DiGA register of prescribable health apps (Germany, BfArM)

1. Introduction

Version followed: the statutory DiGA pathway of § 33a and § 139e SGB V as created by the Digitale-Versorgung-Gesetz (DVG, 19 December 2019) and specified in the DiGAV, described in the BfArM Fast-Track guide (DiGA-Leitfaden, 2020 edition, hosted by the Federal Ministry of Health), with later changes from the Digital-Gesetz (DigiG, 2024) as reported in the GKV-Spitzenverband DiGA report published 1 April 2026 (data to 31 December 2025), and prescribing practice per KBV PraxisInfo (March 2026) and KV Bayerns SOP (10 April 2025). German sources are primary; English renderings are brief paraphrases marked (translated). [source: DiGA-Leitfaden 2020; GKV-SV DiGA-Bericht 2026; KBV PraxisInfo 2026]

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 (January 2025), the KV Bayerns SOP for psychotherapists (25 March 2026) and Deutsches Ärzteblatt (17 May 2022). Individual product status in October 2026 was not confirmed against the BfArM directory itself and remains [uncertain]; the KVB names the directory (diga.bfarm.de/de/verzeichnis) as the place where all reimbursable DiGA are listed, so check the live entry before every prescription. [source: KVB SOP Psychotherapeuten 2026]

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). [source: DiGA-Leitfaden 2020] Once the Federal Institute for Drugs and Medical Devices (BfArM) lists a product in its DiGA directory (DiGA-Verzeichnis), statutory health insurance (GKV) pays for it when a physician or psychotherapist prescribes it, or when the insurer approves it on proof of the indication. [source: DiGA-Leitfaden 2020; BMG Ratgeber DiGA, Stand 8 September 2026]

Core idea of how change happens: most mental-health DiGA deliver structured, largely self-guided psychological programmes (typically psychoeducation plus interactive exercises, often CBT-based) that the client works through between or instead of sessions; the clinical value for a psychotherapist lies in correct indication, embedding the programme in care (bridging waiting time, supplementing therapy, aftercare) and monitoring, not in the app alone. [source: AOK G+G 05/2025 quoting M. Löbner; BPtK Stellungnahme DigiG 10.10.2023] Several sources stress that DiGA do not replace psychotherapy ("ersetzen keine Therapie"). [source: psychotherapeutensuche.de Care-Paket DiGA, 2025]

For the psychotherapist, this guide covers (1) a factual description of how DiGA are listed, prescribed and delivered, and (2) the therapist's own work: indication, informed consent, prescribing where entitled, integration with therapy, monitoring, crisis safety and ending. Product content, module structure and in-app wording belong to each manufacturer's instructions for use and are not reproduced here.

2. Framework

2.1 Legal and regulatory stages of a DiGA (what the register status means)

• Eligibility. Medical device of risk class I or IIa (MDR); since the DigiG, class IIb products may also be listed but must prove a positive care effect at listing and cannot enter on a trial basis. [source: DiGA-Leitfaden 2020; GKV-SV DiGA-Bericht 2026]
• 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, usability, support for providers, quality of medical content and patient safety (§§ 3–6 DiGAV, checklists in Annexes 1 and 2). [source: DiGA-Leitfaden 2020]
• 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 specified patient group (translated). [source: DiGA-Leitfaden 2020]
• Permanent listing (dauerhaft aufgenommen). Granted when evidence of a positive care effect is accepted. [source: DiGA-Leitfaden 2020]
• Provisional listing (vorläufig aufgenommen, Erprobung). Possible when all technical and quality requirements are met but evidence is not yet sufficient: the manufacturer submits a plausible rationale and an evaluation concept by an independent scientific institution; the trial lasts up to 12 months and can be extended once by up to 12 months. Provisionally listed DiGA can be prescribed and are reimbursed during the trial. [source: DiGA-Leitfaden 2020; PTAheute 18.05.2022]
• Delisting (Streichung). If no study results are submitted or BfArM decides negatively, the DiGA is removed; a new application is possible at the earliest 12 months later and only with new evidence; repeated provisional listing is not allowed. [source: DiGA-Leitfaden 2020]
• Numbers. From September 2020 to 31 December 2025, 74 DiGA were added and 16 removed, leaving 58 (48 permanent, 10 provisional). Of the 74, 14 were permanent from the start, 34 moved from trial to permanent, and all 16 removals came from the trial track. [source: GKV-SV DiGA-Bericht 2026] The report names the 16 removed products (Table 6): optimune, re.flex, Vantis, actensio, Selfapy Panik, Selfapy Schmerzen, CANKADO, mebix, Mika, orthopy, My Dose Coach, Rehappy, Kaia COPD, ESYSTA, M-sense Migräne and MindDoc; seven of these were removed in 2025, including MindDoc and Selfapy's chronic-pain course. sinCephalea (migraine) was removed, re-listed for trial by court order and removed again on 22 January 2026. The report gives no indication or reason per product. [source: GKV-SV DiGA-Bericht 2026] By name, the removed products relevant to mental health are Selfapy Panik, MindDoc and Selfapy Schmerzen (a chronic-pain course). [source: GKV-SV DiGA-Bericht 2026; which indications MindDoc covered: uncertain]
• Pricing. Manufacturers set the price alone in the first 12 months; a negotiated price applies from month 13. From 1 January 2026, § 134 SGB V provides for a performance-based remuneration component with mandatory outcome measurement during use (anwendungsbegleitende Erfolgsmessung), under a draft ordinance at the time of the report. [source: GKV-SV DiGA-Bericht 2026] For the client there is no co-payment when prescribed or approved. [source: psychotherapeutensuche.de Care-Paket DiGA, 2025]

