DUX Healthcare – the platform for digital therapeutics and DiGA on DUX Healthcare

DiGA Market Report 2026 – GKV and SVDGV in Dual-Check

Mon, 27 Apr 2026 00:00:00 +0000

By Christoph Eberhardt · CEO, DUX Healthcare · 19 April 2026

Anyone trying to understand the DiGA market end-2025 has to read two reports simultaneously – and recognise that both reports frame the same numbers differently. The GKV-Spitzenverband reports annually to the German Bundestag under § 33a para. 6 SGB V – as a payer that has to administer solidarity-system funds. The Spitzenverband Digitale Gesundheitsversorgung (SVDGV) has published an annual DiGA Report since 2024 – as an industry association consolidating the manufacturer perspective. Both sources are not neutral. Both sources are right where they measure. But every number in this article is attributable to one of the two sources – and the discrepancy between readings is the actual market report.

DiGA Approval 2026 – the Practical Guide for Manufacturers

Wed, 22 Apr 2026 00:00:00 +0000

By Christoph Eberhardt · CEO, DUX Healthcare · As of 17 April 2026

A DiGA application to the BfArM is not a form you fill out on an afternoon. It is a dossier – 26 data blocks under DiGAV § 2 Abs. 1, with CE documentation, clinical evaluation, certificates for information security and data security, data protection concept, evidence study or evaluation concept, liability insurance proof, price statement, and interoperability evidence. Teams touching the regulatory framework for the first time regularly underestimate two things: first, how much of this must be produced before the BfArM is even involved, and second, how quickly the BfArM actually works once the dossier is complete. This guide walks through the application stage by stage, shows which components teams regularly recognise too late, what realistic timelines look like, which cost blocks are not on the BfArM website – and what actually happens after the decision. The regulatory backbone sits in the DiGA knowledge area; this article is the practical addendum.

DiGAV 2026 – What the Second Amendment Really Changes

Tue, 05 May 2026 00:00:00 +0000

By Christoph Eberhardt · CEO, DUX Healthcare · 17 April 2026

The 2nd DiGAV Amendment Ordinance was published in the German Federal Gazette on 27 January 2026 (BGBl. 2026 I no. 22) and modifies the Digital Health Applications Ordinance (DiGAV) at points directly relevant to DiGA manufacturers. Three changes carry the heaviest practical weight: the new Section 6a (§§ 23a–23e) on the Application-Accompanying Success Measurement (AbEM) – the operational substrate of the 20% rule from 1 January 2026; the addition to the application content of AI Act conformity (§ 2 para. 1 no. 4a) and medical-aid/implant data under § 374a SGB V (no. 26); and the inclusion of fitness for work preservation as an independent care effect in § 4 para. 2 no. 2a and § 11b. This article explains what changes for new and existing applications – and where AbEM expansion stage III remains operationally open, even though stage II is fully specified by the draft ordinance and the Federal Gazette text.

Who Qualifies as DiGA Applicant – Legal Manufacturer Bar

Mon, 27 Apr 2026 00:00:00 +0000

By Christoph Eberhardt · CEO, DUX Healthcare · 17 April 2026

“We built the product in Boston, we got our 510(k), and now we want to list it as a DiGA in Germany.” Some version of this sentence comes up regularly in inbound conversations, and the answer is almost never “that works”. Not because the product is wrong – but because the applicant named on a DiGA filing has to be the legal manufacturer of a CE-marked medical device under the MDR, and the MDR requires that legal manufacturer to be established in the EU, or to appoint an EU authorised representative who assumes specific legal duties. This is the applicant-identity question: a frequent reason foreign DTx teams stall on their German market-entry plan at month eight, because the entity that is supposed to sign the BfArM application does not exist yet and cannot be built in a quarter. This article walks through who qualifies, why non-EU companies hit a structural wall, what the three realistic routes into Germany look like, what they actually cost in weeks, and where teams consistently underestimate the work.

