The inclusion of augmented intelligence in medicine: A framework for successful implementation

Artificial intelligence (AI) algorithms are being applied across a large spectrum of everyday life activities. The implementation of AI algorithms in clinical practice has been met with some skepticism and concern, mainly because of the uneasiness that stems, in part, from a lack of understanding of how AI operates, together with the role of physicians and patients in the decision-making process; uncertainties regarding the reliability of the data and the outcomes; as well as concerns regarding the transparency, accountability, liability, handling of personal data, and monitoring and system upgrades. In this viewpoint, we take these issues into consideration and offer an integrated regulatory framework to AI developers, clinicians, researchers, and regulators, aiming to facilitate the adoption of AI that rests within the FDA’s pathway, in research, development, and clinical medicine.