DTAC Standard Harmonisation for Medical Device Regulation

Description

Digital Technology Assessment Framework (DTAC) is used to assess Digital Health Technologies (DHTs) against the core mandatory standards and policies that apply across the NHS and adult social care system. There are several parts to DTAC - Clinical Safety. Information Security, Cyber Security, Interoperability and Usability. DHTs must be assessed against DTAC at the point of purchase within a commissioner or provider organisation. This recommendation is born from the medium to longer term recommendations to harmonise the standards within DTAC to international standards - and reduce international barriers to entry for providers by releasing downstream efficiencies.