Digital health applications (in German: Digitale Gesundheitsanwendungen, DiGA) are medical devices of class I, IIa, and IIb whose functionality is primarily based on digital technologies. DiGAs are reimbursed by health insurance companies in Germany.

1. Features of DiGA

A DiGA is a medical device that has the following features:

  • Risk class I, IIa, or IIb medical device (according to MDR or, under the transitional provisions, according to MDD).
  • The primary function of the DiGA is based on digital technologies.
  • The DiGA is not a digital application that merely serves the purpose of reading or controlling a device; the main digital function must essentially achieve the medical purpose.
  • The DiGA supports the detection, diagnosis, monitoring, treatment, or alleviation of diseases or the detection, treatment, alleviation, or compensation of injuries or disabilities.
  • The DiGA is not intended for primary prevention.
  • The DiGA is used jointly by the patient or the healthcare provider and the patient, i.e., applications only used by the doctor to treat the patient (“practice equipment”) are not DiGA.

2. Examples and counterexamples

Typical examples of such digital health applications (DiGA) are

  • Apps that remind you to take your medication and may even suggest dosages
  • Apps for recording and monitoring blood pressure
  • Medical video consultation for patients (must be more than just a communication platform)
  • Apps for diabetics
  • Apps for pregnancy support

On the other hand, the following medical devices would not be DiGAs

  • An app reports the number of breathing pauses detected by a chest strap to a user the next day. The primary function here would be measurement, and this is not part of the app
  • An app is only used to coordinate video or phone calls between a therapist and a patient. This app would probably not be a medical device, either.

Further examples with detailed explanations can be found in the BfArM’s DiGA guidelines (German)

3. Articles on DiGA

4. Support for DiGA manufacturers

Benefit from the support of the Johner Institute:

  • Here, you can get help classifying your DiGA, formulating the intended purpose, creating the technical documentation, and setting up the QM and IT security management system.
  • You can also benefit from the QM umbrella of the Johner Institute, which will also take on roles such as QM representative, responsible person, or authorized representative for you.
  • Do you have questions about the development and approval of your DiGA? Then, take advantage of the free micro-consulting.
  • In the medical software compact seminar, you will acquire the prescribed competences. You will learn about and meet the statutory requirements for software development.
  • The Medical Device University’s video training courses help you to create a lean and IEC 62304-compliant “software file” step by step. In addition, a complete set of templates takes a lot of work off your hands.
  • Have the IT security of your software reviewed using penetration tests.

Contact us right away so that we can discuss the next steps. This will ensure that the “approval” is a success and that your software or devices are quickly launched on the market.

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