Digital Health Applications Ordinance: Fast track admission for health apps

Until now, it sounded quite odd to receive reimbursement for digital health apps: There are too many and the majority has never been checked for safety and positive effects. Thanks to the "Digital Health Applications Ordinance", these apps can now reach the German market in a regulated way, physicians can prescribe them and statutory health insurance companies reimburse their use.

In this interview with MEDICA-tradefair.com, Prof. Dr. Broich talks about the fast-track admission procedure for digital health apps and the impact these products have during the corona pandemic.

Prof. Dr. Broich, what does Germany's new “Digital Health Applications Ordinance (in German “DiGAV”)” regulate?

Prof. Dr. Karl Broich: The number of digital health applications, or "DiGA" for short, has increased enormously in recent years: For example, apps or web applications can help to better control the course of therapy through a diary function or provide dosage recommendations based on current vital parameters.

With the coming into force of the Digital Supply Act in December 2019, the "app on prescription" for patients was finally introduced into healthcare. This means that around 73 million people insured under the statutory health insurance scheme are entitled to be provided with DiGA. These can be prescribed by doctors and psychotherapists and reimbursed by the health insurance companies.

The BfArM has been involved in shaping this important part of the digitization strategy of the German government and the Ministry of Health from the very beginning. In connection with the "apps on prescription", we are responsible for the evaluation procedures for the applications, as well as for the directory of digital applications that are listed as reimbursable health applications after successful testing.

Within a very short period of time, we have set up an appropriate test procedure for this purpose. This is designed as a "fast track": The evaluation time by the BfArM is a maximum of three months after receipt of the complete application.

The core of the procedure is the examination of the manufacturer's information on the required product properties as well as the examination of a proof to be provided by the manufacturer for the positive supply effects realizable with the DiGA. After successful examination, the DiGA are then listed in a directory and are thus reimbursable by the statutory health insurance companies.   

The directory offers transparency to the user as well as to the prescribing physicians and psychotherapists and helps with the purposeful selection of a DiGA, which fits best the needs of the user.  We have also prepared a guideline that provides information on the procedure, the application procedure and the verification process. This guideline is freely accessible on our website.

How has the corona pandemic changed the demand for digital health applications?

Broich: The corona pandemic has significantly increased the use of digital health services by physicians and patients in a short period of time. The options for exchanging current course parameters in times of limited direct contact and thus being able to keep a constant eye on the course of therapy have certainly increased the demand for digital services.

This is precisely where the added value of these digital health applications lies: Being digital helpers in the hands of patients. And to support and improve everyday care through greater patient sovereignty.

What role does the digital event "virtual.MEDICA" play in this topic?

Broich: "Virtual communication" will continue to accompany us - in line with digital transformation - in the healthcare sector. Let us use this path of interaction to exchange information on current topics and developments in the medical field virtually at any time and from any place. Thus, we jointly advance digitization in the healthcare sector!