2.2 Access route for one client (clinical stages)

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. [source: KVB SOP 2025; KVB SOP Psychotherapeuten 2026]

2.3 Mental-health DiGA examples and status

As of August 2024 per the DPtV table compiled from the BfArM DiGA-Verzeichnis, all of the following were listed permanently (dauerhaft): [source: DPtV Tabelle DiGA Psych, Stand August 2024]

• deprexis (depressive episode and recurrent depression, F32.0–F32.2, F33.0–F33.2; standalone and as therapy support). Manufacturer page: adults 18+, risk class I, 90-day access, prescribable by all physicians and psychotherapists regardless of therapy orientation. [source: deprexis HCP FAQ]
• velibra (panic disorder, agoraphobia with panic, social phobia, generalised anxiety disorder: F40.01, F40.1, F41.0, F41.1; standalone and as therapy support).
• Selfapys Online-Kurs bei Depression (F32.0, F32.1, F33.0, F33.1), which moved from provisional to permanent listing in 2022. [source: PTAheute 18.05.2022] Also Selfapy courses for generalised anxiety disorder (F41.1), bulimia nervosa (F50.2, F50.3) and binge-eating disorder (F50.4, F50.8, F50.9).
• HelloBetter programmes: Panik (F40.01, F41.0), Stress und Burnout (Z73), Diabetes und Depression (E10, E11), Vaginismus Plus (F52.5, F52.6), ratiopharm chronischer Schmerz (F45.40, F45.41, M79.7).
• Others: Novego (depression incl. F34.1), edupression.com, Mindable (F40.0, F41.0), Invirto (anxiety; requires accompanying contracted-physician services), priovi (borderline, F60.31), vorvida (alcohol, F10.1, F10.2), NichtraucherHelden (F17.2), somnio (insomnia; requires contracted-physician services).

As of March 2026, Pharmazeutische Zeitung (citing the BfArM directory) counted more than 20 DiGA for mental disorders. They included seven for depression in adults (deprexis, edupression.com, elona explore, elona therapy Depression, My7steps, Novego, Selfapy) and seven for anxiety (HelloBetter Panik, Invirto, Mindable Panik & Agoraphobie, Mindable Soziale Phobie, Novego, Selfapy GAD, velibra). Oriko (adult ADHD) was listed provisionally until 8 July 2026. [source: PZ 03.03.2026] On 16 October 2026 the KBV DiGA page (latest item 2 July 2026) still listed product-specific EBM codes for permanently listed DiGA. These included somnio (insomnia), Invirto (anxiety) and elona therapy Depression, which points to those three still being permanently listed at that page's last update. [source: KBV DiGA page] MindDoc and Selfapy Panik have been removed (see 2.1). [source: GKV-SV DiGA-Bericht 2026] Full status as of October 2026, including Oriko's status after its trial end date, remains [uncertain]. Always check the current entry before prescribing, because status changes.

