Apps on Prescription - DiGA

Digital Healthcare Act - Get Your Health App Reimbursed

Ready to become DiGA?

Thank you for the request! We will get back to you shortly.

With the new Digital Healthcare Act (DVG), Germany is opening up to digital innovation in healthcare. Starting September 2020 doctors in Germany can prescribe digital health applications approved by BfArM.

What is DiGA?

  • Low risk MDR approved medical device class I and IIa
  • Main functionality relies on digital technology
  • Supports disease detection, monitoring, treatment or relief as well as provides support for compensation of diseases, injuries and disabilities
  • DiGA is used by a patient or by patients and a medical provider together.
"DiGA are digital helpers in the hand of a patient"

Requirements for DiGA

To be listed as DiGA your medical application has to go through BfArM approvement process and fulfill the requirements around:

data protection
Data Protection & Information Security
shield
Safety & Effectiveness
quality
Quality & Interoperability

The DiGA assessment is designed as a fast-track process. Within three months after receiving the application, the BfArM has to assess the DiGA and examine the product's technical features and evidence of its positive healthcare effect.

The assessment process is shown in the scheme below:


scheme

How can DataArt help?

DataArt has necessary resources, expertise and capabilities to become your technological partner in designing, developing and supporting your medical software in accordance with DiGA requirements, including:

  • Medical Data Security
  • User Friendliness
  • Interoperability
  • Medical Device/Wearables Integration
  • MDR Compliance (Medical Device Class I and IIa)

Our Medical Software Development Services

ui/ux
UI/UX Design & Prototyping
medical product
Mobile & Web Apps Development
verification
Verification & Validation Management
quality
Quality Managament
verification
Compliance Management
support
24/7 Support & Maintenance

About DataArt

DataArt is a global software development company with over 20 years of experience in the field of healthcare innovations.

For the last several years we have been creating apps for patients, doctors and other medical staff in the German healthcare space. We are now applying this know-how to help our customers with a new DVG act.