Abstract
Federal health agencies are currently developing regulatory strategies for Artificial Intelligence based medical products. Regulatory regimes need to account for the new risks and benefits that come with modern AI, including safety concerns and unique opportunities, like the potential for autonomous learning, that makes AI dramatically different from traditional static medical products. The current default regulatory regime is to treat AI like a medical device (i.e., as opposed to like a drug or a biologic product). As agencies like the U.S. Food and Drug Administration (FDA) develop new regulation to cover the uniqueness of AI, we suggest they consider adopting aspects of regulation traditionally used in the practice of medicine (i.e., doctors). In fact, FDA is currently undergoing a pilot that moves in that direction. We propose that AI regulation in the medical domain can analogously adopt aspects of the models used to regulate medical providers. We provide this view point to encourage discussion of how medical AI might be regulated. In doing so, we will also review several issues our framework does not resolve.
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