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What is a DiGA and what are the barriers for the market entry?

If BfArM listed an application in the DiGA catalogue, it can be prescribed by physicians.

The Digital Supply Act (DVG) allows digital health applications to be implemented into standard care. The so-called DiGAs are medical devices of risk class I or IIa and which influence the medical care of the patient positively. DiGAs must at least fulfill quality criteria on data protection, information security and others. They must guarantee a positive supply effect by a study and a price for the DiGA must be negotiated with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband). If these barriers are overcome and physicians prescribe the DiGA for their patients, they are reimbursed by the statutory health insurances in Germany for more than 70 million patients.

Do you need more information on DiGAs, please do not hesitate to contact us and we support you for the market access of DiGAs.

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