DiGA. DVG. What Is It Anyway?

On December 19, 2019, the Digital Healthcare Act (DVG) came into effect. The "App on Prescription" is now firmly embedded in healthcare, ensuring that statutory health insurance holders have the right to access digital health applications (DiGA). These applications are prescribed by doctors and psychotherapists for relevant indications and reimbursed by statutory health insurance (GKV). Patients with documented diagnoses can also obtain approval for a DiGA directly from their GKV without a prescription.

What Exactly Is a DiGA?

According to the DVG, a DiGA is a medical device whose primary function is based on digital technologies. This function aims to support:

• The detection, monitoring, alleviation, or treatment of diseases

or

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

via digital technologies.

It’s important to note that a DiGA is not intended for primary prevention. Additionally, it must be usable independently by patients or jointly by healthcare providers and patients. Applications used exclusively by doctors for patient treatment (e.g., practice equipment) are not considered DiGA. Thus, DiGA are "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 devices can apply for their product to be included 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 within three months. As a result, the first DiGA are expected on the market by August.

The BfArM evaluation is based on a strictly regulated set of criteria, including:

1. Manufacturer’s claims regarding the required product characteristics, such as safety, functionality, quality, data protection, and data security.
2. Evidence of a positive healthcare effect, provided through a comparative study conducted by the manufacturer.

If all criteria are met, the product is included in the DiGA Directory and becomes eligible for prescription and reimbursement.

If sufficient evidence of a positive healthcare effect is not yet available but all other criteria are met, the product can be provisionally included. Manufacturers are then granted a 12-month trial period to provide evidence of efficacy through a comparative study. Successful completion of this trial phase results in inclusion in the final DiGA Directory.

Required Product Characteristics, Data Protection & Security

In addition to functionality and quality, DiGA are evaluated on whether they align with the real-life needs of users. In other words, is the DiGA realistically usable in everyday life and does it gain acceptance among users? Consideration of users’ abilities and needs should not be overlooked. Manufacturers must also ensure the ongoing technical functionality, user-friendliness, and further development of their products.

Data protection and security involve ensuring compliance with general data protection regulations (GDPR), the Federal Data Protection Act (BDSG), and the Digital Health Applications Ordinance (DiGAV). DiGA requirements are thus strictly regulated, far exceeding the data security of conventional "wellness & health apps." Processing of personal data is limited to specific purposes and only occurs with user consent. Data is neither processed for advertising purposes nor shared, except for billing and reimbursement with the GKV. This process is strictly prescribed and regulated by the BfArM. Additionally, all individuals employed by manufacturers are subject to confidentiality obligations.

Positive Healthcare Effect

The positive healthcare effect arises from both the medical benefit and patient-relevant procedural and structural improvements in healthcare.

Medical benefits include:

Improvement of health status, enhanced quality of life, shortened disease duration, and extended lifespan.

Procedural and structural improvements include:

Reduced disease-related burdens, increased health literacy, and improved care provision.

In summary: The fast-track procedure defines a comprehensive requirement profile for DiGA 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 be easy to use, secure, and effective.

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

The goal is to ensure that using and prescribing a DiGA involves no additional workload or costs for doctors and therapists. If the use of a DiGA leads to additional contract medical services, doctors and psychotherapists receive additional compensation. (Other providers, such as physical and occupational therapists, are excluded.) It’s also intended that DiGA prescriptions be integrated into existing primary systems and processes, specifically the Muster 16 prescription form. (Note: Psychotherapists can request the Muster 16 form from their Association of Statutory Health Insurance Physicians.)

The prescription of a DiGA should be issued, as usual for a medication prescription, on a paper prescription. Patients then submit this prescription to their GKV (by mail or via the GKV’s electronic portal) and receive a 16-digit prescription code. Using this code, patients can register within the app, which they must independently download from common app stores (Apple App Store & Google Play). This process also aims to promote pseudonymous use of DiGA and data economy.

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

The BfArM DiGA Directory lists all approved digital health applications with detailed information. The aim is to ensure maximum transparency. The DiGA Directory will provide clear information about the requirements manufacturers must meet, as well as comprehensive details about the products’ features and benefits. This guarantees that users, doctors, psychotherapists, and health insurers can make well-informed decisions about using DiGA.

Additionally, manufacturers are required to provide informational material on their application websites and may proactively send these to doctors and therapists, provided this complies with the advertising regulations of the German Medicines Act.