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.
What the 2nd Amendment Is – and Why It Matters
The DiGAV from 08.04.2020 has been amended several times since its first version. The 2nd Amendment Ordinance, promulgated as Article 1 of the ordinance of 27.01.2026 (BGBl. 2026 I no. 22), is the most substantively far-reaching to date: it inserts five new paragraphs as Section 6a, expands § 2 in two strategically relevant places, broadens § 4 with a new processing legal basis, and creates a new study type for fitness-for-work preservation in § 11b.
For manufacturers this is not a “regulatory housekeeping update”. AbEM is the technical substrate of the 20% rule from 01.01.2026 – and it must be collected within the DiGA itself (DiGAV § 23a paras. 1–5, DiGA Guide v3.6 Sec. 6.3). That is an architectural decision, not a reporting task.
GKV-Spitzenverband and SVDGV read the ordinance, predictably, differently: the payer as an overdue step toward more data transparency, the industry as additional compliance burden (GKV-Spitzenverband DiGA-Bericht 2025, SVDGV DiGA-Report 2025). Both positions are legitimate; neither is neutral.
AbEM Obligation and 20% Rule – the Heaviest Change
The new Section 6a (§§ 23a to 23e DiGAV) makes AbEM a binding regulatory regime. Three points worth clarifying in practice:
Who Is Subject to AbEM – and Who Is Not
DiGAV § 23a para. 1 sharply scopes the obligation: AbEM data submission applies only to DiGAs that have already been decided for permanent listing – not to DiGAs in trial. Furthermore, collection of patient-reported health-status data (§§ 23d, 23e) does not apply to DiGAs whose positive care effects were demonstrated exclusively via pSVV (patient-relevant structural and procedural improvements under § 8 para. 3). The choice between medical benefit and pSVV therefore has an AbEM consequence, not just an evidence consequence – an often-underestimated point in application strategy.
What Is Actually Collected (Stage I, binding from 01.07.2026)
Stage I is operationally precise (DiGAV § 23c): scope of use (average time per week), frequency of use (average events per week), and drop-out rate. For DiGAs with ≥ 90-day application duration, a 21-day usage pause counts as drop-out; for shorter durations, 25% of the application duration. A user re-engaging after expiry still counts as a drop-out (§ 23c para. 4 sent. 4). Reporting includes total user count, drop-out rate, distribution of drop-outs across weeks, and average time to drop-out.
What This Means for Product Architecture
DiGAV § 23a para. 5 prescribes uniform questionnaires; DiGA Guide v3.6 Sec. 6.3 adds: collection must take place within the DiGA itself – reminders via email, SMS or push outside the app are prohibited. Concretely: implement in-app reminders and tolerance windows (7 days before expiry to 0 days after); aggregate usage data per calendar quarter and submit semi-annually (15 April, 15 October) via the BfArM forms (DiGAV § 23a para. 3).
The 20% Rule – the Economic Hinge
From 01.01.2026, reimbursement agreements must include a success-dependent price component of at least 20% of the reimbursement amount (§ 134 para. 1 sent. 3 SGB V, DiGA Guide v3.6 Sec. 6.1) – tied in 2026 to usage data, expanded in 2027 with PGI-C and patient satisfaction, and in 2028 with indication-specific PROMs. The reimbursement amount thus splits into a fixed and a success-dependent share; weak AbEM metrics shorten the second.
DUX reading: not a risk transfer that gets compensated – a paradigm shift that demands retention and engagement as product functions, not marketing metrics. DiGA price negotiation with the GKV-Spitzenverband becomes structurally two-tiered: once via the base reimbursement amount, continuously via AbEM metrics.
ePA, § 374a SGB V, and AI Act – New Application Content
The 2nd Amendment expands § 2 DiGAV in two places that read as documentation points but require technical preparation:
§ 2 para. 1 no. 4a – AI Act in the DiGA Application
With no. 4a, applications must include statements on “fulfilment of requirements under Regulation (EU) 2024/1689” – the AI Act – where applicable. Manufacturers of DiGAs with AI components (high-risk AI under Annex III AI Act applies in the health sector) must lay out AI Act conformity in the application. The interplay between MDR classification, AI Act risk class, and DiGA application is developed in the Medical Software hub. The application is not the place to consider the AI Act for the first time.
§ 2 para. 1 no. 26 – Medical Aids and Implants
With no. 26, applicants must specify which data from medical aids and implants under § 374a SGB V the DiGA processes and which product designations are the source. For cardiology, orthopaedics, diabetology, or neurology indications this is no edge case: anyone processing data from implanted pacemakers, CGM systems, or orthopaedic sensors must maintain a robust product catalogue and interface inventory by application submission.
