KYE™ Sector Pack Foundry™

Agentic Governance™ with Authority Finality™ for radiology & medical imaging.

Every AI-assisted imaging decision — a flagged finding, an interpreted study, a Software-as-a-Medical-Device model change, an access to imaging personal data — mapped to a named reporting clinician, bound to the obligation it discharges, and signed into an Evidence Pack™ at the moment it happens. The Medical Imaging 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 imaging providers.

Apply via the FoundrySee the 8-step pipelineBound regulatory perimeter

KYE™ Medical Imaging Authority Pack™, at a glance

Demo data

You learn: What this pack governs and how. You can: Run through it.

  1. MHRA Software as a Medical Device supervision & AI change programme (Predetermined Change…

    KYE Protocol™

  2. MHRA Medical Devices Regulations (clinical responsibility)

    KYE Protocol™

  3. EU AI Act (high-risk AI record-keeping, Article 12)

    KYE Protocol™

  4. UK GDPR (data minimisation and purpose limitation)

    KYE Protocol™

How this widget is built
Demonstrates
KYE™ authority packs
Components
  • The regulated actions
  • Their authority
  • Their evidence
Flow
Each action the pack governs, in order. Architecture diagram
Used on

MHRA SaMD, MHRA Medical Devices Regulations, EU AI Act, UK GDPR — the imaging perimeter.

Hospitals, diagnostic-imaging networks, teleradiology providers, and imaging-device vendors running AI agents across radiology and medical imaging are inside a named-accountability perimeter — clinician oversight of AI-flagged findings, predetermined change control over deployed Software as a Medical Device, and minimised, purpose-scoped handling of imaging personal data. AI-assisted imaging 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 clinician, 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 imaging 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 radiology and medical-imaging 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.

Qualified partners — apply through the Foundry.

Apply via the FoundrySee the three Foundry tiersBound regulatory frameworks