Weight loss app "Oviva": manufacturer to develop digital health applications

Manufacturers of digital health applications (DiGA) must provide certain evidence in order to be approved by the Federal Institute for Drugs and Medical Devices and listed in the DiGA directory. There are currently 65 DiGAs listed there, 36 of which are permanent. Patients can be prescribed DiGA by their doctor and then receive an access code. Insured persons can also request the access code for the paid app from their health insurance provider.

With the law on accelerated digitalization in the healthcare sector, which comes into force in 2023, DiGA will also be subject to stricter requirements, including data protection. However, the fact that they are considered a digital medical device also opens up more possibilities; they can also be used for telemonitoring, for example. We spoke to Thomas Richner, who is responsible for technology at Oviva, about digital health applications. Oviva is a digital weight loss program that is permanently listed in the BfArM directory and is designed to support people who are severely overweight. Among other things, patients can use the app to share information about their eating habits and discuss them with a nutritionist.

heise online: What are the biggest hurdles in bringing a DiGA to market?

Thomas Richner: The biggest challenge is certainly to achieve a permanent listing in the DiGA directory. This requires not only proof of efficacy of the DiGA based on randomized, controlled studies, but also meeting technical requirements for data security and interoperability.

Most DiGAs can successfully complete such an efficacy study. If individual DiGAs fail to achieve permanent listing, this is usually due to the fact that the Federal Institute for Drugs and Medical Devices does not consider proof of efficacy to have been provided. If the proof does not work, this can lead to major challenges for the respective DiGA manufacturer. In the worst case, it can even threaten the existence of the company. If the DiGA was provisionally listed, failure to provide proof of efficacy can lead to the DiGA listing being withdrawn and parts of the turnover having to be repaid.

It is often said that DiGA manufacturers charge a lot of money and become more expensive over time. How do you deal with such and similar criticism?

Digital health applications are generally digital, guideline-based therapies and are not comparable with simple apps that are freely available for free or for a few euros in the app store. I believe that the prices are a result of the high demands placed on a DiGA –, both in terms of the complexity of the software and the compliance requirements. DiGAs have a very high level of protection in the areas of data security and data protection and high requirements for proof of effectiveness.

In principle, the manufacturer is only free to choose the price for its DiGA up to the respective maximum amount limit in the first 12 months after inclusion in the DiGA directory. This maximum amount regulation effectively avoids moon prices that are billed at the expense of the solidarity community and at the same time provides an incentive to research, develop and launch new innovations on the market. After the first 12 months, the price must then be negotiated with the National Association of Statutory Health Insurance Funds.

Roughly speaking, how much do you have to invest to develop a DiGA?

That's difficult to say. Just to be provisionally listed, you're looking at single-digit millions. And of course the continuous development of the DiGA also costs money. This is where investors who like the idea and support it come into play.

What is your motivation behind the very complex process of offering a DiGA?

Oviva already digitized nutritional advice in 2014 with its own app. But we always wanted to do something like a DiGA. In 2020, we completed our Series B financing round, which gave us enough financial resources to develop our DiGA. Of course, we also used the knowledge we already had from our digital nutritional advice. This means that we have made traditional treatment with nutritional advice more efficient for us. We then took the next step with the DiGA.

Incidentally, it's important to remember that obesity was only recognized as a chronic disease in 2013. Since then, DiGAs have been the only real improvement in terms of access to treatment, as they are an accessible, effective option for implementing guideline-based basic therapy.

There are around 220 million people living with obesity in Europe. However, only a fraction of them have the capacity to receive medical support in person. Technology, and therefore DiGA, is the only chance to counteract this pandemic and provide all those affected with effective treatment. With our DiGA, we are focusing on using a digital solution to support people with obesity in their weight management and thus help them to achieve better health.

DiGA providers must also connect their app to the telematics infrastructure. What is the current status for you?

We are one of the first DiGA manufacturers to be connected and approved for both the electronic patient record and the telematics infrastructure. The connection to the ePA will be rolled out to all patients in the near future. However, there are still problems with some health insurance companies, but Techniker Krankenkasse, for example, already fully supports the ePA. But logging in with the health ID will also take a while, as everyone is waiting for the technical service providers and health insurance companies.

Are there any incentives for this?

So far, there are very few incentives, apart from the requirement that this must be implemented. But if you think a few steps ahead, the ePA connection opens up interesting possibilities.

If the DiGA is connected to the ePA and is allowed to transfer data, there is a corresponding DiGA folder in the ePA. The data is also stored here after the DiGA treatment has been completed, while it is deleted in the DiGA. When the basis for allowing DiGA to read data from the ePA is established next year, we will be able to read the historical data again. This has the advantage for patients that they do not have to re-enter the data manually, such as their weight history. The history is then automatically available.

Another interesting point is the interoperability between different DiGAs. For example, if a patient uses another DiGA, relevant data could be shared and synchronized. This would give users and the doctors treating them a better overview. Medical information objects and FHIR HL7 are then used as data formats.

How will this be displayed to the patient?

As an intermediate step, the data is initially saved as PDF files, but also flows into the ePA as structured data. Then, depending on the application, graphs can be displayed, for example.

Do I then have to give the DiGA authorization so that it can write data to the ePA? And will this change in the future?

Exactly, DiGA users must actively consent to the transfer of data in the DiGA. They can also individually specify which data should be passed on. In the ePA itself, patients then specify who is allowed to read all of this data. The patient must also activate one-off or recurring synchronization in the Oviva app and allow access in their ePA or health insurance app Oviva. This access can be revoked at any time. Conceptually, this approval mechanism will not change much, but the user experience will certainly be polished both in the Oviva app and in the health insurance apps.

Some manufacturers are worried that it will become more difficult for insured persons to obtain activation codes for DiGA. What is behind this and what is your view on it?

It is already relatively complex for interested patients to obtain a DiGA: On average, it takes 13 days, whereas a prescription for a medicine can be filled within a few minutes. We manufacturers hoped that this could be improved with the e-prescription for DiGA. However, the first drafts of the corresponding process still provide for critical barriers for patients, for example that they have to actively submit the application for a DiGA to the health insurance company, which then checks whether a prescription is available. Technically, it would also be possible for this to be fully automated. A clear case of: If you digitize a bad process, it remains a bad process. We hope that Gematik and the BMG will reconsider their plans in this regard.

(mack)