Recent developments – at national and international levels – in the regulation and governance of data, AI and medical devices are having significant impacts and potential impacts on the application of technology for health.
These include the ongoing specification and interpretation of the GDPR as it applies to particular forms of data processing (such as processing of genomic data), the overhaul of medical device and in vitro diagnostic device regulation across the EU, the development of an EU AI Act and, a range of parallel developments within the UK to reform similar parts of the legal framework but with different ambitions and mechanisms used.
How are we contributing to the regulation of AI, data and medical devices?
We work with scientists, developers and health professionals—among other stakeholders—to assess the impact of new regulations, respond to proposals and advocate for reform in areas which impact the responsible implementation and diffusion of health innovations. We also seek to translate complex legal positions and communicate key aspects to wider audiences in health and scientific research.
Whilst much of our research into the regulation of data, AI and medical devices is commissioned work we have an extensive catalogue of public resources related to the topic. These include policy briefing and reports.
Recent related PHG Foundation policy briefings:
Data is an area that is constantly evolving, making it a source of continued interest and insight. This briefing provides an understanding of the complexity of bringing together trusted research environments.
Published 2024
This policy briefing will be important to UK-based health researchers whose work involves cross-border data sharing with EU member states.
Published 2023
New data stewardship structures have the potential to mitigate some of the barriers to data sharing. Whilst recognising their potential in the health sector, this policy briefing poses several questions as to how they will work, ethically and legally.
Published 2022