Sources & References

Curated catalog of normative standards, regulatory guidance, vendor documentation, and research used in HealthOS ICU.

Category Audience Status Jurisdiction Search

Closed Truth-Distillation Cycle: A Methodology for Knowledge-Driven Clinical Decision Support

ResearchType for medical sciencefor research organisationsFor

Foundational methodology paper describing the closed cycle of knowledge creation, validation, and compilation for deterministic clinical decision support.

Deterministic Supervisory Control for Critical Care · For Medical Science · For Research Organisations · HealthOS ICU: Full Concept

HealthOS: A Proposed Open Healthcare Operating System

ResearchType for research organisationsfor OEM partnersFor

Contextual reference establishing the concept of a composable healthcare OS; informs the vendor-neutral edge-layer architecture of this platform.

Technical Overview "Reference Architecture"

Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices

GuidanceType for OEM partnersfor clinical institutionsfor research organisationsFor USJurisdiction

FDA guidance on designing interoperable medical devices; informs interface specification, V&V intent and labeling discipline.

✓ Implemented
Used as design basis for interface specification, V&V intent and labeling discipline.

✗ Out of scope
No FDA submission filed for HealthOS ICU v0 (pilot program); US market authorisation not in scope.

Source — FDA · Standards & Interoperability → Interoperability planes

Clinical Decision Support Software — FDA Guidance

GuidanceType for OEM partnersfor clinical institutionsfor research organisationsfor medical scienceFor USJurisdiction

Defines when CDS software is subject to FDA oversight. Critical for positioning the product as non-device CDS under the 21st Century Cures Act.

✓ Implemented
Independent review of basis is supported: each recommendation traces to the term registry / term trace inside the active decision bundle.

✗ Out of scope
Predicate device claim, 510(k) submission and US market authorisation not part of HealthOS ICU v0 (pilot program).

Source — FDA · Safety Kernel and Equipment Control Commands · Glossary → Term registry.

Software as a Medical Device (SaMD): Application of Quality Management System

GuidanceType for clinical institutionsfor OEM partnersFor InternationalJurisdiction

IMDRF framework for QMS applied to SaMD; used to align internal QMS readiness vocabulary.

✓ Implemented
Used to align internal QMS readiness vocabulary; no formal IMDRF self-assessment published.

✗ Out of scope
No formal IMDRF self-assessment published for HealthOS ICU v0 (pilot program).

Source — IMDRF · Regulatory & Geography → Quality management system (QMS)

Software as a Medical Device (SaMD): Key Definitions

GuidanceType for OEM partnersfor clinical institutionsfor medical scienceFor InternationalJurisdiction

Defines SaMD categories including 'software in a medical device'. Used to justify that the platform is not standalone SaMD.

✓ Implemented
Cited to justify product positioning as software in a medical device / accessory / active control system, not standalone SaMD.

✗ Out of scope
This is a definitional and positioning reference only.

Source — IMDRF · Why Not Artificial Intelligence → Regulatory positioning

HL7 Version 2 / MLLP

StandardType for OEM partnersfor clinical institutionsFor InternationalJurisdiction

HL7 v2 over MLLP is the predominant bedside-device messaging protocol. The platform ingests inbound HL7 v2 push at the edge.

✓ Implemented
Inbound HL7 v2 / MLLP push is consumed by the device protocol gateway and routed into the stateful rule-based analyzer in the control / telemetry plane.

✗ Out of scope
No outbound HL7 v2 publication back to HIS; no HL7 v2 ORU result push from product side.

Source — HL7 International · Standards & Interoperability → Equipment Plane

HL7 FHIR R4

StandardType for OEM partnersfor clinical institutionsfor research organisationsFor InternationalJurisdiction

FHIR R4 resources are emitted by the clinical-data facade as a downstream projection of the canonical event log.

✓ Implemented
Observation, Device, DeviceMetric, GuidanceResponse, Provenance, AuditEvent emitted via the clinical-data facade as downstream projection of the canonical event log.

✗ Out of scope
Clinical facade is not the source of truth; FHIR Subscriptions push, Bulk Data, SMART on FHIR auth not implemented.

Source — HL7 International · Standards & Interoperability → Record Plane

IHE Patient Care Device (PCD) Technical Framework

StandardType for OEM partnersfor clinical institutionsFor InternationalJurisdiction

IHE PCD profiles (DEC, PCD-01, ACM) define structured device data communication. The platform reserves an architectural slot for a PCD adapter.

✓ Implemented
Architectural slot for an IHE DEV / PCD adapter (PCD-01 / DEC / ACM) in the reference architecture; four-level vendor adapter model accommodates PCD profile mapping.

✗ Out of scope
Concrete profile actor implementations and IHE Integration Statement are roadmap items.

