Proportionate Access to Linked Healthcare Records

The UK government agrees that faster, more reliable access to linked health data across the UK would significantly strengthen MHRA’s ability to identify, investigate and monitor potential safety concerns for vaccines, medicines and medical devices.

There is clear agreement across the 4 nations that timely linkage of data from GP records, hospitals and other care settings is essential for robust post-authorisation safety surveillance. The COVID-19 pandemic demonstrated the value of rapid access to linked health data, while also exposing the limitations of fragmented systems and inconsistent routes for accessing data across the 4 nations.

Existing data services, including the Clinical Practice Research Datalink, which operates on a 4 nations basis, already provide valuable information, particularly from primary care. However, greater scale and more comprehensive, reliable linkages to secondary care and other healthcare settings are needed to meet MHRA’s requirements for timely and robust safety monitoring. Improved linkage would also strengthen the Yellow Card system by making reporting easier and improving the quality and usefulness of reports.

A strong and comprehensive safety surveillance system also underpins MHRA’s approach to innovation, supporting research, enabling clinical trial recruitment and supporting risk-proportionate regulation. This facilitates access to safe, effective and innovative products in a timelier fashion.

Meeting this recommendation will require an agreed framework for sharing, linking and using health data across the UK, which is supported by strong safeguards for patient privacy and confidentiality. It may also require sustained investment in:

secure systems

data quality

analytical capability

the specialist workforce needed to manage and use linked data effectively

The government recognises that there is more to do to develop and achieve this recommendation. It requires a clear and agreed approach for sharing and using health data across the UK. It will also be necessary to ensure that data from different parts of the health service can be linked in a reliable, consistent and timely way. Strong safeguards to protect patient privacy and confidentiality will remain essential. We will also explore future work with the Heath Data Research Service (HDRS). Any future HDRS work would be complementary to the regulatory safety monitoring described above.

Achieving this recommendation is likely to require significant investment over time, although the scale and timing of any costs will depend on the implementation model adopted. Funding may be needed to develop and maintain secure systems for storing, linking and analysing data, as well as support the specialist workforce needed to manage and use this information effectively. Ongoing investment may also be required to maintain data quality and system performance.

The UK government is committed to working with the devolved governments, respective health services and relevant partners to:

improve access to linked healthcare data across the UK for post-authorisation safety monitoring

maintain strong safeguards for patient confidentiality

In doing this, it will be important to ensure that any UK-wide framework is practical for all 4 nations.

No formal government response published. The Welsh Government had not published a response to the Module 4 report of 16 April 2026 when its page of responses to the UK Covid-19 Inquiry module reports on GOV.WALES was checked on 25 September 2026.

No formal government response published. The Scottish Government had not published a response to the Module 4 report of 16 April 2026 when its collection of responses to the UK Covid-19 Inquiry on gov.scot was checked on 25 September 2026.

No formal government response published. The Northern Ireland Executive had not published a response to the Module 4 report of 16 April 2026 when the Executive Office's publications list was checked on 25 September 2026.

No statement on delivery from Medicines and Healthcare products Regulatory Agency has been found in the sources searched. This is separate from the response above.