This page is part of the MII Implementation Guide Molecular Tumor Board (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, 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

This is the module's own contribution: the security and privacy properties that follow from the kind of data this module carries. Its content is optional — not every module has aspects of its own. If yours does not, the whole section body becomes the following default text (delete the example and TODO boxes below and adopt it verbatim):

Beyond the overarching framework above — the overarching data protection concept, the Broad Consent it rests on, and DIMP — this module carries no data category that raises security or privacy aspects of its own, and it places no module-specific security or privacy requirements on implementers.

Written during migration - review before release. The source guide ships no security-and-privacy section; the following module-specific aspects are PROPOSED from the module's data categories and require review by the module team (Gate B): this module carries genomic data (somatic and potentially germline variants from NGS panel/exome/genome sequencing) documented under the Modellvorhaben Genomsequenzierung (§ 64e SGB V). Genomic raw and variant data have a high intrinsic re-identification potential that profile-level pseudonymisation does not remove, and germline findings can carry information about biological relatives. Implementers SHOULD treat the variant-level resources (Einfache Variante, Copy Number Variant, DNA/RNA fusion, molecular biomarkers) as especially sensitive in DIMP configurations, and SHOULD take the DNPM/MV-GenomSeq governance rules into account when data leaves the site.