Digital Health Interviews: Jonas Albert — How DiGA & DiPA Work and Digital Health in Germany

This is the new episode of Digital Health Interviews, and today our guest is Jonas Albert — a senior consultant and a digital health expert from Germany.

Introduction:

Jonas Albert: currently, he is a Senior Consultant at “fbeta”. He works almost with every stakeholder, including the Federal Ministry of Health and the federal institutes involved in healthcare delivery or regular approval. He also consults industry players who produce, manufacture, and provide services and products in digital health and digital therapy. His main professional issue is how to get digital health innovations into reimbursement. Jonas has a background as a paramedic with the German Red Cross. The fields of active work are Health Policy, Consulting, and Startup Coaching.

As the first guest from Germany in our series of interviews, Jonas Albert briefly described the healthcare system in Germany and how it works.

Jonas Albert: Our healthcare system uses 100% insurance coverage. 90% of our popularity is in the statutory healthcare system, and ten are privately insured. These are significant differences from other markets, where private insurance plays a higher role. In Germany, there is a vast number of insured people, over 60 million at the moment; they are in the public coverage system. Another peculiarity: we have a big focus on our patients’ care. We have single doctors working in private practice who treat publicly insured patients. The same thing is with the hospitals: we have a small private sector — just 15% of the hospitals are privately owned. The rest are half-in-half, owned by public entities and non-profit entities. Out-of-pocket spendings are pretty low. The federal association of public health doctors and the federal association of general statutory health insurance are organs like public stakeholders. They exist independently from the public ministry of health. They decide together mainly what gets reimbursed. The exception is digital health legislation self-governance. The federal ministry of health sets the ruleset. Still, the actors have a high level of independence.

Is the German system effective? As Jonas says, no healthcare system in the world is fully effective. In some ways, Germany is highly effective: people here have terse waiting times compared to other countries and a very high quality of treatment. But cost-effectiveness is probably weak because the spending per capita is relatively high. Germany has no catastrophic out-of-pocket expenditure, such as the US. Compared to its European neighbors, Germany has an excellent and reliable system. The healthcare sector in this country is more vulnerable to the aging of its population. That is similar to Japan’s priority #1: good care for older people.

The first thing that comes to mind concerning Germany is the innovative reimbursement system for digital health apps. Our guest tells a lot about DiGA and how it works.

Jonas Albert: DiGA, in the most basic sense, is a pathway to obtain public health insurance reimbursement for digital therapeutics. This term has become more prominent over the last 5-10 years. You have software that creates a health-relevant benefit by itself concerning three main components: telemedicine, eHealth, and digital therapeutics. We have a smartphone app or web application, which gives you instructions in combination with wearable sensors or without them. You follow these instructions, changing your behavior or performing exercises that actively impact your health. Germany is the only country with a clear and dedicated reimbursement. Most DiGAs are smartphone applications, but the software must be medically certified. An extensive range of health apps are already approved and can be prescribed by a doctor! I’m amazed by how fast it is. Germany has a reputation for being slow. For everything but regarding digital health: here we have new legislation and different stakeholders.

Many DiGAs were listed! Cognitive behavior therapy may be app-driven. So you can have a therapeutic intervention for depression, anxiety, or panic disorders on your phone. Some patients even think it’s much easier to deal with the phone than face-to-face contact with the therapist. All DiGAs have to work by themselves without psychotherapy in this case. For weight loss, you can see what exercises the patients still can do with their conditions, very closely monitored nutrition, with standard outputs to the doctors. There are DiGAs for more complex issues: erectile dysfunction, diabetes, breast cancer, and rest cancer treatment; some improve the quality of life, and some reduce muscular and skeletal pain.

It’s very similar to having medicine prescribed, but this “pharmacy” you can download from every public net. Every DiGA has a pharmaceutical number like a drug. The doctor finds the answers to the questions: What fits the current medical regime? Is the patient willing to use it? DiGAs are prescribed on paper; we are just coming to ePrescription. You have to handle this prescription form with your health insurance. Your health insurance company will generate an unlock code in two to three weeks so that you can use the full DiGA. Some of them are prescribed for 90 days, and some are life-long. The manufacturer of DiGA gets the fee from the patient’s insurance once. There are no in-app purchases; it is prohibited.

The critical thing for insurers and governments should be the effectiveness of DiGA. Federal Institute for Drugs and Medical Devices governs the process, which is rigorous. One of the main tasks of Jonas’s work is to support businesses in designing studies and executing them. DiGAs must be available to a wide range of patients. These medical products should be safe, not endanger the patient, and be easy to use, even for a person with disabilities. A user-friendly interface and design are essential.

A detailed product analysis ensures the technical functioning of a DiGA. The content should respond to the generally accepted state of medical knowledge. The manufacturers should use the collected data for product analysis and not for marketing purposes.

The following step for DiGA is a broader approach for DiPA. These support programs assist home care and reduce nursing and caregiving burdens. The framework looks similar to DiGA but has some differences. The reimbursement for the solutions has a cap of 50 euros per month, and patients will pay any additional cost out of pocket. The solutions will be enabled to patients directly by the long-term insurer for 3 to 6 months.

Jonas makes business consultancy for DiGA and DiPA manufacturers and startup coaching in digital health. He is also a co-author of the research “Why classic Business Modelling doesn’t work for complex business domains — A new Business Modelling approach for Digital Health.”

Jonas Albert: From the start, we look for two things: either we have an existing product that matches best, or we have a product concept idea, target group, or mechanism. We choose the best strategy to develop this product in the best channel for this specific area. We support manufacturers entirely. But firstly, they should answer three questions. 1) How do I generate the evidence that the individual stakeholder needs to give me a reinvestment? 2) What indicators do I need for health insurance to have a selective contract, and what study do I need to become a DiGA? 3) What criteria should I fulfill for the hospital that purchases me as a medical device?

If you plan to create a digital health startup in Germany and apply for DiGA, here is a piece of advice from our guest.

Jonas Albert: Think about your PICOS: Patient, Intervention, Control, Outcome, Study Design. Think about it by yourself or with your company. Evidence is your currency. Marketing in B2C products suggests value that the patients or buyers experience themselves later and keep subscribing. Here you must convince a pair upfront to green light and enabler to prescribe something to the user. He (the user) needs to like your solution in the way he buys it and in the way he uses it. It is vastly different from any other tech product development. We are focusing on how we gain the evidence and, subsequently, how we have all the stakeholders aligned in fulfilling their roles. These roles are far from B2B or B2C classic models. Considering these things, you are at the head of the pack regarding your preparations for going to the German market.

To get more info about DiGA, read our blog article on this topic.

Our previous episode was with Amelia Okulewicz: “BioCam” — Capsule Endoscopy and Machine Learning to Find Pathologies.