§ 6a DiGAV – Interoperability Stays, Maintenance Burden Doesn’t
§ 6a itself is not new but was not relaxed by the 2nd Amendment: DiGAs must be capable of transmitting processed data to the electronic patient record (ePA) under § 341 SGB V, via the gematik interface under § 354 para. 2 no. 6 SGB V and conforming to the specification under § 355 para. 2a SGB V (DiGAV § 6a). Updates to semantic specifications must be implemented within six months – the clause that turns ePA integration into an ongoing maintenance burden. New under § 2 para. 1 no. 21a: the mappability of processed data to ePA specifications must be laid out in the application.
Data-Protection Sharpening: §§ 4 and 11b
§ 4 para. 2 no. 2a and no. 3 – Two New Processing Purposes
No. 2a permits processing for the demonstration of fitness-for-work preservation in the context of a trial under § 139e paras. 4 and 12 SGB V – the data-protection-law mirror of the new § 11b. The DiGAV thereby structurally tracks what was set up in § 139e para. 12 SGB V by the Teilhabestärkungsgesetz of 02.06.2021: DiGAs as pension-insurance benefits for participation, with additional demonstration of fitness-for-work preservation alongside the care effects under para. 2 sent. 2 no. 3 (§ 139e para. 12 SGB V, DiGA Guide v3.6 Sec. 2.1).
No. 3 now explicitly names the creation of the AbEM dataset under § 139e para. 13 sent. 2 SGB V and the substantiation for reimbursement agreements under § 134 para. 1 sent. 3 SGB V as permissible processing purposes. What previously had to be solved through GDPR general clauses and consent architecture is now available as sector-specific legal basis – relevant to the BfArM data-protection criteria catalogue on purpose limitation.
§ 18 para. 2 – AbEM Results Are Not a Substantial Change
A clarification easy to overlook: changes in AbEM results are explicitly not substantial changes under § 18 para. 1 no. 1 DiGAV (DiGAV § 18 para. 2). Without this clarification, quarterly AbEM updates would have formally triggered notification waves. AbEM is a continuous measurement process, not a product change.
What Changes for Existing DiGAs – Transition Periods
The ordinance enters into force the day after publication. For existing DiGAs: no new application. But:
- From 01.01.2026: the 20% rule applies to every new reimbursement-amount agreement – i.e. for all DiGAs whose 12-month free-pricing window ends in 2026 or later (DiGA Guide v3.6 Sec. 6.1).
- From 01.07.2026: AbEM Stage I data collection is mandatory for all permanently listed DiGAs (DiGAV § 23a para. 1).
- By 15.04.2027: first AbEM submission to BfArM – jointly for Q3 and Q4 2026.
- From 01.07.2027 and 01.01.2028: Stages II (PGI-C, patient satisfaction) and III (indication-specific PROMs); first submissions 15.04.2028 and 15.04.2029.
For new applications from entry into force, additional information under § 2 para. 1 no. 4a (AI Act) and no. 26 (§ 374a SGB V data flows) applies, where relevant.
What Remains Open – Stage III and the BfArM List
With the Federal Gazette publication on 27.01.2026 and the concrete shape in Annexes 3 and 4 of the draft ordinance from 03.01.2025, Stage II is substantively fixed – the PGI-C question and the five patient-satisfaction items (incl. NPS) are uniformly prescribed. Three points remain operationally open: the BfArM list of indication-specific questionnaires for Stage III (§ 23e DiGAV), to be published by 01.07.2027 and triggering a 6-month delay where unavailable; the interpretation of tolerance windows in DiGA contexts with irregular usage; and the methodological coupling of success-dependent price components to AbEM metrics at the framework-agreement level between GKV-SV and manufacturers under § 134 para. 4 SGB V. This article will be updated as the BfArM list and the framework agreement become available.
Frequently Asked Questions
Does an existing DiGA need to refile under the 2nd Amendment?
When does the 20% rule actually apply?
The 20% rule applies under DiGA Guide v3.6 Sec. 6.1 to reimbursement agreements from 01.01.2026. It affects every DiGA whose 12-month free-pricing window ends in 2026 or later and enters price negotiations with GKV-Spitzenverband.
The operational lever is not the agreement itself but the AbEM data collection to which the success-dependent share is tied – 2026 usage data, 2027 plus PGI-C and patient satisfaction, 2028 plus indication-specific PROMs. The concrete calculation is governed by the framework agreement between GKV-SV and manufacturers; teams negotiating in early 2026 are negotiating not just a price but a measurement logic.
What is new about § 11b DiGAV – fitness-for-work preservation?
§ 11b is newly inserted as a separate study type by the 2nd DiGAV Amendment and refers, for the proof of fitness-for-work preservation, to the corresponding application of §§ 9 to 11 and 13 to 15 – the established evidence regime applied to a new proof goal.
Background: the Teilhabestärkungsgesetz of 02.06.2021 introduced DiGAs as pension-insurance benefits for participation in § 139e para. 12 SGB V (DiGA Guide v3.6 Sec. 2.1). For indications with realistic fitness-for-work outcomes (musculoskeletal disorders, mental conditions, chronic pain) this opens a second reimbursement path beyond classic GKV listing – with its own evidence logic and its own payer.
Practitioner take