New Report Maps the Legal and Regulatory Landscape for Digital Health Technologies in the UK

The University of Liverpool's Civic HealthTech Innovation Zone (CHI-Zone) has commissioned a comprehensive Legal and Regulatory Mapping of Medical Devices report from leading law firm Hill Dickinson LLP and specialist life science consultancy Medilink North of England. 

Published in May 2026, the report provides a structured overview of the legal, regulatory and assurance frameworks that apply to medical devices, software and wider digital health and care technology in the UK. The report is published in three parts, covering the legal and regulatory framework, practical considerations and NHS and social care deployment. 

It explains how different categories of digital health technologies, including software as a medical device (SaMD), AI‑enabled products and digital mental health technologies, are regulated in practice across their lifecycle. It sets out the key factors used to determine whether a product is classified as a medical device and describes obligations for manufacturers of medical devices, including UKCA and CE marking, quality management systems, technical file preparation, clinical evaluation and post‑market surveillance. It also addresses the position of technologies that fall outside medical device regulation but are still subject to healthcare‑specific requirements. 

The report places a strong focus on assurance and deployment. Specifically, the report sets out the role of the Digital Technology Assessment Criteria (DTAC) and how it brings together expectations around clinical safety, data protection, cybersecurity and interoperability. It also explains statutory clinical safety standards and considers how they apply to health IT systems used in NHS and publicly funded adult social care settings. 

Finally, the report further examines how regulatory approval, NICE evidence standards and commissioning operate alongside one another, as well as consideration of how these apply to AI‑enabled and digital mental health technologies. 

Click here to read the full report for a detailed overview of the legal and regulatory landscape, along with practical considerations for innovators developing and deploying digital health technologies.