AI Governance for Healthcare & HealthTech
The MHRA regulates AI as a medical device. The EU AI Act classifies healthcare AI as high-risk under Annex III, Section 5. NHS procurement increasingly requires AI governance evidence. Clinical AI governance isn't a compliance exercise — it's patient safety governance.
Three regulatory frameworks, one governance gap
Healthcare AI sits at the intersection of medical device regulation, AI-specific legislation, and NHS procurement requirements. Most healthtech companies are building to satisfy one — and missing the other two.
AI as a medical device
The MHRA classifies software that uses AI/ML for diagnosis, monitoring, or treatment decisions as a medical device under the Medical Devices Regulations 2002 (as amended). This triggers conformity assessment requirements, post-market surveillance obligations, and clinical evaluation evidence — regardless of whether the AI is the primary function or an embedded feature.
EU AI Act high-risk classification
The EU AI Act's Annex III, Section 5 explicitly classifies AI systems intended to be used as safety components of medical devices as high-risk. If your healthtech product serves EU patients — or EU-based NHS staff use it — you're in scope for conformity assessments, risk management systems, and human oversight under Articles 9–15, with obligations taking effect August 2026.
NHS procurement is raising the bar
The NHS AI Lab's governance framework and NHSX's guidelines for evidence-based AI set expectations that procurement teams increasingly enforce. Trusts are asking for algorithmic impact assessments, bias audits, and clinical safety documentation before they'll evaluate your product — let alone procure it.
Clinical AI governance that satisfies regulators and procurement
We build governance frameworks designed for healthtech companies — bridging the gap between MHRA requirements, EU AI Act obligations, and NHS procurement expectations in a single, coherent system.
Healthcare AI Governance Assessment
A focused assessment of your AI system's governance posture across all three regulatory dimensions: MHRA, EU AI Act, and NHS procurement readiness. You'll know exactly where the gaps are.
- AI system classification (MHRA medical device + EU AI Act risk tier)
- Gap analysis across MHRA, EU AI Act, and NHS requirements
- Clinical safety and bias risk identification
- Priority action plan with regulatory pathway mapping
Clinical AI Compliance Programme
End-to-end governance implementation: we build your clinical AI governance framework, risk management system, and evidence packages — ready for MHRA review, EU AI Act conformity, and NHS procurement.
- Everything in the Governance Assessment
- Clinical AI risk management system (aligned to ISO 14971)
- Algorithmic impact assessment and bias audit framework
- Human oversight mechanism design for clinical workflows
- NHS procurement evidence package
Retained Clinical AI Advisory
Ongoing governance support as healthcare AI regulation evolves. Monthly reviews, post-market surveillance support, and on-call expertise for your clinical and regulatory teams.
- Monthly governance review and clinical risk assessment updates
- MHRA, EU AI Act, and NHS policy change monitoring
- Post-market surveillance and adverse event governance support
- Priority access for urgent clinical AI governance queries
Governance designed for clinical reality
Healthcare AI governance fails when it's designed by compliance teams who've never watched a clinician use a decision-support tool at 3am. We bring UCD methodology to clinical AI governance — ensuring processes work under real operational conditions.
-
UCD methodology for clinical workflows
20+ years of user-centred design experience applied to clinical settings. Human oversight mechanisms designed around how clinicians actually make decisions — not how governance committees imagine they do.
-
Cross-regulatory expertise
We work across MHRA, EU AI Act, and NHS procurement frameworks — building unified governance that satisfies all three without triplicating your effort.
-
Patient safety as the north star
Clinical AI governance is patient safety governance. Every framework we build is tested against the question: "Does this protect patients?" — not just "Does this satisfy the auditor?"
-
HealthTech-appropriate pricing
Early-stage healthtech companies can't afford Big Four governance programmes. We deliver the same regulatory rigour at pricing that doesn't consume your Series A runway.
Clinical AI without governance is clinical risk without oversight.
Book a free 30-minute scoping call. We'll review your AI system's clinical use case, assess your regulatory exposure across MHRA, EU AI Act, and NHS requirements, and tell you exactly what needs to happen next.