Agentic Governance™ with Authority Finality™ for digital pathology.
Every AI-assisted pathology decision — a flagged whole-slide finding, an interpreted case, a Software-as-a-Medical-Device model change, an access to pathology personal data — mapped to a named reporting pathologist, bound to the obligation it discharges, and signed into an Evidence Pack™ at the moment it happens. The Digital Pathology Authority Pack™ is the KYE Sector Pack Foundry™ productisation that lands Agentic Governance™ — every act has authority, every authority has finality — inside MHRA SaMD, MHRA Medical Devices Regulations, EU AI Act, and UK GDPR-regulated pathology services.
MHRA SaMD, MHRA Medical Devices Regulations, EU AI Act, UK GDPR — the pathology perimeter.
Hospitals, pathology laboratories, diagnostics providers, and pathology-device vendors running AI agents across digital and computational pathology are inside a named-accountability perimeter — pathologist oversight of AI-flagged findings, predetermined change control over deployed Software as a Medical Device, and minimised, purpose-scoped handling of pathology personal data. AI-assisted pathology operations need named-owner accountability and signed, replay-derivable evidence per decision.
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 named reporting pathologist, the obligation discharged, and the delegation chain is materially better evidence: signed at the moment of the decision and Replay-Proof™ against the published JWKS a regulator or notified body can verify offline. KYE™ governs the authority around the model — not the diagnosis itself.
An 8-step pipeline — from AI pathology decision to clinical record.
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. No Foundry-specific framework shape; the protocol evidence layer underneath is identical to every other Pack.
Bound to the canonical digital pathology perimeter.
- MHRA Software as a Medical Device supervision & AI change programme (Predetermined Change Control Plan)
- MHRA Medical Devices Regulations (clinical responsibility)
- EU AI Act (high-risk AI record-keeping, Article 12)
- UK GDPR (data minimisation and purpose limitation)
Regulators of record: MHRA / EU AI Office / ICO. See the clinical-AI authority view for the wider AI-assisted clinical decision picture.