Out in the Open: HHS’s New AI Transparency Rule
Lexology March 21, 2024
The Department of Health & Human Services through the Office of the National Coordinator for Health Information Technology recently updated the process for certification of health information technology. Some of the modifications are intended to address use of artificial intelligence in health IT systems. ONC’s certification is required for certain programs, such as where the health IT will be used for Medicare and Medicaid Incentive programs. It is optional for others. Those who are already certified will need to update their certifications. Those seeking new certifications will be subject to the new process.
The certification process requires developers of health IT to demonstrate that their products satisfy certain criteria. The demonstration can be completed through documentation or through inspection which...