The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidelines for machine learning medical devices with a focus on transparency.
The guidance on transparency for machine learning medical devices, published on June 13, 2024, was developed jointly by the MHRA, the U.S. Food and Drug Administration (FDA), and Health Canada to ensure that information is communicated clearly and relevant to audiences.
This is based on 10 guidelines for good learning practice published by the three organizations in 2021.
The MHRA guidance states: “These guidelines are intended as things to consider when adopting and promoting good transparency practice.
“Our continued work on this topic will help us collaboratively develop, implement, and iterate on good transparency practices and consensus standards in this rapidly evolving field.”
The principles of the guidelines take into account transparency regarding the subjects involved and their motivations for using medical devices.
This includes people using the device, people receiving care using the device, and other stakeholders who may make decisions about the device to support patient outcomes.
The guidance also covers transparency regarding the type of information required, the placement of the information, the timing of the information, and the methods used to support transparency.
This may include information about the medical purpose and function of the device, the conditions under which the device can be used, and an overview of clinical studies.
This guidance explores how software user interfaces can be optimized to support transparency and make information personalized, adaptive, and interactive.
It also advises that information needs should be considered throughout each stage of the product lifecycle, recommending targeted information such as on-screen instructions and warnings as new information is discovered.
In January 2024, the MHRA published its regulatory roadmap for medical device development, which focuses on ensuring all UK patients have access to innovative medical technologies while protecting patient safety.
This was followed on 30 April 2024 by the publication of the MHRA's Strategic Approach to AI.
