Before a drug is approved by the U.S. Food and Drug Administration (FDA), it must demonstrate both safety and efficacy. However, the FDA does not require an understanding a drug’s mechanism of action for approval. This acceptance of results without explanation raises the question of whether the “black box” decision-making process of a safe and effective artificial intelligence model must be fully explained in order to secure FDA approval. This topic was one of many discussion points addressed on Monday, Dec. 4 during the MIT Abdul Latif Jameel Clinic…
