Into the DiGA Directory with HPZenner

A manufacturer-independent institute with DiGA experience

As a manufacturer-independent institute within the meaning of Sec. 139e (4) SGB V, HPZenner Clinical has the experience and knowledge for your success: HPZenner has contributed substantially to the successful listing of several DiGAs in the BfArM DiGA directory — as early as October 2020.

Your listing in the DiGA directory

DiGA listing since 10/2020 - clinical expert

HPZenner is a CRO. We support you comprehensively with your clinical study and your application for listing your app in the DiGA directory.

Evaluation concept. You must submit this with your application for provisional listing. HPZenner Clinical is happy to prepare your evaluation concept. The concept either builds on the results report of your clinical data, or a study concept (CIP, Clinical Investigation Plan) is submitted if you initially apply only for the trial phase. HPZenner can take on both.
Results report of your existing clinical data. You must submit this with your application. We prepare a clinical analysis of the statistical data and summarise the results in a study report in the regulatorily required format (e.g. following Sec. 42b AMG, EU format per the synopsis of ICH Topic E3).
Clinical study/clinical trial to demonstrate positive healthcare effects. Either a retrospective or a prospective study. We have DiGA and BfArM experience with both study types. We are happy to advise you! HPZenner can design and conduct both for you.
BfArM consultation. Individual agreements with the BfArM are possible before application. We are glad to support you. Of course, the BfArM is bound by the normative requirements of SGB V and the DiGAV; agreements can only be made within this framework — concerning, for example, the choice of study design or the concrete implementation of the quality requirements. The BfArM’s consultation services can be used for this.
Manufacturer-independent institute per Sec. 139e (4) SGB V. HPZenner Clinical is a manufacturer-independent institute per Sec. 139e (4) SGB V, headed by Prof. Dr. med. H.P. Zenner.

Study registry and publication of the study report. HPZenner can also handle the registration in the study registry and the publication of the study report for you.

Conformity assessment and CE marking. A further prerequisite for listing in the DiGA directory is a completed MDD/MDR conformity assessment procedure and the marketability of the DiGA demonstrated by CE marking. If conformity assessment and CE marking are still missing, HPZenner can substantially support you there as well.

Certification per ISO 13485 and 27001. If your ISO 13485 and 27001 certifications are still missing: we can help!

We build your DiGA

Instant DiGA production instead of lengthy DiGA development: the DiGA-ready production platform KIBAN for your direct market launch. Launching 2027.

BSI TR-03161

Native iOS and Android app

Swift/Kotlin. BSI TR-03161 pre-certified, pen test pre-passed. No time-consuming, overpriced software development.

Class I

From your content to market approval

You focus on the medical content — we handle technology, security, operations and compliance. To EU market approval (class I) in just a few weeks.

Launching 2027

Save time, money and nerves

Significantly reduced, tailor-made and predictable budget. On request we also produce your videos, texts or audio content.

What you should know about DiGA

DiGA reimbursement by statutory health insurers possible at short notice via fast track since 2020

Since 5 May 2020, health app providers have been able to have their health app listed in the DiGA directory, which is maintained by the BfArM. Once listed, your health app has reimbursement approval and you as the manufacturer receive payment from the health insurer for every medical or psychotherapeutic prescription. Patients receive your health app as a benefit in kind — free of charge. To do so, physicians or psychotherapists prescribe your health app. HPZenner has supported health app manufacturers with CE certification since 2016, and with the fast track into the DiGA directory since 2019.

Positive healthcare effect (pVE) of the DiGA

Whoever is listed in the DiGA directory is reimbursed by the health insurers. For this, a positive healthcare effect (pVE) must be planned, demonstrated and documented. HPZenner can take on the required clinical evaluation concept for pVE planning, the conduct of the required clinical study for pVE demonstration, and the writing of the required study report for pVE documentation.

DiGA prescription by physicians – no advance payment by the patient

The benefit-in-kind principle applies: physicians prescribe — the patient receives a code with which he or she downloads the app free of charge. The manufacturer is reimbursed by the health insurer.

Manufacturer reimbursement for DiGA

The manufacturer is reimbursed by the health insurer: within group-based maximum amounts during the first 12 months; from the 13th month, the price is freely negotiated with the national associations of the statutory health insurers.

Physician remuneration possible

When a DiGA is listed in the directory, physicians receive additional remuneration at any time if additional medical services become necessary through the use of the DiGA in the course of treatment.

The timeline for listing in the DiGA directory

The fast-track implementation provides that manufacturers have been able to apply for listing of a DiGA since summer 2020. The principle: fast track instead of Federal Joint Committee/aids directory — 3.5 months instead of years.

Applying for listing in the DiGA directory

Applications are submitted via the BfArM portal. You apply either for a trial phase with manufacturer reimbursement (provisional listing in the DiGA directory) or for final reimbursement approval (listing in the DiGA directory). The principle: listing in the DiGA directory means reimbursement by the health insurers.