating-the-adoption-and-use-of-artificial-intelligence-as-part-of
[vi] https://www.federalregister.gov/documents/2025/12/23/2025-23641/request-for-information-accelerating-the-adoption-and-use-of-artificial-intelligence-as-part-of
[vii] https://www.federalregister.gov/documents/2025/12/23/2025-23641/request-for-information-accelerating-the-adoption-and-use-of-artificial-intelligence-as-part-of
[viii] https://www.federalregister.gov/documents/2025/12/29/2025-23896/health-data-technology-and-interoperability-astponc-deregulatory-actions-to-unleash-prosperity
[ix] https://www.whitehouse.gov/wp-content/uploads/2025/07/Americas-AI-Action-Plan.pdf
[x] https://www.whitehouse.gov/wp-content/uploads/2025/07/Americas-AI-Action-Plan.pdf
[xi] Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence was the name of the Biden administration’s signature Executive Order on AI. https://www.federalregister.gov/documents/2023/11/01/2023-24283/safe-secure-and-trustworthy-development-and-use-of-artificial-intelligence
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