NHS England has launched a national review, seeking views from suppliers and users of health tech to help improve DCB0129 and DBC0160 standards.
A review is required due to tech advancements and the acceleration of digital transformation, NHSE explains, citing examples such as EPR implementations and the adoption of digital-first approaches to the delivery of health services. “Digital technologies are now central to clinical practice rather than supplementary tools, requiring more sophisticated safety management approaches to protect patients from potential harm,” it adds.
Aside from the emergence and adoption of new technologies, there has also been a shift away from the traditional “waterfall” lifecycle model, according to NHSE, toward an agile approach favouring development, testing, and continuous improvement of digital systems in short cycles to allow for greater flexibility. Other motivations for review include the integration of digital tools into everyday clinical practice and cross-organisational data sharing, “potentially creating new pathways and potential for patient harm if not properly managed”.
A survey is provided to collect views and feedback, asking whether alternative risk management standards should be adopted in place of current standards, whether DCB0129 and DCB0160 should apply to medical devices, and if standards should include specific cybersecurity requirements for health IT systems. It also moves on to look at optional questions around implementation and wider support for the specifications.
Responses from the survey will be anonymised, NHSE confirms, and will be combined with insights collected from 11 focus groups held in 2025 to produce a consultation response report summarising key findings and proposals for revision. Findings will inform support and guidance around implementation, training, and resources, as well as the development of tools and templates, and ensuring compliance mechanisms are effective.
“Some updates, such as revised guidance or templates, may be delivered quickly, while others will require longer-term collaboration with health and social care organisations, technology suppliers, professional bodies, and other partners,” NHSE outlines.
Wider trend: Health tech regulation and innovation
One of the headline announcements of the King’s Speech has been the NHS Modernisation Bill, which sets out plans to abolish NHS England, strip back national bureaucracy, drive forward the Single Patient Record, and streamline patient safety. Of note are measures introduced in the Regulating for Growth Bill, which recognises the need to modernise regulation to support growth and innovation. It points to the potential for “rapid but controlled” testing of AI through regulatory sandboxes, with legal powers allowing rules to be temporarily relaxed to test new products and technologies in real-world settings.
The MHRA has published findings from the National Commission into the Regulation of AI in Healthcare research, pointing to the need to balance a desire to use AI in improving patient care and supporting healthcare professionals, with “safe, fast and trusted” regulation. Almost three-quarters of respondents (73 percent) disagreed or strongly disagreed that the current regulatory framework is sufficient to ensure safety and performance standards; with 61 percent disagreed or strongly disagreed with its effectiveness in tackling data governance and data privacy. 61 percent also thought current requirements for clinical evidence are insufficient, and 65 percent pointed to a need for more to be done on post-market surveillance. Opinions on the impact on innovation were relatively split, with 65 percent of industry commentators considering it to be either “somewhat” restrictive or too restrictive; compared with 77 percent of the public who felt it was too loose or “somewhat” loose.
The Medicines and Healthcare products Regulatory Agency CEO Lawrence Tallon has presented evidence to a parliamentary inquiry on innovation in the NHS, focusing on personalised medicine and AI. Tallon explained measures to accelerate NHS adoption, made a number of predictions on “big changes” to follow the National Commission into the Regulation of AI in Healthcare, and put forward recommendations for UK government. “The way that regulation has been set up historically in our agency and in other agencies has four underlying assumptions, all of which are going to be changed significantly by AI,” Tallon stated. “The first is that there is a very long development time, because bringing a medicine to market takes many years, but AI has a much faster development cycle.” Secondly, the barrier to entry for software as a medical device is lower than that for bringing medicines to market that can cost millions or even billions of pounds. Thirdly, medicine tends to be a static product that “does the same thing before and after being licensed”, whereas AI tends to change and evolve. “Finally, most medicines are developed around fairly high prevalence diseases, but increasingly we’re targeting medicines or software to smaller population diseases,” he added.
