Manatt Health December 14, 2023
This week, the U.S. Department of Health and Human Services (HHS) took its first step in actually regulating the use of artificial intelligence (AI) in health care. Through its Office of the National Coordinator for Health Information Technology (ONC), the agency finalized its “Health Data, Technology, and Interoperability” rule, which among other things establishes a framework for the regulation of AI and other predictive algorithms that are incorporated into electronic health record (EHR) systems used by health care providers.
Scope of Rule’s AI Provisions
The ONC oversees the Health IT Certification Program, under which developers of health information technology (HIT) can seek to have their software certified as meeting certain criteria. While participation in the program is voluntary, EHR developers...