ONC’s Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule seeks to implement provisions of the 21st Century Cures Act and make updates to the ONC Health IT Certification Program (Certification Program) with new and updated standards, implementation specifications, and certification criteria. Implementation of the final rule’s provisions will advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information.  In collaboration with federal partners, including the Agency for Healthcare Research and Quality (AHRQ), Food and Drug Administration (FDA), HHS Office for Civil Rights (OCR), U.S. Department of Veterans Affairs (VA), and the Federal Trade Commission (FTC), the HTI-1 final rule also adopts new policies that will promote greater trust in the predictive decision support interventions (DSIs) used in healthcare. These policies will help enable users to determine whether the predictive DSI is fair, appropriate, valid, effective, and safe, and enable market competition. The policies also align with the FDA’s recent guidance on CDS.

HTI-1 Overview Fact Sheet: Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule (healthit.gov)

HTI-1 At-A-Glance Fact Sheet: Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule (healthit.gov)

For more information on the ONC rule, webinars, and registration for upcoming ONC event please see, Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule

Prioritized Element in All Reactive Surveillance Activities
With the adoption of the decision support intervention (DSI) certification criterion at § 170.315(b)(11) in HTI-1 Final Rule to replace the existing § 170.315(a)(9) Clinical Decision Support (CDS) criterion, ONC has requested that ONC-ACBs be mindful of how the CDS criterion is implemented. While § 170.315(a)(9) is already a prioritized element as outlined by ONC’s surveillance guidance to ONC-ACBs, ONC is requesting ONC-ACBs pay specific attention to how the source attributes outlined within § 170.315(a)(9)(v) are made available to users for review for applicable evidence-based decision support interventions.  What does this mean for developer?

Starting next year, if a developer has a product certified to § 170.315(a)(9) that undergoes surveillance, their ONC-ACB will conduct a review of the product’s ongoing conformance with this criterion focusing on the availability of the source attributes to users as outlined in § 170.315(a)(9)(v) for applicable evidence-based decision support interventions. Each ONC-ACB will determine the best approach to collect this information.

For Certification Program upcoming deadlines and events, please visit the ONC Program Resources page.

To submit questions or comments to ONC please use the Inquiry Portal.