DiGA register of prescribable health apps (Germany, BfArM)

Domain IX · Biomedical, neuro & digital · 2019 · Germany

What it is

Names of delisted DiGA, prescriber groups, the national EBM codes for psychotherapists and one documented delisting case rest on the GKV-Spitzenverband DiGA-Bericht (published 1 April 2026), the KBV DiGA page (latest item 2 July 2026), the vdek FAQ (Stand 12 March 2026), the KBV/KVN PraxisInfo…

Format

• Application to BfArM (Fast-Track). BfArM has three months to decide on a complete application. It checks safety and functional suitability (generally evidenced by CE conformity), data protection, information security, and quality, especially interoperability, plus robustness, consumer protection,…
• Positive Versorgungseffekte (positive care effects). The manufacturer must show either a medical benefit (medizinischer Nutzen) or patient-relevant improvements in structures and procedures (patientenrelevante Struktur- und Verfahrensverbesserungen), generally through a comparative study, for a…

Who practises it, and how they are trained or regulated

• The use period is set per product in the register ("Anwendungsdauer", shown under "Informationen für Fachkreise" together with the PZN) and should be checked there; it does not have to be written on the prescription. Practice software should show the same data, possibly with a delay.
• Only 14 of 74 DiGA (19%) had proven a benefit at listing; trial periods averaged about 20 months against a regular 12. The GKV-Spitzenverband criticises unilaterally set first-year prices, intensive marketing, testimonials, telemedicine "prescription services" and pre-filled certificates, and recommends abolishing the trial track, applying negotiated prices from day one, stricter advertising rules and G-BA…
• This is not a therapy but a regulatory and reimbursement framework. A DiGA (digitale Gesundheitsanwendung, "app on prescription") is a CE-marked medical device of low risk class whose main function is digital and which supports the detection, monitoring, treatment or alleviation of disease; it is used by the patient alone or together with a provider, and is not for primary prevention (translated). Once the Federal…

Evidence status, as the guide reports it

• Application to BfArM (Fast-Track). BfArM has three months to decide on a complete application. It checks safety and functional suitability (generally evidenced by CE conformity), data protection, information security, and quality, especially interoperability, plus robustness, consumer protection,…

Questions to explore with your client

• What drew you to it, and what are you hoping it will change?
• Does it involve any substance, plant preparation, remedy or supplement? Has your doctor or prescriber been told, especially about any medication you take?
• Does it involve fasting, a special diet or 'detox'? Have you discussed this with your doctor?
• Is it a group, retreat or community? How do they respond if someone wants to leave or raises a concern?
• How do you and the practitioner understand what is happening, in spiritual or cultural terms? Is that a source of comfort, worry, or both?
• Who runs it, and what training or registration do they hold?
• What actually happens in a session or meeting, and how often?
• What does it cost, and is there pressure to commit to more?
• How do you feel afterwards, in the hours and days that follow?
• Does it fit with, or clash with, the work we do here?

What practitioners of it watch for

• products started without the required physician involvement.
• automatic renewal without review; loss of access ending structure abruptly.
• missing diagnosis; mismatch of severity; the client feeling criticised for self-help.
• deterioration with nobody watching; the client feeling 'parked'; dropout read as failure.
• reluctance or politeness (Löbner warns sceptical clients tend not to start); a choice driven by advertising.

When to involve someone else

• New or worsening physical symptoms, or advice to stop or change prescribed medication: involve the client's doctor or prescriber.
• Signs of coercion, isolation from family and friends, escalating costs or secrecy: discuss openly and consider safeguarding.
• A crisis or thoughts of suicide: follow your crisis protocol. In the US, call or text 988; in the UK and Ireland, Samaritans on 116 123.

Drawn automatically from the guide's own sections. Stay curious: neither endorse nor dismiss what the client values, and check anything that matters against the full guide and its sources. Not medical advice.