2.4 Evidence requirements and critiques

• 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 prescribing rules. [source: GKV-SV DiGA-Bericht 2026]
• About 1.9 million DiGA were prescribed or approved to end-2025, about 82% activated; about 87% came from physicians or psychotherapists (family physicians 51%), the rest from insurer approvals; mental-health indications made up 27% of use; mean user age 47. [source: GKV-SV DiGA-Bericht 2026]
• The Bundespsychotherapeutenkammer (BPtK) calls insurer approval without a professional prescription "systemfremd" and potentially endangering, wants diagnosis and indication by psychotherapists or physicians before use, favours blended care, opposes provisional listing and calls for proof of medical benefit for all risk classes. [source: BPtK Stellungnahme DigiG 10.10.2023]
• Löbner (University of Leipzig) is quoted that many of the 28 mental-health DiGA have proven useful, some with effects comparable to psychotherapy, but that they do not replace face-to-face therapy or medication and should not be pushed on patients. [source: AOK G+G 05/2025]

3. Guiding principles

• Diagnosis before app. Use a DiGA only with an established ICD-10 indication from the register entry; the indication must be medical (translated: "may only be prescribed if a medical indication exists"). Practical meaning: no prescription from a first phone contact or on request alone. [source: Care-Paket DiGA; BPtK 2023]
• The register entry is the authority. Indication codes, age group, contraindications, required accompanying services, use period, PZN and listing status come from diga.bfarm.de, not from marketing. Practical meaning: open the current entry for every new prescription. [source: KVB SOP 2025; Care-Paket DiGA]
• Supplement, bridge or aftercare, not replacement. Practical meaning: frame the DiGA as part of a treatment plan with a named clinician responsible. [source: AOK G+G 05/2025; Care-Paket DiGA]
• Willingness is a precondition. A client who is sceptical or opposed is likely not to start or to stop. Practical meaning: offer, do not push. [source: AOK G+G 05/2025]
• Self-guided does not mean unsupervised. The prescriber is responsible for making sure the client knows what to do if symptoms worsen. Practical meaning: every prescription comes with a crisis plan and a review date. [source: deprexis HCP FAQ; BPtK 2023 on blended care]
• Exclusions are real. Acute suicidal crises, psychotic disorders and bipolar disorder are listed as unsuitable for deprexis; other products have their own exclusions. Practical meaning: risk screening precedes and accompanies use. [source: deprexis HCP FAQ]
• Transparency about status and evidence. Provisionally listed products have not yet shown a positive care effect. Practical meaning: tell clients whether the product is permanent or on trial. [source: DiGA-Leitfaden 2020; GKV-SV DiGA-Bericht 2026]
• Data protection is part of consent. DiGA must meet DSGVO and DiGAV requirements, but clients should know what is stored, where and with what consent. Practical meaning: discuss data before activation. [source: DiGA-Leitfaden 2020]
• Independence from marketing. The GKV report documents demand-driving marketing and prescription services. Practical meaning: base choice on indication and the register, not manufacturer contact or client-supplied pre-filled forms. [source: GKV-SV DiGA-Bericht 2026]
• Review and stop if no benefit. A follow-up prescription is possible when medically indicated and the goal is likely reachable. Practical meaning: renew only after a documented review. [source: KVB SOP 2025]

4. Intervention inventory

Part A describes how DiGA are delivered as official and professional sources state it. Part B covers the psychotherapist's own interventions. Example language is illustrative wording, not taken from any manufacturer or guideline.

Part A: How DiGA are delivered

A1. Access route: prescription or insurer approval

• Purpose: know the two legal routes so you can explain them and spot problems.
• Steps (as sources describe):
  • Route 1, prescription (Verordnung): physicians and psychotherapists may prescribe; no separate prescribing requirements apply to either group (translated). [source: KBV PraxisInfo März 2026; DiGA-Leitfaden 2020]
  • Route 2, approval (Genehmigung): the client applies directly to the statutory insurer with proof of the indication; the insurer can cover costs without a prescription. [source: DiGA-Leitfaden 2020; KVB SOP 2025]
  • The insurer issues an access code (Freischaltcode) digitally, by post or both; the client activates the product with it. With an e-prescription, clients using the gematik or insurer eRezept app can redeem it directly; otherwise the practice gives a printout the client sends or uploads to the insurer. [source: KBV PraxisInfo 2026]
  • For mental-health programmes such as deprexis, access runs 90 days from activation; a new prescription is needed to continue. [source: deprexis HCP FAQ; Care-Paket DiGA]
• Example language (illustrative): "This programme is paid for by your health insurance. I write the prescription, you pass it to your insurer, and they send you a code to unlock it for about three months."
• Watch for: codes not arriving (client gives up silently); clients who obtained a DiGA by insurer approval or via an online "prescription service" without diagnosis, which the GKV report and BPtK criticise. [source: GKV-SV DiGA-Bericht 2026; BPtK 2023]

