HHS finalizes ‘first of its kind’ AI transparency rule for health care tech firms
The Department of Health and Human Services’ health care tech arm finalized a new rule last week that requires AI developers to detail how products are maintained and monitored -- and goes into effect at the end of 2024.
ChatGPT’s answers to nearly three-fourths of drug-related questions reviewed by pharmacists were incomplete or wrong in a recent study. The research underscores the need for guardrails as artificial intelligence becomes increasingly prevalent in health care.
The U.S. Department of Health and Human Services on Wednesday finalized a broad rule aimed at boosting data interoperability and patient access, including a provision to establish transparency requirements for AI in health software. Under the rule, developers of clinical decision support and predictive tools certified by the agency’s Office of the National Coordinator for Health Information Technology should enable a limited set of identified users to access information.
New regulations surrounding health clinical decision support software and predictive tools aim to boost transparency and mitigate risk in the industry, said Steven Posnack, deputy national coordinator for health information technology.
“It’s been a long time in the making to have an update to this certification criterion to be reflective of technical evolution in industry, as well as in response to some of the new challenges posed by artificial intelligence, machine learning and other types of large language models and the like,” he said.
According to HHS, the HTI-1 rule:
- Establishes first of its kind transparency requirements for the AI and other predictive algorithms that are part of certified health IT;
- Adopts the United States Core Data for Interoperability Version 3 as the new baseline standard within the ONC Health IT Certification Program as of Jan. 1, 2026;
- Revises certain information-blocking definitions and exceptions to support information sharing and adds a new exception to encourage secure, efficient, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common Agreement; and
- Implements the 21stCentury Cures Act’s requirement to adopt a condition of certification for developers of certified health IT to report certain metrics as part of their participation in the certification program.
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“The public feedback and participation in the HTI-1 process was tremendous,” said Micky Tripathi, Ph.D., national coordinator for health information technology. “Through the HTI-1 final rule, our upcoming HTI-2 proposed rule and our broader efforts, ONC continues its important work to build health care’s digital foundation, make interoperability easier and ensure that digital information and tools are being appropriately used to support patient access and to improve the health and well-being of all Americans.”
ONC-certified health IT supports care delivered by more than 96% of hospitals and 78% of office-based physicians around the country. The requirements will go into effect at the end of 2024.