For regulatory affairs and procurement
Regulatory alignment. Which Equity Engine output satisfies which clause.
A framework-by-framework map from the specific regulatory clause you are graded against to the specific Equity Engine output that satisfies it. Built for vendor forms, procurement due diligence, and NICE / MHRA submissions.
How to use this page. Skip to the framework you care about via the table of contents below. Each row shows the clause reference, the output we produce against it, and the engagement it lives inside. Every claim on this page cross-references the specific solution page it comes from.
EU Joint Clinical Assessment (JCA)
Regulation (EU) 2021/2282Applicable 12 January 2025100-day dossier windowUp to 67 PICOs, 16 sub-populations
| Clause / expectation | Equity Engine output | Engagement |
|---|---|---|
| Mandatory patient input into the joint assessment | PICO patient-input datasets formatted to the EUnetHTA 21 template | JCA-Ready Evidence Package |
| Subgroup analysis across relevant sub-populations | Full subgroup analysis across the 8 social factors profiled at panel sign-up | JCA-Ready Evidence Package |
| Dual formatting for NICE reference case and G-BA reappraisal | Dual-format deliverable file, ready for both bodies without re-work | JCA-Ready Evidence Package |
| Lived-experience evidence to support scope-defining PICOs | Structured lived-experience narrative artefacts, tied to specific PICOs | JCA-Ready Evidence Package |
| Ongoing patient-input function for label reviews and amendments | Quarterly-to-monthly Patient Council with written decision record | Patient Council as a Service |
NICE Evidence Standards Framework (ESF)
Section C, Standard 4Health-inequalities considerationDataset-diversity disclosure
| Clause / expectation | Equity Engine output | Engagement |
|---|---|---|
| Documented consideration of health inequalities | Health-inequalities evidence pack, stratified by 8 social factors | ESF/DTAC Evidence Pack |
| Disclosure of dataset diversity | Dataset-diversity statement in NICE ESF Section C format | ESF/DTAC Evidence Pack |
| Sub-population performance evidence | SaMD subgroup performance dossier, if algorithm-based | SaMD Red-Team |
| Ongoing evidence generation post-approval | PMCF equity gap map, alignment to UK PMS 2025 | PMCF Equity Gap Assessment |
NHS Digital Technology Assessment Criteria (DTAC)
Accessibility and inclusionUsabilityDigital-access barriersData protection
| Clause / expectation | Equity Engine output | Engagement |
|---|---|---|
| Accessibility and inclusion evidence for procurement | Accessibility & inclusion assessment, sized to NHS Digital's template | ESF/DTAC Evidence Pack |
| Usability testing across literacy levels | Population-fit usability evidence, spanning literacy and language | ESF/DTAC Evidence Pack |
| Digital-inclusion barriers evidence | Digital-access barrier study across community-partner-recruited users | ESF/DTAC Evidence Pack |
| NHS-procurement-simulation confidence check | Simulation session with an ex-procurement reviewer on our team | ESF/DTAC Evidence Pack |
FDA Diversity Action Plans (DAP)
Guidance under FDORAPhase 3 / pivotal-trial disaggregationRace, ethnicity, sex, age
| Clause / expectation | Equity Engine output | Engagement |
|---|---|---|
| Enrollment disaggregation by race, ethnicity, sex, age | Population-fit performance dossier stratified across the 8 social factors | SaMD Red-Team |
| Subgroup performance evidence for AI/algorithm devices | Adversarial subgroup performance breakdown with confidence intervals | SaMD Red-Team |
| Independent-review letter for defence of live approval | Signed independent-review letter by an ex-notified-body reviewer | SaMD Red-Team |
| Diversity narrative for the DAP itself | Written diversity narrative tied to pre-existing UK panel evidence | JCA-Ready Evidence Package |
UK Post-Market Surveillance 2025 & MHRA Inclusion and Diversity Plan
Statutory Instrument 2024/1368In force 16 June 2025Active look-back for subgroup issues
| Clause / expectation | Equity Engine output | Engagement |
|---|---|---|
| Active (not passive) subgroup surveillance | Structured PMCF gap map with active-surveillance remediation plan | PMCF Equity Gap Assessment |
| Auditable-to-raw-signal PMS process | Editable working file with audit trail, referenceable in tech docs | PMCF Equity Gap Assessment |
| Notified-body simulation before real review | One notified-body simulation session as part of the engagement | PMCF Equity Gap Assessment |
| Inclusion and Diversity Plan patient-input dimension | Standing patient-input function via Patient Council | Patient Council as a Service |
EU MDR Post-Market Clinical Follow-Up (PMCF)
Annex XIV, Part BOngoing device performance evidence
| Clause / expectation | Equity Engine output | Engagement |
|---|---|---|
| Ongoing confirmation of safety and performance in intended population | PMCF gap map cross-referenced against Annex XIV | PMCF Equity Gap Assessment |
| Justification for post-market surveillance sampling frame | Community-partner sampling frame with signed MOUs, over-indexed on under-represented populations | PMCF Equity Gap Assessment |
NIHR INCLUDE
Under-served-groups frameworkPPI expectation for NIHR funding
| Clause / expectation | Equity Engine output | Engagement |
|---|---|---|
| Costed, INCLUDE-aligned PPI plan for grant application | Drop-in PPI plan formatted to NIHR expectations | NIHR PPI Package |
| Community partnerships in place at submission (not aspirational) | Signed community-partner MOUs before grant submission | NIHR PPI Package |
| Payment to participants at NIHR guide rates | Participant payments budgeted transparently at NIHR rates | NIHR PPI Package |
| End-of-grant PPI reporting | End-of-grant PPI report for NIHR return | NIHR PPI Package |
Not sure which clauses you are exposed under?
Take the Regulatory Readiness Scorecard. Twenty questions map you to your regulatory exposure across all seven frameworks above.