How do you evaluate the introduction of DiGA on the German healthcare market? What went well, and what went wrong?
Looking at the early versions of the official reasoning behind the DiGA, you will find that the people behind the DiGA initially were very soft on requirements regarding the evidence behind individual solutions. They argued that “case reports, expert opinions, use observations, studies or other valid data” would be enough. Why? Because “the practical added value of obtaining and evaluating health-related data, the low-risk potential, and the comparatively low cost of digital health applications” justify “not imposing comparably high evidence requirements for the proof of positive health care effects.” Last but not least – the costs of clinical studies of a higher evidence level” would be disproportionate here.”
You could observe how quickly the community of healthcare providers and payers began protesting against this – in my view – a shocking form of “digital exceptionalism.” Digital applications can cause harm. Anything that can have a true effect can also have unwanted consequences. And even if not, we have finite resources. Spending time and money on an app that has no real patient benefit means that we miss the opportunity of an alternative intervention that would bring better value.
Don’t get me wrong. I love the idea of the DiGA. I also appreciate that the government is taking an agile approach to its lawmaking, in which it started launching a new regulation in the country to then learn quickly from the community’s responses and iterate. However, many things could have been thought through better, especially regarding patient safety and proof of effectiveness. We live in an age of evidence-based care, and pretending that these principles don’t apply to digital interventions was bound to create avoidable frustrations.
The pendulum then suddenly swung into another direction, with increased requirements on the evidence front for developers, many of which were unprepared. Various entrepreneurs concluded that it was too early to jump on an unripe new legal construct. In the case of DiGA, many suffered a first-mover disadvantage. As a result, DiGA is already seen as a hype that has reached the trough of disillusionment, and no one I know is willing to put all their eggs in the DiGA-basket. If you can generate additional revenues through DiGA, it’s fine. But you first must create enough value to consumers that you can thrive just fine without becoming a DiGA.
DiGA is a fact, even if it’s not perfect. What would you do differently, and what must be done to improve the adoption of DiGAs on the market?
It’s not enough to simply introduce a new reimbursement scheme and think that this alone creates enough incentives for transforming the market. At the end of the day, solutions will only survive if they truly generate value for patients or providers. However, achieving this is incredibly hard in healthcare. Providing evidence that you achieved it is even harder.
If Germany truly wants to become a leader in evidence-based digital health, it needs a more comprehensive strategy. If I were in charge, I would now set up a fund that gives grants of up to hundreds of thousands of Euros to support comparative effectiveness research for digital interventions. It would help startups get independent money for the evaluation of their solutions by researchers who are free from a financial conflict of interest. As a result, we would probably see a rise of researchers capable of assessing digital health technologies, which are inherently different from classical medical hardware or pharmaceuticals and therefore also need different approaches in their scientific evaluation. Today, by and large, we don’t have enough competencies on the methodological front here.
Secondly, marketing needs to be made easier. Just because you have a new tool on the market doesn’t mean that doctors will magically prescribe it and that patients will be curious enough to use it. For good reasons, there are still a lot of restrictions on what can be done on the marketing front for medical devices, pharmaceuticals, and digital health apps.
However, it is extremely challenging at the moment to inform doctors and patients about the merits of different digital health solutions. A trusted repository or evaluation from an independent committee could be helpful, perhaps something similar to the NHS App library, for example. It will need independent funding and be not only scientifically rigorous but also accessible in the way it communicates its findings in order to be meaningful.
There were 24 apps on prescription at the end of 2021, one year after the introduction of DiGA. Doctors have prescribed 50 000 times DiGAs – it’s just 0,0125% of all, around 400 mln prescriptions dispensed yearly in Germany. So why don’t doctors prescribe DiGAs?
Physicians often have too little evidence of efficacy to prescribe DiGAs. They lack accepted guidelines and trusted resources to keep track of the flood of innovations in the digital world. But it’s also true that doctors are often not trained to add digital to their arsenal.
After months of heavy public discussions around DiGA, 53% of physicians still did not know what DiGA was. This makes clear that we must do more to get these topics into the heads of practising physicians. Medical chambers and professional medical associations are, in my view, essential players who could help drive more awareness and upskill their members.
Most importantly – digital health must become a compulsory part of medical school. And for those who are already working as physicians, there must be continuing education courses that help them critically appraise digital technologies in the context of patient care. Physicians have to educate themselves continuously, but they are pretty free to decide what they learn. Critical competencies such as data protection, evaluation of evidence for digital technologies, and skills in using them – e.g. how to properly run a telemedicine consultation – are rarely part of their self-selected curriculum.
Given your scepticism, does it make sense for startups to have their apps prescribable on the German market?
I strongly advise every digital health innovator not to put all their eggs in the DiGA market. I would even advise against becoming a medical device only to be eligible for reimbursement via DiGA.
If you already have a “Software as a Medical Device” or need to go in this direction anyway, it is a different story. If you can sustain yourself with other revenues and have first compelling data in support of your value proposition, then it is undoubtedly smart to apply for DiGA eligibility. However, if you create your entire strategy around making a living through DiGA, I profess that your company will not get far.
Next year France plans to copy-paste the DiGA approach. Don’t you agree that it’s so far the best solution available on the market and – what’s important – accepted on a political level?
If you speak to leading international investors, they will probably tell you that they are frequently underwhelmed by the ambitions of European entrepreneurs. “Europeans are often happy just to conquer their home country’s market, thereby foregoing multi-billion opportunities.”
Until now, the German DiGA approach paid well into this narrative. Startups who focused their energies on getting into the DiGA stream were quickly dismissed as investing too much in overfitting into one relatively small national market. If this now begins to change because France and potentially others start to follow suit and there is a significant degree of compatibility between the jurisdictions, the resulting scaling effects might change the overall market dynamics of the DiGA approach by order of magnitude or more.
However, your question touches on another, even more, exciting aspect: How can a government make digital fit into an ancient established system? What’s clever about the DiGA approach is that it connects the logic for what’s new to the logic of what’s already there – hence making it politically more palatable. Once this new impulse starts rolling, you can begin to witness an abundant change in the system, like ripples in water. On various occasions, I’ve seen that insurance companies started to adopt new visions as drivers of digital innovation and established novel structures to handle the new tasks, challenges, and opportunities stemming from this obligation to pay for a new breed of healthcare solutions.
So a lot is still in ongoing formation. Great to have France onboard soon. I can’t wait to observe the mid- to long-term effects of the DiGA approach.