Source — IHE International · Standards & Interoperability → Interoperability planes

IHE SDPi — Service-oriented Device Point-of-care Interoperability

StandardType for OEM partnersFor InternationalJurisdiction

IHE SDPi profiles extend ISO/IEEE 11073 SDC for bedside service-oriented interoperability. Informs the vendor adapter layer design.

✓ Implemented
SDPi-compliant adapter is planned as a roadmap item alongside ISO/IEEE 11073 SDC support.

✗ Out of scope
No SDPi actor shipped in HealthOS ICU v0 (pilot program).

Source — IHE International · Standards & Interoperability → Interoperability planes

ISO/IEEE 11073-10207 — SDC: Service-oriented Device Connectivity

StandardType for OEM partnersFor InternationalJurisdiction

Defines a service-oriented protocol for bedside medical device control (write-access). Planned as vendor adapter target for restricted-write pilot.

✓ Implemented
Read path (bidirectional observation over SDC) is partially implemented: the reference architecture reserves an adapter slot and the vendor adapter model already supports ingesting telemetry from SDC-capable devices.

✗ Out of scope
Write path (governed restricted-write control over SDC) is not part of HealthOS ICU v0 (pilot program): native bedside control remains on the roadmap, gated by phased validation and a vendor-supplied access-and-control package.

Source — ISO · Standards & Interoperability → Interoperability planes · Technical Overview "Safety Kernel & Command Envelopes"

SHACL — Shapes Constraint Language (W3C Recommendation)

StandardType for medical sciencefor research organisationsFor InternationalJurisdiction

Used as the constraint layer over the medical knowledge graph. Validation digest is part of every release receipt.

✓ Implemented
Constraint layer over the medical knowledge graph; the validation digest is part of every release receipt issued by the knowledge compiler.

✗ Out of scope
Not used for inbound runtime data validation in the bedside path (handled by deterministic decoders).

Source — W3C · Glossary → Medical knowledge graph store. · Glossary → Evidence-of-fact receipt

PROV-O — The PROV Ontology (W3C Recommendation)

StandardType for medical sciencefor research organisationsFor InternationalJurisdiction

Provenance graph emitted as FHIR Provenance plus internal release receipt with cryptographically chained digests.

✓ Implemented
Provenance graph emitted as FHIR Provenance plus an internal release receipt with cryptographically chained digests for graph, validation, projection, mapping spec and bundle.

✗ Out of scope
Direct PROV-O JSON-LD export endpoint not part of HealthOS ICU v0 (pilot program) surface.

Source — W3C · Glossary → Evidence-of-fact receipt

DICOM Standard

StandardType for OEM partnersfor clinical institutionsfor research organisationsFor InternationalJurisdiction

DICOMweb (WADO-RS/QIDO-RS) used in auxiliary plane for retrospective episode visualization. DICOM is not used for command transport.

✓ Implemented
DICOMweb (WADO-RS / QIDO-RS) used only in auxiliary plane for retrospective episode visualization, augmented by results and audit data.

✗ Out of scope
DICOM is not used as bedside command transport, not as stream-mode ingress, not to carry command intents.

Source — DICOM Standards Committee · Standards & Interoperability → Auxiliary Plane

ISO 13485:2016 — Medical devices — Quality management systems

StandardType for OEM partnersfor clinical institutionsFor InternationalJurisdiction

Quality management system standard for medical device lifecycle. Informs design controls and change-controlled gates.

✓ Implemented
Design controls and change-controlled gates for validation, audit and security live in active-draft governance artifacts.

✗ Out of scope
No notified-body certificate issued; QMS certification is a separate productisation track.

Source — ISO · Regulatory & Geography → Quality management system (QMS)

ISO 14971:2019 — Medical devices — Risk management

StandardType for OEM partnersfor clinical institutionsFor InternationalJurisdiction

Risk management framework for medical devices. Risk management process outlined in supporting research; formal RMF is not part of HealthOS ICU v0 (pilot program).

✓ Implemented
Risk management framework outlined in supporting research; formal hazard analysis integration into product RMF is not part of HealthOS ICU v0 (pilot program).

✗ Out of scope
No formal hazard analysis dossier published yet.

Source — ISO · Regulatory & Geography → Risk management

IEC 62304:2006+AMD1:2015 — Medical device software — Software life cycle processes

StandardType for OEM partnersfor clinical institutionsFor InternationalJurisdiction

Software lifecycle standard for medical devices. Lifecycle structure and change control implemented through governance artifacts.

✓ Implemented
Software lifecycle structure (design / spec / runbook gates), change control through the compiled bundle and release receipt, anomaly handling via the audit event log.

✗ Out of scope
SOUP register, formal classification (Class B / C) and full IEC 62304 dossier are not part of HealthOS ICU v0 (pilot program).

