Unlike many other medical apps, DiGAs are reviewed and CE-certified as medical devices, making them technically secure and compliant as it pertains to data protection regulations and data security requirements. Studies have shown that medical apps improve patient care and health. In Germany, these criteria are carefully examined by the Federal Institute for Drugs and Medical Devices (BfArM). At present, the BfArM temporarily or permanently lists twelve applications in the directory of reimbursable DiGAs ("DiGA directory") for patients, doctors, and health insurance companies.
Developers can use the so-called fast-track procedure for inclusion in the DiGA directory within a few months. In a MEDICA-tradefair.com interview, Dr. Benedikt Zacher, founding partner at DiGA Factory, explains: "One essential requirement is that the application is designed for the patient and not for the medically savvy user or the physician. The DiGA must facilitate communication and patient guidance, thus enabling partial self-management of the diagnosis, therapy, or healing process."
The app receives a preliminary admission into the DiGA directory if it meets various technical requirements, but no so-called positive care effects ("Positive Versorgungseffekte") have yet been demonstrated. The latter must be done in a subsequent test procedure.
"Mika" is one of the apps that has achieved preliminary admission. It targets cancer patients, provides information, and accompanies patients with a personalized support program that reduces levels of depression, anxiety, and disease and treatment-related symptoms. Prof. Anja Mehnert-Teuerkauf from the University Hospital Leipzig is involved in the development of the digital health application. She provides insights from the physician’s perspective in a MEDICA-tradefair.com interview: "We had to address many important questions pertaining to the tracking of the psychosocial effects of cancer on patients or the types of resources that can help patients to cope with their disease. We also discussed how this app can provide emotional support and foster self-management of psychological distress."
Unlike other health apps, the DiGA objective is not to offer a digital product that promotes a healthy lifestyle. A DiGA is intended to provide benefits for the patient and the healthcare system. Zacher also highlights this approach: "During the development process, it is essential to start with the desired end result in mind and work backwards from there. This means that you define the medical purpose of the product, and developers should work backwards and consider the steps that must be completed by the end of the DiGA process."
This means that potential providers of a digital health application must incorporate the certification and medical device approval process right from the start. This includes the plausible justification of the positive care effects, which – as with other medical devices – must be demonstrated in a study. Costs and effort increase exponentially if this study is treated as an afterthought and is conducted retroactively.