NHSE to consult on clinical registry data plans following opposition

Exclusive: NHS England will consult on controversial plans to consolidate patient data from England’s clinical registries in a single platform, following opposition from patient groups.

In 2022, NHSE announced that it would combine more than 37 clinical registries in a single unified registry solution called the NHS England Outcome Registries Platform (ORP).

Clinical registries, which are often set up by individual clinicians, are designed to understand specific medical conditions or groups of patients.

The ORP was created to collect details of the implantation of medical devices to measure patient outcomes, following recommendations in the Independent Medicine and Medical Device Safety Review (2020).

Seven clinical registries were planned to be included in the ORP from summer 2024, following the addition of the major trauma, breast implant, and the cochlear implants registries in March 2024.

However NHSE faced objections from patient groups and the Federation of Clinical Registries (FCR), about its failure to engage or consult with clinical registry providers and other stakeholders.

Patient groups, including the Haemophilia Society and Anthony Nolan, also expressed opposition to the National Haemophilia Database (NHD) being subsumed by the ORP.

In response to concerns, NHSE has set up an expert reference group, including clinical registry providers and patient groups, led by Stella Vig, NHS national medical director for secondary care and quality.

Vig told Digital Health News that NHSE is “working with stakeholders to develop a new strategy for clinical audits and registries, which will direct future work on clinical audit, quality improvement and patient safety to bring further benefits to patients”.

The group will develop a draft National Clinical Audits and Registries strategy, to be consulted on in 2025.

Kate Burt, chief executive of the Haemophilia Society, told Digital Health News: “We are pleased that our concerns have been listened to and that the National Haemophilia Database will continue, for now, to be run independently of NHS England.”

She added that the society will “continue to press our case that, in line with the Infected Blood Inquiry’s recommendations, the National Haemophilia Database is run by the United Kingdom Haemophilia Centre Doctors’ Organisation (UKHCDO)”.

Recommendations from Sir Brian Langstaff, chair of the Infected Blood Inquiry, published on 20 May 2024, highlighted the need for the NHD to continue to operate outside the NHS and called for NHSE to “immediately halt any plans” for taking over the database.

Ken Dunn, chair of the FCR, told Digital Health News: “NHSE have taken on board the fact that the total lack of engagement about the ORP was a major cause of upset and should not have happened.

“But, as with all these discussions and consultations, it depends how much notice is actually taken of that engagement and only time will tell.”

Despite the engagement with stakeholders, Vig confirmed that the “vital” ORP programme has “categorically not been paused”, adding that NHS has “accelerated the collection of medical device data under the Medical Devices Outcome Registry, which is part of the ORP”.

“The tracking and monitoring of devices and implants is crucial to patient safety,” she said.