Source — ISO · Regulatory & Geography → Software lifecycle

IEC 82304-1 — Health software — Part 1: General requirements for product safety

StandardType for OEM partnersfor clinical institutionsFor InternationalJurisdiction

Health software product safety standard. Referenced as part of the product safety framework.

✓ Implemented
Referenced for general health software safety framing; formal assessment is planned alongside the IEC 62304 dossier, not part of HealthOS ICU v0 (pilot program).

✗ Out of scope
No formal IEC 82304-1 dossier or certification for HealthOS ICU v0 (pilot program).

Source — ISO · Regulatory & Geography → Software lifecycle

MDCG 2019-11 — Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745

GuidanceType for OEM partnersfor clinical institutionsFor EUJurisdiction

EU MDR guidance on when software qualifies as a medical device. Used as classification basis for positioning as accessory / regulated MDSW.

✓ Implemented
Used as classification basis for product positioning as accessory / regulated MDSW, not standalone SaMD.

✗ Out of scope
This is a positioning reference, not a conformity statement. CE marking not part of HealthOS ICU v0 (pilot program).

Source — European Commission · Why Not Artificial Intelligence → Regulatory positioning

SAHPRA — South African Health Products Regulatory Authority

RegulatorType for clinical institutionsfor OEM partnersFor South AfricaJurisdiction

South Africa first-market regulatory entry. Establishment licensing and clinical evaluation guideline as the entry path. Link points to SAHPGL-MD-04 v4, the classification guideline document, not the SAHPRA homepage.

✓ Implemented
South Africa is the first-market regulatory entry target; establishment licensing and clinical evaluation path under active planning.

✗ Out of scope
No SAHPRA registration filed for HealthOS ICU v0 (pilot program).

Source — SAHPRA · Regulatory & Geography → Geographic priority

BoMRA — Botswana Medicines Regulatory Authority

RegulatorType for clinical institutionsfor OEM partnersFor BotswanaJurisdiction

Regulatory body for Botswana; secondary market target in Sub-Saharan Africa.

✓ Implemented
Botswana is a secondary market target following South Africa entry.

✗ Out of scope
No BoMRA submission planned for HealthOS ICU v0 (pilot program).

Source — BoMRA · Regulatory & Geography → Geographic priority

ANVISA RDC 657/2022 — Brazil Medical Device Regulation

RegulatorType for clinical institutionsfor OEM partnersFor BrazilJurisdiction

Brazilian medical device regulatory framework. Cited as fast-follow market option.

✓ Implemented
Cited as a fast-follow market option (Brazil); RDC 657/2022 framework reviewed for compatibility.

✗ Out of scope
No ANVISA submission planned for HealthOS ICU v0 (pilot program).

Source — ANVISA · Regulatory & Geography → Geographic priority

NPRA — National Pharmaceutical Regulatory Agency (Malaysia)

RegulatorType for clinical institutionsfor OEM partnersFor MalaysiaJurisdiction

Malaysia regulatory entry, third market in the go-to-market sequence after South Africa and Botswana.

✓ Implemented
Malaysia is a planned market target following South Africa and Botswana entry.

✗ Out of scope
No NPRA registration filed for HealthOS ICU v0 (pilot program).

Source — NPRA · Regulatory & Geography → Geographic priority

PPB — Guideline on Regulation of Medical Device Software in Kenya (MDSW)

RegulatorType for clinical institutionsfor OEM partnersFor KenyaJurisdiction

Kenya Pharmacy and Poisons Board guideline on medical device software (SaMD/SiMD) regulation, including AI-device guidance. Direct guideline document, not the ppb.go.ke portal homepage.

✓ Implemented
Kenya is a planned market target, fourth in the go-to-market sequence.

✗ Out of scope
No PPB submission filed for HealthOS ICU v0 (pilot program).

Source — PPB Kenya · Regulatory & Geography → Geographic priority

CDSCO — Central Drugs Standard Control Organisation (India)

RegulatorType for clinical institutionsfor OEM partnersFor IndiaJurisdiction

India regulatory entry, next market after Malaysia and Kenya in the go-to-market sequence.

✓ Implemented
India is a planned market target following Malaysia and Kenya entry.

✗ Out of scope
No CDSCO submission filed for HealthOS ICU v0 (pilot program).

Source — CDSCO · Regulatory & Geography → Geographic priority

Regulation (EU) 2024/1689 — Artificial Intelligence Act

RegulatorType for OEM partnersfor clinical institutionsFor EUJurisdiction

EU framework regulation for artificial intelligence; referenced as a description of the framework, not a conformity qualification under Article 3(1) — see /regulatory/.

