MII IG PRO
2027.0.0-ballot.1 - Germany

This page is part of the MII Implementation Guide PRO (v2027.0.0-ballot.1: 2027 Ballot 5) 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

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Official URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-pro/ImplementationGuide/mii-ig-pro Version: 2027.0.0-ballot.1
Active as of 2026-09-11 Computable Name: MII_IG_PRO

Introduction

This specification describes the FHIR representation of the Core Dataset (CDS) extension module PROs, PROMs and Derived Metrics of the Medical Informatics Initiative (MII). It standardises the collection, scoring and secondary use of patient-reported health data for the German healthcare system, enabling cross-site comparability of PRO data through uniform FHIR-based implementations.

The module is primarily based on the FHIR Structured Data Capture (SDC) specification and covers the complete workflow Questionnaire → QuestionnaireResponse → score Observation — from validated instrument definitions through capture to computed, traceable scores.

Publication  
Version 2027.0.0-ballot.1 (CalVer YYYY.n.n)
Status active
Realm DE

Scope

The PRO Library currently carries more than twenty instruments — from the PHQ family, EQ-5D-5L, PROMIS profiles and EORTC QLQ-C30 through PRO-CTCAE, MIDOS2 and WHODAS 2.0 to the PCOR-MII PSS screening set. Every instrument follows the same architecture: canonical item identities (ID systematics), answer scales with ordinal weights, machine-readable capabilities, and a score pipeline along the three scoring channels.

Four instruments (HADS, EPDS, CES-D, K6) are represented as metadata-only references for licensing reasons.

Target audience

Software vendors and implementers

Form renderers, EHR/KIS integrations, ePRO apps, ETL pipelines and scoring services.
→ start with the Implementer Guidance — five rules every implementation must respect.

Studies and researchers

Instrument selection, licensing tiers, and what the collected data means downstream.
→ start with the Researcher Guidance.

Contents

  • Guidance — getting started, use cases, ID systematics, capabilities, and the 2027 concepts (CAT, national questionnaire server, derived metrics).
  • PRO Library — all instruments with focus, items, language, scoring and licence at a glance.
  • Scoring — client-side, server-side (CQL) and externally pre-computed scores, including the medical-device boundary.
  • Conformance — the KDS-wide rules (requirements language, Must Support, missing data) are maintained centrally by the Meta module; module-specific Security and Privacy considerations are part of this guide.
  • Profiles and the further artifacts — the normative FHIR resources.
  • Changelog — all versions including the 2027.0.0-ballot preparation.

Authors and contact

  • Thomas Debertshäuser
  • Mathias Rose
  • Fabian Praßer
  • Karoline Buckow
  • Franziska Klepka

Feedback and questions: via the GitHub repository or the MII channels.

The MII-authored FHIR structures of this module are published under CC0; third-party instrument texts keep their own licence terms — see the licence column of the PRO Library and the copyright element of each resource.