A2. The register entry (DiGA-Verzeichnis)

• Purpose: the only authoritative source on whether and for whom a product is prescribable.
• Steps (as sources describe): use only the official directory (diga.bfarm.de); under information for professionals find the PZN and use period; check indication codes, age group, access routes (app, web), languages and whether accompanying contracted-physician services are required (e.g. Invirto, somnio, per DPtV 2024). [source: KVB SOP 2025; Care-Paket DiGA; DPtV Tabelle 2024]
• Example language (illustrative): "Let me check the official register with you, so we both see what this programme is approved for and what it requires."
• Watch for: outdated lists in practice software or flyers; provisional status and its end date; delisting (the product stops being reimbursable). [synthesis]

A3. Provisional, permanent and delisted status

• Purpose: inform clients accurately about evidence and continuity.
• Steps (as sources describe): provisionally listed DiGA are prescribable and reimbursed during a trial of up to 12 months (extendable once by up to 12); after positive study results they become permanent, otherwise they are removed. [source: DiGA-Leitfaden 2020; PTAheute 18.05.2022] All 16 removals to end-2025 came from the trial track. [source: GKV-SV DiGA-Bericht 2026]
• Example language (illustrative): "This one is on a trial listing. It has met the safety and data requirements, but its benefit is still being studied. That is a reason for us to review it closely."
• Watch for: a client part-way through a product that is delisted, or whose manufacturer becomes insolvent (the GKV report notes nine manufacturer insolvencies). Once a DiGA is removed, it can no longer be prescribed or approved at GKV expense. After an insolvency, the insurers' repayment claims may go unpaid. [source: GKV-SV DiGA-Bericht 2026] One documented case is M-sense Migräne (withdrawn by the manufacturer, 2022). The app stayed downloadable and usable, and prescriptions and activation codes already issued could still be redeemed. The manufacturer covered the costs temporarily, because insurers no longer had to pay for codes redeemed after the listing ended (translated). [source: Deutsches Ärzteblatt 17.05.2022] The sources set out no general rule on continued access after delisting, so in each case ask the insurer and the manufacturer. [uncertain]

A4. Data protection and security requirements

• Purpose: answer client questions factually.
• Steps (as sources describe): DSGVO applies, supplemented by the BDSG (notably § 22 for health data); processing for DiGAV purposes needs explicit, voluntary consent, must be proportionate and purpose-limited, and optional consents can be refused or withdrawn without losing the core service; under the 2020 guide, processing is limited to Germany, EU/EEA states, Switzerland and countries with an EU adequacy decision. [source: DiGA-Leitfaden 2020] The 2020 guide's rules on transfers to US providers reflect law at that time and should be checked against the current DiGAV [uncertain: not verified]. Since 1 January 2025, manufacturers must prove compliance with BSI technical guideline TR-03161 through a certificate (§ 139e Abs. 10 SGB V); cloud processing of health data requires a C5 attestation under § 393 SGB V. [source: PwC, secondary] Many DiGA can store data in the electronic patient record (ePA). [source: BMG Ratgeber DiGA 2026]
• Example language (illustrative): "Apps on prescription have to meet German data-protection and security checks before they are listed. You still decide about optional consents, and you can say no to those and keep using the programme."
• Watch for: clients with particular confidentiality concerns (shared devices, partner surveillance, employer phones); clients who think the therapist sees all app data. [synthesis]

A5. Accompanying medical services and billing (descriptive)

