The Institute
Independent assurance in regulated healthcare environments
AIHRI is an independent private conformity assessment organisation specialising in the governance, clinical integration, safety and continuing oversight of artificial intelligence in healthcare services.
I. Institutional purpose
Why the Institute exists
Artificial intelligence in healthcare shapes clinical workflows, professional accountability, information governance and patient-safety controls.
Assurance in this setting cannot be limited to algorithmic performance. It must address the organisational and service conditions in which an AI system is introduced, supervised and maintained. AIHRI exists to provide structured, evidence-led assessment of those conditions, undertaken with the discipline expected of a healthcare environment and the technical understanding required by modern AI.
II. Mandate
Four institutional functions
Assess defined AI-enabled healthcare services against approved scheme requirements.
Assemble competent multidisciplinary assessment teams calibrated to each scope.
Maintain separation between assessment, review, decision and appeals.
Provide transparent, scope-specific assurance without replacing statutory regulation.
III. Independence
Structurally separate from the parties it assesses
AIHRI is organisationally separate from scheme owners, healthcare providers, AI developers, software vendors and certification clients.
AIHRI does not provide certification consultancy, preparation services or advisory engagements to organisations it assesses. The separation between assessment, review, decision and appeals is structural, and is maintained across every engagement.
IV. The meaning of “Regulatory Institute”
A precise use of a familiar word
AIHRI is an independent private conformity assessment organisation. It does not exercise statutory regulatory powers and does not replace the functions of competent authorities, notified bodies, professional regulators or healthcare licensing bodies.
In the Institute's name, “Regulatory” refers to its focus on evidence, standards and responsible operation within regulated healthcare environments. It does not indicate statutory authority, official recognition or any function reserved to competent authorities and public regulators.
V. Operating principles
Principles that govern assessment practice
These principles apply across every scope, engagement and decision. They are the conditions under which AIHRI's judgements are formed.
Independence
Structural separation from scheme owners, healthcare providers, AI developers, software vendors and certification clients.
Impartiality
Assessment judgements are protected from commercial, personal and organisational influence.
Competence
Assessment teams collectively hold the clinical, technical, information security and quality expertise relevant to each scope.
Evidence
Conclusions are drawn from structured evidence assessed against defined criteria, not from reputation or intent.
Confidentiality
Information obtained during assessment is protected and used only for the purposes for which it was provided.
Proportionality
The depth and intensity of assessment are calibrated to the clinical, technical and organisational risk of each service.
Procedural fairness
Findings, decisions and appeals follow defined procedures with clear rights of response and independent review.
Continual improvement
Assessment practice, competence and procedures are reviewed and refined against operational experience and evolving standards.
VI. Legal identity
Formal identifying information
- Legal name
- AI Health Regulatory Institute Limited
- Legal form
- Private company limited by shares
- Company number
- CRO 798450
- Registered address
- Abbots Grove Avenue, Knocklyon, Dublin, Ireland
- Jurisdiction
- Ireland
Engagement
Institutional and professional engagement
AIHRI welcomes engagement from healthcare organisations, accreditation and public-interest stakeholders, and from professionals interested in independent assurance work.