DiGA - Explained Briefly and Clearly

On December 19, 2019, the Digital Healthcare Act (DVG) came into force. The "App on Prescription" is thus anchored in healthcare and ensures that statutory health insurance holders have a right to access digital health applications (DiGA). These are prescribed by doctors and psychotherapists for the relevant indication and reimbursed by statutory health insurance (GKV). Patients can also have a DiGA approved directly through their GKV without a medical prescription, upon proof of a confirmed diagnosis.

So What Exactly Is a DiGA?

According to the DVG, a DiGA is a medical device whose primary function is based on digital technologies. This primary function consists of supporting the

• detection, monitoring, alleviation, or treatment of diseases

or

• detection, alleviation, treatment, or compensation of injuries or disabilities

through digital technologies.

Additionally, it should be noted that the DiGA does not serve primary prevention and must also be usable independently by patients or jointly by healthcare providers and patients. That is, applications that are used solely by doctors to treat patients ("practice equipment") do not count as DiGA. DiGA are thus "digital helpers" in the hands of patients.

How Does a Technology-Based Medical Device Become a DiGA?

Since May 2020, manufacturers of technology-based medical products have been able to apply for inclusion of their product in the DiGA Directory through a fast-track procedure. The application is submitted to the Federal Institute for Drugs and Medical Devices (BfArM) and reviewed by them within 3 months. Accordingly, the first DiGA are expected on the market in August.

The review by the BfArM is conducted based on a strictly regulated catalog of criteria.

Among other things, the following are reviewed:

1. The manufacturer's information on the required product characteristics. These concern safety, functional suitability, quality, data protection, and data security.
2. In addition, the manufacturer must provide evidence of a positive healthcare effect through a comparative study.

If all criteria are met, inclusion in the DiGA Directory follows and the DiGA is eligible for prescription and reimbursement.

If there is not yet sufficient evidence for a positive healthcare effect, while all other criteria are met, a provisional inclusion follows. The manufacturer is then granted a 12-month trial phase in which evidence of efficacy must be provided through a comparative study. Upon successful completion of the trial phase, inclusion in the final DiGA Directory follows.

Required Product Characteristics, Data Protection & Security

Among the required product characteristics such as functional suitability and quality, DiGA are particularly examined for whether they are oriented to the real-life situation of users. That is, is the DiGA realistically usable in everyday life and does it also lead to acceptance among users? The consideration of the abilities and needs of users should not be neglected. Furthermore, manufacturers ensure in this context the permanent technical functionality, user-friendliness, and further development of their product.

Data protection and security involves ensuring and complying with the general data protection framework conditions (GDPR), the Federal Data Protection Act (BDSG), as well as the Digital Health Applications Ordinance (DiGAV). Requirements for DiGA are thus strictly regulated and far exceed the data security of conventional "wellness & health apps." The processing of personal data is limited to the specific intended purpose and exclusively with the consent of the user. Data is neither processed for advertising purposes nor shared. The only exception to data sharing is when it concerns billing and reimbursement with the GKV. However, this is strictly prescribed and regulated by the BfArM. Furthermore, all persons working for a manufacturer are subject to confidentiality obligations.

Positive Healthcare Effect

The positive healthcare effect results from the medical benefit as well as patient-relevant procedural and structural improvements in healthcare.

Medical benefit includes:

Improvement of health status, improvement of quality of life, shortening of disease duration, as well as extension of lifespan.

Procedural and structural improvements include:

Reduction of disease-related burdens, increase in health literacy, as well as improvement of care.

In summary: Through the fast-track procedure, a comprehensive requirement profile for DiGA is defined for the first time. The focus is particularly on user-friendliness, performance, data protection, information security and demonstrating a positive healthcare effect. In other words: a DiGA must above all be easy to use, secure and useful.

What Changes for Me as a Doctor or Therapist? And How Do I Prescribe a DiGA?

The goal is not to create additional work or costs for doctors and therapists for using and prescribing a DiGA. If additional contracted medical services arise through the use of DiGA, doctors and psychotherapists receive additional compensation. (Other healthcare providers such as physical and occupational therapists are excluded from this). Furthermore, the goal is to have the prescription of DiGA done through the primary system and integrated into already familiar processes, more precisely the Muster 16 form. (Note: Psychotherapists can apply for the Muster 16 form from their regional Association of Statutory Health Insurance Physicians.)

The prescription of a DiGA should then be issued on a paper prescription, as is usual with a medication prescription. The patient submits this to their GKV (by mail or via the electronic portal of the respective GKV) and then receives a 16-digit prescription code. With this prescription code, the patient can register within the app that they have previously downloaded independently through the common app stores (Apple App Store & Google Play). Through this procedure, among other things, pseudonymous use of DiGA and data economy are pursued.

How Will I Be Informed as a Doctor or Therapist About the Offerings and Respective Changes?

In the DiGA Directory of the BfArM, all approved digital health applications are listed with information. A maximum degree of transparency is aimed for. The DiGA Directory will provide clear information regarding the requirements to be fulfilled by manufacturers, as well as comprehensive information on the characteristics and performance of the product. This guarantees that users, doctors, psychotherapists, and health insurance companies can make well-informed decisions regarding the use of DiGA.

Furthermore, manufacturers are obligated to provide informational materials via their application website and are authorized to proactively send these to doctors and therapists, as long as this occurs within the framework of the requirements of the Medicinal Products Advertising Act.