• Purpose: know which products need physician involvement and what follow-up checks exist.
• Steps (as sources describe): the first prescription is not billed separately; it is part of the insured-person and basic flat fees (translated). [source: KBV DiGA page] Physician services alongside a DiGA are paid only when BfArM has specified them for that DiGA. [source: KBV/KVN PraxisInfo Jan 2025] For permanently listed DiGA, each product with specified services has its own EBM code (64 points each, currently paid outside the budget, translated). Codes relevant to mental health: 01471 somnio, billable by specialists and psychotherapists who bill under EBM chapters 16, 21, 22 and 23, once per quarter; 01474 Invirto, billable by physicians and psychotherapists authorised for behaviour therapy, once per indication per illness episode, not by video; 01479 elona therapy Depression, also limited to those authorised for behaviour therapy. For provisionally listed DiGA, the flat fee 86700 (EUR 8.15) applies under Annex 34 BMV-Ä, but its list of eligible groups includes physician groups only, not psychotherapists. [source: KBV DiGA page, read 16 Oct 2026] Some DiGA require contracted-physician services during use (e.g. Invirto, somnio). [source: DPtV Tabelle 2024] Codes change, so check the current KBV and KV information. [source: KBV DiGA page]
• Example language (illustrative): "This programme also needs a check-in with your GP, so I'll coordinate with them."
• Watch for: products started without the required physician involvement. [synthesis]

Part B: The psychotherapist's interventions

B1. Diagnostic clarification and indication check

• Purpose: ensure the DiGA fits a confirmed diagnosis and the client's risk profile, as the BPtK requires before use. [source: BPtK 2023]
• Steps:
  1. Complete your normal diagnostic assessment and code the ICD-10 diagnosis.
  2. Check severity against the register entry (some depression DiGA cover only mild to moderate or recurrent episodes; others include severe). [source: PZ 03.03.2026]
  3. Screen for listed exclusions (e.g. for deprexis: schizophrenia, schizoaffective disorder, acute psychosis, bipolar disorder, acute suicidal crisis). [source: deprexis HCP FAQ]
  4. Check age (most mental-health DiGA are for adults; deprexis 18+). [source: PZ 2026; deprexis HCP FAQ]
  5. Check practical prerequisites: current smartphone or computer, internet, reading level, language. [source: Care-Paket DiGA]
• Example language (illustrative): "Before we talk about apps, I want to be sure what we're treating and that a self-guided programme is safe for you right now."
• Watch for: comorbidity outside the indication, current suicidal ideation, substance use, cognitive or literacy limits. Signs it's working: a documented diagnosis that matches a listed indication. [synthesis]

B2. Selecting a product with the client

• Purpose: match the programme to diagnosis, goals and preferences.
• Steps: compare two or three listed options for the diagnosis on the register (indication, format, languages, status); look at the manufacturer's description together; ask what the client imagines doing each week; prefer permanent listings unless there is a reason otherwise [synthesis].
• Example language (illustrative): "There are several programmes for this. Some are web-based, some are apps. Which would you actually open on a tired evening?"
• Watch for: reluctance or politeness (Löbner warns sceptical clients tend not to start); a choice driven by advertising. [source: AOK G+G 05/2025; GKV-SV DiGA-Bericht 2026]

B3. Psychoeducation, informed consent and shared decision-making

• Purpose: an informed, voluntary decision.
• Steps: explain what the programme is (structured self-help, not therapy); its listing status and what that means; duration and renewal; data handling and optional consents; crisis limits (the app does not monitor emergencies unless the entry says so); your role and review date; the alternatives (waiting list, other DiGA, face-to-face therapy, medical review). Document consent. [synthesis based on DiGA-Leitfaden 2020; deprexis HCP FAQ; Care-Paket DiGA]
• Example language (illustrative): "This is an option, not a requirement. It can help many people, it won't replace our work, and if you don't like it we can stop without any problem."
• Watch for: the client agreeing to please you; misunderstanding that the app is 'the therapy'. Working: the client can repeat back what it is, for how long, and what to do in a crisis. [synthesis]

B4. Issuing the prescription (where entitled)

