HHS Drops AI Model Card Requirement From Health IT Certification

The Office of the National Coordinator for Health Information Technology at the U.S. Department of Health and Human Services finalized the HTI-5 rule on October 26, the department said in a press release, projecting savings of more than $1.5 billion in regulatory costs. The rule removes 14 of the certification program's 60 criteria and revises seven others, Healthcare Dive reports.

Health IT products that use AI, machine learning or other predictive algorithms will no longer need model cards describing their training sources, performance and validation data. Developers also will no longer need to submit annual plans for testing certified products in clinical settings.

The final rule retains privacy and security criteria that the proposed version could have removed. ONC also deferred decisions on proposed information blocking changes, including definitions that would cover autonomous AI systems. Many certification changes will take effect 60 days after publication in the Federal Register, while others will take effect on January 1.