Regulation and governance of data, AI and medical devices

 

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.

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For manufacturers and notified bodies collectively navigating the landscape of synthetic data and its use as evidence.

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Synthetic data for development of AI as a medical device  (PDF 1MB)

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