Fast-Track Procedure – What is it?

The German Digital Healthcare Act introduced the option of an “app on prescription” for patients in the healthcare sector. Insured persons are entitled to the provision of digital health applications (DiGA) and to reimbursement of their costs by the statutory health insurance funds - with or without a doctor's prescription! In order for the costs of a DiGA to be reimbursed by the statutory health insurance funds, it must successfully pass the fast-track test procedure of the German Federal Institute for Drugs and Medical Devices and be included in the DiGA directory. Manufacturers of DiGAs can then make their products available to patients free of charge and at the same time benefit from reimbursement by the statutory health insurance funds.

Check the chances of inclusion

Our DiGA Quick Check assesses whether a DiGA meets the requirements for a successful fast-track procedure and inclusion in the DiGA directory. The manufacturer's information on various criteria such as regulatory requirements, data protection and user-friendliness is checked for completeness. Check your chances of a successful fast-track procedure and inclusion of your application in the DiGA directory now with our free  Quick-Check!

What is the Quick Check for?

The next steps are based on the result of the Quick Check. If inclusion in the DiGA directory is likely to be achieved, the next step is to submit an application. If your DiGA is not yet eligible for inclusion in the DiGA directory, you should check which steps are required to set up your product as a reimbursable DiGA. Preliminary inclusion during a trial period may also be an option.

DiGA Fast-Track Check

With the inclusion of their DiGA in the DiGA directory, manufacturers of digital health applications have the opportunity of making their products available to around 73 million people insured by statutory health insurance such that they are eligible for reimbursement. With our free Quick Check, you can check whether the application for inclusion of your DiGA in the directory can be successful.

About us

100% Expertise. 0% Nonsense. We have extensive experience in product compliance management and combine consulting practice and research in cybersecurity law. Our advice is: Smart. Efficient. Spot on.

RAin/ Attorney-at-law Miriam Schuh

Salary Partner and Head of Healthcare at reuschlaw

Contact us

Do you have questions about the fast-track procedure or need support in assessing the chances of successful inclusion of your DiGA in the directory? We are here to help. Write to us or give us a call! We will get back to you as soon as possible.

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    Joachimsthaler Str. 34
    D-10719 Berlin
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    info@reuschlaw.de
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