BfArM Data Protection Criteria – the Practical Deep-Dive

Tue, 05 May 2026 00:00:00 +0000

By Christoph Eberhardt · CEO, DUX Healthcare · As of 17 April 2026

The BfArM Data Protection Criteria are the instrument with which the Federal Institute for Drugs and Medical Devices operationalises the GDPR for Digital Health Applications. Since 1 August 2024, DiGA manufacturers have been obliged under DiGAV § 4 Abs. 8 to implement the catalogue determined by the BfArM under § 139e Abs. 11 SGB V. The current version 1.0 was published on 24 April 2024 and contains around 150 testable individual requirements across twelve test areas. Unlike the GDPR’s general clauses and unlike the purely cybersecurity-oriented BSI TR-03161, the BfArM criteria are explicitly tailored to the DiGA-specific situation: pseudonymous use, purpose-bound processing under § 4(2) DiGAV, strict third-country rules, separate consents, electronic withdrawal routes, grace period after the end of the prescription. This article walks the catalogue in detail – with verbatim-cited requirement IDs, from an engineering perspective, for teams not looking for the checkbox but for the architectural decision.

EU DTx Market Map 2026 – 10 Countries Compared

Mon, 27 Apr 2026 00:00:00 +0000

By Christoph Eberhardt · CEO, DUX Healthcare · 19 April 2026

A DTx company expanding across Europe in 2026 faces ten national reimbursement projects, not one European market. The MDR harmonises the regulatory gate – CE marking is portable across the EEA – but reimbursement remains national competence, and every country runs its own logic. This article maps the ten European markets that matter for digital therapeutics: where reimbursement is operational, where pilot frameworks exist without statutory reimbursement, and where the path is fragmented or absent. Written for DACH-based DTx companies after a DiGA listing and for international DTx companies sequencing European entry; the German DiGA pathway as a reference point.

BSI TR-03161 Certification – A Practitioner's Guide

Tue, 05 May 2026 00:00:00 +0000

By Christoph Eberhardt · CEO, DUX Healthcare · 17 April 2026

BSI TR-03161 – the Technische Richtlinie (Technical Guideline) of the Bundesamt für Sicherheit in der Informationstechnik (BSI – Germany’s Federal Office for Information Security) titled “Anforderungen an Anwendungen im Gesundheitswesen” – is the regulatory artefact that decides whether a DiGA (Digitale Gesundheitsanwendung) can be filed at the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) or not. Since 1 July 2025, a TR-03161 certificate is a formal precondition for application completeness: no certificate, no listing, full stop (DiGA Guide v3.6 Sec. 3.4). International DTx teams entering Germany routinely treat TR-03161 as a side-track they can handle in a final quarter. In practice it is one of the load-bearing architectural decisions of a DiGA project — the cybersecurity standard against which five DiGA projects under contract on our mHealth Suite platform have been individually tested. This article is a practitioner’s guide to what TR-03161 actually demands, what certification really costs, where teams stumble, and how the “ohne Auflagen” (without conditions) vs. “mit Auflagen” (with conditions) outcome is decided.

DiGA vs FDA SaMD – What Translates, What Doesn't

Mon, 27 Apr 2026 00:00:00 +0000

By Christoph Eberhardt · CEO, DUX Healthcare · 17 April 2026

Most US DTx companies arrive at DiGA with an FDA mental model: a risk-based classification, a cleared device, a cybersecurity section in a premarket submission, and – separately, later, painfully – a reimbursement conversation with CMS, commercial payers, and employer-sponsored plans. That mental model is not wrong for the US. It is partially transferable to Germany, and the parts that do not transfer are the parts that matter most. A DiGA is not a German 510(k). It is a combined regulatory-and-reimbursement instrument, built on top of a European CE mark under the MDR, with clinical-evidence, cybersecurity, and data-protection bars that look superficially similar to the FDA regime and diverge in structure, scope, and legal weight. This article maps the two pathways for a US audience, flagging what transfers, what does not, and where the surprises sit.

