Governance Platform

Governance Compliance Programme

A governance layer for regulated AI systems in healthcare.

Lifecycle Governance Agency helps healthcare institutions establish documented ownership, human oversight, governance evidence and continuing review for clinical AI and robotics.

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Most organisations don't know their AI risk exposure

Healthcare organisations are deploying AI without clear classification under the EU AI Act. Unclassified systems may be high-risk — triggering strict obligations.

  • Regulatory exposure
  • Audit readiness gaps
  • Unclear accountability
  • Operational blind spots

Programme Entry — Governance Baseline

Delivered within 2–4 weeks.

AI and robotics system inventory
Intended-use review
Preliminary EU AI Act role and risk mapping
Provider and deployer responsibility mapping
Governance gap analysis
Initial accountability map
Prioritised implementation roadmap

Deliverable

Governance Baseline Report

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90-day implementation route

The continuation of the Governance Compliance Programme, following the Governance Baseline.

1

Phase 1 — Discover & Classify

Inventory AI and robotics systems, review intended use, and map preliminary EU AI Act roles and risk levels.

2

Phase 2 — Assign & Implement

Assign accountability and human oversight, and implement governance controls, policies and evidence structures.

3

Phase 3 — Record & Review

Establish continuing review, board reporting and audit-readiness evidence across the lifecycle.

Aligned with leading frameworks

EU AI ActNIS2 DirectiveISO 27001NEN 7510GDPR / UK GDPR

Our approach translates regulatory requirements into operational governance your organisation can implement immediately.

Regulatory scope and role

LGA supports the institutional implementation of governance obligations. The following clarifies the scope of our role.

  • Article 17 concerns providers’ quality management systems for high-risk AI.
  • Article 72 concerns providers’ post-market monitoring obligations.
  • Article 26 includes important obligations for deployers of high-risk AI.
  • LGA supports the institutional implementation and evidence interface between provider and deployer responsibilities.
  • LGA does not exercise statutory regulatory authority.

Start with clarity

Understand your regulatory exposure before making decisions.

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Limited onboarding capacity — we work with a small number of organisations per quarter.

LGA – Lifecycle Governance Agency

Operational Governance for AI & Robotics

Lifecycle Telehealth group BV

Trading as Lifecycle Governance Agency

Enterprise number: BE 0878.090.520

© 2026 Lifecycle Governance Agency. All rights reserved.

Lifecycle Governance Agency provides governance implementation and evidence-support services. It does not act as a regulator, notified body, certification body or legal adviser.

Clinical AI Registry™ is a proprietary framework of Lifecycle Governance Agency.