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Most patients feel it is important to be informed when artificial intelligence (AI) will play a role in their care. Although most anticipate that AI will make health care at least somewhat better in the next five years, many express concerns about misdiagnosis, privacy breaches, unintended consequences of AI, and increased costs. These mixed feelings highlight the importance of addressing patient concerns and providing clear, accessible information.
As of October 2023, the FDA had identified 692 artificial intelligence/machine learning-enabled products that received clearance for marketing, with sustained growth projected for both submission volume and model diversity.1 Thus, an understanding and appreciation for the expectations and category-specific considerations for these novel medical devices is needed to best navigate the regulatory hurdles on the pathway to approval.
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