Fabian Oppel: Sabrina, at the beginning, we can hear the sounds of nature – birds twittering, water splashing, frogs. What does this have to do with our topic of health apps?
Dr. Sabrina Schubert: These are sounds that are used in digital therapies, for example, in apps for treating tinnitus. They are a good example of how digital applications can be used for therapeutic purposes today.
Oppel: The term “health apps” is very broad. What exactly does this mean and what are digital health applications, or DiGAs (Digitale Gesundheitsanwendungen)?
Schubert: Health apps basically include all mobile phone applications that people use to support their health – from pedometers to therapy apps. DiGAs are a small, specially regulated subgroup. These apps are eligible for prescription by doctors and paid for by statutory health insurance providers if they went through an approval process before and demonstrated their efficacy.
Oppel: What exactly makes an app a DiGA?
Schubert: To qualify as a DiGA, an app must be approved as a medical product and be aimed at patients with a specific diagnosis, and there must be studies corroborating its efficacy. A DIGA also must comply with stringent data protection and security standards. After approval, the app is included in an official register. In Germany, there is also the option of provisional approval so that innovations can be translated more quickly into health care services.
Oppel: How does the reimbursement procedure for such applications work?
Schubert: In the first year, providers can largely set the price themselves. Often, this is several hundred euros per patient and quarter. Only after this initial period, prices are negotiated with the health insurance companies. The idea behind this model is to promote innovation and boost the market for digital applications.
Oppel: From an economic perspective, why are health apps particularly interesting?
Schubert: Because a new market is emerging here that first has to sort itself out. For example, we are analysing whether regulation promotes or inhibits innovation. The question here is how much scientific evidence is required without making innovation unnecessarily difficult, especially for smaller firms or start-ups.
Oppel: What role do health apps currently play in the health care system?
Schubert: There is a difference between lifestyle apps and medical applications. Lifestyle apps like step counting or calory tracking apps are used by many people. But the share of medical applications such as DiGAs is still relatively small although they are now part of the health care system. Also, these apps are only approved for low-risk diseases: They can support medical treatments, but they cannot replace them.
Oppel: How is the efficacy of such apps tested?
Schubert: Currently, there is a strong focus on classic randomised controlled trials as we know them from drug research. Patient groups with and without app use are compared. However, this is more difficult with digital applications because there are no real “placebo apps”, for example.
Oppel: Are there alternative approaches?
Schubert: Yes, using ‘real-world’ data is increasingly being discussed. This involves using data that is generated during actual use – such as usage data from apps or measurements from wearables. This data could be utilised more in future to evaluate efficacy.
Oppel: What are the findings of previous studies on the market for health apps?
Schubert: We are seeing an increase in the number of apps on the market, which is a result of regulation. But the number of scientifically based applications is not increasing at the same rate. New apps also are often created in areas where such services already exist, such as mental health. So far, we have seen hardly any new developments for many other diseases.
Oppel: Where is there room for improvement in regulation?
Schubert: It would be an improvement, for example, if bureaucratic hurdles for low-risk applications were reduced. Also, real-world data could be taken more into account. Another approach would be to base reimbursement more on how intensively patients actually use an app – in other words, on what is known as adherence.
Oppel: A new research project is currently underway at ZEW on that particular topic. Can you tell us more about it?
Schubert: In the DEKODE project, we are working with partners from academia and practice to investigate how patients use health apps and which factors influence their usage behaviour. To do this, we combine surveys, insurance data and anonymised app usage data. The project’s aim is to integrate digital applications more effectively into health care and to further develop reimbursement models.
Oppel: Will research on digital health markets be further expanded at ZEW?
Schubert: Yes, this field of research is currently growing significantly at ZEW. We deal with issues at the interface of digitalisation, reimbursement schemes and innovation in the health care market. This is particularly important because compared to other countries, Germany still has some catching up to do when it comes to digitalising the health care system.
This text is an abridged version of the interview. In the full podcast, numerous aspects are explored in greater depth, additional examples are presented and research findings are explained in more detail.
