---
type: source
title: "iatroX Clinical AI Insights 2026: OpenEvidence Has No DTAC Assessment or MHRA Registration for UK Deployment — US-Centric Corpus Adds Clinical Risk"
author: "iatroX Clinical AI Insights"
url: https://www.iatrox.com/blog/openevidence-chatgpt-5-medwise-ai-iatrox-uk-clinicians-dtac-nice-esf
date: 2026-03-20
domain: health
secondary_domains: []
format: blog-analysis
status: processed
priority: medium
tags: [openevidence, nhs-dtac, nice-esf, uk-healthcare, clinical-ai-safety, belief-5, regulatory-compliance, corpus-bias]
---

## Content

iatroX Clinical AI Insights is a UK-focused clinical AI review publication that evaluates tools through the lens of NHS governance requirements (DTAC, NICE Evidence Standards Framework, MHRA). Multiple 2025-2026 reviews compare OpenEvidence against UK-compliant alternatives.

**Key findings from multiple iatroX reviews:**

**1. OE UK governance status:**
- "OpenEvidence's UK-specific governance (DTAC/DCB) is not explicitly positioned on its public pages"
- OE qualifies as a US-focused tool being used informally by UK clinicians — not formally NHS-deployed
- OE has no published DTAC assessment, no MHRA Class 1 registration listed, no NICE ESF submission

**2. US-centric corpus clinical risk:**
- OE is "built on a US-centric corpus"
- May cite AHA (American Heart Association) guidelines instead of NICE guidelines
- May suggest FDA-approved drugs that are: (a) not licensed in the UK, or (b) not cost-effective for NHS prescribing (not on formulary)
- May reference dosing standards or treatment pathways that differ from BNF (British National Formulary)
- This is a CLINICAL SAFETY RISK for UK physicians, distinct from the demographic bias or automation bias documented in prior sessions

**3. OE 2026 UK expansion signals:**
- OE has "signalled plans for global expansion as a key 2026 and beyond initiative"
- UK, Canada, Australia identified as "English-first markets with lower regulatory barriers"
- But "lower regulatory barriers" perception may be inaccurate for UK: NHS requires DTAC + MHRA Class 1 for formal deployment

**4. OE "Visits" documentation tool (August 2025):**
- OE Visits auto-generates clinical notes + enriches with evidence-based guidelines
- Described as "hybrid documentation+CDSS" — directly competes with the 19 registered NHS AVT suppliers
- Not on NHS England's supplier registry (launched January 2026)
- Would require DTAC + MHRA Class 1 for formal NHS procurement

**5. UK landscape context:**
- UK-native compliant alternatives exist: iatroX, Medwise AI, Praktiki, Pathway — all DTAC-compliant with UK guideline corpus
- NHS England's April 2025 ambient scribing guidance requires clinical safety case (DCB0160), DPIA, mandatory human verification

## Agent Notes

**Why this matters:** iatroX provides the clearest independent assessment of what OE's governance gap means for UK clinical practice. The corpus risk is a different category from the demographic bias / automation bias concerns documented in prior sessions — it's not about LLM failure modes but about CONTENT misalignment with clinical practice guidelines. A UK physician querying OE about hypertension management may receive AHA recommendations (different thresholds than NICE) or be directed to drugs not available on NHS formulary. This is immediately actionable clinical harm, not a probabilistic risk.

**What surprised me:** OE characterizing UK as a market with "lower regulatory barriers" relative to the US. The UK NHS actually has MORE formal digital health procurement governance than the US (no equivalent to DTAC in the US at federal level). OE's US-market framing may be a strategic misjudgment about UK regulatory requirements.

**What I expected but didn't find:** Any indication that OE has begun a DTAC assessment process in preparation for its stated 2026 UK expansion. Given the January 2026 supplier registry launch and April 6 DTAC V2 deadline, OE has had 3+ months to begin compliance — and no announcement.

**KB connections:**
- New failure mode for OE in UK context: US corpus → guideline mismatch → wrong recommendations for UK practice (distinct from demographic bias, automation bias, misinformation propagation)
- Directly extends the OE safety opacity thread from Sessions 8-11 into the UK market context
- The 19-vendor registry provides UK competitive context: OE Visits is behind UK-native tools in governance compliance
- Connects to the EU AI Act forcing function: if OE targets UK/EU expansion, regulatory compliance is not optional

**Extraction hints:**
- New claim: "OpenEvidence's US-centric corpus creates a clinical safety risk for UK physicians that is distinct from LLM failure modes: AHA vs. NICE guideline misalignment and off-formulary drug suggestions in a market where OE has no DTAC assessment or MHRA registration"
- This claim is PROVEN (the governance gap is documented; the corpus misalignment is documented; no counter-evidence from OE)
- This is a UK-specific extension of the Session 11 "OE model opacity" finding — different mechanism, same transparency gap

**Context:** iatroX is an independent UK clinical AI review publication. Not affiliated with any AI company. Reviews are conducted from a clinical governance perspective. Multiple consistent reviews across 2025-2026 confirm the governance gap.

## Curator Notes
PRIMARY CONNECTION: OE model opacity thread (Sessions 8-11) — extended to UK clinical corpus mismatch
WHY ARCHIVED: Provides a previously undocumented clinical risk category for OE in non-US markets: guideline mismatch, not just LLM failure modes
EXTRACTION HINT: Extract as "OE UK deployment risk" claim, keeping scope to UK clinical practice (NICE vs. AHA corpus misalignment); link to DTAC absence finding
