February 2020

Towards the end of 2019, the German Federal Parliament introduced a simplified process for approval and reimbursement of digital health apps prescribed to patients covered under the statutory health insurance (SHI). This brings opportunities for both developers of digital tools and for patients, who suffer from chronic diseases and who may be able to better and more effectively manage their everyday conditions thanks to the advances in mobile technologies. Details of the criteria and requirements which must be met to be paid and the approval process were issued in the draft of the executive order in February.

A particularly important development is that the benefit of the app can be shown not only in improvement of clinical health status, but also improvement in the patient’s quality of life.  In addition, improvement in treatment pathways, like adherence to guidelines or eased access to healthcare provision could be also acknowledged as benefits. Additional benefit must be shown in comparative studies, conducted in the EU – preferably Germany. Data protection and exclusion of transferring data for promotional uses are relevant criteria for approval.  The lack of a comparative study, however, does not disqualify the app for consideration.  A trial approval is possible with the condition that the developer must bring the needed clinical evidence within 12 months – with possible extension period of further 12 .

The financial side: Fees for the application will be limited up to an amount of 9900 Euro. The price of the app will be negotiated between the manufacturer and the National Associations of SHI funds (GKV-SV).

Implications for Innovators

The introduced reimbursement of digital health apps in Germany provides many chances for manufacturers of innovative digital health solutions. If the draft of executive order will be approved by the lawmaker without major changes, it is the most favorable environment for adaption and coverage of digital health products globally.

— Authored by Dr. Jörg Burkowitz, Director at BHA Germany.

The BHA European office in Berlin, Germany, can support manufacturers and developers in market access of their digital health products and offers both strategic and operational guidance in the process. To learn more about the digital health app reimbursement and implications for innovators please contact us.