MII Implementation Guide Microbiology - Local Development build (v2027.0.0-ballot2) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Security and Privacy

This section addresses security and privacy experts. General requirements are in the FHIR core specification — Security & Privacy Module and the security checklist. This page does not repeat them; it links the overarching data protection framework and states what is specific to this module.

1. The overarching data protection concept

The overarching data protection concept of the Medical Informatics Initiative governs how patient data may be processed for research across the network of Data Integration Centers: it covers the legal basis (the MII Broad Consent), the roles of the Data Integration Centers and Use & Access Committees, and the cross-site application scenarios (feasibility queries, distributed analyses, data and biosample provision). Everything this module specifies operates inside that framework — this guide adds no processing purpose of its own.

2. De-identification, minimisation and pseudonymisation (DIMP)

How data leaving a Data Integration Center is de-identified in practice is specified by DIMP (De-Identification — Minimisation — Pseudonymisation) in the data portal documentation: direct identifiers are removed, data elements not needed by the approved project are dropped, and identifying values are replaced by project-specific pseudonyms (FHIR Pseudonymizer configuration). The profiles of this module describe data before DIMP is applied; which elements survive a concrete data release is decided per project by the DIMP configuration, not by this guide.

3. Module-specific aspects

Three properties of microbiological findings are specific to this module.

A finding is sensitive without a diagnosis. The test code names the target: an HIV, tuberculosis or hepatitis result is readable from Observation.code even where no Condition exists. Access rules keyed to diagnoses do not see it.

Colonisation status outlives the episode. MRSA, VRE, LRE, LVRE and the MRGN classes describe the person rather than the encounter and steer isolation and admission decisions — yet they are modelled as ordinary Observations, with nothing in the resource marking that weight.

IfSG notification runs elsewhere. Many of the pathogens representable here are notifiable under the German Infection Protection Act. That duty is discharged through demis; receiving these resources for research neither satisfies nor substitutes for it. This module defines no reporting workflow and no notification status.