• Purpose: prescribe correctly.
• Steps (as sources describe): psychotherapists use Muster 16 or the e-prescription. Muster 16 (paper) is still allowed "bis auf Weiteres" (until further notice). E-prescribing has been possible since January 2026 if the practice software has a KBV-certified DiGA module, and it is voluntary. [source: KBV PraxisInfo 2026; KBV DiGA page] If the client has no app to redeem an e-prescription, give them a printout (KBV notice, 2 July 2026). [source: KBV DiGA page; KVB SOP Psychotherapeuten 2026] On Muster 16 the code field shows 999999999 instead of the practice number. Enter the PZN and the name of the DiGA, one DiGA per form ("Pro Verordnung darf nur eine DiGA verordnet werden"); the use period is not required. Several DiGA for different indications are possible, as no maximum quantities per patient currently apply. [source: KBV PraxisInfo 2026; KVB SOP Psychotherapeuten 2026] The prescription must be medically indicated, appropriate and economical; do not use prescription texts pre-filled by the manufacturer without adapting them to the individual client. Document the indication and why the DiGA is appropriate. [source: KVB SOP Psychotherapeuten 2026; Care-Paket DiGA] Who may prescribe: KBV, vdek and the GKV-Spitzenverband name "Ärzte und Psychotherapeuten" (physicians and psychotherapists) and do not distinguish psychological psychotherapists from child and adolescent psychotherapists. [source: KBV DiGA page; vdek FAQ 2026; GKV-SV DiGA-Bericht 2026] The cited sources neither exclude child and adolescent psychotherapists nor confirm them explicitly [uncertain]. In practice the product's age range limits use, because most mental-health DiGA are adult-only. [source: PZ 2026]
• Example language (illustrative): "Here's the prescription. Send it to your insurer today, and tell me next time whether the code came."
• Watch for: wrong PZN; pre-filled forms brought by clients from manufacturers or online services, which the GKV report criticises. [source: GKV-SV DiGA-Bericht 2026]

B5. Bridging a waiting period

• Purpose: offer structured help while a therapy place is pending. Sources name bridging waiting time as a use. [source: Care-Paket DiGA; AOK G+G 05/2025]
• Steps: after initial assessment, prescribe a fitting DiGA; give a written crisis plan; agree on one or two brief check-ins (phone or video) during the wait [synthesis]; when therapy starts, review what the client did and carry over useful material.
• Example language (illustrative): "Until we can start weekly sessions, this programme gives you something structured to work on. If things get worse while you wait, call me or use the crisis numbers on this sheet."
• Watch for: deterioration with nobody watching; the client feeling 'parked'; dropout read as failure. [synthesis]

B6. Integrating a DiGA into ongoing psychotherapy (blended care)

• Purpose: use the programme as between-session practice. The BPtK favours embedding DiGA in the treating clinician's care, and some products are listed for use alongside therapy (e.g. deprexis, velibra, Novego, per DPtV 2024). [source: BPtK 2023; DPtV Tabelle 2024]
• Steps: [synthesis]
  1. Look at the programme's module overview (manufacturer information) so you know its concepts and vocabulary.
  2. Agree which modules fit current therapy goals.
  3. Start sessions with a short review: what was done, what was useful, what was confusing.
  4. Link app exercises to in-session work (e.g. a thought record from the app becomes material for cognitive work).
  5. Resolve contradictions between the app's approach and yours openly.
• Example language (illustrative): "Bring what you did in the app this week. We'll use the parts that fit and drop what doesn't."
• Watch for: the app's model clashing with your orientation; the client using the app to avoid session topics; over-burdening with homework. Working: client brings app material spontaneously. [synthesis]

B7. Monitoring benefit, adherence and adverse effects

• Purpose: decide whether to continue, and catch worsening early.
• Steps: set a baseline with a validated symptom measure you already use [synthesis]. Review at about mid-period and before day 90. Ask how often the client uses the programme, which modules they have completed, their mood after modules, and any distress the content triggered. Document this in the record ("Die Nutzung wird in der Patientenakte dokumentiert", the use is documented in the patient record). [source: Care-Paket DiGA] Bill a follow-up check only where a current product-specific code lists your professional group (e.g. 01471, 01474, 01479). Psychotherapists are not among the groups eligible for the flat fee for provisionally listed DiGA (86700). [source: KBV DiGA page, read 16 Oct 2026] How to report suspected device-related incidents and what you are obliged to do: [uncertain: not verified].
• Example language (illustrative): "On a scale you'd recognise, has this made a difference? And has anything in the programme made you feel worse?"
• Watch for: non-use (the BPtK wanted non-use, e.g. no repeat use within 14 days, to end reimbursement automatically) [source: BPtK 2023]; rising scores; shame about not using it. Working: measurable improvement and the client using skills outside the app. [synthesis]