DiGA AbEM 2026 – the Application-Accompanying Performance Measurement

Wed, 22 Apr 2026 00:00:00 +0000

By Christoph Eberhardt · CEO, DUX Healthcare · As of 17 April 2026

The application-accompanying performance measurement (AbEM) is mandatory from 1 July 2026 for all permanently listed DiGAs with at least one demonstrated medical benefit. The first data delivery to the BfArM follows on 15 April 2027. The most common mistake teams currently make is reading AbEM as a reporting obligation – as a dashboard bolted on at the end of a sprint. AbEM is an architectural decision: it reaches into account model, usage telemetry, in-app survey logic, consent architecture, and data protection concept at the same time – and, through the 20% rule under § 134 SGB V from 2026, it couples a fifth of the reimbursement price to measurable product behaviour. Teams treating AbEM as if it were a dashboard are building the wrong vessel. This article explains why – and what a clean AbEM data model actually requires.

Build – DiGAs and DTx in 12 weeks to CE approval

Wed, 06 May 2026 00:00:00 +0000

Phase 01 · BUILD

Digital therapeutics, the way only a platform can build them.

From therapeutic concept to a CE-marked product under MDR at DiGA compliance level. Twelve weeks, not twelve months.

Book a call with Christoph Pricing

12 weeks

to CE certification (Class I/IIa). Three to six times faster than in-house development.

80+ modules

pre-validated, indication-agnostic, combinable for your specific intended purpose.

14 years

of mobile expertise – the last seven as a Software-as-a-Medical-Device specialist.

Go Beyond – DTx Distributor for emerging markets

Wed, 06 May 2026 00:00:00 +0000

Phase 03 · GO BEYOND

DTx Distributor for emerging markets.

Analogous to the pharma distributor: we licence your DTx, re-implement it on local regulation, certify it and operate it in emerging markets. You receive revenue share – without market risk, without upfront cost.

Book a call with Christoph View models

1 role

DTx Distributor – analogous to the pharma distributor. You carry no market-entry risk; DUX takes over approval, operations and buyer interface and settles via revenue share.

Investors – the platform thesis for digital therapeutics

Wed, 06 May 2026 00:00:00 +0000

For investors

Compliance as a platform. Not as a product.

DUX Healthcare builds the regulatory infrastructure on which digital therapeutics scale faster, with more audit evidence, and across markets. We are looking for partners to fund the platform phase.

Request investor deck The thesis in brief

1 platform

indication-agnostic, modular, MDR- and DiGAV-ready – built once as a compliance substrate, not per product.

2 BSI standards

TR-03161 per DiGA (our DiGAs: passed without conditions) · TR-03185 audited as the first company (process level; formal certificate pending). Regulatory first-mover.

Platform – Build, Scale, Go Beyond

Wed, 06 May 2026 00:00:00 +0000

Platform

One platform, three engagement models.

The mHealth Suite takes your DTx from therapeutic concept to CE marking under MDR in 12 weeks. We operate it as your DTx Operations Partner in every market with statutory reimbursement – and distribute it as your DTx Distributor in emerging markets. All on the same platform foundation.

Book a call with Christoph The three phases

1 platform

indication-agnostic, modular, MDR- and DiGAV-ready as a compliance substrate. The infrastructure was built once – not per product.

Scale – DTx Operations Partner in markets with statutory reimbursement

Wed, 06 May 2026 00:00:00 +0000

Phase 02 · SCALE

DTx Operations Partner wherever reimbursement is statutorily defined.

Further indications, further markets with DiGA-adjacent reimbursement systems – on the same platform foundation. As in Build: DUX operates your DTx as your DTx Operations Partner, with predictable monthly cost per market instead of a flat licence.

Book a call with Christoph View segments

1 role

DTx Operations Partner – in Build and in Scale. One cost structure for development and ongoing operations, no cost break when moving into additional markets.

About DUX Healthcare – Platform Provider from Karlsruhe

Wed, 22 Apr 2026 00:00:00 +0000

Company · About us

Fourteen years of mobile. Seven of them as a medical device software specialist.

DUX Healthcare emerged from fluidmobile GmbH. Platform before project – the consequence of a decade of mobile development in a regulated market.

