How to Get DiGA Approval in Germany. Digital Health Interviews: Sebastian Vorberg

Digital therapeutics can improve the course of diseases. Most chronic disorders are addressed by behavior change or exercise programs. In Germany, so-called DIGAs (Digitale Gesundheits Anwendung = Digital Health Application) are covered by health insurers. If you are planning to get approval for your healthcare idea in Germany, learn more about it by watching our talk with Sebastian Vorberg.

Introduction:

Sebastian Vorberg: a lawyer with 22 years of experience; has been working with digital projects for 12 years. He takes care of the development of digital health startups and projects. Co-Founder of Bundesverband Internetmedizin — the association of people coming together about digital health. Founder and CEO of the Institute of Quality and Regulations for Digital Health, where all the regulation parts, from the idea to the appearance at the market, take place. His primary clients are startups of any stage.

Data protection and information security are one of Sebastian’s services, but he does that more on a legal side: “We are not the auditors; we provide the things like security systems and all the staff the software needs.”

He deals with his vision of the problem of data leak cases in Germany, and it’s rather outsized.

Sebastian Vorberg: “In my opinion, that’s not so bad to find such leaks because we see problems and things that shouldn’t be opened. After solving them, we’ll have safer work. In Germany, as I noticed, there is a strong opinion about these wounds, and people make a lot of noise. But I think it’s good: it’s secure, and people work hard on it. You cannot solve everything in the first row. Our hackers are not doing blackmail; they just show the problems we have.”

Then we speak about the massive news that Moderna decided to sue Pfizer and BioNTech because of the illegal use of its research and discoveries. Does it look like the time of saving humanity in any possible way is over?

Sebastian Vorberg: “It’s a kind of an intense dive, how data comes from A to B. I think it’s good if we have all the research in one safe place; if you have a big money interest in these things, it’s not good that someone can just take your data. It’s a good reason to have sued them and stop this topic not to happen again.”

Getting back to startups: in many countries and companies, it’s a common practice to give out stock options to employees. That motivates them even more since they are more interested in the startup’s success. Is this a common practice in Germany as well?

Sebastian Vorberg: “The practice of having many people working on their own “baby” is always good. If you have too many people in your company, you should have someone investing and working: you should prepare different contracts for them. It could be a good interest in earning money later on. If you’re getting into the startup business, you always have an idea that something’s working out. You are not just working for the next 100 euros; you work for the future.”

In Sebastian’s opinion, the whole process of DiGA initiative in Germany was too fast for this country: “We didn’t expect that. That was an excellent offensive to get there, but now we are stuck and are not so fast anymore. If you come to Germany with such a fast track, people will say it is too quick for them. Being fast doesn't come to a good end; it comes to a good start. We are working hard to have the process done and bring it to something reliable; we are in the slow connecting part, and hopefully, we’ll come to the fast ending.”

How can a startup become a DiGA? First, you should have a good idea; you need something medical used by a patient with a purpose. Then you get this purpose done, you have to do a medical part, about how you can make an effort in the sphere. After providing all the things that come up with a DiGA status, you need the evaluation part. That’s the most challenging aspect: you should prove the effect. It takes a lot of time and money; after that, you have excellent chances of getting into DiGA’s list. If your medical application, software, or device is ready, you can be approved as a DiGA in a year; if it doesn’t — 1,5 or 2 years. It is the best way to do it if you want to be in the reimbursement part. Germany also has DiPA for the homecare: it’s another good option to realize your possibilities. The companies whose products weren’t approved for DiGA’s directory most likely can’t operate on the market and make money.

Sebastian Vorberg: “If you can't prove medical effect, if you have, for example, a pharmaceutical company and the pills are useless, you won’t sell them. You need to have a good impact and prove it. In this way, you must be sure that you’ll win. You should answer the following questions:

• What do I want to prove?

• What is its effect?

• What have I done to reach it?

• Should I have to do any trials?”

Telemedicine in Germany was forbidden until 2018. Physicians complained that it was hard when starting, but the coronavirus changed this situation. Telemedicine is at a pretty good rate, but Germany has extensive regulations and very high standards for it.

Sebastian Vorberg: “The software developers are always in trouble, and the physicians need some connector between them, software and physical devices to implement. The doctors say it’s too complicated, and I think they are right: it’s not practical, and they have no motivation to do it. We need some pushing and practical easy ways to keep telemedicine going. The competition between startups in this sphere is not high, because all of them have their niche to work in, but they are struggling very hard for their ideas. It’s not a problem of competition, it’s a problem of long-lasting. You have to make a deep breath to stay in the game. Telehealth will never be a part of a DiGA; a law says there must be no physicians in DiGA. It’s only patients focused, but we have a specific way to reimburse the physicians in this part. It’s not well-payed; not all the officials think it is very important, so they don’t make a strong push, and it’s difficult to have a good reimbursement in it. If you focus on that and make it practical, and effective, you can live with it. You will probably have a good business case to develop it. We would see who’s going to provide reliable reimbursement services.”

To feel comfortable in this sphere in Germany, everybody should have a specific subject for work: evaluation, law, regulation, etc. You will have difficulties if you don’t have a practical professional guide. You won’t get the experience you need at the moment.

Want to try yourself in DiGA universe in Germany? Get some pieces of advice from our today’s guest: “Don’t be too quick, be long-lasting. It’s a sophisticated and conservative business. You must have a profound, clear idea, money, time, and capacity. If you have all that, you will be successful. The first barrier to take is tough.”

Our previous episode was with Hannes Klöpper: HelloBetter — a Story of Success for Mental Health Startup.