ZPP certification instead of medical-device approval — no clinical trial required.
02 · Competent authority
The
Zentrale Prüfstelle Prävention (ZPP) — certifies on behalf of a cooperative of statutory health insurers (practically all Ersatzkassen, AOK regional funds, IKK funds, BKK funds, Knappschaft, SVLFG); operated day-to-day by Team Gesundheit GmbH, Essen; BfArM plays no role here
03 · Payer & co-pay
Payer: Statutory health insurance fund (GKV), per each fund’s own bylaws (Satzung); Co-pay: the law sets no fixed reimbursement rate — common practice (varies by fund) is 80–100% of the course fee, usually capped (often around €75–150/course) and limited to typically 1–2 courses per calendar year; the insured person almost always pays upfront — the provider is paid directly, and reimbursement follows only after the certificate of attendance is submitted to the insurer
04 · Regulatory approval
Not a medical device — no CE mark, no MDR classification required; the only gate is ZPP certification of the course content, the course leader’s qualifications, and (where used) the underlying course concept, per the Leitfaden Prävention
05 · Data-protection certification
General GDPR obligations apply, but there is no dedicated BfArM-style data-protection criteria catalogue as for DiGA/DiPA; no BSI TR technical guidelines apply, and there is no requirement to connect to the ePA; exception: for digital offerings certified under
Chapter 7 of the Leitfaden Prävention, an additional
ISO 27001 certification of the information security management system (ISMS) is required — non-delegable to a hosting platform, it must cover the responsible organisation itself
06 · Clinical evidence — RCT & real-world data
No clinical trial (RCT) or real-world evidence is required for courses certified under Chapter 5 of the guideline (fixed course structure, e.g. 8–12 weekly sessions) — certification here only checks course content, structure and quality against the
Leitfaden Prävention guideline, not medical effectiveness in the DiGA sense; exception: flexible, app-based digital offerings certified under Chapter 7 require their own scientific efficacy proof (typically a longitudinal study) and, after that, an efficacy evaluation to extend beyond the initial (1-year-only) certification year (
see row 13)
07 · Health-economic assessment
None — neither an IQWiG-/AMNOG-style cost-benefit assessment nor outcome-linked pricing elements as introduced for DiGA from 2026
08 · Access / prescription
No physician prescription needed — the insured person books directly with a certified course provider (online or in person); some funds additionally take a physician-issued prevention recommendation under § 25 or § 26 SGB V into account, but it is not a mandatory access requirement
09 · Eligible user
Any statutorily insured person entitled to prevention benefits — unlike DiGA, not tied to a specific diagnosed condition, but to the relevant action area (e.g. exercise, nutrition, stress management, substance-use prevention)
10 · Reimbursement / pricing model
The provider sets the course price freely — there is no central price negotiation with GKV-Spitzenverband as for DiGA; typical course fees run around €75–250 for a full course (usually 8 sessions); the fund reimburses after course completion based on the submitted certificate of attendance, typically 80–100% up to a fund-specific cap
11 · Application / listing process
Fully online via the ZPP’s
quality portal — the provider submits session-by-session lesson plans, participant materials and proof of the course leader’s qualifications; the review is centralised, free of charge and nationwide,
typically completed within 10 working days; unlike DiGA there is no separate per-fund listing step — a positive result is automatically recognised by every participating fund
12 · Trial / provisional listing
No provisional/permanent listing model as with DiGA for courses certified under Chapter 5 — every certification is fully valid from the outset; exception: prevention offerings certified under Chapter 7 of the Leitfaden Prävention initially receive only a provisional certification — proof of scientific efficacy must be submitted within the first year (
see row 13)
13 · Time limit / re-evaluation
Certification is
generally valid for 3 years from the date it’s granted, after which free re-certification for a further 3 years is available; online course concepts, as well as digital offerings certified under Chapter 7, instead receive only a 1-year initial certification, extendable by 2 years once an efficacy evaluation is submitted; any change to a certification-relevant course detail (e.g. a new course leader, an altered concept) automatically triggers a new review
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