Mitigating AI Product Liability Risk in Life Sciences: A Principle-Based Approach By Jaclyn Jaeger Wednesday, November 1, 2023
Medical devices enabled by artificial intelligence/machine-learning (AI/ML) software are transforming the life sciences and healthcare industries in many positive ways, but they also potentially create new product liability risks that regulators have only just begun to address. In the race between AI and digital health regulations, it’s critical that life sciences companies keep pace to mitigate the risks. “AI products are advancing at a much faster rate than the regulations that govern them,” said Erin Bosman, a partner at Morrison Foerster and founder and co-head of the firm’s AI Group. To date, the FDA has authorized more than 600 AI/MLenabled medical devices, with 171 new ones having just been approved in October, according to the FDA’s Center for Devices and Radiological Health (CDRH) database. Because AI/ML-driven devices continue to learn and develop new capabilities, “product designers cannot test each possible foreseeable use or misuse,” Bosman added. Moreover, there exists a large void of knowledge and research into how AI systems can fail—all factors that make AI/ML-driven devices difficult to uniformly regulate, she said. 28th Annual Conference on
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FDA Guidance In the United States, regulators have begun with a principle-based approach. In April 2023, the Food and Drug Administration (FDA) published draft guidance proposing recommendations for what information to include in a pre-determined change control plan (PCCP) as part of a marketing submission for an AI/ML-enabled device. The draft guidance incorporates stakeholder feedback from a 2019 FDA discussion paper and represents next steps in the development of a regulatory framework for AI/ML-enabled devices, as described in the FDA’s January 2021 action plan. By way of background, the FDA first introduced the PCCP framework in the 2019 discussion paper as an optional mechanism for AI/ML-enabled device makers when submitting a plan for modifications during the initial premarket review stage. The Food, Drug, and Cosmetic Act was later amended with the addition of section 515C, providing the FDA express authority to approve or clear PCCPs for devices requiring premarket approval or premarket notification. Specifically, Section 515C provides that a new marketing submission for specified, planned modifications to a device are not required and, thus, do not require rereview by the FDA, so long as the modifications are within the scope of the originally authorized PCCP. The draft guidance brings further clarity. “To address the data-driven nature of ML-enabled devices, which lends itself to rapid technological improvement over time, the PCCP mechanism described in this guidance provides a way for developers to pre-specify specific, planned device modifications and how those modifications will be implemented,” Matthew Diamond, chief medical officer of the FDA’s Digital Health Center of Excellence, said in an FDA webinar. “Our aim is for this type of technological agility to be facilitated by the regulatory agility of the PCCP.” A new marketing submission will be needed when an authorized device has been significantly modified. In practical terms, that means life sciences companies should closely review any change that may be outside the scope of an authorized PCCP to determine whether a new marketing submission is needed. Because PCCPs are optional to use, device makers “may continue to implement device changes via additional premarket submissions to FDA, as applicable,” Diamond said.
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