Apps on prescription – soon possible through the
Digital Supply Act (DVG)
A giant step for patients and manufacturers:
Health apps can be prescribed in future
One of the major barriers to innovation in the digital healthcare market is the lack of market access for manufacturers. In addition to the narrowly limited application scenarios, manufacturers must conclude so-called selective contracts with individual health insurance companies in order to get their applications into routine use for exclusively the insured members of this insurance company. Access to all insured persons or a possible future-oriented financing are not widely clarified.
This is now to change fundamentally with the adoption of the DVG (Digitales Versorgungs-Gesetz) in the Federal Cabinet and is to come into force with legal effect from the beginning of 2020.
What does this mean for manufacturers of health apps and other
Digital Health Applications (DiGA) ?
- The market with the 73 million patients currently covered by health insurance will be accessible immediately
- This is possible for applications that are pure software products or have a high proportion of software
- Admission as 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 concrete medical benefit for the patients or their care by service providers (structural improvement).
- The functionalities serve to detect, treat or alleviate diseases, 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 examination. The BfArM has 3 months to test the application. In addition to the prerequisites, safety (quality), data security, data protection and functionality are also tested.
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 paid for by health insurance companies.
What do you as a manufacturer have to pay special attention to?
When formulating the intended use, pay attention to the basic conditions for a possible inclusion in the DiGA. In addition, you should deal with the approval of your product according to the MDR (Medical Device Regulation) at an early stage.
During the conception you should consider technical and organisational aspects in order to face such a large market with sufficient application and service quality.
Who will support you in this process?
- The BfArM takes over the testing of the applications and also offers advice
- hih (Health Innovation Hub) of the BMG provides up-to-date information
- PTA GmbH, as an experienced consulting company in the development of software as a medical device, helps you to consider the concerns of the DVG at an early stage in development, documentation and organisation.