--- title: "KYE™ Clinical AI Governance Pack™ — EU/UK clinical-AI market entry · KYE™ Sector Pack Foundry™ · KYE Protocol™" description: "The Clinical AI Governance Pack™ — a KYE™ Sector Pack Foundry™ expert-pack delivering the EU/UK governance and market-entry layer for AI clinical decision support and medical question-answering. Maps every AI clinical answer to a recorded authority-to-inform, a GDPR Article 9 health lawful basis, an EU AI Act / EU MDR / UK MHRA conformity declaration, a signed Evidence Pack™, and a clinician-in-the-loop review." url: https://kyeprotocol.com/foundry/clinical-ai-governance-pack/ lang: en source: "KYE Protocol" --- > The Clinical AI Governance Pack™ — a KYE™ Sector Pack Foundry™ expert-pack delivering the EU/UK governance and market-entry layer for AI clinical decision support and medical question-answering. Maps every AI clinical answer to a recorded authority-to-inform, a GDPR Article 9 health lawful basis, an EU AI Act / EU MDR / UK MHRA conformity declaration, a signed Evidence Pack™, and a clinician-in-the-loop review. KYE™ Sector Pack Foundry™ # Agentic Governance™ with Authority Finality™ for clinical AI in the EU and UK. A clinical AI that informs a decision — a clinical decision support recommendation, a medical question-answer — needs a regulatory layer to operate in the EU and UK: who authorised the AI to inform this decision, the GDPR Article 9 basis for the health data it used, the EU AI Act and EU MDR / UK MHRA conformity behind it, and the clinician who reviewed it. The Clinical AI Governance Pack™ is the KYE™ Sector Pack Foundry™ productisation that supplies that layer — the governance and market-entry scaffolding US health-AI answer engines currently lack. [Apply via the Foundry](https://kyeprotocol.com/sector-pack-foundry/apply/) See the 8-step pipeline Bound regulatory perimeter Illustrative — the authority + evidence record KYE Protocol™ produces for a single governed action (sample data). ## KYE™ governs whether the AI may inform — not whether the answer is right. This is the honest scope. KYE Protocol™ is not a clinical model and not a clinical answer engine. It does not generate medical answers and it does not assess clinical truth. It governs _authority-to-act_: whether an AI clinical agent may inform a given clinical decision, and it proves the basis — the authority, the lawful basis, the conformity, and the human oversight. The clinician holds authority-to-act; KYE™ records that the authority existed and the oversight happened. See the wider [clinical-AI authority](https://kyeprotocol.com/clinical-ai/) view for the cross-speciality picture. ## EU AI Act, EU MDR, UK MHRA, GDPR Article 9 — the clinical-AI perimeter. A clinical AI that informs care in the EU or UK sits inside a named-accountability perimeter: the EU AI Act treats Annex III health systems as high-risk; EU MDR and UK MHRA treat clinical decision support as a regulated medical device; GDPR Article 9 governs the health special-category data the AI processes. Clinical-AI vendors, telemedicine providers, and hospital AI functions need recorded authority and signed, replay-derivable evidence per answer to place the product into clinical use. ## Better evidence than reconstructed logs — signed at the moment, derivable from public keys alone. The dominant evidence today is after-the-fact reconstruction. A KYE Protocol™ Evidence Pack™ plus Authority Finality™ outcome bound to the authority-to-inform, the GDPR Article 9 basis, the conformity declaration, and the reviewing clinician is materially better evidence: signed at the moment of the answer and Replay-Proof™ against the published JWKS a regulator or notified body can verify offline. KYE™ governs the authority around the answer — not the clinical content. ## An 8-step pipeline — from AI clinical answer to recorded basis. The Pack rides the canonical productisation shape: rule pack, dictionary, sector pack, obligation manifest, expert-pack envelope, coverage attestation, SKU row, and this marketing surface. It composes over the MEDS clinical-data evidence layer and reuses the Governed Research Rail evidence shape (source-pinned, no-hallucination, Ed25519 replay-proof). No Foundry-specific framework shape; the protocol evidence layer underneath is identical to every other Pack. ## Bound to the canonical clinical-AI perimeter. - **EU AI Act (Annex III health systems as high-risk; conformity and record-keeping, Article 12; human oversight, Article 14)** - **EU MDR / UK MHRA Medical Devices Regulations (clinical decision support as a regulated medical device)** - **MHRA Software as a Medical Device supervision (intended purpose and clinical oversight)** - **GDPR / UK GDPR Article 9 (health special-category data lawful basis)** Regulators of record: EU AI Office / MHRA / ICO. See the [EU AI Act](https://kyeprotocol.com/compliance/eu-ai-act/), [MHRA Medical Devices Regulations](https://kyeprotocol.com/compliance/mhra-mdr-2002/), and [GDPR](https://kyeprotocol.com/compliance/gdpr/) coverage maps. ## Qualified partners — apply through the Foundry. [Apply via the Foundry](https://kyeprotocol.com/sector-pack-foundry/apply/) [See the three Foundry tiers](https://kyeprotocol.com/sector-pack-foundry/) [Bound regulatory frameworks](https://kyeprotocol.com/frameworks/) ## Canonical surfaces This Pack is one projection of the [KYE™ Sector Pack Foundry™](https://kyeprotocol.com/sector-pack-foundry/) — the productisation rail of [KYE Protocol™](https://kyeprotocol.com/). Every in-scope answer emits a signed [Evidence Pack™](https://kyeprotocol.com/evidence-pack/).