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Turning Your Health App Into A DiGA

The London International Office | HPZenner Clinical Germany | +44 7981 859 404 | london-office@hpzenner.com

What is a DiGA?

A DiGA (German: digitale Gesundheits-Anwendung) is a prescribed DT
- to be operated by the patient
- some initial support by a physician is allowed
- it is medical a device that is CE labelled according to EU legislation
- it is included in the German National BfArM Registry
- the German Health Insurance System is liable to pay

There are three major DiGA market entry barriers

(i) The first barrier is the fulfillment of high clinical requirements. For inclusion in the DiGA directory these are examined intensively and in all details by the BfArM over a period of weeks.

(ii) According to § 139e Abs.4 SGB V, the manufacturer cannot himself demonstrate the fulfillment of the clinical requirements for inclusion in the DiGA directory, but must commission a manufacturer-independent institute for this purpose. As a manufacturer-independent institute in the sense of the German § 139e Abs.4 SGB V, HPZenner Clinical has the experience and knowledge for your success: HPZenner CRO contributed significantly to the successful inclusion of some of the first DiGAs in the BfArM DiGA directory. For further manufacturers, evaluation concepts and study protocols have already been prepared for the BfArM.

(iii) High patient data protection requirements: The regulatory requirements of EU Data Protection Regulation, DiGAV, ISO 27000 series or TR 03161 must be met. Tapping of medical data for commercial purposes is not permitted. Data flow to countries with a lower data protection level than the EU standards must be technically and legally excluded.

Inclusion of your Health App in the DiGA directory

HPZenner Clinical supports you in various ways in the application for inclusion in the DiGA directory

- Evaluation concept. You have to submit this concept with the application. HPZenner Clinical will be pleased to prepare your evaluation concept. The concept is either based on the results report of your clinical data or a study concept (CIP, Clinical Investigation Plan) is submitted if initially only an application for the trial phase is submitted. Both can be taken over by HPZenner.

- Results report of your clinical data to date. You must submit this at the time of application. We will prepare a clinical analysis of the statistical data and summarize the results in a study report in the regulatory format (e.g. following § 42b AMG, EU format according to the synopsis of ICH Topic E3).

- Clinical study/clinical trial to demonstrate positive effects on care. Either through 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 prior to application. We are happy to support you. Of course, the BfArM is bound to the normative guidelines in the SGB V and in the DiGAV. Agreements can only take place within this framework and then, for example, concern the selection of the study design or the concrete implementation of the quality requirements. The consulting services of the BfArM can be used for this purpose.

- Manufacturer-independent institute according to § 139e Abs.4 SGB V: HPZenner Clinical is a manufacturer-independent institute according to § 139e Abs.4 SGB V, managed by Prof. Dr. med. H.P. Zenner.

Furthermore, HPZenner can take care of the registration in the study register and the publication of the study report for you.

The prerequisite for inclusion in the DiGA register is still the completed MDD/MDR conformity assessment procedure and the marketability of the DiGA proven by the CE marking. If the conformity procedure and CE marking are still missing, HPZenner and partners can also provide you with significant support. You may need:
-QM system according ISO 13485
-Technical documentation according EU MDR
-Clinical evaluation according MEDDEV 2.7/1 rev. 4
-Conformity declaration (EU MDR class 1 product) or certification by a EU Notified Body (in case of a 2a classification according EU MDR)

Background knowledge on DiGA

Since 2020, health app providers have the opportunity to have their health app included in the DiGA directory. The DiGA directory is maintained by the BfArM. As soon as the health app has been included in the DiGA directory, your health app will be approved by the health insurance fund and you, as the manufacturer, will receive remuneration from the health insurance fund for each medical or psychotherapeutic prescription. Patients receive your health app as a benefit in kind, i.e. free of charge. For this, doctors or psychotherapists must prescribe your health app. Since 2016, HPZenner has supported health app manufacturers with CE certification, and since 2019 with the fast-track for inclusion in the DiGA directory.

Positive supply effect (pVE) of DiGA.
Those who are in the DiGA directory will receive remuneration from health insurance companies in the future. For this, a positive supply effect (pVE) must be planned, proven and documented. HPZenner can take over the prescribed preparation of the clinical evaluation concept for the pVE planning, the execution of a prescribed clinical study for the pVE proof and the writing of the prescribed study report for the pVE documentation.

DiGA physician prescription on prescription - without pre-funding by the patient.
The principle of payment in kind applies: doctors prescribe - the patient receives a code with the help of which he/she downloads the app free of charge. The manufacturer is reimbursed by the health insurance company.

Manufacturer remuneration for DiGA
The manufacturer is remunerated by the health insurance company: in the first 12 months Within the framework of group-related maximum amounts, from the 13th month the price is freely negotiated with the health insurance (GKV) top associations.

Physician reimbursement possible
If a DiGA is listed in the directory, physicians receive additional remuneration at any time if additional medical services are required as a result of the use of the DiGA in the course of treatment.

The timeline for inclusion in the DiGA directory
for the implementation of Fast Track provides that, starting in the summer of 2020, applications can be submitted by manufacturers for the inclusion of a DiGA in the directory. The rule here is: Fast Track instead of Joint Federal Committee/Heil-/Hilmittelverzeichnis - 3.5 months instead of years.

Application for inclusion in the DiGA directory
The application is submitted via the BfArM portal. The application is either for a trial phase with reimbursement of the manufacturer (temporary inclusion in the DiGA list) or for final approval by the health insurance fund (inclusion in the DiGA list). The following applies: Inclusion in the DiGA list means: reimbursement by the health insurance funds.