Book a call with Christoph View certifications

2012 Karlsruhe

Founded as fluidmobile GmbH. Continuously in Karlsruhe, with continuous leadership in the technical core.

14 years

Mobile expertise – the last seven years as a Software-as-Medical-Device specialist.

Certifications at DUX – ISO, BSI, BfArM

Wed, 22 Apr 2026 00:00:00 +0000

Company · Certifications

Five pieces of evidence. Five effects. One platform.

ISO 13485, ISO 27001, BSI TR-03185, BSI TR-03161 per DiGA, BfArM Data Protection Criteria – each solves a different regulatory requirement. Here is which is which and what it concretely means for your product.

Book a call with Christoph To the evidence

What this is about

What certifications really mean in the DiGA market.

The German DTx market is full of certification claims that do not hold up on closer inspection: “GDPR-compliant” is not a certification, “BSI-compliant” without a TR reference is not a statement, “ISO-like QMS” is nothing at all. This page describes which five pieces of evidence we carry at DUX Healthcare, what each of them means for a Digital Health Application (DiGA) – and where one piece of evidence ends and the next begins.

Contact – DUX Healthcare

Wed, 22 Apr 2026 00:00:00 +0000

Company · Contact

Straight to Christoph. Or via the form.

We prefer the short first call. 30 minutes, bookable directly in the calendar. If writing suits you better, use the form below.

Book a slot with Christoph Go to form

Before you write

Which path fits your question?

First call about the platform – book directly with Christoph. We listen first before we answer. Calendar link.

Jobs – platform development for regulated markets

Wed, 22 Apr 2026 00:00:00 +0000

Company · Jobs

Platform development – in a regulated market that is growing.

We grow with pace and substance. Better to integrate properly than to fill positions quickly – currently accepting unsolicited applications, targeted roles coming soon.

Unsolicited application to jobs@dux-healthcare.com About DUX

How we grow

Substance before speed.

We grow slowly and deliberately. Before a new position is advertised, the most recently hired colleagues have to be integrated – the platform depth and regulatory knowledge cannot be onboarded in four weeks. That is why the list of open positions is often short and sometimes empty.

Partners – the network around the mHealth Suite

Wed, 22 Apr 2026 00:00:00 +0000

Company · Partners

No platform without a network.

Certification institutes, integration partners, market access specialists – who works in the orbit of DUX and why this division of labor is relevant to your project.

Book a call with Christoph Partner types

Why partners

The platform handles a lot – but not everything. The partners handle the rest.

The mHealth Suite covers product development, regulatory documentation, cybersecurity evidence, and ongoing operations. It does not cover: certification audits by independent bodies, specific integrations into medical infrastructure, national market entry outside Germany, consulting-heavy regulatory support on the customer side.

Legal Notice

Fri, 20 Mar 2026 00:00:00 +0000

Information pursuant to § 5 TMG

DUX Healthcare GmbH (formerly fluidmobile) Bachstraße 43 76185 Karlsruhe

Commercial Register: HRB 714595 Registration Court: Amtsgericht Mannheim

Represented by: Christoph Eberhardt, Thomas Wolters

Contact

Phone: +49 721-754 072 39 Email: contact@fluidmobile.de

VAT ID

VAT identification number pursuant to § 27a of the German VAT Act (Umsatzsteuergesetz): DE283169796

EU Dispute Resolution

The European Commission provides a platform for online dispute resolution (ODR): https://ec.europa.eu/consumers/odr/.

You can find our email address in the legal notice above.

Privacy Policy

Fri, 20 Mar 2026 00:00:00 +0000

1. Privacy at a Glance

General Information

The following information provides a simple overview of what happens to your personal data when you visit this website. Personal data is any data that can be used to personally identify you. For detailed information on data protection, please refer to our privacy policy below.

Data Collection on This Website

Who is responsible for data collection on this website?

Data processing on this website is carried out by the website operator. You can find the operator’s contact details in the section “Notice Regarding the Data Controller” in this privacy policy.