Digital Health Applications (DiGA) – Digital Medical Devices in German Care
Contents
What are digital health applications under DiGA?
DiGA is the German term for specified digital medical devices that may enter healthcare provision through Germany's DiGA framework. Products commonly include smartphone or browser applications whose digital functions support a medical purpose.
Not every health app is a DiGA. Calling something a therapy app, or establishing that it is a medical device, does not replace assessment of the particular requirements. Inclusion in the directory maintained by BfArM is central to its status within the DiGA system.
Why are DiGA relevant to pharmaceutical and healthcare companies?
Digital applications can provide an additional component in care pathways. Companies may encounter questions about collaboration, evidence and clear explanation of the service. The application should be assessed according to its actual medical function rather than viewed solely as another communication channel.
Professionals and patients need to understand the purpose, intended use and limitations. Access and reimbursement information should also be current and specific. A general statement about digital healthcare is insufficient to explain an individual product's position.
Which aspects should teams distinguish?
Assessment should address several separate levels.
- Medical device: Examine the intended purpose and regulatory requirements relevant to the particular application.
- Directory status: Check current inclusion and whether listing is provisional or permanent using the BfArM directory.
- Evidence: Assess the demonstration required under the applicable rules and what the available findings actually support.
- Use: Explain eligibility, accessibility, support and the intended care context clearly.
Directory status and supporting evidence need to be considered together. Claims should remain within the particular indication and conditions supported by the assessment.
What communication challenges arise?
Software updates may change a digital product. Information about functionality, data processing and support therefore needs a controlled updating process. Technical engagement alone is not proof of a medical effect.
Collaborations with pharmaceutical organizations should make roles, funding and information flows transparent. Privacy, medical device and advertising requirements need assessment for the actual service. Marketing material should not present provisional listing as completion of every evidence requirement for all effects claimed.
What does a positive healthcare effect mean?
Applicable requirements may concern medical benefit or patient-relevant improvements to healthcare processes and structures. Improved health literacy differs from a measured symptom improvement, for example. Communication should identify the type of effect claimed. The BfArM DiGA directory supports checking the specific application, current status and published information.
Conclusion: Assess the application and its current status
DiGA connects digital functions with a defined route into Germany's healthcare system. Intended purpose, evidence and current directory status are essential to communication. Clear distinction from general health apps supports an accurate assessment.
