Introduction
The Department of Health and Human Services (HHS), through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC), published a proposed rule on December 29, 2025, titled "Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity." This proposal, issued under President Trump's Executive Order 14192 on deregulation, seeks to eliminate redundant certification requirements and refine information blocking exceptions. Set for a 60-day comment period ending February 27, 2026, the rule addresses burdens on health IT developers and providers while promoting innovation and FHIR-based interoperability. It responds to stakeholder feedback and aligns with HHS goals to enhance competition and patient access to electronic health information (EHI), potentially saving billions in compliance costs.
Background and Key Players
The proposal builds on the 21st Century Cures Act's mandate for interoperable health IT, implemented through prior rules like the 2020 Cures Act Final Rule. ASTP/ONC, overseeing the Health IT Certification Program, identified outdated criteria through public input and RFIs, such as the CMS-ASTP/ONC RFI. Key players include HHS Secretary Robert F. Kennedy Jr., ASTP/ONC officials like Michael Lipinski, and standards bodies like HL7, which developed FHIR. The rule emphasizes deregulation to "unleash prosperity," as per Trump's EO, by reducing private expenditures on compliance. Precedents include the 2015 Edition Final Rule's focus on burden reduction and recent enforcement discretion notices easing requirements.
Deregulatory Actions in Certification Program (Part 170)
The proposal removes 34 of 60 certification criteria and revises seven, targeting redundancies and promoting FHIR APIs. For instance, it eliminates privacy and security criteria (§170.315(d)), citing HIPAA's sufficient safeguards, and clinical criteria like "family health history" (§170.315(a)(12)), deemed widely adopted. "Transitions of care" (§170.315(b)(1)) is simplified to focus on C-CDA receipt, aligning with FHIR trends. Evidence from CHPL data shows high adoption rates, e.g., 96% of hospitals use certified EHRs. Perspectives vary: developers welcome reduced testing burdens, while providers fear loss of standardization; however, the rule argues market forces will sustain essential functions.
Short-term implications include immediate cost savings for developers, estimated at $1.53 billion present value. Long-term, it fosters innovation, as quoted from the rule: "enables ASTP/ONC to reset the Certification Program's regulatory scope and establish a new foundation on which to build FHIR-based API requirements." Different views highlight potential risks to interoperability without mandates, but the proposal cites E.O. 14192's emphasis on competition.
Revisions to Information Blocking Regulations (Part 171)
The rule proposes refining exceptions to prevent misuse. It removes the "third party seeking modification use" condition (§171.204(a)(3)), addressing concerns of anti-competitive withholding of EHI. The "manner exception exhausted" condition (§171.204(a)(4)) is revised to require offering all alternatives, replacing "same" with "analogous" and "substantial number" with "any" to curb abuse. The TEFCA Manner Exception (subpart D) is eliminated, as TEFCA's maturation reduces its necessity. Quotes from the rule underscore intent: "reduce the risk of an actor misusing it." Implications include enhanced EHI flow, benefiting patients and innovators, though some actors worry about increased compliance scrutiny. Perspectives: patient advocates praise reduced barriers; developers seek clarity on remaining exceptions.
Potential Implications and Perspectives
Short-term, developers gain flexibility, potentially accelerating FHIR adoption and AI integration. Long-term, the rule could transform health IT into a "FHIR-forward future," per the proposal, but risks fragmentation if standards lag. Stakeholders like HL7 and CDC are key for FHIR advancements. Balanced views: proponents see burden relief; critics fear weakened protections. The rule avoids endorsing positions, emphasizing market-driven innovation.
