DUX · Healthcare

Wissen

Practitioner guides on DiGA approval, BSI certifications, data protection criteria and outcome measurement. With paragraph- and requirement-level IDs, for regulatory and product teams who use the material daily.

Christoph Eberhardt · CEO, DUX Healthcare

DIGA · LEAD ARTICLE

DiGA – practitioner knowledge for digital health applications

How the BfArM procedure really runs, what data protection and BSI certifications demand today, and what AbEM means for pricing from 2026 onwards.

  • 25 Min
  • 12 Paragrafen
  • 22 Belegquellen

Articles

  1. 01

    Approval

    DiGA approval 2026 – the practitioner’s guide for manufacturers

    The six BfArM stations, the 26 data blocks under § 2 DiGAV, realistic costs between €500,000 and €2M, and the six pitfalls that cause applications to fail.

    • 15 Min
    • 18 Belegquellen
  2. 02

    Data protection

    BfArM Data Protection Criteria in detail

    Around 150 individual criteria with RFC-2119 grammar, split into twelve thematic blocks. What ‘documented’ means versus ’established’, and where teams disproportionately often face requests for further information.

    • 22 Min
    • 24 Belegquellen
  3. 03

    Outcome measurement

    AbEM – the new Performance Measurement

    Three phases from 2026/2027/2028, PROM integration with tight tolerance windows, the 20 % rule, and why AbEM is an architectural decision – not a dashboard.

    • 12 Min
    • 17 Belegquellen

In German

  1. 04

    Cybersecurity

    BSI TR-03161 Certification – A Practitioner’s Guide

    What the cybersecurity certification actually requires for DiGA applicants. Scope across mobile, web and backend (~366 requirements), realistic €50k–€150k per-DiGA cost, and how the with-conditions vs. without-conditions outcome is decided.

    • 14 Min
    • 12 Belegquellen

Content pillars

  • DiGA From intended purpose to BfArM listing – BSI certifications, AbEM, pricing. 4 articles · online
  • Reimbursement paths Paths beyond DiGA – DiPA, HMV, NUB, ZPP, selective contracts. – · in preparation
  • Medical device software MDR, IEC 62304, software classification and clinical evaluation. – · in preparation
  • International markets Inbound (world → DE) and outbound (DE → world) – Legal Manufacturer, market-entry paths. – · in preparation
  • Strategy & business models Platform vs. in-house development, pricing, cap-table effects. – · in preparation

Further deep-dives are published in waves. If you need a specific guide, write to hello@dux-healthcare.com – many articles emerge from real practitioner questions.

Ask directly

Until the Knowledge Base is complete – ask us directly.

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