How FDA Regulates Artificial Intelligence in Medical Products

Health care organizations are using artificial intelligence (AI)--which the U.S. Food and Drug Administration defines as "the science and engineering of making intelligent machines"--for a growing range of clinical, administrative, and research purposes. This AI software can, for example, help health care providers diagnose diseases, monitor patients' health, or assist with rote functions such as scheduling patients. Although AI offers unique opportunities to improve health care and patient outcomes, it also comes with potential challenges. AI-enabled products, for example, have sometimes resulted in inaccurate, even potentially harmful, recommendations for treatment.1 These errors can be caused by unanticipated sources of bias in the information used to build or train the AI, inappropriate weight given to certain data points analyzed by the tool, and other flaws. The regulatory framework governing these tools is complex. FDA regulates some--but not all--AI-enabled products used in health care, and the agency plays an important role in ensuring the safety and effectiveness of those products under its jurisdiction. The agency is currently considering how to adapt its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways that are difficult to foresee.2 This brief describes current and potential uses of AI in health care settings and the challenges these technologies pose, outlines how and under what circumstances they are regulated by FDA, and highlights key questions that will need to be addressed to ensure that the benefits of these devices outweigh their risks.