DiGA – Digital Therapeutic Health Application

Michael Roehl, Managing Director ACM
The physician’s leather medical bag will soon need to add another compartment for digital therapeutics or DTx for short. Digital therapeutics are evidence-based, clinically evaluated medical devices or software which, like an app, can be downloaded to your mobile phone. These digital therapies are used to treat a variety of diseases and disorders. Over the past five years the US Food and Drug Administration has approved an increasing amount of prescription DTx which complement more familiar drug therapies. This trend, although more recent, is also becoming more pronounced in Germany.

German Digital Therapeutics

Since October 2020 the Digital Health Care Act (Digitale-Versorgung-Gesetz), has enabled people in Germany with statutory health insurance to receive digital therapeutics as a prescription therapy. The German term for this is digitale Gesundheitsanwendungen or DiGA for short. Patients can get a DiGA prescription, without financial co-payments, directly from their health care providers. Since the passing of the Digital Health Care Act, the costs of the DiGA, which is considered a new standard of care benefit, are covered by the patient’s health insurance.

Requirements for Classification as a Digital Therapeutic in Germany

The following criteria are required for a digital therapeutic to be defined as a DiGA in Germany:
  • it needs to be classified as a medical device class I or IIa
  • it must be based on a digital technology
  • it cannot be used exclusively to collect data from a device or for controlling a device
  • it must be used to support the recognition, monitoring, treatment or alleviation of diseases or the recognition, treatment or alleviation or compensation of injuries or disabilities
  • it must be used only by the patient OR
  • it must be used by the patient and the patient’s healthcare provider

Registering a Digital Therapeutic in Germany

DiGAs are registered with the German Federal Institute for Drugs and Medical Devices (BfArM). The DiGA directory is located at the BfArM website https://diga.bfarm.de/de/verzeichnis?type=%5B%5D In order to be recognized as a DiGA and thus be billable as a service of the statutory health insurers, DiGA manufacturers must first submit an application to the BfArM. For a quicker process, applicants can apply for a fast-track review which takes a maximum of three months after receipt of the complete application to be processed and for the DiGA to be registered in the directory. As of March 2022, over 500 DiGA applications have been submitted for review. From this number, 21 DiGAs have been approved by the BfArM on a provisional basis and an additional 10 DiGAs have been approved on a permanent basis. For a DiGA to be successfully registered in the directory, it must demonstrate positive health care effects backed by evidence provided by a comparative, ideally randomized, clinical trial (RCT). The comparison group can be either treatment without the use of the DiGA, or treatment with another comparable digital therapeutic. The positive health care benefit is defined in the Digital Health Applications Regulation and is similar to the corresponding standards for the evaluation of drugs. Patient-relevant beneficial effects are defined as:
  • the improvement of the state of the patient’s health
  • the reduction of the duration of a disease
  • the evidence of a positive healthcare effect
  • the prolongation of survival
  • the improvement in the quality of life
To demonstrate a positive health care benefit, the manufacturer must submit RCT results showing that the use of the DiGA is superior to not using it, while meeting all standard medical study requirements. Applicants who claim a medical benefit for a DiGA must show that patient-relevant endpoints, in particular morbidity, mortality or quality of life, are positively influenced. In addition to demonstrating positive health care effects, the DiGA applicant needs to show that the DiGA adheres to statutory data protection and data security requirements as well as functional suitability and user-friendliness.

Patient Access to Digital Therapeutics in Germany

In Germany, DiGAs can be prescribed to patients directly by their health care provider. Alternatively, patients can access information related to DiGAs by visiting the BfArM registry and selecting a DiGA which matches their diagnosis from the following areas: cardiovascular, metabolic diseases, oncology, MSK, nervous system, renal system, hearing disorders, psychiatric disease or digestive system. The registry is easy to navigate and provides ample information about each DiGA including the rational given for appproval by the health authorities, prescription information and where to download the DiGA. After downloading the DiGA, the patient can receive reimbursement of any costs from their health insurance.


The trend towards increasing use of prescription digital therapeutics as a complement to more traditional pharmaceutical therapies is expected to grow in the US and Germany. In fact, the current global digital therapeutics market value of approximately 3.5 billion USD is projected to grow to 24 billion USD by the end of this decade. As clinical evidence and regulatory approvals continue to spur digital therapeutics use, it is likely that this new category of medicine will become a key part of traditional care delivery. For further information or support on RCTs with the aim of registration of your digital therapeutic in Germany, please contact roehl@allied-clinical.com.

About the author: Michael Roehl is the Executive Director of Allied Clinical Management GmbH, a clinical research organization based in Berlin, Germany. ACM has conducted clinical trials in oncology, cardiovascular disease, ophthalmology, respiratory illness, metabolic disorders, women’s’ health, dermatology and regenerative medicine on behalf of leading pharmaceutical and medical device companies.
Michael Roehl, Managing Director ACM

Please contact Mr. Michael Roehl,
Executive Director of ACM Recruiting, for further information: