Security and data protection

Prototype, not a medical device

The POC ran on a pseudonymized hackathon dataset. The POC environment no longer exists. This page describes its posture and the production path.

Data protection rules

• Patient text goes to an LLM only through an EU Data Zone gateway. The API refuses other models.
• Embeddings run on a local model inside the API container. Report text goes to no embedding service.
• The vector table stores no text. It holds only a FHIR reference and the vector.
• The MCP server refuses to start without a data declaration: synthetic or eu-data-zone.
• Demo data that KomPACS adds is tagged simulated in FHIR.
• The public demo uses synthetic patients only. It runs in the browser and has no server.
• Insurer data is optional. Its source is the patient’s own consented statement.

Threat model (POC)

• In scope: internet scanners and bots. A reviewer who asks how data and access are handled.
• Out of scope: a targeted attacker, insider threat, availability attacks.

In place in the POC

• One public entry point: a reverse proxy with TLS and a login. The API had no public ingress.
• Security headers: HSTS, nosniff, X-Frame-Options: DENY, no-referrer. Request body limit 1 MB.
• The API connected to IRIS as a least-privilege user. It had only the FHIR database roles and the SQL projection role.
• Anonymous FHIR requests got 401. No predefined IRIS account had a default credential.
• Base images pinned by digest. The API image had no build tools and ran as a non-root user. hadolint and trivy scanned the images.
• Secrets came from the platform secret store. No secret was in git or in an image.

Known POC gaps

• IRIS had a public address. FHIR, HL7 and the management portal used basic auth without TLS.
• No audit log export. No per-user login: all users shared one demo account.

Production path

Area	Control
Network	IRIS in a private subnet, no public address. NIS/RIS send HL7 over MLLP with TLS. Partners connect over VPN or a private link.
Identity	Hospital SSO. Doctor and Collector roles map to IdP groups.
IRIS	One least-privilege user per service. TLS on the web gateway and superserver. Management portal not exposed. IRIS audit on.
Supply chain	Images scanned in CI, pulled with a managed identity. Distroless runtime.
Data	Retention and access review per hospital policy. Data stays in the hospital or in an EU region.
Regulation	Hospitals are NIS2 operators. If MDR applies, the integrator certifies the product.