---
title: "KYE™ Digital Pathology Authority Pack™ — digital & computational pathology · KYE™ Sector Pack Foundry™ · KYE Protocol™"
description: "The Digital Pathology Authority Pack™ — a KYE™ Sector Pack Foundry™ expert-pack delivering Agentic Governance™ with Authority Finality™ for digital and computational pathology. Maps every AI-assisted pathology decision to a named reporting pathologist, the MHRA SaMD / MHRA MDR / EU AI Act / UK GDPR obligation it discharges, and the signed Evidence Pack™ it emitted."
url: https://kyeprotocol.com/foundry/digital-pathology-authority-pack/
lang: en
source: "KYE Protocol"
---

> The Digital Pathology Authority Pack™ — a KYE™ Sector Pack Foundry™ expert-pack delivering Agentic Governance™ with Authority Finality™ for digital and computational pathology. Maps every AI-assisted pathology decision to a named reporting pathologist, the MHRA SaMD / MHRA MDR / EU AI Act / UK GDPR obligation it discharges, and the signed Evidence Pack™ it emitted.

KYE™ Sector Pack Foundry™

# 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.

[Apply via the Foundry](https://kyeprotocol.com/sector-pack-foundry/apply/) See the 8-step pipeline Bound regulatory perimeter

## 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](https://kyeprotocol.com/clinical-ai/) view for the wider AI-assisted clinical decision picture.

## 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 decision emits a signed [Evidence Pack™](https://kyeprotocol.com/evidence-pack/).