{"id":4005,"date":"2023-09-05T08:28:17","date_gmt":"2023-09-05T06:28:17","guid":{"rendered":"https:\/\/www.bayoomed.com\/entwicklung\/diga\/"},"modified":"2026-10-08T12:48:39","modified_gmt":"2026-10-08T10:48:39","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>

In what ways do DiGAs provide support?<\/h3><\/h3><\/div>

DiGA provide support in areas such as the treatment of diseases and the management of medical conditions, and\u2014since the latest update\u2014may also include telemedicine services. They can take the form of a smartphone app or a web application accessible via a browser.<\/p>\n

However, before a DiGA enters the market, the Federal Institute for Drugs and Medical Devices (BfArM) verifies that it meets all requirements. Learn more in our blog post about the six key facts that manufacturers should definitely keep in mind.<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>

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

The Federal Institute for Drugs and Medical Devices (BfArM) will add your DiGA to the DiGA directory if it meets all requirements, including those related to safety, usability, quality, medical benefit, data protection, and data security.<\/p>\n

Here\u2019s what the process<\/b> looks like for a digital health application to be included in the DiGA directory (BfArM)<\/b>:<\/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 pursuant to:<\/h5><\/div><\/div><\/div>

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

Primary function is based on digital technology<\/p>\n

Intended use is health-related<\/p>\n

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

Safety<\/p>\n

Usability and Quality of the Medical Device<\/p>\n

Details in accordance with DiGAV<\/b><\/span><\/p>\n<\/div><\/div><\/div>

Medical Benefits<\/p>\n

or<\/p>\n

patient-relevant improvements in structure and processes<\/p>\n

(Conducting studies may be necessary)<\/p>\n

Details in accordance with DiGAV<\/b><\/span><\/p>\n<\/div><\/div><\/div>

Privacy Policy<\/p>\n

and<\/p>\n

Data Security<\/p>\n

Details in accordance with DiGAV<\/b><\/span><\/p>\n<\/div><\/div><\/div>

Chapter 3 of SGB V<\/p>\n

or<\/p>\n

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

Medical (or psychotherapeutic) prescription or approval by 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 Benefits<\/strong><\/p>\n