Legislative developments in the medtech markets aren’t progressing as fast as the technologies and innovations in it, but – especially over the last few years – they significantly sped up, opening new possibilities for digital therapeutics (DTx) apps and other healthcare software. One of the countries leading this change is Germany, with its simplified path for digital health applications (DiGA) to become reimbursable by the healthcare system.

Since we’re working with one of our clients on building software that’s aimed to become a DiGA in 2024, we figured it would be best to ask them for their perspective in a quick Q&A, which you can find below. But first, let’s start with some basics.

Digital health applications and DiGA Fast-Track in Germany

Why now

Increased usage of mobile devices and new technologies is clearly visible in pretty much every area of our lives. However, many people have been reluctant to take advantage of those when it comes to matters that have to do with their health – until quite recently. The COVID-19 pandemic has significantly sped up the adoption of digital health innovations – causing a 53% increase in the use of health-related apps over the past two years.

And so, the legal and healthcare systems had to follow – starting with EU-wide regulatory changes, such as the Medical Device Regulation (MDR), and moving on to legislation on the country level. Quite surprisingly, Germany – with one of the most complex and rigid healthcare systems in Europe – has been one of the first countries to embrace these developments and enable its citizens to use digital health apps to improve their wellbeing.

Prescribable digital health applications

MDR helped clarify that some software can and should be treated as a medical device (SaMD) in Europe – and a similar approach has been taken by the FDA in the United States. Since medical devices can be prescribed, nothing now stands in the way of the same being true for medical apps that help detect, monitor, treat, or alleviate different medical conditions.

But, just as medications and medical aids need to follow specific certification procedures to become prescribable and refundable, so do digital health apps. For now, only a few countries have taken on the challenge of creating appropriate legislative environments for this to become possible. And Germany, with its Digital Health Application Regulation (Digitale Gesundheitsanwendungen-Verordnung – DiGAV) that came into force in April 2020.

DiGA in Germany

The DiGAV regulation covers „the requirements and processes for the examination of the eligibility of digital health applications for reimbursement by the state health schemes”. We won’t go here into how the German healthcare system works or what the state health themes are, but we do recommend you to check out the list of recommended readings at the end of this article if you’re planning on developing a DiGA. 

The DiGAV itself isn’t a light reading material, but BfArM (the German Federal Institute for Drugs and Medical Devices) provides its guide and other materials that make digesting it a little easier. The truth is, if you’re building a DiGA or any Software as a Medical Device, you’ll need to have someone on board who takes care of the regulatory matters or work with external consultants who will guide you through this process.

In any case, Germany may be one of the best places to start if you don’t plan to sell your digital health app directly to the end-users, but rather as a reimbursed medical device (in this case by the German healthcare system or an insurer).

The DiGAV contains a checklist you can use to verify whether your software complies with all the IT security, quality, and interoperability requirements. If you check all the boxes and your SaMD has positively gone through MDR certification (class I or IIa – so, low-risk to the patient), you are eligible to go through a „fast track” assessment procedure and become listed in the DiGA Directory in just 3 months.

DiGA is just the beginning – Q&A with Michał Ryś from ABAStroke

There’s no better way to learn about DiGA than helping to build one. Such is the case with one of our clients, ABAStroke. They’ve partnered up with us to build an app that’s a digital at-home rehabilitation of post-stroke cognitive deficits that utilizes ABA (Applied Behavior Analysis) methodology in combination with machine learning (AI) algorithms.

At Revolve Healthcare, we take care of ISO 13485-compliant software development from start to finish. We work with amazing subject-matter experts (including neuropsychologists, psychologists, and neurologists), design and usability specialists, machine learning engineers, and some other people on the client side. We also provide assistance and guidance on regulatory matters on an ongoing basis, to ensure the certification process (more on this below) is as smooth as possible.

We could (and we will!) tell you more about the project, but here we want to focus on why ABAStroke decided to pursue the DiGA path. In a quick Q&A with Michal Rys, the CEO and co-founder of the startup, we dive deeper into the subject of digital health applications. We also explore how legislation in more and more countries brings on new opportunities for app creators, patients, and… entire healthcare systems!

[Revolve Healthcare:] How and why did the outlook of digital health applications change over the last few years?

[Michał Ryś:] Back in 2016, when we were telling people that we aim for our mobile to be prescribed (just like a medication), the reaction was usually a kind pat on the shoulder – one that meant they thought our business model sounded amazing, but also crazy. Over the years, regulators have done a great job to make this a reality though. First in the USA, then in Germany, they created legal frameworks that support the development and growth of this market.

And even though the COVID-19 pandemic has been nothing to be happy about, it – without a doubt – led to the biggest breakthroughs and sped everything up. People have been, quite literally, forced to start using digital healthcare solutions, which caused the biggest entry barrier to burst. Digital health applications stopped being perceived as gadgets for tech geeks and started to be seen as fully-fledged solutions in the medical sector.

