Compliance for healthcare and care providers using AI.
AI in clinical or patient-facing decisions falls under the EU AI Act’s high-risk tier. Fundamental Rights Impact Assessment is not optional.
Why this matters
Healthcare AI sits in the high-risk tier — FRIA is mandatory.
Healthcare AI systems, including triage, decision support, and patient-facing chatbots, are classified high-risk under Annex III.
Fundamental Rights Impact Assessment (FRIA) is mandatory before deployment.
MHRA, CQC, and ICO all increasingly scrutinise AI governance during inspections.
Recommended packs
The two tiers most healthcare businesses need.
Clear pricing. 14-day refund.
Professional
For practices using AI for admin, triage support, or patient comms — Article 50 disclosures, oversight, vendor register.
- AI Acceptable Use Policy
- AI Literacy Policy
- Article 50 Transparency Disclosures
- Human Oversight SOP
- AI Incident Response Procedure
- Vendor AI Risk Register
High-Risk Ready
For clinical, decision-support, or patient-facing AI — full Annex III deployer pack with FRIA.
- Everything in Professional
- Fundamental Rights Impact Assessment
- Risk Management Plan
- Conformity Self-Assessment Checklist
FAQ
Common questions for healthcare.
We’re a private GP practice using AI for admin only. Are we still caught?
If the AI touches clinical workflow in any way, you’re likely in high-risk territory. If strictly admin, standard AI literacy and acceptable use policies apply.
Does this replace MHRA AIaMD compliance?
No. MHRA regulates AI as a medical device. The EU AI Act is broader and covers governance, literacy, transparency, and deployer obligations. Both apply to AI-integrated clinical products.
How does this interact with CQC?
CQC inspectors increasingly ask about digital governance, including AI use. Holding documented policies helps demonstrate the “Well-led” KLOE.
Reviews
Customer voices, coming soon.
“Real reviews from UK healthcare businesses will appear here as our first customers complete their packs.”
Placeholder
Ready to get your healthcare compliance pack?
Tailored to your business. Delivered in minutes. Defensible for years.