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Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity

Detected July 29, 2026 · in Healthcare AI Regulation (FDA / ONC)

ASTP/ONC proposes deregulatory actions to reduce burdens on health IT developers, including AI/ML-based clinical decision support and SaMD, by removing or revising certification requirements and standards.

Aforeworn detected this change in the Healthcare AI Regulation (FDA / ONC) space on July 29, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Low urgency. Health IT developers, medical device companies, health tech startups, digital health compliance teams, and health systems using certified EHR technology. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Not specified in excerpt; check the Federal Register notice for comment period end date.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Healthcare AI Regulation (FDA / ONC) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.

What changed

Proposed rule identifies deregulatory actions to reduce regulatory burdens under ONC Health IT Certification Program, potentially easing certification requirements for AI/ML-based health IT and interoperability standards.

Who it affects

Health IT developers, medical device companies, health tech startups, digital health compliance teams, and health systems using certified EHR technology.

What you must do

Review the proposed rule and submit comments by the deadline (if any) to influence final rule; monitor for final rule to adjust compliance strategies.

Deadline

Not specified in excerpt; check the Federal Register notice for comment period end date.

Source: https://www.federalregister.gov/documents/2025/12/29/2025-23896/health-data-technology-and-interoperability-astponc-deregulatory-actions-to-unleash-prosperity

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