B8. Crisis and safety planning

• Purpose: keep risk management with a human clinician.
• Steps: before activation, check suicidality; give a written plan with personal warning signs, coping steps, contacts and emergency numbers (in Germany 112 and TelefonSeelsorge 0800 111 0 111, as deprexis lists); tell the client that acute suicidal risk needs immediate medical or psychotherapeutic care, not the app; recheck risk at each review. [source: deprexis HCP FAQ] Some products include alert features (e.g. Selfapy bulimia course refers users to help when symptoms are severe); do not rely on them as monitoring. [source: PZ 03.03.2026; synthesis]
• Example language (illustrative): "The programme can't see if you're in danger. If you have thoughts of ending your life, that's when you contact me, your GP, 112 or the TelefonSeelsorge, not the app."
• Watch for: emergence of suicidal ideation, psychotic or manic symptoms (listed exclusions for deprexis) and stop or pause use with medical review if they appear. [source: deprexis HCP FAQ; synthesis]

B9. Coordinating with physicians

• Purpose: collaborative care where medical input is needed.
• Steps: inform the GP or psychiatrist (with consent) when a DiGA is started; arrange physician involvement where the register requires contracted-physician services (e.g. Invirto, somnio); suggest a medical review when physical causes, medication questions or severe depression are present. Never advise a client to start, stop or change medication; route to the prescriber. [source: DPtV Tabelle 2024; synthesis]
• Example language (illustrative): "Your medication questions belong with Dr. X. I'll let them know you've started this programme, if that's all right."
• Watch for: two clinicians prescribing different DiGA for the same problem without knowing; GP-prescribed DiGA (family physicians issue about half of all prescriptions) without psychological follow-up. [source: GKV-SV DiGA-Bericht 2026; synthesis]

B10. Clients who arrive with a DiGA already in use

• Purpose: assess and integrate self-initiated or insurer-approved use.
• Steps: ask how they got it (insurer approval, GP, online service); check the diagnosis against the product indication; check for exclusions; decide together whether to continue, integrate or stop. [synthesis based on BPtK 2023; GKV-SV DiGA-Bericht 2026]
• Example language (illustrative): "Good that you've already tried something. Let's check whether this programme really fits what's going on for you."
• Watch for: missing diagnosis; mismatch of severity; the client feeling criticised for self-help. [synthesis]

B11. Follow-up prescription, ending and aftercare

• Purpose: continue only when helpful; end well.
• Steps: a follow-up prescription for the same DiGA is possible if medically indicated and the goal is likely to be reached (and keeps progress data for deprexis). [source: KVB SOP 2025; deprexis HCP FAQ] Otherwise end with a review of learned skills, a relapse-prevention plan and an aftercare route; DiGA can also be used for aftercare after therapy. [source: AOK G+G 05/2025; synthesis] If a product is delisted, explain, and choose another listed product or other care. [synthesis]
• Example language (illustrative): "Three months are up. Let's look at what changed and decide whether another round would really add something."
• Watch for: automatic renewal without review; loss of access ending structure abruptly. [synthesis]

