DTAC V2.0 - What's Changed

There have been recent changes to the DTAC Standard: NHSE has released

Version 2.0 on 24/02/2026. Here is a glance at the key requirements:

Landscape

The NHS Digital Technology Assessment Criteria (DTAC) is an assessment framework for care commissioners and providers to use when assuring Digital Health Technology (DHT) products.

It covers the core standards, policies and best practice required for use in the NHS and adult social care across 5 areas:

• clinical safety

• data protection

• technical security

• interoperability

• usability and accessibility

DHTs must be assessed by commissioners and care providers against the standards and policies they are required to meet for them to be considered safe for use in the Health and Social Care system in England.

DTAC brings clarity and consistency to the assurance process, which reduces burden on industry and healthcare organisations.

DTAC is comprised of 4 sections A - D covers:

• A - Company information: non-assessed section

• B - Value proposition: non-assessed section

• C - Technical questions: assessed sections

• D - Usability and accessibility

It can be an intensive document to complete as it relies on inputs from a number of other sources. The possible supporting documents to be provided are:

• A11 - CQC Report

• B4 - User journeys and data flows

• C1.1 - Pre-Acquisition Questionnaire Form

• C1.2.3 - Clinical Safety Case Report

• C1.3.4 - Hazard Log

• C2.2.1 - Information Commissioner's registration

• C2.2.2 - Data Protection Impact Assessment (DPIA)

• C2.2.4 - Products terms and conditions regarding use of user data, end user licence agreement or equivalent

• C3.1 - Cyber Essentials Certification

• C3.2 - External Penetration Test Summary Report

• D1.1 - User Journeys and/or how the product fits into a user pathway or journey

Change

Manufacturers must provide this form in lieu of the older v1.0 form from 6 April 2026 when requested by Health and Care organisations to facilitate assurance of Digital Health Technology products. Prior to this date, care providers should accept whichever version (1.0 or 2.0) is provided by the manufacturer.

Main changes are:

Software or AI as a Medical Device

• C1.11 - Must confirm if AI / Software and Medical Device (SaMD) under UK MDR 2002

Pre – Acquisition Questionnaire required

Manufacturer

• Explicit Definition of manufacturer

Responsibility for Design

Manufacture

  Packaging or Assembly

Product Type Options

• Standalone software applications as distinct category

User Journeys - Data Flows

• More Structured

Data flows between Product and Health IT systems

DPIA is acceptable

Clinical Safety Scope

• Hardware bundled with Software must be covered in DCB0129

Usability and Accessibility

Explicitly clarified as comparative only

Outcome

There are 25% fewer questions to be completed in V2.0 – which will be true for many suppliers

There is better scope guidance, DTAC will be faster to complete for manufacturers as a result again for most suppliers

If you're supplying Software or AI as Medical Devices, then V2.0 has some added requirements which will require additional input

There are new C1.11 entries - a Pre-Acquisition Questionnaire