Embargoed until 4:00 am CT/5:00 am ET, Monday, Nov. 10, 2025

DALLAS, TX - November 10, 2025 (NEWMEDIAWIRE) - Hundreds of health care artificial intelligence (AI) tools have been cleared by the U.S Food and Drug Administration (FDA), yet only a fraction are rigorously evaluated for clinical impact, fairness or bias.[1] [2] Furthermore, FDA review only a covers a small portion of health AI tools being developed and used in health care. The American Heart Association (Association), a global force changing the future of health for all, today released a new science advisory urging health systems to adopt clear and simple rules for using AI in patient care.

Published in the Association’s flagship journal, Circulation, the advisory, “Pragmatic Approaches to the Evaluation and Monitoring of Artificial Intelligence in Healthcare,” introduces a pragmatic, risk-based framework for evaluating and monitoring artificial intelligence (AI) tools in cardiovascular and stroke care. It builds on prior published AI frameworks to identify critical gaps in current practices. The Advisory includes key principles to help health systems build effective AI governance for selecting, validating, implementing, and overseeing AI tools. The four guiding principles for health systems in deploying clinical AI proposed are: strategic alignment, ethical evaluation, usefulness and effectiveness and financial performance. These principles will help ensure AI tools deliver measurable clinical benefit while safeguarding individuals from known and as yet, unknown harms.

“AI is transforming health care faster than traditional evaluation frameworks can keep up,” said Sneha S. Jain, M.D., M.B.A., volunteer vice chair for the American Heart Association AI Science Advisory writing group, clinical assistant professor of medicine in cardiovascular medicine at Stanford Health Care and the Director of the GUIDE-AI Lab. “Our goal is to help health systems adopt AI responsibly, guided by pragmatic, risk-tiered evidence generation that ensures innovation truly improves care.”

The advisory highlights that while AI tools can enhance diagnostic accuracy and efficiency, many are deployed without rigorous local validation or bias assessment. A recent survey found that only 61% of hospitals using predictive AI tools validated them on local data prior to deployment, and fewer than half tested for bias.[3] This variability is most pronounced among smaller, rural and non-academic institutions, raising concerns about consistent care delivery across a variety of patient populations and safety.

The American Heart Association’s extensive network of nearly 3,000 hospitals participating in the Get With The Guidelines® quality improvement programs, including more than 500 rural and critical access facilities, positions it as a trusted leader in advancing responsible AI governance. The Association has committed over $12 million in research funding in 2025 to test novel health care AI delivery strategies for safety and efficacy.

The science advisory writing group outlines that monitoring of AI tools cannot end after deployment. Performance of AI tools may drift as clinical practice changes or patient populations differ.[4] They emphasize that health systems should integrate AI governance into existing quality assurance programs and define clear thresholds for retraining or retiring tools if performance declines.

“Responsible AI use is not optional, it’s essential,” said Lee H. Schwamm, M.D., FAHA, volunteer member of the American Heart Association committee on AI and Technology Innovation, senior vice president and chief digital health officer of the Yale New Haven Health System and associate dean of digital strategy and transformation at Yale School of Medicine. “This guidance provides practical steps for health systems to evaluate and monitor AI tools, ensuring they improve patient outcomes and support equitable, high-quality care.”

Writing group volunteer members include: Sneha S. Jain, M.D., MBA, (Vice Chair); Shinichi Goto, M.D., Ph.D.; Jennifer L. Hall, Ph.D.; Sadiya S. Khan, M.D.; Calum MacRae, M.D., Ph.D.; Cyril Ofori, M.D.; Cheryl Pegus, M.D., M.P.H.; Michael Pencina, Ph.D.; Eric Peterson, M.D.; Lee H. Schwamm, M.D., (Chair) on behalf of the Council on Clinical Cardiology, Stroke Council, Council on Quality of Care and Outcomes Research, Council on Cardiovascular and Stroke Nursing and Council on Lifelong Congenital Heart Disease and Heart Health in the Young.

The Association receives more than 85% of its revenue from sources other than corporations. These sources include contributions from individuals, foundations and estates, as well as investment earnings and revenue from the sale of our educational materials. Corporations (including pharmaceutical, device manufacturers and other companies) also make donations to the Association. The Association has strict policies to prevent any donations from influencing its science content and policy positions. Overall financial information is available here.

The purpose of an American Heart Association Science Advisory is to provide rapid, clear and consistent Association positioning on scientific issues. Advisories are statements on an evolving, prominent scientific issue of great interest to the public and to health professionals. All American Heart Association Science Advisories undergo peer review and are reviewed and approved by the Association’s Science Advisory and Coordinating Committee (SACC), the highest scientific body of the Association.

Additional Resources:

• Multimedia is available on the right column of release link.
• After Monday Nov. 10, 2025, view the manuscript online.
• American Heart Association news release: Urgent need to develop best practices to advance use of AI in cardiovascular care
• Follow American Heart Association/American Stroke Association news on X @HeartNews
• Follow news from the Circulation @CircAHA

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About the American Heart Association

The American Heart Association is a relentless force for a world of longer, healthier lives. Dedicated to ensuring equitable health in all communities, the organization has been a leading source of health information for more than one hundred years. Supported by more than 35 million volunteers globally, we fund groundbreaking research, advocate for the public’s health, and provide critical resources to save and improve lives affected by cardiovascular disease and stroke. By driving breakthroughs and implementing proven solutions in science, policy, and care, we work tirelessly to advance health and transform lives every day. Connect with us on heart.org, Facebook, X or by calling 1-800-AHA-USA1.

For Media Inquiries: 214-706-1173

Sarah D. Williams: sarah.d.williams@heart.org

For Public Inquiries: 1-800-AHA-USA1 (242-8721)

heart.org and stroke.org