NHS England has launched an evaluation survey designed to collect data on the current Digital Technology Assessment Criteria (DTAC) and the impact of future changes.
“The DTAC process is currently undergoing a review, to introduce efficiencies, based on industry and NHS need,” NHSE states. “Throughout the review, NHS England have engaged extensively with industry and NHS partners, to understand the opportunities to introduce efficiencies into the DTAC process.”
The survey first collects information from respondents on their role in the completion of DTAC forms for their organisation, the status of their product and its classification as a medical device, and the category of product that the device or solution falls into.
Later questions aim to gather details on respondents’ understanding of the DTAC process and assessment, as well as their experiences, asking for opinions on whether DTAC adds value and is “fit for purpose”; whether it is consistently applied between trusts; and whether the process is “clear and straightforward to complete”.
To learn more, or to complete the survey, please click here.
Wider trend: Regulation and technology across health and care
Earlier this year, the UK government published a response to a report from the Regulatory Horizons Council about the regulation of AI as a medical device, accepting all 15 of its recommendations, and offering insight into current work and next steps in this space.
The Department for Science, Innovation and Technology launched a new round of the Regulators’ Pioneer Fund, offering up to £5.5 million in total funding for innovation in critical sectors and helping support the delivery of the Plan for Change. The latest round of funding is open to regulators and local authorities, looking to support projects such as AI in healthcare and smarter ways to test out new treatments.
Regulations from the Medicines and Healthcare products Regulatory Agency have entered into force, requiring manufacturers to “actively monitor” the safety and performance of medical devices once on the market. The post-market surveillance regulations have been designed to help identify potential safety issues earlier and to enable faster responses to incidents and emerging risks, the agency shared.
