What are digital health applications (DiGA)?

What defines a DiGA

• Medical device of class I or IIa
• Primary function based on digital technologies
• Used for detection, monitoring, treatment or alleviation
• Used by insured persons, sometimes together with treating physicians
• Listed in the BfArM directory

The path to the directory

The manufacturer submits an application and must demonstrate among other things:

• CE marking as a medical device
• Requirements for data protection and information security
• Interoperability
• Evidence of positive healthcare effects – the actual test

There is a provisional inclusion with a trial period during which the evidence must be provided.

For Practices

Listed DiGA can be prescribed; the costs are covered by the health insurance. For the practice, this means a prescription similar to a medicinal product.

For Developers

The effort is substantial: medical device conformity, evidence study, security requirements. This is a multi-year project requiring significant budget – not a by-product of an existing application.

Clarification

An app for appointment management, a patient portal or a documentation solution are not DiGA. The difference lies in the purpose: treatment versus administration.

HealthFusion is not a DiGA and is not offered as such.

Regulations are evolving. Check the current status before making decisions.