5. Handling problems

• Client never activates the code. Check the insurer step and device access; ask about ambivalence; offer to activate together at the start of the next session; drop the plan without blame if the client is not interested. [synthesis; Löbner on motivation: AOK G+G 05/2025]
• Early dropout or non-adherence. Normalise; ask what got in the way (time, tone, technical problems, content too hard); shorten to one module a week; link to session goals; if still unused after a review, end it rather than renew. Dropout is named as a limitation in a cited article. [source: Care-Paket DiGA; synthesis]
• Worsening or overwhelm from content. Pause the programme, review which content triggered distress, reassess risk and diagnosis, consider stepping up to more intensive or medical care. [synthesis]
• Emerging suicidality, mania or psychosis. Follow your standard risk-assessment procedure; stop self-guided use where these are listed exclusions; arrange urgent medical or psychiatric review; update the safety plan. [source: deprexis HCP FAQ; synthesis]
• Rupture: client feels fobbed off with an app. Acknowledge it; make clear the app is optional and not a substitute for you; re-agree the treatment plan. The BPtK warns ineffective DiGA can leave people with mental disorders feeling helpless and less motivated for therapy. [source: BPtK 2023; synthesis]
• Conflict between app model and your therapy. Name the difference, keep what is compatible, and stop if it confuses the client. [synthesis]
• Data-protection worries. Explain DiGAV requirements and optional consents; if the client remains uneasy, do not prescribe. Advise on device privacy (lock screen, shared devices). [source: DiGA-Leitfaden 2020; synthesis]
• Product delisted or manufacturer insolvent mid-use. Inform the client, document it, and switch to another listed product or other care. A removed DiGA can no longer be prescribed or approved at GKV expense. [source: GKV-SV DiGA-Bericht 2026] In the one case documented here (M-sense, 2022), codes already issued could still be redeemed and the manufacturer covered the costs temporarily. [source: Deutsches Ärzteblatt 17.05.2022] The cited sources give no general rule, so the client should ask their insurer and the manufacturer. [uncertain]
• Pressure from marketing, pre-filled forms or 'prescription services'. Prescribe only after your own assessment; decline requests that lack an indication. [source: GKV-SV DiGA-Bericht 2026]
• Insurer approval without diagnosis. Offer an assessment; if the indication does not fit, say so and recommend stopping or switching. [source: BPtK 2023; synthesis]
• Under-18 clients. Most mental-health DiGA are adult-only; check the register's age group; for children and adolescents use other routes (e.g. hiToco ADHD parent training, listed provisionally per PZ 2026, is aimed at parents). [source: PZ 03.03.2026; deprexis HCP FAQ]
• Older or digitally inexperienced clients. Check access and skills, offer a guided first log-in, or choose non-digital care. [synthesis]
• Uncertain status or changing rules. Check the live register and current KBV/KV notices before each prescription; billing codes and pricing rules changed in 2024–2026. [source: KVB SOP 2025; KVB SOP Psychotherapeuten 2026; GKV-SV DiGA-Bericht 2026]

Sources

• DiGA-Leitfaden (BfArM Fast-Track-Verfahren nach § 139e SGB V), 2020 edition, Bundesministerium für Gesundheit
• GKV-Spitzenverband: DiGA-Bericht 2025 (§ 33a Abs. 6 SGB V), published 1 April 2026
• KBV PraxisInfo: DiGA elektronische Verordnung, Stand März 2026
• KV Bayerns: SOP Digitale Gesundheitsanwendungen, 10 April 2025
• KV Bayerns: SOP Digitale Gesundheitsanwendungen für Psychotherapeuten, 25 March 2026
• Bundesministerium für Gesundheit: Digitale Gesundheitsanwendungen (DiGA), Stand 8 September 2026
• DPtV: Tabelle DiGA Psych (from the BfArM DiGA-Verzeichnis), Stand August 2024
• BPtK: Stellungnahme zum Digital-Gesetz (DigiG), 10 October 2023
• deprexis: FAQ for healthcare professionals (manufacturer)
• Pharmazeutische Zeitung: Diese DiGA gibt es, 3 March 2026 (page 1) and page 2
• PTAheute: Zwei Statuswechsel im DiGA-Verzeichnis, 18 May 2022
• AOK G+G 05/2025: Digitale Helfer bei Depressionen & Co. (T. Severin, 21 May 2025)
• psychotherapeutensuche.de: Care-Paket DiGA (2025, commercial provider)
• PwC: TR-03161 und C5 – Das Fundament für sichere DiGA (secondary)
• BfArM DiGA-Verzeichnis (diga.bfarm.de/de/verzeichnis): the authoritative list of reimbursable DiGA; product status in this guide is taken from the GKV-SV, KBV, DPtV and PZ sources and is not confirmed against the live directory [uncertain]
• GKV-Spitzenverband: DiGA-Bericht 2025 (PDF, published 1 April 2026)
• KBV: Digitale Gesundheitsanwendungen (Verordnung, EBM-Leistungen)
• KBV PraxisInfo „Apps auf Rezept – DiGA“, Januar 2025 (via KV Niedersachsen)
• vdek: FAQ Digitale Gesundheitsanwendungen (Stand 12.03.2026)
• Deutsches Ärzteblatt: Zweite DiGA kann nicht mehr verordnet werden, 17.05.2022