UK Law and Practice Contributed by: Amélie Chollet, Hannah Curtis and David Dennis, CMS
Ongoing Data Protection Reform The UK government is considering changes to data protection law, though the extent of these changes is not yet finalised. The Data (Use and Access) Bill is expected to pass in 2025, one central aim of which is to reduce the compliance burden for organisations in the UK. Overall, the regulatory landscape for digital healthcare in the UK is evolving, with a clear policy focus on patient safety, data protection and the effective regulation of rapidly advancing digital health technologies.
• require minimum cybersecurity standards. The MHRA has begun issuing secondary legisla- tion and guidance to refine the above framework. For example, in late 2024 the MHRA launched an “Emerging Roadmap” including a statu- tory instrument to clarify vigilance and report- ing requirements for devices on the market. It also announced plans (consultation in Novem- ber 2024) to introduce “abridged approvals” for devices already approved by major foreign regu- lators (FDA, TGA, etc). Extension of CE Mark Acceptance The UK government has extended the accept- ance of CE-marked medical devices on the GB market until 30 June 2028 (or 2030 for in vitro diagnostics), providing a transitional period for compliance with new UK requirements.
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