Governance and leadership
Accountability, oversight structures and decision rights for AI-enabled services within the organisation.
AI Health Regulatory Institute
Independent assurance for AI-enabled healthcare
AIHRI is a specialist conformity assessment organisation focused on the governance, clinical integration, safety and continuing oversight of artificial intelligence in healthcare services.
I. Institutional rationale
Healthcare-suited assurance for a technology used in clinical care
Product-only evaluation is not sufficient once an artificial intelligence system enters clinical use.
An AI-enabled service is not only an algorithm. It is a set of organisational decisions, clinical workflows, information systems and professional judgements. AIHRI assesses those conditions with the discipline expected of a healthcare setting and the technical understanding required by modern AI.
The Institute is organisationally separate from scheme owners, healthcare providers, AI developers, software vendors and certification clients. That separation is structural, and is maintained across every assessment.
II. Assurance model
Six domains of assessment
The public assurance model addresses six interdependent domains, tailored to the scope and risk profile of each service. Each domain is assessed against defined criteria and supported by structured evidence.
Clinical integration and human oversight
How AI outputs enter clinical workflows, the role of professional judgement and the conditions for meaningful human review.
Data infrastructure and security
Provenance, quality, protection and lifecycle of the data on which AI-enabled services depend.
Regulatory and ethical alignment
Alignment with applicable healthcare, data protection and AI-specific obligations, and with recognised ethical expectations.
Workforce competence
The knowledge, training and role clarity of staff who deploy, supervise or rely on AI-enabled services.
Monitoring and continual improvement
Ongoing performance monitoring, internal audit, incident response and structured improvement over time.
III. Independence by design
Assessment, decision and appeals held apart
AIHRI separates scheme ownership from certification operations, commercial administration from technical judgement, assessment from certification decision and certification decision from appeals review.
Primary path
Assessment team
Evidence gathering
Independent technical review
Record examined
Certification decision
Separate personnel
Separate path
Appeals
Independent panel
Appeals are heard by personnel structurally separate from the assessment team and from the certification decision-maker.
IV. Assessment lifecycle
A defined, proportionate assessment path
The lifecycle is evidence-led and calibrated to each service's clinical, technical and organisational risk profile. Every stage carries a defined purpose and a defined output.
Enquiry and eligibility
Initial contact and confirmation that the requested object and scope fall within AIHRI's assessment remit.
Application and scope review
Formal application, definition of the services and boundaries proposed for assessment and confirmation that competence is available.
Risk profiling
Structured profiling of clinical, technical and organisational risk to shape assessment depth, sampling and team composition.
Competence-based team allocation
Assignment of assessors whose combined competence matches the specific scope, with conflicts of interest reviewed and recorded.
Assessment planning
Documented plan setting objectives, evidence expectations, activities, interfaces and timing.
Remote assessment where applicable
Confirmation of scope, documented readiness, governance structure and assessment planning through documentary review and structured interviews.
On-site assessment where applicable
Verification of actual implementation, workflows, interviews, technical controls and evidence in operational context.
Findings and corrective actions
Objective findings, classification of nonconformity, agreed corrective actions and verification of resolution.
Independent technical review
Review of the assessment record by personnel independent of the assessment team for completeness and adequacy.
Certification decision
Decision to grant, refuse, maintain, reduce, suspend, withdraw or reinstate certification, taken by a competent decision-maker separate from the assessment team.
Attestation
Issuance of the formal attestation reflecting the decision, defined scope and applicable conditions.
Surveillance and reassessment
Planned surveillance, material-change review and periodic reassessment across the certification cycle.
Appeals and complaints
Independent handling of appeals against decisions and of complaints about AIHRI's conduct or service.
V. Competence
Multidisciplinary by design
AIHRI assessment teams collectively hold the competence relevant to each scope. No individual is presumed to hold every competence. Roles are organised into structural categories.
Audit and clinical
Auditors and practising clinicians who evaluate management systems and clinical integration.
Lead Auditor
Plans and leads assessments, integrates evidence across domains, chairs the assessment team and manages the assessment record.
Clinical Domain Expert
Contributes clinical perspective on intended use, workflow integration, human oversight and patient-safety implications of the AI-enabled service.
Technical and information security
Specialists in AI systems and healthcare information security supporting the assessment team.
AI Technical Expert
Evaluates model governance, data lineage, validation, performance monitoring, change control and technical assurance of the AI component.
Information Security Specialist
Evaluates information-security controls, data protection, secure data lifecycle and technical assurance relevant to the service.
Decision, impartiality and appeals
Personnel structurally separated from assessment, responsible for certification decisions, impartiality oversight and appeals.
Independent Certification Decision-Maker
Reviews the complete certification record and grants, refuses, maintains, reduces, suspends, withdraws or reinstates certification within authorised scope.
Impartiality and Appeals Experts
Provides independent oversight of impartiality across certification activities and, where called, reviews appeals independently of the original decision.
VI. Professional network
An expert network committed to public-interest assurance
AIHRI engages practitioners in clinical, technical, information security, quality and governance disciplines. Selection is based on demonstrable competence and independence. Engagement is structured to preserve impartiality across the certification cycle.
VII. Standards and accreditation
Working to internationally recognised conformity assessment standards
AIHRI is pursuing accreditation under ISO/IEC 17065. Formal accreditation status and scope will be published following completion of the accreditation process.
VIII. Contact
Contact the Institute
AIHRI welcomes enquiries from healthcare organisations, professional bodies, accreditation and public-interest stakeholders. Do not submit patient information or confidential clinical data through this website.