Insights Condition and Maintenance of Certification (45 CFR 170.407)

The Office of the National Coordinator for Health IT (ONC) is requesting OMB approval for a new collection of information finalized in the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing Final Rule. This new information collection request which pertains to the Insights Condition and Maintenance of Certification requirements is found at § 170.407. As a Condition of Certification in § 170.407(a), a health IT developer must submit responses in accordance with the established Insights Condition of Certification requirements with respect to all applicable certified health technology a health IT developer offers under the Program. As a Maintenance of Certification in § 170.407(b), a health IT developer must provide responses annually (once a year) to the Insights Condition of Certification for any applicable certified health IT that have or have had an active certification at any time under the Program during the prior six months to an independent entity. For the purposes of estimating potential burden, we believe the independent entity will take approximately 5 minutes to review a response submission for completeness per § 170.407(a), and approximately 30 minutes to submit the completed response submission to ONC per § 170.407(b), based on how many products a certified health IT developer may be required to submit responses for.

The latest form for Insights Condition and Maintenance of Certification (45 CFR 170.407) expires 2027-05-31 and can be found here.

Insights Condition and Maintenance of Certification (45 CFR 170.407)

Federal Enterprise Architecture: Health - Health Care Services