63
medical device surveillance were, in many ways, ill-suited to the rapid pace and unique risks of digital mental health products. The Digital Mental Health Project team updated existing PMS guidance for SaMD with examples of how harm could occur in association with the use of these products. In parallel, updated PMS legislation more broadly reflects requirements for all medical devices, including software and AI:
Real-time data collection Instead of relying solely on
periodic reviews, the guidance encourages continuous data gathering from users and clinicians to spot emerging risks. Rapid response mechanisms Streamlined processes for reporting, investigating, and acting on safety concerns mean that issues have greater potential to be addressed before they escalate. Integration with digital platforms With improved technology comes the advent of enhanced capability of PMS systems which should be better embedded in digital product ecosystems, enabling seamless feedback and proactive risk management. User-centric surveillance Patients are not just passive recipients but active participants, empowered to report issues and contribute to ongoing product improvement using systems such as the Yellow Card scheme, run by the MHRA. In this way, PMS becomes not a static checkpoint but a continuous cycle of learning, responding, and improving throughout a product’s lifecycle.
Made with FlippingBook Digital Publishing Software