Recommendation COVID-M4.4: 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.

The Scottish Government accepts this recommendation in principle.

The Scottish Government notes that this recommendation will require the leadership of the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA), as medicines regulation and safety is a reserved matter and responsibility rests with the UK Government. However, the Scottish Government is supportive and accepts the broad principle of the recommendation. Proportionate and timely access to linked healthcare data across the UK would significantly accelerate the identification and assessment of safety signals for vaccines and therapeutics and substantially strengthen vigilance capabilities.

There is a clear need for the MHRA to access linked data from primary care, secondary care and other care settings, such as homecare services, in a timely manner, alongside administration data, to better understand safety issues and strengthen post-authorisation surveillance particularly learning from the challenges experienced during Covid-19.

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

Yellow Card (YC) reporting is a UK wide mechanism to gather safety data, and normalising reporting is a key aim for the Scottish Government and supports the recommendation. CIREG members highlighted the need for clear public information on medicine and vaccine safety, including how the Yellow Card scheme enables members of the public and healthcare professionals to report suspected side effects and supports ongoing safety monitoring.

Scotland's development of the NHS Scotland MyCare App provides a valuable opportunity to incorporate direct links to YC reporting and explore possible solutions to link YC data to other datasets. CIREG members highlighted the importance of establishing accessibility and improving public awareness and uptake of the MyCare App as key prerequisites for achieving the intended benefits of direct YC reporting functionality. Raising awareness of the YC scheme itself is a continual activity for the Scottish Government and relevant stakeholders, including healthcare professionals, parents and children and young people. Further considerations also include how the YC can be integrated into Scottish prescribing systems that builds on work already underway in England.

The Scottish Government is committed to working with the UK and other Devolved Governments, respective health services and relevant partners to improve access to linked healthcare data across the UK for post-authorisation safety monitoring, while maintaining strong safeguards for patient confidentiality. In doing this it will be important to ensure that any UK-wide framework is practical for all four nations.

The Scottish Government already has excellent linked medicine data in primary care, in-patient secondary care and home care in Scotland through our work to establish a Medicines in Acute and Chronic Care in Scotland (MACCs) data asset which provides near-universal coverage. We will engage with the MHRA on taking its work on population-scale safety surveillance forward.

CIREG members stressed the importance of being open and clear about how data is collected, protected, shared and used, to help build public trust and confidence.

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

4.1 The Welsh Government recognises the importance of ensuring that health data and digital systems can support the timely access to good quality data to facilitate safety monitoring. This must be done in a proportionate way, with strong safeguards for patient confidentiality.

4.2 Public Health Wales already provides health surveillance data to the Medicines and Healthcare Regulatory Agency including through the yellow card scheme and other established arrangements. This helps support clinical safety, and public confidence in national vaccination programmes and therapeutics. However, the Welsh Government accepts that there is more to be done in delivering this recommendation and enabling the safe and consistent access to linked data.

4.3 As set out in the response to recommendation 3, Wales has made significant technical progress through the ongoing development of the Welsh Immunisation System. This is helping to create a national vaccination record, using linked data, while supporting public health surveillance, recording and clinical audit.

4.4 The Welsh Immunisation System currently supports several major programmes, including Covid-19, influenza and Respiratory Syncytial Virus (RSV). Further work is planned to expand this approach across all vaccination programmes. This will support improved surveillance, service planning and the assessment of safety signals, to inform both the work of the Medicines and Healthcare products Regulatory Agency and Public Health Wales.

4.5 Work has started on a refreshed Digital and Data Strategy for health and care in Wales. This will set the long-term direction for improving digital services and making better use of data.

4.6 Implementing this recommendation in full, will require careful consideration of the legislative and governance arrangements needed to support ongoing, proportionate access to linked health data. Any arrangements must continue to protect patient confidentiality and comply with the relevant data protection requirements.

4.7 Progress to date has been limited in part by the current regulatory framework. The Welsh Government is exploring potential changes to address these barriers. This includes working with the UK government on matters reserved to the UK government, including data sharing and governance, to support a more sustainable and effective approach to the safe and responsible use and sharing of public health data.

4.8 The Welsh Government and Public Health Wales will continue to work actively with the Medicines and Healthcare Products Regulatory Agency to improve access to health surveillance information needed to support safety monitoring, in line with this recommendation.

Accepted in Principle

The DHSC and Medicines and Healthcare products Regulatory Agency (MHRA) are leading on the response to this recommendation.

The Covid-19 pandemic highlighted the importance of ensuring that the Medicines and Healthcare Products Regulatory Agency (MHRA) can secure quicker access to linked health data from GP records, hospitals and all healthcare providers across the UK. This would help them identify and investigate potential safety concerns for vaccines and medicines quicker and improve ongoing safety monitoring. However, progressing this recommendation in full will require resolving a number of practical and legal challenges, together with consideration of funding mechanisms and wider resource requirements. While preliminary discussions led by MHRA have been initiated to explore potential legal gateways for the sharing and use of patient data across England, Scotland, Wales and Northern Ireland, there is not yet an agreed approach. There is consensus that the most effective approach would involve linking multiple datasets, particularly primary and secondary care data, to enable both granular and aggregated analysis.

Funding will likely be needed to develop and maintain secure systems for storing, linking and analysing data, as well as to support the specialist workforce needed to manage and use this information effectively. Ongoing investment will also be required to maintain data quality and system performance. We are giving consideration to how these measures could be funded, but we are likely to require additional investment.

As with the closely linked recommendation 4 in the Module 3 report, DoH (NI) officials will continue to engage with colleagues across the UK, led by DHSC and MHRA officials, to ensure that the impact of implementing this recommendation here is fully understood and accounted for, while maintaining strong safeguards for patient confidentiality.