techUK's call for evidence for MHRA consultation on AI regulation

techUK is seeking evidence to inform its response to the MHRA consultation on AI regulation, gathering views from across the sector on key challenges and considerations. Submissions will help shape industry input into how AI technologies are regulated within medicines and healthcare.

Purpose and why it matters

The MHRA’s Call for Evidence: National Commission into the Regulation of AI in Healthcare gathers perspectives to shape the National Commission’s recommendations for a new regulatory framework for AI in healthcare, with MHRA publishing recommendations in 2026.

Last year the government set its ambitions, via the 10 Year Health Plan for England and the Life Sciences Sector Plan, explicitly aiming for the NHS to become “the most AI-enabled healthcare system in the world,” which depends on regulation that is simultaneously safe, fast, and trusted. The Commission is positioned as a route to UK-wide leadership in regulatory science for AI, bringing together technology, health, legal, patient and public voices.

Key regulatory themes included in the consultation

Safety and performance (pre- and post-market): Whether existing medical device assurance processes are adequate for AI tools, including newer categories such as foundation models, LLM-enabled tools, and “agentic AI” (systems coordinating multiple AIs).
Boundaries and classification: How regulation should draw lines around what counts as a medical device, and how AI systems should be risk-classified.
Post-market surveillance (PMS) and vigilance: How to monitor real-world performance, including continuous learning/updates, incident reporting, and data-sharing between providers and manufacturers.
Data governance and privacy: How responsibilities are managed across the ecosystem using existing legislation (e.g., Data Protection Act 2018; Data Use and Access Act 2025) and practical mechanisms like data-sharing agreements and DPIAs.
Transparency and evidence requirements: Whether requirements for transparency and clinical evidence are sufficient for AI tools and deployment contexts.
Overlap of assurance regimes: Managing the intersection between device regulation, professional oversight, and service regulation, to avoid duplication and prevent gaps.
Liability and responsibility across the supply chain: Whether existing legal frameworks create uncertainty, and how responsibilities should be distributed among manufacturers, healthcare organisations, and clinicians.

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Viola Pastorino

Junior Programme Manager, Health and Care Team, techUK

Viola Pastorino is a policy, governance, and strategic communication specialist.

She joined techUK as the Junior Programme Manager in the Health and Care Team in April 2024.

She has obtained a Bachelor of Sciences in Governance, Economics, and Development from Leiden University, and a Master's programme in Strategic Communications at King's College London. Her academic background, leading up to a dissertation on AI policy influence and hands-on campaign development, is complemented by practical experience in international PR and grassroots project management.

She is skilled in qualitative and quantitative analysis and comfortable communicating findings to varying stakeholders. Above all, she is deeply passionate about the intersection of technology and government, especially how technology and global discourse shape one another, the processes that lead to belief polarisation and radicalisation of communities, and crafting strategic narratives that steer public discourse.

Outside of work she loves reading, live music light operation, and diving.

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Health and Social Care Programme activities

techUK is helping its members navigate the complex space of digital health in the UK to ensure our NHS and social care sector is prepared for the challenges of the future. We help validate new ideas and build impactful strategies, ultimately ensuring that members are market-ready. Visit the programme page here.