Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, on what date work on digitally linking Medicines and Healthcare products Regulatory Authority Yellow Card information to NHS clinical records (a) began and (b) is expected to be completed.

The Medicines and Healthcare products Regulatory Agency (MHRA) has been working with the National Health Service to explore approaches to facilitate digital linkage of Yellow Card information to clinical records, and to potentially enable faster access to information, where considered necessary for an assessment. Any such approach would be subject to strict information governance controls and prior consultation with stakeholder groups.

In 2020, the MHRA began delivery of a substantially enhanced Yellow Card platform under the SafetyConnect programme, aligned to the recommendations in Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review. The new infrastructure is designed with the intent of enabling connectivity to other systems, to facilitate the exchange of information. During that time the MHRA has engaged with the NHS around the evolving technical options for robust and secure connectivity and enhanced user journeys. The first step in these enhancements is use of the common NHS login capability within Yellow Card, which is expected to go live in 2024.

Deeper connectivity between systems will be subject to internal and external stakeholder engagement and substantial information governance controls, with elements completed over a phased and multi-year work plan.