From 2021 health apps can be prescribed by doctors in Germany

The expansion of the digital network in the health care system is taking a big step forward: From January 1, 2021, the Digital Supply Act (Digitale-Versorgung-Gesetz, DVG) will apply in Germany, which aims to improve patient care through digitalization and innovation. In addition to the digitalisation of vaccination cards, maternity logs and patient files, as well as the promotion of video consultation hours, it should be possible in the future for doctors to prescribe health apps. The statutory health insurance will cover the costs for this.

Which apps can be prescribed?

Apps that are paid for by health insurance companies can be used, for example, to diagnose or treat a disease, such as the evaluation of blood sugar measurements, or to remind people to take their medication and go to preventive medical checkups. Some apps monitor the vaccination status, act as a patient/clinical diary or allow you to make doctor’s appointments. Other apps help to promote health-conscious behaviour, such as fitness trackers or nutrition and workout apps. However, apps can also be prescribed to help with tinnitus or depression. The spectrum ranges from digital diaries for diabetics to supporting apps for migraine patients or pregnant women.

Requirements for the approval of an app

In order to be approved for assumption of costs by health insurance companies, an app must first be tested by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) for data security, data protection and functionality. Once the BfArM has tested an app and included it in the list of reimbursable medical devices, the test phase begins. Now, according to the appropriate diagnosis, the physician in charge can prescribe the approved health app. For one year, the health insurance companies bear the costs of the app. During this period, app developers must prove that their software contributes to a better medical care for users. These rules apply not only to new products, but also to apps that are already available. From mid-May 2020, providers can submit an application to the BfArM for their app to be tested.

Document the medical success of an app with the Healex Site Management System

In order to prove the health benefit of an app within the given time frame, conducting clinical studies offers a reliable and efficient solution.

With the Site Management System (SMS), Healex provides the leading communication platform for the exchange of information and data between principal investigators, researchers and sponsors in clinical studies. For the presentation and maintenance of study contents, all legal and regulatory aspects of study management can be entered and managed, e.g. protocol codes, trial sites, trial objectives, inclusion criteria and patient characteristics, study design, sponsors and monitoring. With the Healex SMS, studies can be managed multicentric across all phases.

Currently, more than 6000 researchers and 350 hospitals are already using the system to manage clinical data with the highest data protection standards.

Therefore, the SMS is a convenient solution for planning and conducting your own clinical trials, which can validate the health benefits and quality of a medical app.

Through the compact and secure management of all study-related data, the medical success of an app can thus be reliably proven, so that after being tested appropriately, the app can be prescribed according to plan.

Further information about the Healex Site Management System: https://healex.systems/en/solutions/sms-en/