Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing
ONC final rule updates EHR certification to require algorithm transparency, including source code disclosure, risk management, and bias audits for AI/ML used in certified health IT.
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 High urgency. Health IT developers (including AI/ML vendors) seeking or maintaining ONC Health IT certification, and health systems using certified EHRs with AI/ML features. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Effective 60 days after publication (March 9, 2024). Compliance deadlines vary by certification type; developers must comply upon next certification renewal or within 24 months for existing certified products.. 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
New Conditions and Maintenance of Certification requirements for AI/ML algorithms: developers must provide source code, training data, performance metrics, and conduct bias audits; algorithms must be transparent and explainable.
Who it affects
Health IT developers (including AI/ML vendors) seeking or maintaining ONC Health IT certification, and health systems using certified EHRs with AI/ML features.
What you must do
Review all AI/ML algorithms in certified products, prepare documentation (source code, training data, performance metrics, bias audit results), and update certification submissions to meet new transparency requirements.
Deadline
Effective 60 days after publication (March 9, 2024). Compliance deadlines vary by certification type; developers must comply upon next certification renewal or within 24 months for existing certified products.
Never miss a change like this again
Aforeworn watches Healthcare AI Regulation (FDA / ONC) around the clock and alerts you the moment a rule moves — with a plain-English brief on what to do.
Start your free trialRelated changes in Healthcare AI Regulation (FDA / ONC)
- Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device
- HIPAA Security Rule To Strengthen the Cybersecurity of Electronic Protected Health Information
- Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity
- Nondiscrimination in Health Programs and Activities
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability