Regulatory & Geography
HealthOS ICU is not registered as standalone software as a medical device (SaMD).
Regulatory positioning
The positioning — based on IMDRF SaMD Key Definitions and MDCG 2019-11 — is software in a medical device / active control system accessory:
- Requires a medical device (bedside monitor) as host
- Does not independently perform a medical purpose without the host device
- Supervisory mode by default; write-path only with clinician confirmation
This positioning reduces regulatory burden at entry and allows phased market entry aligned with clinical validation milestones.
In summary, the same three sources — on the regulatory page →
EU Artificial Intelligence Act
Regulation (EU) 2024/1689 has been in force since August 2024. For medical-device manufacturers and for HealthOS ICU partners on the European market, it sets a frame that must be met.
| Provision | What it establishes | Source |
|---|---|---|
| Article 3(1), recital 12 | Definition of an AI system; systems based on rules defined solely by humans fall outside the definition | EUR-Lex → |
| Commission guidelines on the AI-system definition (February 2025) | How to apply the Article 3(1) definition | European Commission → |
| Article 6(1), Annex I | An AI system that is a product or a safety component of a product under Annex I legislation (which includes the 2017/745 medical devices regulation) subject to mandatory third-party conformity assessment is high-risk | EUR-Lex → |
| Articles 9–15 | Obligations of a high-risk-system provider: risk management, data and data governance, technical documentation, record-keeping, transparency, human oversight, accuracy, robustness and cybersecurity | EUR-Lex → |
| Article 113 | Application timeline: for Annex I high-risk systems — August 2027 per the regulation’s text; as of this writing the European Commission has proposed a postponement as part of the digital-legislation simplification package — check the current text | EUR-Lex → |
The evidence the regulation requires from a high-risk system — a log of every command with its outcome, rule version, and confirming person; human confirmation for equipment-control commands; technical documentation assembled from evidence-of-fact receipts — HealthOS ICU produces as a product of normal operation.
Qualifying the platform’s recommendation-computation method under the Article 3(1) definition is a matter for regulatory assessment in each market-entry jurisdiction.
Applicable standards
| Standard | Role | Status |
|---|---|---|
| ISO 13485:2016 | QMS design controls | Partial |
| ISO 14971:2019 | Risk management | Planned |
| IEC 62304 | Software lifecycle | Partial |
| IMDRF SaMD QMS | QMS vocabulary | Reference only |
| FDA CDS guidance | Non-device CDS basis | Partial |
Detailed evidence — in the conformance matrix →
Traceability as a Product Property
Medical regulation — ISO 14971, IEC 62304 — is built around traceability. In the architecture of HealthOS ICU, traceability is not a separate line of work, — it is a product property: knowledge changes only through a governed path, execution produces evidence bound to a version of that knowledge, and audit requests are answered with files.
The practical consequence for a regulatory programme: the dossier is assembled from evidence that already exists, rather than reconstructed after the fact. Reconstruction after the fact is a known cause of regulatory programmes failing: by the time you need to prove what was executing on a given day, there is nothing left to prove it with.
Market Entry Sequence
South Africa (SAHPRA)
First target market. SAHPRA establishment licensing + clinical evaluation path. Two anchor clinical partner institutions identified. Target: first deployment under clinical evaluation within 18 months.
Botswana (BoMRA)
Secondary Sub-Saharan Africa entry following South Africa clearance. BoMRA pathway compatible with SAHPRA precedent.
Brazil, Malaysia, Kenya
- Brazil: ANVISA RDC 657/2022 — Class II medical software path
- Malaysia: NPRA Class B/C medical device registration
- Kenya: PPB Class B medical device
India (CDSCO)
CDSCO Class B/C medical device; largest long-term volume opportunity.
EU/US — Monitoring
Evidence from the South African clinical evaluation may be used in CE/FDA submissions. The EU AI Act applies to manufacturing partners on the European market regardless of the platform’s own deployment geography.
Documents
Regulatory & Geography → · Conformance Statements →
Discuss a regulatory partnership in your jurisdiction. Contact for regulatory partnership →