There are several issues related to the addition of new health apps to the Directory of Digital Health Applications (DiGAs) by the Federal Office for Drugs and Medical Devices (BfArM):
- Slow Adoption: Despite the expansion of e-health offerings in Germany, adoption remains uneven. As of the second quarter of 2022, 96 percent of outpatient practitioners were linked to the telematics infrastructure, up from 90 percent in 2020
- Regulatory Framework: In the past two years, four new laws and regulations have expanded the regulatory framework for e-health in Germany. However, the implementation and understanding of these new laws could be challenging.
- Reimbursement Limitations: As of April 2022, reimbursement for teleconsultations has been capped at 30 percent of total consultations for a given physician practice. This can limit the use of digital health applications.
- Interoperability and Infrastructure: There is a need to strengthen the interoperability, governance, and infrastructure of the health information exchange.
- Value Realization: A McKinsey analysis estimated the value of digital health solutions for the German health system at an annual value potential of €42 billion. So far, only €1.4 billion, or just over 3 percent, of this value has been realized.
From September 2023 to January 2024, the Federal Office for Drugs and Medical Devices (BfArM) added four new health apps to its Directory of Digital Health Applications (DiGAs), making them eligible for reimbursement. These apps, which can be prescribed by physicians and psychotherapists, are covered by health insurance. As of now, the DiGA Directory lists 53 health apps, while six apps have been removed.
On December 11, 2023, the Directory welcomed the “Mindable: Soziale Phobie” app, developed by Mindable Health GmbH in Germany. This app is designed for individuals over 18 years old who are dealing with social phobia. It provides users with tools to manage and reduce their social anxiety, including cognitive behavioral therapy (CBT) exercises, psychoeducational content, and attention training. Users can also track and export data related to their anxiety symptoms and behaviors. The app supports German, English, and French languages and costs €765.
The “Untire®” app, developed by Tired of Cancer B.V. in the Netherlands, was added to the Directory on December 25, 2023. This evidence-based digital health application is specifically designed to alleviate fatigue in breast cancer patients and survivors. It incorporates elements of CBT, acceptance and commitment therapy (ACT), psychoeducation, and mindfulness-based exercises. Additionally, it includes specific movement exercises to promote physical activity. The app, available in German, English, and Dutch, costs €618.
On December 30, 2023, the “actensio” app, developed by mementor DE GmbH in Germany, was included in the Directory. This digital application is intended for the treatment of hypertension. It provides evidence-based and guideline-compliant content on lifestyle intervention, helping users to modify their eating habits, incorporate more exercise into their daily routines, and improve their stress management. The app is available in German and costs €593.81.
The “glucura Diabetestherapie” app, developed by Perfood GmbH in Germany, was added to the Directory on January 11, 2024. This app is designed for the treatment of type 2 diabetes mellitus. Over a three-month period, users can make personalized nutritional adjustments and implement established lifestyle modification approaches to manage their condition. The app aids in reducing postprandial glucose variability, body weight, and long-term blood sugar (HbA1c). It is compatible with various blood sugar sensors that meet the criteria for data export from CGM systems. The app is available in German and costs €499.80.
For more detailed information in German, please refer to the original sources (Mindable: Soziale Phobie, (Untire®), (actensio), and (glucura Diabetestherapie).
In addition to these, the Directory also saw the introduction of the “Health Companion” app, developed by Health Companion Inc., UK, on January 15, 2024. This app is designed to provide comprehensive health tracking and personalized health insights to users. It supports the tracking of various health parameters like heart rate, sleep patterns, and physical activity. The app is available in English and costs €350.