What Qualifies a Health App for German Statutory Health Insurance Coverage?
German statutory health insurers (GKV) cover digital health tools under two separate legal frameworks: §33a SGB V for CE-marked medical device software listed in the BfArM DiGA directory, and §20 SGB V for certified prevention courses. A wellness app falls into neither category. This article maps out the three tiers and what each one requires.
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When people in Germany ask whether a digital health tool will be covered by their statutory insurer, the answer depends almost entirely on which legal category the tool falls into — not on how sophisticated it is, how many sensors it reads, or how popular it is in the app store.
German statutory health insurance (GKV) covers digital health under two separate legal frameworks, each with its own requirements, its own regulatory authority, and its own funding structure. A third category — the wellness app — sits outside both frameworks. Understanding where any given tool fits requires asking one question first: does this software have a medical intended purpose?
Three tiers, three different legal answers
Tier 1: CE-marked medical device software (DiGA) — full GKV coverage
The first tier is governed by §33a of the Fifth Social Code (SGB V), introduced in 2019 and most recently amended by the Digital-Gesetz of March 2024. It creates a statutory entitlement: GKV-insured persons have a right to be supplied with digital health applications whose main function is based essentially on digital technologies and which are intended to support the detection, monitoring, treatment, or alleviation of disease or the detection, treatment, alleviation or compensation of injuries or disabilities.
The critical word is "intended." A DiGA must be a CE-marked medical device — specifically, a device of risk class I, IIa, or IIb under EU MDR (Regulation (EU) 2017/745). This means the manufacturer must have established a defined medical intended purpose, completed conformity assessment, and placed a CE mark on the product before it enters the market.
CE marking alone does not trigger GKV coverage. The DiGA must also be listed in the BfArM DiGA directory, maintained by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) under §139e SGB V. Once listed, an insured person can access it either through a prescription from a treating physician or psychotherapist, or through health insurer approval following documentation of the relevant medical indication.
The fast-track process under §139e SGB V. Manufacturers apply to BfArM through the fast-track procedure. BfArM assesses five areas: safety, functionality, quality, interoperability, and data protection and security. A certificate to BSI Technical Guideline TR-03161 has been mandatory since 1 January 2025. The fast-track process is designed to take three months from submission of a complete application.
Positive care effects. Manufacturers must also demonstrate that the DiGA delivers positive care effects — patient-relevant endpoint data, or documented improvements in structural and procedural quality of care. Provisional listing is possible for twelve months while the required evidence is gathered; the manufacturer must then submit the data to secure permanent listing.
Pricing under the DiGAV from 2026. The Digital Health Applications Ordinance (DiGAV), amended in February 2026, requires application-accompanying success measurement (AbEM) to be published in the directory, and specifies that performance-dependent price components must make up at least 20 percent of the reimbursement amount from 1 January 2026.
Tier 2: §20 SGB V prevention courses — partial reimbursement up to €150 per year
The second tier is governed by §20 SGB V — the statutory framework for primary prevention and health promotion. It operates on entirely different legal terrain. There is no medical intended purpose involved; instead, eligibility depends on whether the course addresses one of the health action fields defined in the GKV-Spitzenverband Leitfaden Prävention (Prevention Guideline) — currently: exercise and fitness, stress and relaxation, nutrition, and addiction prevention.
GKV insurers reimburse eligible prevention courses at up to €150 per insured person per year. As of 2026, this cap applies equally to digital and in-person formats. This is a reimbursement right — insured persons typically pay first and claim back — not a right to full coverage in the way §33a DiGA works.
What the certification process requires. Prevention courses must be certified by the Zentrale Prüfstelle Prävention (ZPP) and must meet the criteria set out in the Leitfaden Prävention. Certification applies to specific offerings, not to a product category or an app in general.
Can a digital format qualify? Yes. Chapter 7 of the Leitfaden Prävention specifically addresses digital prevention offerings and allows courses to be certified in fully digital formats. In digital courses, evidence of effectiveness and quality assurance — including ISO certification and documented data protection arrangements — must be provided.
The human course leader requirement. One structural requirement applies regardless of delivery format: a certified course leader — a real person with the qualifications specified in the Leitfaden — must be part of the offering. Chapter 5 (classical courses) and Chapter 7 (digital courses) both require this. An autonomous app, without any human instructor component, cannot be certified under §20 SGB V. This is not a technical limitation; it is a legal requirement that reflects how the §20 framework was designed.
Tier 3: Wellness apps — no GKV coverage pathway
The third category is the wellness app: software that offers lifestyle awareness, personal data trends, and health visualisation without claiming to detect, diagnose, monitor, treat, or prevent any medical condition.
Wellness apps sit outside both frameworks above. They are not CE-marked medical devices, so §33a SGB V does not apply. They are not structured prevention courses with a certified human instructor, so §20 SGB V does not apply.
This is a structural position, not a gap that wellness apps are expected to close through minor adjustments. Entering Tier 1 would require the developer to establish a medical intended purpose, obtain CE marking as a medical device, meet BfArM's clinical evidence requirements, and price the product for GKV reimbursement through the DiGAV framework. Entering Tier 2 would require building a structured programme around a qualified human instructor and submitting it for ZPP certification. Neither path is simply an administrative registration; both reflect the nature of the different regulatory regimes.
Why this distinction matters in practice
The practical consequence for consumers is clear. If you are looking at a digital health tool and asking whether your GKV insurer will cover it, the first check is whether it appears in the BfArM DiGA directory. If it does, your insurer will fund it upon prescription or approval. If not, the question is whether it is a ZPP-certified §20 prevention course — and whether the certification documentation shows a human course leader. If neither, it belongs in the wellness category: unsubsidised by law.
