Healthcare compliance

HTI-5 Final Rule: 14 Health IT Certification Criteria Removed and What Changed

ONC's HTI-5 final rule removes 14 certification criteria and revises seven, including changes to predictive AI transparency, testing, and interoperability. Explore the affected requirements, implementation timelines, and implications for developers and healthcare organizations.

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TL;DR:
HTI-5 removes 14 health IT certification criteria, revises seven, and scales back certain AI transparency, testing, and reporting requirements. Health IT developers must distinguish the affected requirements from those still in place, while healthcare purchasers may need to review related vendor documentation.

What You Need to Know

The change: ONC removes 14 certification criteria, revises seven, and retains 39 unchanged.
Who is affected: Developers participating in ONC certification are directly affected. Hospitals and other technology purchasers may have related documentation considerations.
Why it matters: HTI-5 removes specified predictive AI transparency requirements from certification, but removing a certification requirement does not necessarily mean the underlying software capability or information will disappear.
What to do first: Compare affected certification criteria with existing product records and organizational procedures.
Key dates: Most changes take effect on the final rule's general effective date; others take effect January 1, 2027. Certain transitions-of-care requirements remain until January 1, 2030.

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