18. July 2019

Digital Supply Act

Apps on prescription – soon possible thanks to the Digital Supply Act (DVG)

A huge step for patients with health insurance and manufacturers:
Health apps can be prescribed in future

One of the biggest obstacles to innovation in the digital healthcare market is the current market access for manufacturers. In addition to the strictly limited application scenarios, manufacturers must conclude so-called selective contracts with individual health insurance funds in order to get their applications into routine use for the insured persons of these funds only. Access to all insured persons or possible future-oriented financing have not been clarified across the board.

This is now set to change fundamentally with the adoption of the DVG (Digital Supply Act) by the Federal Cabinet, which will come into force at the beginning of 2020.

What does this mean for manufacturers of health apps and other
Digital health applications (DiGA)?

  • The market, which currently has 73 million health insurance patients, is immediately accessible
  • This is possible for applications that are pure software products or have a high proportion of software
  • Approval as a medical device according to MDR, class I or IIa (not higher) is a prerequisite
  • In addition, a medical benefit for the patient or the care must be proven.
  • The purpose includes a specific medical benefit for patients or their care by service providers (structural improvement).
  • The functionalities are used to detect, treat or alleviate illnesses, injuries or disabilities.

How does the process work?

Digital health applications that meet the requirements are registered with the BfArM (Federal Institute for Drugs and Medical Devices) for testing. This has 3 months to check the application, and in addition to the requirements, security (quality), data security, data protection and functionality are also checked.
The application can then either be included directly in the DiGA list or on a trial basis for 12 months if the positive supply effects can only be proven in the course of use.
As soon as an application is included in the DiGA list, it can be prescribed by a doctor and is covered by health insurance.

What do you have to pay particular attention to as a manufacturer?

When formulating the intended purpose, pay attention to the boundary conditions for possible inclusion in the DiGA. You should also look into obtaining approval for your product in accordance with the MDR (Medical Device Regulation) at an early stage.
When designing the concept, they should take technical and organizational aspects into account in order to meet such a large market with sufficient application and service quality.

Who will support you?

  • The BfArM is responsible for testing the applications and also offers advice
  • The hih (Health Innovation Hub) of the BMG offers up-to-date information
  • As an experienced consulting company in the development of software as a medical device, PTA GmbH helps you to take the requirements of the DVG into account at an early stage in development, documentation and organization.

Dr. Thomas Steinmann

Sector Manager Life Science

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