{"id":4005,"date":"2023-09-05T08:28:17","date_gmt":"2023-09-05T06:28:17","guid":{"rendered":"https:\/\/www.bayoomed.com\/entwicklung\/diga\/"},"modified":"2026-08-28T15:52:15","modified_gmt":"2026-08-28T13:52:15","slug":"diga","status":"publish","type":"entwicklung","link":"https:\/\/www.bayoomed.com\/en\/development\/diga\/","title":{"rendered":"Digital Health Applications (DiGA)"},"content":{"rendered":"

Digital health application: The app on prescription<\/h2><\/h2><\/div>

This is an opportunity for you to advance digital healthcare, expand your portfolio, and gain access to a reimbursement pathway that is unique on an international scale. This is because, under the Digital Healthcare Act (DVG), individuals with public health insurance are now entitled to DiGA services, which can be prescribed by doctors and psychotherapists and reimbursed by health insurance providers. Alternatively, patients can apply for reimbursement for a DiGA directly through their health insurance provider.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

What does DiGA support?<\/h3><\/h3><\/div>

DiGAs provide support in areas such as the treatment of diseases and the management of medical conditions, and, as of the latest update, may also include telemedicine services. They can take the form of a smartphone app or a web application for a browser.<\/p>\n

However, before entering the market, the Federal Institute for Drugs and Medical Devices (BfArM) checks whether a DiGA meets all the requirements. Read our blog post to find out more about the six facts that manufacturers should be aware of.<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>

Would you like to bring a DiGA to the market?<\/h3><\/h3><\/div>

Inclusion in the DiGA directory by the Federal Institute for Drugs and Medical Devices is granted if your DiGA meets all requirements, including safety, suitability for use, quality, medical benefit, data protection and data security.<\/p>\n

The pathway of a Digital Health Application until its inclusion in the DiGA Directory (BfArM)<\/b> looks like this:<\/p>\n<\/div><\/div><\/div><\/div><\/div>

<\/i>
Characteristics of a DiGA:<\/h5><\/div><\/div><\/div>
<\/i>
DiGA meets requirements for:<\/h5><\/div><\/div><\/div>
<\/i>
ensures positive supply effects:<\/h5><\/div><\/div><\/div>
<\/i>
DiGA meets requirements for:<\/h5><\/div><\/div><\/div>
<\/i>
No exclusion of DiGA according to:<\/h5><\/div><\/div><\/div>

Medical device<\/span><\/p>\n

main function based on digital technology<\/p>\n

purpose of use is health-related<\/p>\n

low risk potential (class I, IIa or IIb)<\/p>\n<\/div><\/div><\/div>

security<\/p>\n

Suitability for use and quality of the medical device<\/p>\n

details according to DiGAV<\/b><\/span><\/p>\n<\/div><\/div><\/div>

medical benefit<\/p>\n

or<\/p>\n

patient-relevant improvement of structure and processes<\/p>\n

(studies may be required)<\/p>\n

details according to DiGAV<\/b><\/span><\/p>\n<\/div><\/div><\/div>

Data protection<\/p>\n

and<\/p>\n

Data security<\/p>\n

details according to DiGAV<\/b><\/span><\/p>\n<\/div><\/div><\/div>

chapter 3 SGB V<\/p>\n

or<\/p>\n

negative decision by the G-BA<\/p>\n<\/div><\/div><\/div>

A medical (or psychotherapeutic) prescription or approval from the health insurance provider<\/strong><\/h5>\n<\/div><\/div><\/div><\/div><\/div>

The positive supply effect<\/h3><\/h3><\/div>

The positive care effect of digital health applications<\/h2><\/h3><\/div>

Medical benefit<\/strong><\/p>\n