Safety and compliance
Trust in clinical technology depends on more than product functionality. Journai Health is developing clinical safety, information governance, security and interoperability processes alongside the platform.
Compliance status
Implementation and assessment status across safety, security, and interoperability requirements.
| Area | Status | Notes |
|---|---|---|
| Clinical safety | ||
| DCB0129 | Planned before clinical pilot | Clinical risk management documentation in development. |
| DCB0160 deployment support | Planned before clinical pilot | Deployment guidance to be developed with pilot partners. |
| Medical-device applicability assessment | Applicability being assessed | Classification assessed as intended purpose and functionality evolve. |
| Incident management | In implementation | Incident reporting processes being defined. |
| Interoperability | ||
| FHIR UK Core | In implementation | Alignment in progress against UK Core profiles. |
| SNOMED CT | Planned before clinical pilot | Terminology mapping planned as part of UK Core implementation. |
| dm+d | Planned before clinical pilot | Medicines terminology support planned for medication-related workflows. |
| Assessment and assurance | ||
| DTAC | Applicability being assessed | Assessment against Digital Technology Assessment Criteria as product scope evolves. |
| DSPT | Requires internal confirmation | Data Security and Protection Toolkit alignment to be confirmed with pilot organisations. |
| Cyber Essentials | Planned before clinical pilot | Certification planned as part of pre-pilot security programme. |
| Cyber Essentials Plus | Planned before clinical pilot | Extended certification under consideration. |
| Supplier assurance | Planned before clinical pilot | Third-party supplier assessment framework in development. |
| Business continuity | Planned before clinical pilot | Continuity planning to be finalised before live deployments. |
| Data protection and security | ||
| DPIA support | In implementation | Support for partner DPIAs as part of pilot onboarding. |
| Information governance | In implementation | IG frameworks being developed with legal and clinical advisors. |
| Data hosting and residency | Requires internal confirmation | UK data residency approach to be confirmed before live patient data processing. |
| Encryption | In implementation | Encryption in transit and at rest designed into platform architecture. |
| Access control | In implementation | Role-based access control concepts implemented in MVP. |
| Audit logging | In implementation | Audit trail concepts for access and changes in MVP design. |
| Model governance | In implementation | Version control, review workflows and output monitoring in development. |
| Accessibility | ||
| WCAG 2.2 AA | In implementation | Accessibility improvements ongoing; formal audit planned. |
Clinical safety
- DCB0129
- Planned before clinical pilot
- Clinical risk management documentation in development.
- DCB0160 deployment support
- Planned before clinical pilot
- Deployment guidance to be developed with pilot partners.
- Medical-device applicability assessment
- Applicability being assessed
- Classification assessed as intended purpose and functionality evolve.
- Incident management
- In implementation
- Incident reporting processes being defined.
Interoperability
- FHIR UK Core
- In implementation
- Alignment in progress against UK Core profiles.
- SNOMED CT
- Planned before clinical pilot
- Terminology mapping planned as part of UK Core implementation.
- dm+d
- Planned before clinical pilot
- Medicines terminology support planned for medication-related workflows.
Assessment and assurance
- DTAC
- Applicability being assessed
- Assessment against Digital Technology Assessment Criteria as product scope evolves.
- DSPT
- Requires internal confirmation
- Data Security and Protection Toolkit alignment to be confirmed with pilot organisations.
- Cyber Essentials
- Planned before clinical pilot
- Certification planned as part of pre-pilot security programme.
- Cyber Essentials Plus
- Planned before clinical pilot
- Extended certification under consideration.
- Supplier assurance
- Planned before clinical pilot
- Third-party supplier assessment framework in development.
- Business continuity
- Planned before clinical pilot
- Continuity planning to be finalised before live deployments.
Data protection and security
- DPIA support
- In implementation
- Support for partner DPIAs as part of pilot onboarding.
- Information governance
- In implementation
- IG frameworks being developed with legal and clinical advisors.
- Data hosting and residency
- Requires internal confirmation
- UK data residency approach to be confirmed before live patient data processing.
- Encryption
- In implementation
- Encryption in transit and at rest designed into platform architecture.
- Access control
- In implementation
- Role-based access control concepts implemented in MVP.
- Audit logging
- In implementation
- Audit trail concepts for access and changes in MVP design.
- Model governance
- In implementation
- Version control, review workflows and output monitoring in development.
Accessibility
- WCAG 2.2 AA
- In implementation
- Accessibility improvements ongoing; formal audit planned.
Governance areas
Clinical safety
- Clinical Safety Officer appointment in progress
- Hazard-log and safety-case documentation in development
- Human oversight required for all clinically relevant outputs
- Incident reporting processes being defined
Data protection
- Lawful processing aligned with UK GDPR
- Data minimisation and role-based access
- DPIA support for pilot partners
- Patient-identifiable data only under appropriate governance
AI governance
- Source traceability in summary outputs
- Hallucination and omission testing in progress
- Model versioning and output monitoring in development
- Third-party provider assessment underway
Medical-device applicability
The regulatory classification of software depends on its intended purpose and functionality. Journai Health assesses applicable UK medical-device requirements as product capabilities and intended uses evolve.
Discuss a clinical information workflow.
Speak with Journai Health about evaluating the platform within a defined workflow in your organisation.