DiGa 2 refers to health legislation and rules in Germany which came into effect on December 19, 2019. DiGA aims to open up the medical space by allowing Digital Health apps to be prescribed by doctors, just as they prescribe medications today. Technically, DiGA oversees all medical devices and digital technologies and regulates the way these health technologies can and cannot be given to patients in the country. This also means, in the German system, that DiGA oversees what apps’ costs will be covered by the healthcare system. In the German healthcare system, medication and digital health applications that are prescribed, are ultimately paid for by the German healthcare system or insurance (not the patient).
However, for a health technology to be prescribable, it must be on an approved list, called the ‘DiGA Directory’. Digital Health can be included on this list following an assessment phase. But DiGA is a huge opportunity for digital health companies globally, because upon inclusion on the DiGA Directory, their application will begin being prescribed by doctors around the country and the German healthcare system will pay for the use of the application. Digital Health can go from a market of health-conscious, tech-savvy urbanites to the general population after they are added to this list.
For digital health globally the opportunity is clear. The German healthcare system will not only prescribe approved apps but it will pay for those apps. This opens up the door to millions of users and an entirely new go-to-market strategy. But how can American companies get on the DiGA Directory and start getting their apps prescribed?
The first step for any Digital Health doing business in Europe, or processing the data of any European Citizen, is to make sure that they are GDPR compliant. GDPR, the EU data protection law, applies to all companies doing business in the EU and all companies who process any data of any European Citizen or resident even if the company in question doesn’t do business in the EU. Regardless, if you’re a US digital health company, you should be GDPR compliant to avoid the risks.
Once you are GDPR compliant, there is a very specific process you will need to go through to be on the DiGA directory. Unfortunately, much of the documentation on this process is in German but it is a process we help global Digital Health navigate all the time.
BfArM functions much like the FDA in the United States and when it comes to evaluating digital health applications it treats them in a similar fashion to how the FDA would examine a drug. However, there are much less data requirements and apps do not need to go through clinical trials like a drug would.
Our teams can help you with this documentation. Click here to contact us about BfArM compliance.
In order to support the DiGA initiative, BfArM has actually agreed to allow applications to be fast tracked, guaranteeing a response in as little as 3 months. The regulator looks specifically at the digital health's data on:
Safety for patients,
Data protection (GDPR compliance),
Evidence of successful outcomes from the app.
Along with the obvious focus on the success of the application, there is a very strong focus on the technical security and compliance of the application. The regulator released a detailed guide, which you can access here (but is only available in German).
The German healthcare system is a mix of public and private entities. The system provides base levels of care for all citizens and then citizens purchase either public or private insurance for higher levels of care. There are about 2,000 hospitals in Germany, 30 of which are university hospitals. These hospitals are broken down into 3 distinct groups: public Hospitals, Charitable Hospitals and Private Hospitals.
This level of detail is important because digital health software must be able to integrate with thousands of relevant hospitals, health agencies and insurance companies in order for it to be widely prescribed and, in order for the digital health company to get paid.
These integrations are something that Vertrical has worked in with US Digital Health start-ups in the past and we’d be happy to share some insights with you individually.
The idea of apps being able to be prescribed is gaining traction globally. In 2018, the FDA approved an app called reSET-O, which can now be offered as a prescription to combat opioid use. In 2020, the FDA granted clearance to De Novo an Apple Watch prescription application, along with another called NightWare that helps with PTSD. While the pace of approvals in the USA is hastening, there is no fast-track DiGA-like solution on the horizon.
This means that DiGA is unique for the time being, though other European countries are likely to follow Germany’s lead. DiGA also remains a huge opportunity for American Digital Health to open the European market with a new go-to-market strategy where doctors prescribe their application and health services cover the cost.
Contact us to learn how to get the DiGA Directory and Start Getting your App Prescribed in Germany!