Expertise

Expertise

NHS assurance and DTAC V2

End-to-end DTAC V2 readiness, evidence delivery and NHS buyer assurance for software-based digital health, SaMD and AI health technology.

Two clinicians reviewing information on a tablet together.

How it is used

Specialist input, applied at the right moment.

When this expertise matters

  • The product is approaching an NHS pilot, procurement, framework or adoption conversation and needs a credible DTAC V2 evidence pack.
  • A previous DTAC response was built around the older form and needs to be reviewed against the v2 baseline now in use from 6 April 2026.
  • Clinical safety, data protection, technical security, interoperability, usability and accessibility evidence exists, but it is fragmented across teams.
  • The product sits on the boundary between digital health technology, SaMD, AI health technology or connected medical device software.
  • NHS buyers, ICBs, trusts or evaluation partners are asking for assurance evidence before commercial deployment can move.

Capability areas

  • DTAC V2 scope and applicability assessment for software-based digital health technologies.
  • Full DTAC gap analysis across clinical safety, data protection, technical security, interoperability, usability and accessibility.
  • Evidence design and implementation for DCB 0129, DCB 0160 alignment, DPIA, ROPA, DSPT, security, accessibility and technical assurance.
  • Buyer-ready evidence pack creation, including clear ownership, version control, sign-off status and document traceability.
  • Coordination of product, clinical, IG, security, technical and leadership stakeholders into one practical readiness plan.
  • Support through NHS buyer questions, challenge sessions, evidence refreshes and adoption assurance conversations.

Typical outputs

  • DTAC V2 readiness review and gap report.
  • Prioritised evidence roadmap with owners, blockers, dependencies and buyer-critical actions.
  • Completed or updated DTAC response pack with supporting evidence index.
  • Clinical safety, information governance, security, accessibility and interoperability evidence set.
  • NHS buyer assurance pack for pilots, procurement and adoption conversations.
  • Ongoing DTAC maintenance plan so evidence stays current as the product, standards and NHS expectations evolve.

Start here

Need this capability on a project?

Neural Vibe can coordinate the right specialist input without making your team manage a fragmented compliance bench.

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