Synthetic data in health-related research
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Synthetic data – artificial data that closely mimic the properties and relationships of real data – are not a new concept but technological advances have led to great optimism about their potential for health research and innovation. However, generating synthetic health data from real patient data has led developers and regulators to question the extent to which they may remain ‘personal data’, governed by data protection law.

Our 2023 report, Are synthetic health data ‘personal data’?, was independently commissioned by the MHRA to assess the status of synthetic health data under data protection law. More recently, with the MHRA we worked with a multidisciplinary group of experts to develop a set of regulatory considerations for those working with synthetic data, AI and medical devices.
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Head of Humanities, Colin Mitchell, explains what is synthetic data and why it could be useful in health research. As Colin notes, and as we discuss in detail in ‘Are synthetic health data personal data?’, developers using synthetic data may still need to consider privacy issues.
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These reports are intended to provide general information and understanding of the legal framework. Neither should not be considered legal advice, nor used as a substitute for seeking qualified legal advice

 

The Synthetic Data for Development of AI as a Medical Device (AIaMDs) report, produced by the Medicines and Healthcare products Regulatory Agency (MHRA) and the PHG Foundation, outlines these considerations, building on and complementing existing regulatory guidance.

This marks an important and exciting first step for manufacturers and notified bodies collectively navigating this evolving landscape. The report provides crucial groundwork, though more work is required to move past these preliminary ideas.

Synthetic data for development of AI as a medical device  (PDF 1MB)
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The use of synthetic data in AIaMD development introduces specific considerations where used in regulatory submissions.

Synthetic Data for Development of AI as a Medical Device (AIaMDs)

July 2025
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Read the related paper by Puja Myles, Colin Mitchell,  Elizabeth Redrup Hill, Luca Foschini and Zhenchen Wang.

High-fidelity synthetic patient data applications and privacy considerations (PDF download)

Published in the Journal of Data Protection and Privacy August 2024
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Our evaluation of the legal framework, regulatory guidance and commentary to assess whether—or in what circumstances—synthetic health data might be considered ‘personal data’.

Are synthetic health data ‘personal data’?

May 2023
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