DUX · Healthcare
Knowledge
Practitioner guides on DiGA approval, reimbursement paths, medical-software foundation, international markets, and digital-health strategy. With paragraph- and requirement-level IDs, for regulatory, product, and business teams that use the material daily.
The five knowledge areas
- DiGA
BfArM procedure, DiGAV 2026, AbEM, BfArM data-protection criteria, BSI TR-03161, pricing.
- 01 DiGA Approval 2026 – the Practical Guide
- 02 DiGAV 2026 – the Second Amendment
- 03 BfArM Data Protection Criteria – Deep-Dive
- 04 BSI TR-03161 Certification – Practitioner's Guide
- 05 DiGA AbEM 2026 – Performance Measurement
- Reimbursement paths DiGA, DiPA, HMV, ZPP, NUB, selective contracts, Innovation Fund – the decision framework before the product decision. Overview
- Medical software MDR, IEC 62304, ISO 13485, ISO 14971, BSI TR-03185, AI Act – foundation stack beneath DiGA. Overview
- International markets
Inbound (world → DE) and outbound (DE → Europe) – legal manufacturer, PECAN, mHealthBelgium, NHS DTAC, MepV.
- 01 Market Access Germany – International DTx Guide to DiGA
- 02 Who Qualifies as DiGA Applicant – Legal Manufacturer Bar
- 03 EU DTx Market Map 2026 – 10 Countries Compared
- 04 DiGA vs FDA SaMD – What Translates, What Doesn't
- Business & strategy
Market reports, build-vs-platform, pharma companion, investor perspective – DiGA as a business model.
- 01 DiGA Market Report 2026 – GKV and SVDGV in Dual-Check
Ask directly
Concrete regulatory or platform question? Talk directly.
Thirty minutes with Christoph on DiGA strategy, reimbursement paths, build-vs-platform, or international expansion. No sales pitch, with an honest assessment of whether DUX helps or not.
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