The government is intending to introduce a new regulatory regime for health digital technology, amid concerns the current system is confusing and fragmented.
A code of conduct for data drive technology, set to be published by the Department of Health and Social Care on Wednesday afternoon, includes a commitment to “introduce a trusted approval scheme for digital technology in health and care.”
It acknowledged the NHS Apps Library, set up last year, was a good “first attempt” but a more “rigorous and sophisticated approach” was needed.
This would include streamlining systems that increased regulatory scrutiny based on the risk associated with the technology and a clearer complaints process, the document said.
It would need to be “robust enough to safeguard patients and assure commissioners and purchasers considering a given product”, the code said.
It said: “Successful introduction of trusted approvals will enable suppliers to demonstrate that their product complies with the code of conduct. This in turn will provide a level of assurance to commissioners and purchasers in health and social care, providing an easier and better-defined route to market.”
Health minister Lord James O’Shaughnessy revealed the code, which includes broad guidelines on how the NHS should work with digital tech companies, at the Health and Care Innovation Expo in Manchester on Wednesday.
Lord O’Shaughnessy said: “This is an important step towards creating a safe and trusted environment in which innovation can flourish to the benefit of all our health.”
In July, HSJ revealed growing concerns about the regulation of digital technology used in the NHS, particularly for software that had been classified as a medical device.
The Medicines and Healthcare products Regulatory Agency has seen a surge in the registration of medical software in recent years, most of which have provided little to no information about the safety and effectiveness of the device.
It is not clear from the code whether a new approval regime would mean for the future of the MHRA process or the NHS app library.