The app on prescription
Digital health applications (DiGA) have been available as an “app on prescription” since 2019. Under the Digital Health Care Act (DGV), people with statutory health insurance are now entitled to DiGAs, which can be prescribed by doctors and psychotherapists and reimbursed by health insurers. Alternatively, patients can apply directly to their health insurer for reimbursement. DiGAs provide support in the diagnosis and treatment of illnesses and in dealing with medical complaints, among other things. They can be delivered as an app for smartphones or as a web application for browsers.
This is an opportunity for manufacturers to promote digital medical care. However, the Federal Institute for Drugs and Medical Devices (BfArM) first evaluates whether a DiGA meets all the requirements.
As medical devices, they must be CE-marked, are subject to the requirements of the Digital Health Applications Ordinance (DiGAV), and are included in the DiGA directory after successful evaluation by the BfArM. A shortcut for preliminary (at first) listing in the directory often used by manufacturers is the Fast Track procedure of the BfArM.
Learn more about the six facts manufacturers should be aware of in our blog post.
Do you want to launch a DiGA?
Do you have an idea for a digital health application? We know which regulatory requirements have to be met during development and approval. From interoperability to data protection and cybersecurity – the experienced team of BAYOOMED develops and realizes your DiGA together with you.
With the enactment of the DVPMG, penetration testing is now mandatory for all DiGA, not only for those with an increased need for protection. The goal of penetration testing is to quickly identify security vulnerabilities and create maximum data security. We are happy to support you in creating the test concept in accordance with the BSI’s implementation concept for penetration tests and taking into account the current OWASP Top 10 security risks. In order to maintain objectivity, all our penetration tests are carried out by our BAYOOTEC experts.