As pressure mounts of regulators to act in order to prevent potentially harmful outcomes of deploying AI in healthcare, the MIT Jameel Clinic hosted a one-day event giving MIT faculty and industry experts the opportunity to engage with regulators on developing policy for AI in health. The meeting created an opportunity to inform regulators of the latest advancements in AI, while allowing MIT faculty and industry experts to propose new ideas for regulatory frameworks for AI in health. Key issues addressed were data availability for AI researchers, cross-institutional education about AI and more consultation between regulators and primary users of AI tools. A key outcome of the day was the decision to prolong the discussion and for the MIT Jameel Clinic to host more workshops of a similar nature to keep AI regulators informed on the latest developments in the field.
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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 for Machine Learning in Health (Jameel Clinic) AI and Health Regulatory Policy Conference, which ignited a series of discussions and debates amongst faculty; regulators from the United States, EU, and Nigeria; and industry experts concerning the regulation of AI in health.
As machine learning continues to evolve rapidly, uncertainty persists as to whether regulators can keep up and still reduce the likelihood of harmful impact while ensuring that their respective countries remain competitive in innovation. To promote an environment of frank and open discussion, the Jameel Clinic event’s attendance was highly curated for an audience of 100 attendees debating through the enforcement of the Chatham House Rule, to allow speakers anonymity for discussing controversial opinions and arguments without being identified as the source.
Rather than hosting an event to generate buzz around AI in health, the Jameel Clinic's goal was to create a space to keep regulators apprised of the most cutting-edge advancements in AI, while allowing faculty and industry experts to propose new or different approaches to regulatory frameworks for AI in health, especially for AI use in clinical settings and in drug development.