The Digital Supply Act DiGA and the app on prescription

Digital health applications ("DiGA") were introduced in Germany via the Digital Healthcare Act. DiGAs are medical apps that are included in a directory maintained by the BfArM and can then be prescribed by doctors. Manufacturers are reimbursed by the health insurance funds. It is therefore an "app on prescription". To be included as a DiGA, a number of requirements must be met:

  • It must be a low-grade medical device.

  • The main function must be the use of digital technologies.

  • The numerous requirements of the DiGAV regarding safety, functionality, data protection and information security must be met.

  • The fast-track procedure at the BfArM must be successfully completed.

The speakers will provide the necessary details from their consulting practice. They will also take a look at the current implementation status, including the current state of negotiations on app remuneration and the new draft law on DiGA in care.

Further topics:

During the event, the speakers will discuss:

  • What is a DiGA?

  • What exact requirements must be met?

  • What is the application procedure?

  • When should the app be registered?

  • What remuneration can the manufacturer expect and what is the implementation status?

  • What challenges arise due to the start of application of the MDR?

  • Where is the boundary between lifestyle/wellness app, medical device and DiGA?

  • What plans are there for the care sector?

  • What happens in the event of breaches of the law?

Moderation:

  • Dr. Klaus Eichenberg | Managing Director of BioRegio STERN Management GmbH

  • Anja Reutter | Public Relations Manager of BioRegio STERN Management GmbH

Speakers:

Registration

Participation is free of charge.

Registration is possible via BioRegioSTERN.