What are the legal and regulatory conditions that must be met in the development process?
Zacher: Legislative changes mean that apps can now be prescribed by doctors and costs will be reimbursed through German health insurance. As a result, digital healthcare apps or consumer health apps aim to be certified as DiGAs or “apps on prescription” as these apps are often not certified. But the latter is the crucial point. 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. In the last part of this process are price negotiations with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), which approves reimbursement amounts. It is also important to incorporate data protection standards and information security during software development right from the start. According to the new MDR guidelines, quality management systems must likewise be certified in the future.
What are the technical challenges in developing a DiGA?
Zacher: The challenges depend primarily on the type of application. This is contingent on the software complexity or whether it is combined with hardware. Many DiGAs are generally apps. That is why you must take a cross-platform approach and consider all possible requirements for a quality management system in the different versions. You should directly include and meet the requirements of the certification to facilitate an easy update integration at a later point. It is also important to consider software documentation as it relates to data protection and data security.
How can DiGAs improve the lives of patients?
Zacher: The Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) came into effect in 2010 and introduced the “app on prescription” as part of healthcare provided to patients. The basic idea was to use the benefits of digitization and enable patients to systematically use digital health technologies to better manage and track their health and wellness-related activities. The advantage is that the user is less dependent on the public health infrastructure. For example, chronic diseases require continuous monitoring. If the specialist clinic is too far away, DiGAs can step in to collect and transmit the necessary data, thus facilitating a certain level of self-management.