The Medicines and Healthcare products Regulatory Agency (MHRA) has released new transparency guidelines for machine learning medical devices. The guidance, developed in collaboration with the FDA and Health Canada, aims to ensure clear and relevant communication of information to users. It builds upon previous principles for good learning practice set forth in 2021.
According to the MHRA, the guiding principles emphasize the importance of transparency for all stakeholders involved in the use of medical devices, including patients and healthcare providers. The guidance outlines the type of information that should be provided, the timing of its delivery, and the methods for ensuring transparency throughout the device’s lifecycle.
The guidance also addresses how the user interface of machine learning medical devices can be optimized to enhance transparency, allowing for personalized and reciprocal communication. It recommends providing targeted information, such as on-screen instructions or alerts, as new information becomes available.
Additionally, the MHRA recently outlined its regulatory roadmap for medical device development, prioritizing patient safety and access to innovative technologies. This was followed by the agency’s strategic approach to artificial intelligence in April 2024.
