<p>Artificial intelligence (AI) tools are increasingly being used in medicine, including for drug discovery, healthcare administration, disease diagnosis, and treatment.&nbsp; Such AI applications show considerable promise for improving healthcare, but also present several legal and ethical issues relating to accuracy, transparency, bias, privacy and the “pacing problem.”&nbsp; The Food and Drug Administration (FDA) has some innovative steps to regulate health care AI, but there are significant gaps and weaknesses in the agency’s oversight of healthcare AI.&nbsp; In some cases, the FDA lacks jurisdiction to regulate certain AI applications or concerns, and for other applications and concerns the FDA does have jurisdiction but its current oversight is incomplete.&nbsp; A number of soft law programs have been launched to try to fill these gaps in FDA oversight.&nbsp; Nine different AI healthcare soft law programs are reviewed in this Article, including their objectives and mechanisms for governing AI.&nbsp; These soft law programs have a number of strengths, including greater agility and flexibility than government regulation, the opportunity to involve
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