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Are synthetic health data ‘personal data’?ReportCommissioned by the MHRA, we evaluated the current legal framework, regulatory guidance and latest legal commentary to assess whether—or in what circumstances—synthetic health data might be considered ‘personal data’
Artificial intelligence for genomic medicineReport As well as investigating the limitations of AI for genomic medicine and the challenges to realising its full potential for health, this report and its companion briefing, sets out seven priority policy actions to help make AI work to best effect for genomic medicine.
Algorithms as medical devicesReportA resource for regulators and policy makers, this report makes recommendations for improving the regulation of digital medical devices
Regulation of data, AI and medical devices ResearchWe work closely with a host of stakeholders – policy and decision makers, health professionals, regulators and researchers. Sometimes this includes direct engagement with politicians to inform them about relevant developments and convene or join discussions about our policy priorities.
Synthetic health data, real regulatory challengeBlogSynthetic health data is a new form of data generation which demands new regulatory approaches to deliver the benefits to patient care we all would like to see, argues Dr Colin Mitchell
Black box medicine and transparencyReportA series of reports each examining a different aspect of the problem of human interpretability of machine learning in healthcare and research. In clarifying the requirements for transparency and explanation we aim to improve patient and public trust in these technologies. This work was made possible with funding from the Wellcome Trust.
Integrating AI with other novel technologies to detect and prevent oesophageal cancerReportIn Project DELTA (integrateD diagnostic solution for EarLy deTection of oesophageal cAncer), the PHG Foundation led ethical, and legal research into personalised risk prediction and AI driven pathology to detect oesophageal cancer, and its pre-cursor, Barrett’s oesophagus.
Journeys, experiences and best practices on computer modelled and simulated regulatory evidenceNewsIn the era of AI and digital health innovation, the importance and value of computer modelled and simulated evidence for clinical trials is increasing, yet uncertainty remains on its regulatory acceptability. New report examines whether and how increased regulatory acceptance of such evidence can be achieved.
What do patents tell us about the nature and trajectory of medical AI?BlogWhat can we learn by examining the patenting trends for medical AI or machine learning over 20 years? The answer is a surprising amount.
Reflections and key questions on data and AI for healthNewsThe regulation and governance of AI, data and digital health was the theme for this year’s WYNG-Hatton conference.
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