The rapid advancement of artificial intelligence (AI) in medicine is paving the way for the potential development of artificial general intelligence (AGI), a revolutionary technology capable of understanding and solving complex medical problems with human-like proficiency. However, regulatory challenges, particularly from the U.S. Food and Drug Administration (FDA), pose significant obstacles to integrating AI into electronic medical records (EMRs). The FDA’s evolving policies increasingly classify AI-driven clinical decision support software (CDSS) as medical devices, subjecting them to strict premarket review, which could hinder their adoption in healthcare settings.
Regulatory concerns stem from issues such as automation bias and the integration of multiple data sources, which may obscure the reasoning behind AI-generated insights. While the 21st Century Cures Act initially aimed to provide exemptions for CDSS tools that support but do not override clinical judgment, recent FDA guidance has narrowed these exemptions, potentially stifling innovation. A return to the original intent of the 21st Century Cures Act could ensure that AI enhances medical care without being unnecessarily constrained by regulatory barriers.
At Greenlight, we recognize that seamless integration of new technology is critical to advancing patient care. We are committed to providing solutions that enhance clinical decision-making while ensuring compliance with evolving healthcare regulations. Our goal is to bridge innovation and responsibility, ensuring that we are continuously striving for improved patient outcomes.
Read the full article here: New FDA Policies Could Limit the Full Value of AI in Medicine | JAMA Forum | JAMA Health Forum | JAMA Network