No tier is inherently superior. A wellness app is not inferior to a DiGA because it lacks GKV coverage. The absence of a medical intended purpose is precisely what keeps it out of the regulatory perimeter that medical device software must operate within — including the clinical evidence requirements, the conformity assessment process, and the BfArM fast-track evaluation. Lower regulatory burden and lower regulatory risk go together.
Where Sam Health fits in
Sam is a wellness app. It reads health data from Apple Health on iPhone — which means users with Apple Watch, Garmin, Oura, WHOOP, or any other device that syncs to Apple Health can supply data to Sam — and presents the data as trends and personal insights for lifestyle awareness.
Sam does not have a medical intended purpose. It is not listed in the BfArM DiGA directory. It does not include a certified human course leader and is not submitted for §20 SGB V certification. It belongs in Tier 3: a wellness tool for everyday health awareness, not a reimbursable medical intervention.
Sam is a wellness app, not a medical device. It does not diagnose, detect, treat, or screen for any medical condition. For any health concern, always consult a qualified healthcare professional.
Try Sam HealthSources
- §33a SGB V (Digitale Gesundheitsanwendungen), as amended by the Digitale-Versorgung-Gesetz (December 2019), DVPMG (June 2021), and Digital-Gesetz (March 2024). dejure.org. https://dejure.org/gesetze/SGB_V/33a.html. Accessed 16 May 2026.
- Verordnung über das Verfahren und die Anforderungen zur Prüfung der Erstattungsfähigkeit digitaler Gesundheitsanwendungen in der gesetzlichen Krankenversicherung (DiGAV), as amended 01.02.2026. Gesetze-im-Internet. https://www.gesetze-im-internet.de/digav/BJNR076800020.html. Accessed 16 May 2026.
- BfArM DiGA directory (Verzeichnis für Digitale Gesundheitsanwendungen). Bundesinstitut für Arzneimittel und Medizinprodukte. https://diga.bfarm.de/de. Accessed 16 May 2026.
- BfArM: The Fast-Track Process for Digital Health Applications (DiGA) according to Section 139e SGB V — A Guide for Manufacturers, Service Providers and Users (Version 3.6, December 2025). https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.html. Accessed 16 May 2026.
- GKV-Spitzenverband: Kriterien zur Zertifizierung von Präventionskursangeboten gemäß Kapitel 5, Stand 06.01.2026. https://www.gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/praevention__selbsthilfe__beratung/praevention/praevention_leitfaden/Kriterien_zur_Zertifizierung_von_Praeventionskursangeboten_gemaess_Kapitel_5_Stand_06.01.2026.pdf. Accessed 16 May 2026.
- §20 SGB V (Primäre Prävention und Gesundheitsförderung). sozialgesetzbuch-sgb.de. https://www.sozialgesetzbuch-sgb.de/sgbv/20.html. Accessed 16 May 2026.
- Regulation (EU) 2017/745 (EU MDR). EUR-Lex. https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng. Accessed 16 May 2026.
Frequently Asked Questions
Can a health app be reimbursed by a German statutory health insurer?+
Yes, but only under specific conditions. German statutory health insurers (GKV) cover digital health applications under §33a SGB V — but only if the app is a CE-marked medical device listed in the BfArM DiGA directory. A second, partial reimbursement pathway exists under §20 SGB V for certified prevention courses. A general wellness app qualifies under neither framework.
What is a DiGA and how does it differ from a wellness app?+
A DiGA (Digitale Gesundheitsanwendung) is a CE-marked medical device with digital functions intended to support the detection, monitoring, treatment, or alleviation of disease. It must be listed in the BfArM DiGA directory under §139e SGB V. A wellness app, by contrast, has no medical intended purpose and does not seek CE marking — which also means it is not subject to the clinical evidence requirements that DiGA must satisfy.
How does a DiGA get listed in the BfArM directory?+
The manufacturer submits an application to BfArM through the fast-track process under §139e SGB V. BfArM assesses safety, functionality, quality, interoperability, data protection, and data security — including a TR-03161 data security certificate, mandatory since 1 January 2025 — and whether the DiGA demonstrates positive care effects. The fast-track process is designed to take three months from a complete application.
Can a digital app qualify for §20 SGB V prevention funding?+
A digitally delivered course can be certified under §20 SGB V, but it must include a qualified human course leader — even in its digital format. A standalone app without any human instructor component cannot be certified under §20. GKV insurers reimburse eligible prevention courses at up to €150 per insured person per year.
What is the difference between §33a and §20 SGB V for digital health?+
§33a SGB V creates a statutory entitlement: insured persons have a right to be supplied with listed DiGA, funded entirely by the insurer after prescription or approval. §20 SGB V creates a reimbursement right of up to €150 per year for certified prevention courses. The underlying regulatory frameworks — EU MDR for DiGA, GKV prevention guidelines for §20 — are entirely separate and do not overlap.
Does data protection matter for DiGA approval?+
Yes, significantly. Since 1 January 2025, DiGA manufacturers must obtain a data security certificate to BSI Technical Guideline TR-03161. Data protection and security are among the mandatory criteria assessed by BfArM in the fast-track process. The Digital Health Applications Ordinance (DiGAV), most recently amended in February 2026, sets out the detailed requirements.
What happens to wellness apps that make medical claims without DiGA certification?+
An app that claims to detect, monitor, treat, or alleviate a medical condition is likely classified as medical device software under EU MDR — and must obtain CE marking and meet all associated requirements before being placed on the EU market. Medical claims may not be made without CE marking for that intended purpose. A wellness app that avoids medical claims sits outside EU MDR entirely and is not required to go through BfArM certification.