One stack per hospital, integrator-owned
Decision
Section titled “Decision”- One product: the same container stack (IRIS for Health, API, UI) for every hospital.
- Two ways to run it: on-premises at the hospital, or a managed EU-cloud tenant per hospital that the integrator operates. No patient data is shared between tenants.
- The hospital changes nothing. KomPACS connects through standards the hospital already has: HL7 v2 orders, FHIR R4, a PACS availability feed. Later DICOM and ePACS for the fetch.
- Central part without patient data: the verified-contact directory of hospitals.
- After the hackathon, a licensed Czech IT integrator owns, distributes and supports the product. The hospital pays the integrator.
Why not pure SaaS
Section titled “Why not pure SaaS”Hospitals are NIS2 operators. Approval for patient data in a public cloud is slow. A cloud tenant still needs a VPN to the hospital NIS and PACS. So the managed tenant is an option, not the only path.
Regulatory line
Section titled “Regulatory line”- Intended purpose: find and fetch prior imaging. No diagnosis.
- The Collector confirms every relevance verdict.
- A human in the loop alone does not take software out of MDR (MDCG 2019-11). If MDR applies (Rule 11, likely class IIa), the integrator certifies the product.
Consequences
Section titled “Consequences”The POC differs from production. See the table in Deploy for a hospital.