Digital health founder? This is how your health app achieves Diga approval
No time right now?
So-called digital health applications (Diga) are considered a decisive innovation in the Digital Supply Act. Because if startups can offer their application as an “app on prescription”, that opens up an enormous sales market for them. In order for the inclusion in the Diga directory to work, founders should consider a few important factors.
The Digital Supply Act gave the go-ahead for the “App on Prescription” last year. Since then, digital health applications can be approved and then prescribed by doctors and reimbursed by health insurers. Patients benefit directly from the patient-centered, digital offers for treating diseases. But the reform also represents a milestone for health start-ups: It opens up a market with potentially 73 million statutory insured users.
The prerequisite for this is that an app is included in the so-called Diga directory of the Federal Institute for Drugs and Medical Devices (BfArM). However, the hurdles for this are anything but low. Apps have to meet high security, quality, data protection and security standards. That is also the reason why so far only from over 500 applications six manufacturers have received a Diga approval.
It is particularly difficult for many startups to prove the so-called positive supply effect. The BfArM supplies one for this 139 pages long guide – However, in practice it is clear that this alone does not answer all questions by far.
In order to keep an overview in the diga jungle, it helps as an app developer to orientate oneself on the following four factors in order to quickly gain methodical access to the topic and to follow a promising approval path from the start.
1. Don’t just look at the medical benefits
Does your app deliver clear medical added value? Well! However, the “procedurally and structurally positive supply effects” are just as important here. And it is precisely these effects that come to the fore at Diga: Apps give patients easier access to care, promote health literacy and support patients in the medical decision-making process. So even the relief of caring relatives represents a real added value, which is recognized as a positive care effect in the Diga approval process.
Since the health system has so far largely “overlooked” these effects, it is difficult to provide scientific evidence for these procedural and structural health care effects. The internationally recognized methods and endpoints with which these effects can or must be detected do not yet exist in some cases. Fortunately, the BfArM’s interpretation of the quality of the selected methodology is currently still broad – it must be quantitatively measurable, scientifically validated and justified by an independent evaluator. And the BfArM will also be happy to provide information as to whether this selected methodology, including the measurement process and endpoints, then also fits. You should therefore deal with the topic of “evidence of positive health care effects” at an early stage and include appropriate quantitative measurement methods and endpoints in the preliminary studies.
Tip: A multidisciplinary team of experts and consultants, including health care researchers and social scientists, is extremely helpful in understanding and strategically planning these quality certificates as early as possible in the app development.
2. Take care of patients early as subjects for the pivotal / evidence-based studies
Access to patients – the so-called “recruiting” – is currently the biggest problem for approval studies in the pharmaceutical industry, not only because of Corona. The problem is not so much the patients, who usually like to participate in scientific studies, but rather the Study centers. The various ethics committees are used to drug approvals (AMG) and also know the medical device approval procedures (MPG), but the first studies for e.g. sensor technologies or app development and testing are often neither AMG nor MPG studies . The experience with technology development in this “Non-AMG / Non-MPG” area is limited. There are also aspects of data protection, privacy and data management.
Tip: Include sufficient study centers (such as medical practices or clinics) in the project before you apply for approval so that you can recruit enough patients in the first three months. Finally, the option of the so-called Fast Track enables the Diga to be prescribed (for the time being) alongside the registration study. However, the duration of the registration study in this fast track is usually only twelve months. As a result, there is almost no time to organize the study and patient recruitment after the preliminary approval.
3. An accompanying health economic evaluation helps to keep an eye on costs
A very important aspect, which is not highlighted in the guidelines and which is not required at all for scientific evidence, is the question: How expensive is the respective Diga? What can it cost? And how do I actually negotiate the remuneration for each patient after the evidence is provided? It is clear that arguments are necessary for this – and it is probably not enough that only the positive supply effects were achieved.
Tip: A cost-benefit analysis of the Diga is actually not required by the BfArM, but it is more than helpful to plan an accompanying economic evaluation study during the preliminary studies or the approval study. Because after a positive evaluation of the Diga, the final costs still have to be negotiated. At the moment there is still a lot of excitement and hectic about the cost negotiations that follow the approval. The first Diga are already in this phase and it remains important for everyone else to take a close look at these processes. Last but not least, investors will also ask relevant questions if you still need the necessary change for the Diga development.
4. Make sure you think about marketing your Diga
As soon as you, as a Diga manufacturer, have obtained (provisional) approval for the Diga, you can sell it. To do this, however, you have to come to the patients and / or doctors who want the Diga or can prescribe it. Even if the Diga comes to patients directly through the health insurance company, access must be created for marketing. In addition, there are the basics of the advertising ban. This penetration of the open market is enormously underestimated by providers. One can hardly imagine that the medical profession will look forward to hordes of Diga representatives or that they will remember a myriad of passwords and communication platforms. During their medical studies, doctors learned at least something about the use, effects and side effects of drugs – there is not (yet?) The same for the new Diga.
Tip: Think carefully about how you want to reach patients with your Diga (maybe the pharmacies are also a good sales outlet?) – and above all: What does that mean for your own business model? In the medium to long term, there will certainly be bridging technologies here, integration into comprehensive patient data management platforms, the HIS and PVS systems or completely new (tele) medical supply platforms that solve this end of the digitalization initiative in medicine, but currently are the still big open questions that require an individually adapted solution.
It’s all a question of planning
Meeting the Diga requirements is not that easy at first – and also at second – glance. But not impossible either. Above all, it is important to weigh up beforehand whether the undertaking is feasible in terms of time and economy for your – often very young – company. Since every Diga has to be a medical product, you have to face considerable costs and effort. So don’t be reckless with your investment. Diga certification takes a lot of time, but can be more than worthwhile if the decision has been made carefully and if all the peculiarities of the approval process have been observed. Although you should invest a certain amount of time in the approval, it is important not to neglect the (further) development of the product under any circumstances. Because regardless of the approval process, one truth applies universally: Only good apps that are accepted by the user will have long-term success.
