DiGAs - digital health applications on medical prescription on the rise

The introduction of digital healthcare applications (DiGAs) as part of the Digital Healthcare Act (DVG) at the end of 2019 could give digital healthcare solutions in Germany an enormous boost in the future. We asked expert Christian Weigand what benefits this will bring for medical and nursing staff, the people being treated and other stakeholders, and how this will change healthcare. Not only does he conduct research in this area at Fraunhofer IIS, but as CTO at the Digital Health Application Center he also advises companies on how to sign up for DiGA.

Christian, DiGAs is not a new term from the youth language, but the abbreviation for "Digital Health Application". Can you explain what we can imagine by it?
Christian Weigand: Digital health applications (DiGAs or the "app on prescription") are, since the new Digital Care Act for providers in the German healthcare system, a far-reaching way to get reimbursed for telemedicine services. Specifically, this means that patients can be prescribed digital health apps approved by their doctor, such as medications. With around 71 million people with statutory health insurance, Germany thus offers a market for digital health solutions that is unique in the world.

A DiGA is thus, simply put, compared to medication, a type of digital therapy form. Drugs, however, as we all know, have to go through a lengthy approval process before we as patients are allowed to take them. How is that with DiGAs? Are there similar approval procedures there, how do they run, and who checks whether a digital care solution becomes a DiGA?
Christian Weigand: DiGAs have to meet various requirements even before they are registered with the Federal Institute for Drugs and Medical Devices (BfArM), which ensure both security in terms of data protection and the Medical Devices Act. For example, each DiGA must already be a certified medical device prior to registration. In addition, there are high requirements for data protection and security, and the so-called positive supply effect is also checked by the BfArM. This must relate to the medical benefit or also to the area of patient-relevant procedural and structural improvements and is usually proven by appropriate study results.

So not every app or digital health application is automatically a DiGA. How does that differentiate itself and what does that mean for those who want to use such an application?
Christian Weigand: Applications that precisely do not provide any medical benefit or corresponding improvements cannot be approved as DiGA. An example would be a fitness tracker app, which is included with many smartwatches. But primary prevention apps also cannot be included in the DiGA directory. Basically, the approval process and inclusion in the DiGA Directory provides assurance to medical professionals and those being treated that tested DiGAs actually add value to their health and are, to the best of our knowledge, state of the art.

Cue security: The topic of data protection and data security has been omnipresent for years and in the past was often cited by critics as an argument against digitization in healthcare. Are DiGAs secure and can I trust that my data is really protected in this process?
Christian Weigand: On the one hand, the General Data Protection Regulation (DSGVO) naturally also applies to DiGAs, and on the other hand, medical devices have to comply with certain data protection and security requirements, which are taken into account during certification. In addition, DiGA approval will require the manufacturing company to have an audited IT security management system (ISMS) in the future. This must continuously check the application for vulnerabilities during the operation of a DiGA and, if necessary, the emerging security gaps must be closed immediately by the company.

On January 01, 2021, the electronic patient record (ePA) of the statutory health insurance funds has been launched. In this, all my diagnosis, therapy and other health data will be stored in the future. Are the DiGAs and the ePAs of the health insurance companies networked with each other?
Christian Weigand: The legal regulations for DiGA approval already require the manufacturing companies to achieve a certain degree of interoperability - more precisely, that different systems can work together as seamlessly as possible. Thus, the use of open standards to be able to transfer data is aimed at. This also explicitly includes the connection with the ePA, which has been accessible since 01.01.2021, and its subsequent versions for semantic interoperability.

This means that we now no longer only receive medication, but also apps prescribed by the doctor. But how do I then redeem such a prescription? Probably not at the pharmacy, right? And are there already first DiGAs that are approved?
Christian Weigand: The prescription that the doctor issues for a corresponding diagnosis contains a numerical code, the Pharma Central Number (PZN), similar to that for drugs, which identifies the DiGA exactly. The person receiving care downloads the app from their provider's app store and submits the prescription to their health insurer. From them, they receive an unlock code that can now be used to unlock the app for the duration of the therapy.

Currently, eleven digital health apps can already be prescribed, and more than another 70 are in the registration process. On the page of the BfARM there is the DiGA directory, which lists all approved apps and the data relevant for approval.

Suppose I have an idea for a DiGA and now want to implement it. Who can I turn to in Bavaria? Who will help me, for example, in the search for collaborations or clinical trials?
Christian Weigand: Bavaria is very well positioned here. In addition to networks and platforms such as the Cluster Medical Technology with the Medical Valley and the ZD.B Topic Platform Digital Health and Medicine , the Free State also offers good funding programs for research and development projects. The H+ Digital Health Innovation Program also offers start-ups good support. We at the Digital Health Application Center (dmac GmbH) in Bamberg have focused on advising and supporting application providers, e.g., in clinical trials or but also in the approval as DiGA. We analyze the respective project, identify the problems that still need to be solved and work with the companies in so-called solution workshops to develop targeted solutions with our respective experts.

Finally, one more question for you Christian: What exciting developments besides the DiGAs are there currently and which are still coming up in the next few years?
Christian Weigand: A currently big topic is also the Hospital Future Fund. Here, over four billion euros are to be invested in the digitization of hospitals over the next few years. In the course of this year, the so-called Digital Supply and Care Modernization Act (DVPMG) is then to come into force, which will then, among other things, also create the prerequisite for digital care applications (DiPAs) and, in principle, also make care more digital. The electronic patient record (ePA) launched at the beginning of this year will also be further expanded (keyword: semantic interoperability) and will receive new functions such as the option to donate data for research. In addition, eArztbrief and eRezept are topics in the future, as is generally a stronger networking of service providers, carriers and patients.