What Influence Does DiGa Have on Health Tech?

DiGA, Germany’s new health legislation is already making waves and sparking debate on both sides of the Atlantic. However, there is a lot of misunderstanding about what DiGA is and what it does. To be fair, much of this is driven by the fact that almost all the government documentation about DiGA is in German. So what is DiGA and does it show us what the future of health technology looks like? 

DiGA came into force in December 2019. It essentially allows doctors in Germany to prescribe digital applications as treatment. The prescription authorises insurance companies to cover the cost of the treatment (in this case the cost of the app). In short, DiGA opens a new sales channel for health tech companies. 

DiGA Germany: How Companies Can get on their Apps Prescribed in Germany

There is a full English Language deep dive available here but essentially the German equivalent of the FDA has a fast-track programme whereby it evaluates and approves apps in 3 months. One of the biggest hurdles for American companies (other than the language barrier) is the need to comply with GDPR. However, most American health tech actually needs to comply with GDPR anyway, as the law is incredibly broad and applies to the majority of US Health techs. 

DiGA Germany: The Future or a Passing Fad?

Whenever we’re faced with massive headlines in the health tech space, we need to take a step back and ask ourselves: is this the future or a fad? DiGA Germany fits into a broader context of changes in the health systems globally. The shift to online care is driven by the pandemic, the digitalization of health data and the newfound interest in health investment following COVID. 

DiGA Germany isn’t even the first attempt by health regulators to make apps available on prescription. The FDA has already approved several applications, including an Apple Watch application, to treat specific illnesses and as part of rehabilitation. The difference between DiGA and the FDA approach is that DiGA has created an entire department to fast track health tech applications into the health system. I would say that Germany didn’t have the idea of “apps on prescription” first, but they have refined the idea and created a model for other countries to follow. 

What are the challenges for American Health Techs in taking advantage of DiGA?

The opportunity that DiGA presents is huge for health tech companies as it opens up an entire new go to market strategy, with doctors prescribing their applications. However, there are some challenges that need to be thought through first. 

The 'language is a barrier' is a small but persistent challenge as the entire process requires an understanding of the German language. What’s more, the German health system includes thousands of hospitals and various insurance companies. Depending on the application in question, you might need to connect securely and compliantly to a number of different sources. Finally, there is the need to comply with GDPR when processing any of the data required, but as mentioned above, most US health techs need to comply with GDPR whether they know it or not!

In conclusion, DiGA Germany is a huge opportunity for American Health Tech Companies, as it allows them to get their software prescribed. Digital Health can leave a niche, wellness focused persona and become mainstream, thanks to the assistance of doctors when onboarding patients. However, American Health Techs will need a trusted local partner, who knows the German system and how to deploy compliant and scalable health tech.