ESF/DTAC Evidence Pack.
The digital-health evidence pack aligned to NICE ESF Standard 4 and NHS DTAC, including the subgroup evidence NHS procurement now asks about first.
A submission-ready evidence pack combining population-fit evidence, accessibility and inclusion assessment, and dataset-diversity documentation.
Digital-health founders, product leads and NHS-facing commercial teams entering procurement in the next 6 to 12 months.
Why this exists
NICE Evidence Standards Framework Standard 4 requires digital-health developers to demonstrate consideration of health inequalities and to disclose dataset diversity. NHS Digital Technology Assessment Criteria (DTAC) embed accessibility and inclusion criteria into procurement. Developers who cannot answer the subgroup question get delayed, deferred, or declined.
The ESF/DTAC Evidence Pack is the specific artefact NHS procurement reviewers and NICE assessors ask for. Not a re-formatted version of your CE technical file. Not a marketing deck. The pack itself.
What is included
- Population-fit evidence, stratified by the eight social factors profiled on the Equity Engine panel
- Accessibility and inclusion assessment, covering literacy, language, disability access and digital access
- Dataset diversity statement, formatted to NICE ESF Section C
- Subgroup performance evidence pack sized to the DTAC template
- Written justification file that references every claim back to primary evidence
- One NHS-procurement simulation session with an ex-procurement reviewer on our team
- Editable working file for your commercial team
What is not included
- Product engineering changes required to close the gaps we identify, those are your build team's scope
- Contract negotiation with a specific NHS Trust, we produce the pack, you close the deal
How it works
Weeks 1 to 2. Kickoff. We map your intended use, target Trusts and current evidence base against ESF Section C and DTAC.
Weeks 3 to 7. Panel deployment. Longitudinal surveys, usability studies and lived-experience narrative capture from the populations most likely to be under-represented in your training data.
Weeks 8 to 10. Pack assembly, procurement simulation, handover to your commercial team.
Where this fits
Priced at the mid-tier of a specialist regulatory-affairs engagement. Fixed, so your regulatory and commercial teams can budget from a single line item. Cheap enough that a DTAC assessor's rejection is the more expensive alternative.
Take the Regulatory Readiness Scorecard.
Twenty questions, six domains. A plain-English diagnosis of your regulatory exposure, and the specific fixed-price engagement that closes each gap.