The ONC HTI-1 (Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing) Final Rule was published January 9th, 2024. Issued by the Office of the National Coordinator for Health Information Technology (ONC), the Rule goes into effect February 8th, 2024.
Now for those of you with A LOT of time on your hands, the Rule can be read here. For those who don’t have time, here are my initial takeaways.
- Algorithm Transparency: The Rule introduces transparency requirements for artificial intelligence (AI) and other predictive algorithms used in Certified health technology. It emphasizes the need for these algorithms to be fair, appropriate, valid, effective, and safe (FAVES). Developers must provide end users with “source attributes” to help assess the algorithms for the FAVES criteria. The Rule defines predictive decision support interventions (DSI) as technology supporting decision-making based on algorithms or models that derive relationships from training data.
- Adoption of USCDI Version 3: The United States Core Data for Interoperability (USCDI) Version 3 becomes the new baseline standard within the ONC Health IT Certification Program, effective January 1, 2026. This standard includes numerous new data elements. A good summary of the Version 3 is available here.
- Enhanced Information Blocking Requirements: The Rule revises certain information blocking definitions and exceptions to support information sharing. It also adds a new exception to encourage secure, efficient, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common Agreement (TEFCA).
- New Reporting Metrics for Certified Health IT: The Rule implements a Condition of Certification for developers of Certified health IT to report certain metrics as part of their participation in the Certification Program. These metrics provide insights into the usage of Certified health IT in care delivery.
- Clarifications and Modifications in the Health IT Certification Program: The Rule updates the certification program by changing the approach to naming new editions, modifying standards and certification criteria, and revising conditions of certification.
Quite a bit of clarification will be needed to understand all the nuances in the Rule. ONC is scheduling a series of information sessions to help provide understanding and provide explanations. You can register for those sessions at: https://www.healthit.gov/topic/laws-regulation-and-policy/health-data-technology-and-interoperability-certification-program.