Harmonising Medical Device Standards with International Requirements

Digital Technology Assessment Framework (DTAC) is used to assess Digital Health Technologies (DHTs) against mandatory standards and policies across the NHS and adult social care system. DTAC covers five key areas: Clinical Safety, Information Security, Cyber Security, Interoperability, and Usability. All DHTs must be assessed against DTAC before purchase by NHS commissioner or provider organisations. This opportunity involves harmonising DTAC standards with international standards to reduce barriers to entry for healthcare technology providers, streamline regulatory processes, and create operational efficiencies across the digital health ecosystem. Suppliers of medical devices and digital health technologies should understand this initiative as an opportunity to align with evolving assessment frameworks and potentially simplify market access across both UK and international markets.