{"id":4005,"date":"2023-09-05T08:28:17","date_gmt":"2023-09-05T06:28:17","guid":{"rendered":"https:\/\/www.bayoomed.com\/entwicklung\/diga\/"},"modified":"2024-08-07T13:39:35","modified_gmt":"2024-08-07T11:39:35","slug":"diga","status":"publish","type":"entwicklung","link":"https:\/\/www.bayoomed.com\/en\/entwicklung\/diga\/","title":{"rendered":"DiGA"},"content":{"rendered":"

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

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

An opportunity for you to drive forward digital medical care, expand your portfolio and open up an internationally unique reimbursement channel. This is because, under the Digital Healthcare Act (DGV), people with statutory health insurance are now entitled to the provision of DiGA, which can be prescribed by doctors and psychotherapists and reimbursed by health insurance companies. Alternatively, patients can also apply directly to their health insurance provider for reimbursement of a DiGA.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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

Among other things, DiGAs provide support in the treatment of illnesses and the management of medical complaints and, since the latest update, may also include telemedical services. This can be an app for the smartphone, but also a web application for the browser. 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. This is how a digital health application gets listed 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 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>

medical (or psychotherapeutic) prescription or approval by the health insurance company<\/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