Of course, the road ahead of us is still long and winding, but over the last few years, the market for digital health products has grown faster than anyone could have expected. In “normal” conditions, such developments would take 10 or 20 years – and some maybe even more.

[RH:] You’re a Polish company, but you decided to go through the DiGA Fast-Track and launch your app in Germany as the first market. Why’s that? And what are the next countries on the list?

[MR:] Germany has very precise requirements for mobile applications that can be refunded in its healthcare system. This helps in planning to expand to this market. While we’ve always been technologically strong in Poland, the business and legislative side of things haven’t been so great. And we’ll probably have to wait a little longer before business catches up with tech.

In the meantime, the German healthcare system is very straightforward about its needs and expectations, so this country seems ideal as the first market for a digital health application. The next obvious targets are other countries of the European Union since becoming certified with a CE mark class IIa under MDR (one of the key DiGA pre-requisites) opens a path to enter each of those markets.

But even though the EU seems like the natural way for us to expand, we’re also looking at the United States. It’s a market we know well – from our past experiences with building a mobile health app. At the same time, that’s where about 20% of the global market is from ABAStroke’s perspective. However, entering the US requires getting FDA approval – and that’s a complex process that will take a while to go through.

[RH:] Is it difficult to become a DiGA in Germany? What are the key challenges?

[MR:] Actually, it’s quite “simple”. I mean, the things you have to do are pretty much the same for every DiGA:

  • prove clinical effectiveness of the digital product you’ve created, 
  • ensure the highest level of privacy and security, 
  • become ISO 13485 and ISO 27001 certified, 
  • and – in the end – get the CE mark as a medical product of class IIa (MDR).

Once you have all that, you just need to fill in the BfArM application and wait for up to 3 months to obtain the DiGA status and price negotiations with GKV-SV (National Association of Statutory Health Insurance Funds). And then, voilà, your app is refunded in Germany.

[RH:] Is Germany a good place to launch a digital health application? Would you recommend others to also start there?

[MR:] If you’re talking about the refundation model, then absolutely. ABAStroke is following this path exactly since we aim to become a participant in the healthcare system. But you need to remember that there are other ways for a digital health app to enter a market. For example, you can use a standard SaaS model to get to the patients and doctors. I’m not a fan of this solution though, since it relies much more on marketing than clinical effectiveness. But if you’re considering it, I think the US market would be the best one to launch in first.

[RH:] MDR, CE, ISO 13485 and 27001… There are a lot of regulations and standards you need to comply with if you want to become a DiGA. How do you wrap your head around all that?

[MR:] You have to have your timeline and calendar figured out, hire the best people, and work with top subcontractors. In our case, Revolve Healthcare helps a lot as our key technology partner. The company is ISO 13485 certified and takes care of the technical documentation that will become the basis of our certification process.

In general, if you’re planning to get a CE mark as a class IIa medical product under MDR, I would suggest starting to prepare for it about two years in advance. This will allow you to coordinate everything at a comfortable pace – with just the right amount of pressure.

Where to start

Building a certifiable digital health application is not a piece of cake. Nor should it be, as – in the least – it’s supposed to help people live better, healthier lives. Thus, it must meet certain standards and you, as a current or future DiGA creator, should know what those standards are and what is expected of you, your team, and your technology.

There are quite a few places where you can read up on what DiGAs are and how to best prepare to launch one. But there are three we think you should begin with. They will guide you through the entire DiGA creation and development process, and point you in the right direction when it comes to things like regulatory matters, technical requirements, the design of clinical studies, and much more.

  1. The Fast-Track Process for Digital Health Applications (DiGA) according to Section 139e SGB V – A Guide for Manufacturers, Service Providers and Users – official DiGA guide from the German Federal Institute for Drugs and Medical Devices (BfArM) 
  2. DiGA VADEMECUM – How to Launch Digital Health Apps in the German Healthcare System – an encyclopedia of knowledge on everything from how the German healthcare ecosystem has evolved over the years, to legal requirements of becoming a DiGA, suggestions on how to approach software development, and tips on getting through to the healthcare professionals, institutions, and patients. 
  3. BfArM’s website with up-to-date information about DiGA (if you’re looking for the freshest ones, they will most likely be in German – but Google Translate deals with German-to-English translation very well), DiGA directory (where you can check out what kinds of apps are already listed and refunded as DiGAs), and some great resources for anyone thinking of launching a digital health application in Germany. 

If all of this seems a little overwhelming, or it’s not but you would still like to talk to somebody about the regulatory and technical aspects of developing a digital health application – we’re here for you. With many great specialists on board (including our Head of Regulatory Affairs), ISO 13485 certified processes, and experience with clients like ABAStroke, we’re happy to share our know-how with you. We’re also always eager to learn about new exciting digital health projects. You can get in touch with us here (and no, you don’t have to request a quote!).

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