Enhancements to FDA Draft AI Guidance
ACR® provided comments to the U.S. FDA regarding the draft guidance to address risk management approaches throughout the lifecycle of AI-enabled medical devices.
Read moreThe American College of Radiology® (ACR®) is tracking 20 bills across 12 states addressing artificial intelligence (AI) and more bills are expected to be introduced. These bills focus on a range of issues including consumer protection, health insurance, utilization review, transparency and the ethical use of AI. Many of these bills share common themes — such as promoting transparency in AI use by health insurers, financial investments in projects to advance AI applications in healthcare, regulating AI systems in healthcare, and preventing discrimination through AI algorithms within prior authorization systems.
House Bill (HB) 1297 would regulate AI practices by healthcare insurers.
HB 5590 would prohibit health insurers from using AI to deny health insurance claims.
Senate Bill (SB) 37 would require governmental entities to develop AI system usage plans. It would also create the Georgia Board for AI to provide guidance to governmental entities in their development of artificial intelligence system usage plans.
SB 1425 would regulate the use of AI in health insurance to ensure consumer protections and oversight.
HB 1620 would require healthcare providers and insurers to disclose their use of AI in decision-making and communications regarding patient care or insurance coverage.
HB 823 would require developers of generative AI systems to publish training data used for AI systems.
HB 820 would require health insurers to ensure AI is used appropriately in utilization review.
SD 2635 — This is the fiscal report from the University of Massachusetts about AI-related legislative matters. In April 2024, UMass Chan Medical School and MITRE, operator of federally funded research and development centers, established the Health Al Assurance Laboratory, a collaborative initiative to advance health artificial intelligence in the public interest. The initiative, the first in Massachusetts, aims to ensure AI technology in health care is safe and effective. Funding for the initiative was provided by an award from the Innovation Institute at the Massachusetts Technology Collaborative and matching private investment funds. Additionally, UMass Chan received a $555k award from the Innovation Institute at the Massachusetts Technology Collaborative to establish a Health AI Assurance Lab.
HB 4037 would establish requirements for health data utilities to manage AI-based health data exchanges. The bill promotes interoperability between health care entities, the state, and other participants.
HB 1535 would establish a task force to study AI applications, risks, and policy recommendations.
Assembly Bill (AB) 768 would enact the New York Artificial Intelligence Consumer Protection Act. It prevents the use of AI algorithms to discriminate against protected classes. SB 1962 was introduced in the Senate as a companion bill.
AB 3356 would regulate high-risk AI systems, requiring registration, licensing, and an ethical code of conduct.
AB 3265 would create the New York Artificial Intelligence Bill of Rights to provide protections for residents and ensure AI systems making decisions impacting lives do so lawfully with oversight.
AB 3993 would prohibit discrimination through clinical algorithms, with exceptions for algorithms addressing health disparities.
AB 3991 would establish requirements for the use of AI, algorithms, or software tools in utilization review and management, including definitions of AI.
SB 4276 would require entities to notify individuals about their use of personal information, focusing on targeted advertising.
SB 13 would regulate AI use by health insurers to promote transparency and accountability in managing coverage and claims.
SB 815 would regulate the use of AI in health benefit plan utilization review.
HB 2298 would establish a grant program to support AI technology for scanning medical images for cancer detection.
HB 1168 would require developers of generative artificial intelligence systems or services to post documentation regarding the data used to train the system or service.
To stay current on state legislative developments relevant to radiology, view the ACR policy map or receive state-specific reports from Fiscal Note. For more information on these bills or to opt in to state-specific reports from Fiscal Note, contact Eugenia Brandt, ACR Senior Government Relations Director.
Enhancements to FDA Draft AI Guidance
ACR® provided comments to the U.S. FDA regarding the draft guidance to address risk management approaches throughout the lifecycle of AI-enabled medical devices.
Read moreACR Support in Congressional Testimony
ACR submitted congressional testimony in support of funding the National Institute of Health in federal fiscal year 2026.
Read moreCY2026 Medicare Advantage Final Rule
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