The UK is tightening how digital health tools are approved and monitored while reinforcing patient data protections. Here is what these changes mean for everyday care in 2025 to 2026 and the practical steps to take.
Why this matters now
More NHS services are using apps, remote monitoring and AI triage. New UK rules and pilots are setting clearer expectations for safety, evidence and data use. Understanding what is regulated, how evidence is gathered and how your NHS data can be used will help you choose tools wisely, ask better questions in clinic and keep control of your information.
What is changing in regulation
- Post‑market surveillance reforms to UK medical device rules took effect on 16 June 2025. These focus on how devices are tracked and checked once in use.
- Broader pre‑market reforms have been consulted on and are still in development. Binding AI‑specific changes are not yet in force, so this area remains in flux.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is testing routes for AI in care. The AI Airlock sandbox runs through March 2026, and a real‑world evidence programme began in January 2025 to improve how performance data supports approvals and NHS adoption.
- If software, including AI, has a medical purpose, it is likely classed as a medical device in the UK and must meet UK Medical Devices Regulations before clinical use.
- NICE is expanding its role in digital health, including evidence standards and ethical guidance for AI. A new Office for Digital Health aims to make approval and reimbursement pathways for NHS digital tools clearer.
How this affects your care in 2025 to 2026
You may see more AI‑enabled triage, remote monitoring and app‑based support. Safeguards are strengthening, but they are still evolving. It is reasonable to ask your clinician when AI is involved and how a human professional oversees decisions that affect your diagnosis or treatment.
Regulators are focusing on several practical areas: data protection and privacy, device safety and performance, telemedicine quality and clinical effectiveness. They are also paying more attention to AI and machine learning safety, cybersecurity, interoperability and digital therapeutics. Expect more scrutiny of how tools are updated and how well they work in real‑world NHS settings.
Using apps and devices safely: quick checks
- Check it is a medical tool, not just a wellness app. If it claims to diagnose, treat or guide care, ask whether it meets UK Medical Devices Regulations and whether it has UKCA or CE mark lineage, or a NICE evaluation.
- Ask who is responsible for your care. For online or remote clinics, check the provider is properly registered, for example with the Care Quality Commission in England, and confirm how your records are shared with your GP.
- Read the privacy notice before you sign up. See what data is collected, where it is stored and whether it is shared or sold. Consumer wellness apps may sit outside NHS oversight.
- Keep yourself cyber safe. Update devices and apps, use strong passwords and multi‑factor authentication and download only from trusted app stores.
Your data rights, simply explained
Health information is protected under UK GDPR and the Data Protection Act 2018 as special category data, which carries stricter rules. Wherever you live in the UK, you can ask to access your data, correct errors and complain if you are unhappy with how your information is handled.
In England, the National Data Opt‑out allows you to opt out of some secondary uses of your NHS data, such as certain research and planning. It does not cover every use and it does not apply UK‑wide. You can review your choices in the NHS App or ask your GP practice for help.
What to watch next
Some details are still being worked out. The government has not yet finalised the pre‑market device reforms or any binding AI‑specific changes. It is also not yet clear how the new Office for Digital Health will translate into everyday NHS reimbursement and procurement for apps and AI tools. Expect updates through 2025 to 2026 as the MHRA completes pilots and guidance is refined.
The bottom line for patients
More digital tools are coming into routine care. Choose ones that are clearly regulated, ask how AI is supervised by clinicians, check your data settings and keep your devices secure. These simple steps make new technology more useful and safer to use.
Find out more
- Medical devices: post-market surveillance - GOV.UK — MHRA guidance on post‑market surveillance for medical devices — explains the new PMS requirements, incident reporting and what regulators monitor once devices (including software/AI with a medical purpose) are in use.
- Evidence standards framework (ESF) for digital health technologies | NICE — NICE’s Evidence Standards Framework for digital health technologies — outlines the evidence expected for apps and AI tools (including adaptive algorithms) to show clinical effectiveness and value to the NHS.
- Opt out of sharing your health records - NHS — Official NHS page on the National Data Opt‑out — how to view or change your opt‑out, what it covers and how to check your settings in the NHS App.
- Device security guidance | National Cyber Security Centre — National Cyber Security Centre device‑security guidance — practical advice for keeping phones, tablets and health apps secure (updates, passwords, multi‑factor authentication and safer device practices).
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