Earning Trust for AI in Health 2025

Post-market surveillance of medical devices BOX 3 “Post-market surveillance is a set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that have been placed on the market, and to identify the need to take any action. Post-market surveillance is a crucial tool to ensure that medical devices continue to be safe and well performing, and to ensure actions are undertaken if the risk of continued use of the medical device outweighs the benefit.” World Health Organization (WHO). (2020). Guidelines for Post-Market Surveillance and Market Surveillance of Medical Devices, Including In Vitro Diagnostics. https://www.who.int/ publications/i/item/9789240015319Evaluation efforts are a pivotal practice for establishing trust in AI technologies. This encompasses rigorous methodologies for both pre-market validation and ongoing post-market surveillance, assessing the safety, effectiveness and fairness of AI technologies in health. There is a strong consensus among health stakeholders that post-market surveillance (see Box 3) enables the early detection of new risks and iterative adaptation, which is particularly suited for AI technologies. It involves life-cycle monitoring of AI technologies using real-world data to ensure continued safety and efficacy, as the accuracy of AI technologies can change between development and post-deployment. 2.3 Post-market surveillance can help cope with the evolving nature of AI Post-market surveillance includes approaches such as pharmacovigilance methods that aim to detect and prevent adverse effects in AI-enabled medical devices. For example, the FDA has developed dedicated tools28 designed to spot changes to inputs of medical devices enabled with AI, monitor their outputs and recognize why their performance varies. Earning Trust for AI in Health: A Collaborative Path Forward 12