OEM Partners
For OEM Partners
Medical device manufacturers — Philips, Dräger, GE class and comparable companies — face a double pressure: procurement committees demand clinical decision support in the device, and the European AI regulation classifies AI-based decision support as a high-risk system.
The problem we solve
Embedding clinical decision support into an OEM device ecosystem means solving four things at once:
Protocol translation
Across standards generations — HL7 v2, IHE PCD, ISO/IEEE 11073 SDC — without losing device-data meaning.
A safe write path
A command to the device must not void the device's own certification.
Clinical governance
A system a hospital's clinical authority can approve and present to an auditor.
Regulatory obligations
If the decision support is AI-based, the EU AI Act classifies it, as part of the device, as high-risk: the manufacturer bears risk management, record-keeping, human oversight and technical documentation — already at the preparation stage, in full once the application deadlines arrive.
Most OEMs solve each of these independently, at high cost, on a timeline set not by the market but by the regulator. OEM R&D teams cannot afford to build and validate a proprietary supervisory-control stack for every market segment.
Our answer
HealthOS ICU provides a vendor-neutral supervisory edge layer that attaches to existing OEM device output without modifying the device itself.
We do not replace your OR/ICU data-integration platform — we execute a physician-authorized command over data you already collect. The entry point of HealthOS ICU is the bedside-device protocol, not the institution’s data hub.
| Level | Integration | OEM requirement | Status |
|---|---|---|---|
| 1 | Read-only telemetry via HL7 v2/MLLP | HL7 v2 output (any version) | Available now |
| 2 | Structured telemetry via IHE PCD | PCD-01 / DEC profile support | Available now |
| 3 | Bidirectional observation via ISO/IEEE 11073 SDC (read) | SDC-capable device | Roadmap |
| 4 | Governed command write-back via the SDC write path | Vendor access-and-control package | Roadmap |
Levels 1–2 are available now. Levels 3–4 are on the roadmap together with specific vendor partners.
Partnership program
OEM partners get:
Capability profile documentation for their device lines
Integration test bench (replay-mode, deterministic) for validation
Draft IHE-style integration statement for procurement purposes
Access to the phased validation protocol for restricted device control (pilot)
Documents and training
Whitepaper
Vendor interoperability.
Standards & interoperability
Planes and protocols.
Conformance matrix
Status for every standard.
OEM Integration Program
Capability profiles, vendor adapter conformance, four-level strategy.
The P-OEM Program Certificate can support a P-OEM delivery profile. Delivery still requires an active commercial entitlement, site binding, and fulfillment approval.
Discuss integrating your equipment with HealthOS ICU.