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Digital health apps: apps on prescription

App on prescription: digital health apps have been eligible for prescription in Germany since 2020.
Image: © elenabsl / AdobeStock

Mobile health support via smartphone

Since October 2020, it has been possible to prescribe digital health apps to patients in Germany. Among other purposes, the healthcare apps are intended to help recognize, treat, and alleviate illnesses as well as improve quality of life.

Digital health apps, or DiGAs for short, are defined as medical devices of a low risk class that are based on digital technologies.

A DiGA must always have a medical indication, in other words it must be clear what diagnosis, illness, or disorder the app is to be used for. In addition, a digital health app should never replace seeing a doctor or taking medication, but instead is intended to complement and support treatment. DiGAs thus differ from generally accessible fitness apps aimed at promoting health or preventive healthcare apps.

However, statutory health insurance firms only cover the costs of medical apps if they have first been assessed by the German Federal Institute for Drugs and Medical Devices (BfArM) and listed in the directory for digital health apps.

The DiGA directory: these apps have already been approved

In the DiGA directory, doctors and patients can find all the digital health apps that have been successfully assessed and approved by the BfArM. The directory provides interested parties with a simple and transparent overview of the individual apps and lets them access detailed information such as:

  • Manufacturer and name of the DiGA
  • Intended medical use in accordance with medical device law
  • Instructions for use of the DiGA in accordance with medical device law

Insured persons are also given information about the DiGA, including:

  • Purpose, content, how it works, and use
  • The app’s features
  • Data protection, privacy, and security
  • Technical prerequisites, such as hardware and software requirements

As of October 2021, the DiGA directory already has more than 20 apps listed, which have been approved as a supportive measure for patients with cardiological problems, tinnitus, obesity, anxiety, depression, and other indications.

The medical app “M-sense”, for example, offers self-help to migraine patients. With this digital health app, users can identify individual triggers of their migraines and record the frequency and severity of their attacks as well as accompanying symptoms. Personalized lessons and relaxation exercises can help those affected to independently get a better handle on their migraines and reduce the pain intensity.

Although the use of a DiGA can provide relief to patients, it does not replace treatment by medical specialists.

How a DiGA is prescribed

In principle, any doctor can prescribe any app listed in the DiGA directory through the German statutory health insurance system. Currently, this is still done via a paper prescription that patients have to submit to their statutory health insurance company. The health insurance provider then confirms that it will cover the costs of the requested DiGA.

Insured persons can also request a DiGA from their statutory health insurance fund of their own accord. After the health insurance provider verifies that the applicant is insured there, the applicant will be required to additionally provide a doctor’s certificate attesting to the medical indication. Once the necessary documentation has been submitted, the applicant will receive a prescription code they can enter in the downloaded app in order to launch it.

“DiGA info” created to make DiGAs more accessible to doctors

Although the digitalization of healthcare is making headway in Germany, the new concept of apps on prescription is being met with skepticism by many doctors. According to an estimation made by the German National Association of Statutory Health Insurance Funds, the digital health apps have so far only been prescribed 17,000 times (as of September 2021).

In September of this year, the five e-health companies aidhere, mementor, Newsenselab, Selfapy, and Vivira Health Lab established the information body “DiGA info”. Its goal is to provide medical professionals with comprehensive and practical information on the topic of DiGAs.

Alongside general information, it also aims to explain how digital health apps can be used in day-to-day medical practice. Information material, trained advisers, and online training courses are also offered to teach healthcare professionals about the safe use of DiGAs.

Digital health apps for simplifying self-help

Due to the current shortage of medical specialists, it can take months for patients to get an appointment for treatment. Digital health apps can bridge the long waiting time until an appointment and give users the ability to take their own measures to improve their quality of life. However, for that to work, both patients and doctors must be given all the necessary information on the DiGA digital health trend and its benefits.

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