FDA strengthens AI regulation to ensure patient safety and innovation in healthcare
News-Medical.Net October 16, 2024
As AI technology evolves rapidly, the FDA is tackling the challenge of balancing innovation with patient safety, shaping regulations that ensure AI tools remain effective throughout their entire lifecycle.
A Special Communication published in the Journal of the American Medical Association (JAMA) examined the regulation of artificial intelligence (AI) in healthcare by the United States (U.S.) Food and Drug Administration (FDA). It also explored AI’s potential in clinical research, development of medical products, and patient care while highlighting the key areas to address as regulations are adapted for some of AI’s distinctive challenges in biomedicine and healthcare.
Background
Advances in AI have immense potential for transforming biomedicine and healthcare. Expectations from AI often exceed those from previous medical technologies such...