Digital health applications listed in the DiGA directory can be prescribed by physicians and psychotherapists in the out-patient sector at the expense of statutory health insurances in Germany.
This means that DiGAs can be prescribed to 72 million potential patients in the primary healthcare market.
Digital health applications that do not yet meet all the requirements to receive a final listing in the DiGA directory can apply for preliminary inclusion at the BfArM. Then, the manufacturer has one year to submit the required evidence of a "positive care effect." During this time, the health insurance company pays the price set by the manufacturer.
"M-sense-Migraine," provisionally listed on the DiGA directory since late 2020, has now had its name removed from the directory. According to FAQs on the company's website, they has determined that "not all requirements for permanent listing" can be met and has therefore discontinued the "app on prescription" project.
This is the second health application to be removed from the DiGA directory.
A total of 95 applications for provisional inclusion and 32 applications for permanent inclusion (total 127) have been submitted to the BfArM to date, of which 19 have been included provisionally and 11 permanently. 9 applications have received negative decisions, 67 have been withdrawn by the applicant and 19 are still being processed.
Our experience in advising DiGA manufacturers as well as these figures proves that the requirements for DiGAs are high and underestimated by most manufacturers.
More information on DiGAs can be found in our download area.
You are a manufacturer of a medical device and have questions about DiGAs or you are looking for the appropriate path to be successful with your medical device on the German healthcare market? Please contact us, we are happy to help you.
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