The AI cycle of health inequity and digital ageism: mitigating biases through the EU regulatory framework on medical devices.

"IV.B.4. Limited Transparency and Public Disclosure In relation to potential problems with transparency in the conformity assessment phase, another limitation may be the limited transparency on health outcomes for specific (older) age groups warranted by the MDR. The MDR only requires manufacturers of implantable and Class III medical devices to summarize ‘the main safety and performance aspects of the device and the outcome of the clinical evaluation’ in the publicly accessible EUDAMED database.82 This means that for most AI medical devices, this information is not available. As a result, there is limited public disclosure of performance on subpopulation-specific data. This lack of transparency makes it impossible to inform patients or health professionals about whether new medical devices are safe and effective for specific age groups and to include this as a consideration in medical decision-making for individual older patients.83 Another challenge is that the EUDAMED database currently does not specify whether the approved medical device makes use of AI techniques—it only specifies whether it is software."