Product Liability Suits for FDA-Regulated AI/ML Software

The 21st Century Cures Act confirmed the FDA’s authority to regulate certain categories of software that, increasingly, incorporate artificial intelligence/machine learning (AI/ML) techniques. The agency’s September 27, 2019 draft guidance on Clinical Decision Support Software proposed an approach for regulating CDS software and shed light on plans for regulating genomic bioinformatics software (whether or not it constitutes CDS software). No matter how the FDA’s regulatory approach ultimately evolves, the agency’s involvement in this sphere has an important – and underexamined – implication: FDA-regulated software seemingly has the status of a medical product (as opposed to an informational service), which opens the door to product liability for defects causing patient injury. When a diagnostic or treatment decision relies on FDA-regulated CDS software, will mistakes invite strict liability, as opposed to being judged by the professional or general negligence standards of care that traditionally governed diagnostic and therapeutic errors? This article explores the policy rationales for product liability suits and asks whether such suits may have a helpful role to play as an adjunct to FDA oversight in promoting safety, effectiveness, and transparency of CDS software as it moves into wider use in clinical health care settings