✓ Implemented
Per-command event log, human confirmation, and technical documentation drawn from release receipts — the evidence a high-risk system would need under the regulation — are produced as a by-product of normal operation.

✗ Out of scope
No conformity statement is made under the regulation; qualification of the recommendation computation path under Article 3(1) is a regulatory assessment specific to each jurisdiction.

Source — EUR-Lex (Official Journal of the EU) · Regulatory & Geography

HIPAA — Health Insurance Portability and Accountability Act (US)

RegulatorType for OEM partnersfor clinical institutionsFor USJurisdiction

US health-data privacy and security statute; referenced to frame the same architectural properties as GDPR for a future US-market path. A badge is not a certificate — see /conformance/.

✓ Implemented
Cited to frame US health-data handling considerations for a future US-market path; the same architectural properties as GDPR (audit event log, Provenance, export de-identification) apply. No covered-entity or business-associate determination made.

✗ Out of scope
No HIPAA compliance assessment, Business Associate Agreement, or Security Rule audit conducted for HealthOS ICU v0 (pilot program).

Source — U.S. HHS · Conformance Statements

Philips IntelliBridge Enterprise / IntelliVue / MDIP / ICCA — Public Documentation

Vendor documentationType for OEM partnersFor

Philips bedside monitoring and ICU integration documentation; informs vendor interoperability matrix and write-scope claims.

✓ Implemented
Used as basis for the vendor interoperability matrix; per-vendor write-scope claims pinned to vendor public statements only.

✗ Out of scope
Site does not assert any private capability beyond what Philips publishes; per-site validation packs are separate productisation work.

Source — Philips · Technical Overview "Vendor Interoperability Matrix"

Dräger Infinity / SDC / Evita / Atlan / MEDIBUS.X — Public Documentation

Vendor documentationType for OEM partnersFor

Dräger critical care device public documentation; informs vendor interoperability matrix for anaesthesia and ventilation.

✓ Implemented
Used as basis for the vendor interoperability matrix; per-vendor claims pinned to Dräger public documentation only.

✗ Out of scope
Site does not assert private capability beyond what Dräger publishes.

Source — Dräger · Technical Overview "Vendor Interoperability Matrix"

GE Healthcare Aisys CS2 / CARESCAPE — Public Documentation

Vendor documentationType for OEM partnersFor

GE Healthcare critical care device documentation; informs vendor interoperability matrix for anaesthesia workstations.

✓ Implemented
Used as basis for the vendor interoperability matrix; per-vendor claims pinned to GE Healthcare public documentation only.

✗ Out of scope
Site does not assert private capability beyond what GE Healthcare publishes.

Source — GE Healthcare · Technical Overview "Vendor Interoperability Matrix"

WHO — Emergency, Critical and Operative Care

ResearchType for clinical institutionsfor medical scienceFor InternationalJurisdiction

WHO guidance on emergency and critical care systems; contextual basis for geographic market prioritisation and unmet clinical need framing.

Regulatory & Geography · For Clinical Institutions

South Africa first deployment target — 18-month clinical evaluation window

ResearchType for clinical institutionsfor OEM partnersFor South AfricaJurisdiction

Internal planning target ("first deployment within a clinical evaluation window of 18 months", whitepapers/regulatory.md), not a measured outcome — no deployment has occurred yet. Recorded so the number has a provenance record rather than floating unattributed on the page (icu-landing-impl.plan.md §3.9).

Technical Overview "Regulatory & Geography"

World Bank Open Data — Health Infrastructure

ResearchType for clinical institutionsfor research organisationsFor InternationalJurisdiction

Data source for quantifying unmet need in target markets (Sub-Saharan Africa, South/Southeast Asia).

Regulatory & Geography

Rospatent decision to grant — machine-readable representation of medical knowledge

RegulatorType for research organisationsfor medical scienceFor RUJurisdiction

Application No. 2025138295/28 (086558), filed 2025-12-25; decision to grant issued 2026-05-26; granted patent No. 2865309. Deep link to the individual case file in the FIPS open register was not available at the time this record was written — url points to the registry portal, not the specific case.

Rospatent: decision to grant a patent on machine-readable representation of medical knowledge

Rospatent decision to grant — semantically correct automatic ECG interpretation

RegulatorType for research organisationsfor medical sciencefor clinical institutionsFor RUJurisdiction

Application No. 2025138300/14 (086567), filed 2026-03-12; decision to grant issued 2026-08-03; granted patent number not yet published at time of writing. Deep link to the individual case file in the FIPS open register was not available at the time this record was written — url points to the registry portal, not the specific case.

Rospatent: decision to grant a patent on semantically correct automated ECG interpretation

Executable knowledge through the OR/ICU supervisor ecosystem

ManuscriptType Medical informaticsArea for medical sciencefor research organisationsfor clinical institutionsFor