Digital health applications: Between criticism and innovation

Digital health applications, so-called DiGA or “apps on prescription”, divide opinion. They are often criticized for being too expensive and not providing sufficient benefits. However, manufacturers must meet strict requirements to bring a DiGA to market maturity. In addition to proof of medical effectiveness, data protection, IT security and interoperability with the telematics infrastructure, the “health data highway”, are mandatory. In recent years, legislators have even tightened the rules regarding data protection and effectiveness.

Nevertheless, DiGAs are repeatedly criticized: the costs are questioned, the bureaucratic hurdles for patients and doctors are high, and integration into care does not always run smoothly. At the same time, the number of prescriptions is constantly growing, and many patients benefit from digital therapies, which are often available more quickly than traditional treatments.

We spoke to Dr. Mario Weiss about these challenges. He is the founder and CEO of Gaia AG, which has launched seven DiGAs on the market – including Deprexis for the treatment of depression and other applications for chronic diseases such as multiple sclerosis. In the interview, Weiss talks about the hurdles involved in bringing DiGA to the market and what he believes needs to be improved.

heise online: What was your motivation to enter the DiGA market?

Mario Weiss: The German DiGA system is unique internationally and represents a special opportunity for us. If a product is approved as a DiGA, this is a guarantee of high quality.

I have been looking into how algorithms can be used in behavioral medicine for years – when AI was not yet on everyone's lips –. Behavioral medicine focuses on changing patients' behavior to improve their health. This includes aspects such as eating healthier, exercising more and also changing mindsets. The latter falls within the field of psychotherapy. Our flagship product in the field of digital therapy, Deprexis, has set global standards in this area. Not only is it certified and demonstrably effective, it also has over 15 years of research tradition and has been researched globally – in the USA, South America and Asia, for example.

What particular hurdles are there?

One major hurdle is access for patients. While medication is available in minutes, many patients wait almost 13 days, and in the case of the AOKs even up to four weeks, for their digital therapy because health insurance companies exceed the statutory two-day deadline for activation. And the current e-prescription draft will worsen this, not better. The redemption process remains technically complicated, bureaucratically overloaded, and health insurance companies retain their role as gatekeepers. This contradicts the original intention of the legislator that doctors should make treatment decisions and not health insurance companies. It undermines trust in digital medicine.

Some describe DiGA as“dead” or “dying”. What's wrong with that?

Nothing. They are being used therapeutically like never before. The number of prescriptions has been rising for years, acceptance among doctors and patients is growing, and the German government has expressly committed to strengthening them in the coalition agreement. What we are seeing is that innovation is being slowed down by excessive bureaucracy. One example? The EU certificate for information security is about 27 pages long. The German special path: over 150 pages. If we carry on like this, we will lose our lead because we will have to invest more time and money in bureaucracy than in research and development.

Are your DiGAs already connected to the telematics infrastructure and the electronic patient file? What about the health ID, are there still legal hurdles?

Our DiGAs are fully connected to the telematics infrastructure and are already compatible with ePA 3.0. They generate healthcare-related data that can be fed directly into the ePA if required. This provides an unprecedented insight into the actual healthcare situation. In addition, registration via the health ID is already technically possible, but it has hardly been used to date.

How does this differ from its use in other countries?

In Germany, the product is actually recognized as a DiGA. In other countries, such applications are often used in different settings. In the USA, for example, we see a fundamentally different perception of digital therapies. There, people don't speak disparagingly of 'apps on prescription', but of 'novel therapies', of innovative, behavior-based interventions. In the USA, the largest study to date on a digital therapy for MS against fatigue is currently starting, co-financed and supported by the US government, based on our DiGA Elevida. This shows how seriously such therapies are taken internationally and the potential of this innovation “Made in German”.

Two years ago, security researchers discovered a vulnerability in Deprexis. What was it like back then?

In 2023, one of our research servers was hacked. No DiGA was actually affected. But I think it's generally very good that the hacker scene points out security gaps. That's better than criminals doing it.

There is a lot of discussion about the evidence and benefits of DIGAs. Is this justified?

It's like with medication – As a good doctor, you know what to use for which patient. When it comes to digital therapeutics, there are experienced colleagues who can differentiate which applications are really helpful. Products such as Deprexis are often recommended because they are tried and tested and there has been 15 years of research proving their effectiveness. Nevertheless, there are also applications that raise the question of what added value they offer. This also applies to medicines.

The costs are also repeatedly criticized, and your most expensive app Levidex is listed as costing 2077.40 euros per quarter. What would you say to that?

Levidex is used for multiple sclerosis. The development costs for the therapy software are very high. This is due to the severity and complexity of the disease. At the same time, there are few users, as the disease affects around 0.3 percent of the population. Of course, a therapy that is used by more people is more economical. But we also need research and innovation in niche indications. And if it is proven to work, as is the case with our therapy, then a fair, differentiated price is needed to refinance the extremely high costs of research and development.

In the areas of interoperability, data protection and IT security, there are justifiably equally high and increasing demands.

You have criticized the statements of the GKV-Spitzenverband that DiGAs are useless and too expensive. What do you have to counter this?

Pharmaceutical expenditure amounted to around 53 billion euros last year. The DiGA share of this amounted to 0.2 percent. And DiGAs are supposed to be the cost drivers? There is an aggressive and unscientific attitude of certain health insurers towards digital therapies, while at the same time they bring their programs to the market without sufficient evidence and safety. Some health insurance companies unfortunately stand out ingloriously here. But there are also health insurance companies that recommend our products and save money as a result. Patients who recover quickly with demonstrably effective products are also 'cheaper' than those who wait forever for therapy and are 'self-medicated' with products of dubious effectiveness.

What would you like to see for the future of digital therapy in Germany?

A fair process that, for example, evaluates the development and reimbursement of special indications such as multiple sclerosis differently to general indications. In addition, some health insurance companies should change their attitude and stop pushing products with dubious efficacy in the interests of their patients to supposedly save money.

(mack)