First DiGAs reveal needs for amendments

Last week, the first two DiGAs were approved by the federal institute of drugs and medical devices (BfArM) and then listed in the DiGA catalogue.

However, one of the already approved apps revealed security lacks regarding data and information security as the German magazine “Handelsblatt” reported this morning (October 12th). The lacks are solved by the manufacturer already but they seem to raise questions concerning the approval process by BfArM.

Moreover, as the “Handelsblatt” reports, the Reimbursement process of DiGAs is not yet finalized in practice which means that the listed DiGAs cannot yet be prescribed by the physicians. To solve this situation, further discussions and alignments between physicians and manufacturers are needed to guarantee the acceptance of DiGAs in regular healthcare.

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