On December 13, 2023, the Office of the National Coordinator for Health Information Technology (ONC) released a final rule: Health Data, Technology, and Interoperability: Certification Program Updates (.pdf), Algorithm Transparency, and Information Sharing, also known as HTI-1. This final rule followed a draft rule that APA responded to earlier in 2023 (.pdf). In our letter to ONC dated June 20, 2023, we applauded ONC’s proposals to improve the accountability and transparency of health IT products to customers, regulators, and policymakers. We encouraged ONC to go further to facilitate meaningful improvement and evolution in analytic capabilities and health outcomes by expanding governance and stakeholder engagement structures, using data derived from health IT vendors to iteratively improve data governance and regulation, and partner with psychiatrists to advance health IT initiatives in psychiatric settings. We also encouraged health IT developers to embrace this transparency and accountability.

The final rule includes several key policy advancements, many of which APA and our members advocated for. First, the rule mandates the adoption of new baseline data standards (Version 3 of the United States Core Data for Interoperability, or USCDI v3) by ONC-certified health IT products. USCDI v3 includes new required data classes around social determinants of health as well as a mental/cognitive status data element. The final rule also establishes transparency requirements (.pdf) for augmented or artificial intelligence (AI) and other predictive algorithms within certified health IT, requiring “source attribute” transparency including the demographic characteristics of data used to train evidence-based decision support interventions (DSIs). The final rule also includes additional information blocking(.pdf) requirements and exceptions, with a separate new information-blocking proposed rule out for public comment.

The final rule also requires developers of certified health IT products to report metrics on product use and performance as a condition of maintenance of certification, called the “Insights Condition (.pdf).” The final rule also discontinues year-themed editions of certification criteria.

While the ONC’s HTI-1 final rule aligns with much of APA’s perspective on promoting interoperability for mental health, there is room for improvement on key components including broader transparency requirements for AI-enabled health technology products, enhanced support for clinicians in avoiding activities that constitute information-blocking, and support to clinicians that do not yet use ONC-certified health IT products. APA will continue to work closely with members and advocate at the agencies to ensure that health IT regulations reflect the lived experiences and needs of membership and the patients we serve.