Digital health applications: Becoming listed in the DiGA directory

What is a digital health application (DiGA)?

A digital health application (DiGA) is an app, or a desktop or browser application, which helps you identify, monitor, treat, alleviate or compensate illnesses, injuries or disabilities. Under the German Digital Healthcare Act (DVG), this ‘app on prescription’ can be prescribed by doctors and psychotherapists, or patients can apply directly to their health insurer to access a DiGA, and the health insurer reimburses the costs. Before that, the DiGA must have passed an assessment procedure by the German Federal Institute for Drugs and Medical Devices (BfArM) whereby the manufacturer must demonstrate that the DiGA has a positive healthcare effect. This can either be a medical effect or process optimisation that improves treatment. In addition, a DiGA must meet numerous requirements with regard to data protection, usability and quality.

How a digital health application becomes listed in the DiGA directory

What is the DiGA directory for?

A DiGA is covered by health insurers as soon as it has been listed in the directory of reimbursable digital health applications (DiGA directory). The directory contains comprehensive information on the features and potential benefits of each DiGA. The goal is to enable policyholders, doctors, psychotherapists and health insurers to compare DiGAs and make an informed choice.

What is the fast-track process?

Once the application to be listed in the directory has been submitted, the BfArM assesses the DiGAs. The evaluation time for a DiGA is usually three months from receipt of the complete application. This quick assessment procedure is known as the ‘fast-track process’.

What specifications are checked by the BfArM?

Applications made to the BfArM must fulfil a number of criteria. They must demonstrate a positive healthcare effect, meaning they must offer patients a medical benefit or improve the usual structures and processes used in treatment. DiGAs should also be safe and easy to use for all patients. That’s why the BfArM examines data protection and information security as well as usability and performance.

How can the positive healthcare effect be proven?

Manufacturers of digital health applications must demonstrate the positive healthcare effect using quantitative comparative studies. These studies must be well planned and set up, professionally executed, statistically evaluated and described in a detailed clinical study report. If relevant studies are not yet available when the application is submitted, the manufacturer can apply for a provisional listing, which is limited to one year. During that time, a study must be conducted that provides evidence for the positive healthcare effects. In individual cases the period may be extended to two years.

Who determines the price of a DiGA?

Once the digital health application has passed all the tests, it is finally added to the BfArM’s DiGA directory, marking the end of the BfArM assessment process. The subsequent price negotiation with the German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) is detailed in a framework agreement between the manufacturers and the GKV-Spitzenverband.

The price negotiation begins six months after the final listing, or, in the case of a provisional listing, at the point when the manufacturer is notified about the final listing. If the manufacturer decides before or during the negotiation to remove their DiGA from the directory, they must negotiate part payment for the reimbursement period. The negotiated price comes into effect one year after the DiGA listing at the earliest. Before that, manufacturers are free to set the sales price as they wish.

Our services

We support you throughout the fast-track process and the testing phase, from submitting your application to the BfArM to being listed in the DiGA directory.

We help you put together your application, research relevant evidence and prepare it for the application.

We plan and support the studies necessary for the fast-track process.

We help you prepare for consultations with the BfArM and accompany you to the appointments.

We provide you with decision-making criteria and assistance for setting the price and conducting price negotiations with the GKV-Spitzenverband.

Our extensive experience can help you get your digital health application listed

From her work in AMNOG medicinal product evaluation and her many years of committee activities, Professor Dietrich has extensive experience in evaluating new technologies and setting prices in German statutory health insurance. She is supported by a team of medical writers and statisticians who help her plan studies, compile clinical study reports, evaluate data and prepare evidence in line with requirements.
Professor Dietrich’s knowledge of the structures and processes in the healthcare sector allows her to understand the needs and requirements of all the stakeholders. A DiGA’s success depends not least on alleviating concerns and meeting the expectations of manufacturers, doctors and health insurers.