Health AI governance is growing, but lacks unified policy frameworks

Health AI governance policies have exploded in recent years, but remain fragmented, across more than 100 issuing bodies, according to a new Health & AI Policy Index developed by Mount Sinai researchers.

The researchers analyzed 240 healthcare AI-related policies published between 2016 and 2025 to develop the Health & AI Policy Index. They published findings from a Jan. 1, 2026, snapshot of the index in npj Digital Medicine. The research comes as health AI governance in the U.S. remains fragmented across various coalitions and industry groups, as well as a patchwork of state laws.

The researchers found that while the health AI governance landscape appears to have grown rapidly, activity is diffused across more than 100 issuers, including regulators, governments and standards organizations. 

The policies are primarily focused on transparency and are advisory in nature rather than binding clinical rules, the research shows. Additionally, equity and safety concerns are typically addressed within broader governance and performance requirements. The most concrete obligations fall on providers, regulators and developers rather than patients or payers.

"Taken together, these patterns suggest a governance environment where expectations about documentation, oversight, and risk management accumulate faster than clear, enforceable rules for specific AI uses, creating challenges for health systems, developers, and policymakers interpreting overlapping signals while planning deployments," the researchers wrote in the study.

Further, the research found that state statutes account for most high-impact policies, setting conditions and restrictions on when certain tools can be used. Sector-specific regulators and international organizations appear more often in policies focused on documentation, governance and assurance practices for health systems and developers.

The index is intended for clinicians, health system leaders, compliance and legal teams, developers, payers, lobbyists and policymakers. It includes policies released in the U.S., at the state and federal levels, as well as international frameworks with health relevance.

The index and research performed using it aim to enhance healthcare stakeholders' and policymakers' understanding of AI governance policies, identify approaches likely to be effective and pinpoint policy gaps.

"Questions around transparency, patient safety, and accountability are becoming central to the future of health care AI," said study senior author Girish N. Nadkarni, M.D., chief AI officer of the Mount Sinai Health System, in the press release. "Our work helps identify where policy efforts are growing, where gaps remain, and where additional coordination may be needed."

Anuja Vaidya has covered the healthcare industry since 2012. She currently covers healthcare IT and innovation, including artificial intelligence, digital healthcare, EHRs and interoperability.