Affected person teams for individuals with blood issues have raised considerations about NHS England’s plans to consolidate the nation’s medical registries in a single platform.
There are greater than 100 medical registries in England – many arrange by particular person clinicians – designed to know particular medical circumstances or teams of sufferers.
In 2022, NHSE introduced plans to mix greater than 37 medical registries in a single unified registry answer known as the NHS England Consequence Registries Platform (ORP).
The platform is meant to fulfil suggestions of the Paterson Inquiry (2020) and the Impartial Medication and Medical Gadget Security Evaluation (2020), to gather particulars of the implantation of medical gadgets to measure affected person outcomes.
The tender for the ORP contract, value £969,544, was gained by software program supplier NEC Software program Options UK in February 2023.
Three medical registries went dwell within the ORP in March 2024: the most important trauma registry, the breast implant registry and the cochlear implants registry, with seven extra anticipated to go dwell in summer season 2024.
Nonetheless, the Haemophilia Society and stem cell transplant charity Anthony Nolan are amongst affected person teams to precise opposition to the plans.
Yasmin Sheikh, head of coverage and public affairs at Anthony Nolan, advised Digital Well being Information: “Whereas we welcome information enchancment and innovation, there’s been a regarding lack of transparency and engagement from the Outcomes Registries Programme to date.
“There must be rather more session about any future adjustments with affected person organisations and the medical neighborhood, to make sure this work really meets the wants of every medical space”.
She added that it’s “essential that the programme works intently with the federated information platform and safe information environments programmes, making certain that none of this work is going on in silo.”
In the meantime, Kate Burt, chief government of the UK Haemophilia Society, Nigel Hamilton, chair of Haemophilia Northern Eire and Alan Martin, director of Haemophilia Scotland have written a joint letter to Professor Stephen Powis, nationwide medical director for NHSE, elevating considerations about affected person security.
Within the letter dated 6 June 2024, seen by Digital Well being Information, they categorical sturdy opposition to the Nationwide Haemophilia Database (NHD), which is at present run by the UK Haemophilia Centre Docs’ Organisation, being subsumed by the ORP.
They word that suggestions from Sir Brian Langstaff, chair of the Contaminated Blood Inquiry, printed on 20 Might 2024, spotlight the necessity for the NHD to proceed to function exterior the NHS and request that NHSE “instantly halt any plans for taking up the NHD”.
“There was no session with the affected person organisations or the NHD and no enterprise case has been offered.
“We due to this fact haven’t any confidence that affected person data could be protected or that ORP understands the scope and complexity of the NHD,” the letter says.
The Federation of Medical Registries (FCR), a bunch of clinicians who handle medical registries, says there has not been correct engagement or scrutiny on the ORP and there was no session with the prevailing suppliers of medical registries.
Its members say that the platform is weak to cyber assault as a result of it’s accessible to the general public reasonably than being situated on the safe Well being and Social Care Community (HSCN) and fails to fulfill NHS safety requirements as a result of it isn’t protected by multi-factor authentication (MFA).
Ken Dunn, chair of the FCR advised Digital Well being Information that medical registry suppliers have skilled “big difficulties” discovering out concerning the ORP plans from NHSE.
“We now have clinicians, IT individuals and admin workers across the nation being advised by NHSE that they should entry this method to place in a variety of delicate affected person element, however what occurs if the insecurity of the system permits entry to the information by hackers?” Dunn added.
Responding to considerations, a spokesperson for NHSE stated: “The monitoring and monitoring of gadgets and implants is essential for affected person security.
“NHSE is dedicated to assembly the very best requirements in cyber safety and information safety, and the ORP meets all acceptable safety requirements.”
They added that when the ORP contract was awarded, MFA was not a requirement for externally dealing with internet-based methods, however this shall be in place by July 2024.
All of the organisations eligible to submit information to the ORP usually are not linked to HSCN, however all technical, operational and procedural safety controls are endorsed inside the ORP’s system degree safety coverage, they stated.
A spokesperson from NEC Software program Options UK advised Digital Well being Information that the contract for the ORP platform was awarded underneath the Crown Industrial Service Vertical Software Framework they usually have delivered it in accordance with NHSE’s safety and information safety necessities.
On the time of publication the Haemophilia Society had not acquired a response to its letter to NHSE.