EIT Health Germany Series 7: How Can A Digital Health Solution Become a "DiGA App" in Germany?
With the digital health market maturing, startups increasingly need to not only offer a good user experience but also comply with rigorous regulatory requirements and test their solutions in clinical trials. They need to go through long certification processes. For a few years now, Germany has in place a clear workflow for making digital health apps reimbursable.
A German startup, ProCarement developed a digital care solution for patients with heart failure. The solution encompasses three components: an MDD-certified mobile app for the patient to record his vital parameters, ProCarement Care Centers with individual personal contacts for patient care, and a protected web portal for medical providers.
Since April 2022, doctors in Germany can get reimbursed for telemedicine services for patients with heart failure. ProCarement is trying to help healthcare providers adopt a hybrid model of care for heart failure patients through a B2B2C model. At the moment, the company doesn’t sell anything directly to patients. However, patients taken care of by professionals in the ProCarement network do use an application that enables them to store all the medical data from medical devices (blood oxygen saturation, blood pressure, ECG, etc. through Bluetooth transmission). Patient data is then transferred to the care center, where heart failure specialized nurses monitor patients and can call them in case of a detected problem. Clinicians can access patient data through a web portal.
How does an app become a prescribable DiGA app?
Germany has a clear process in place for apps to be on the list of mobile apps which can be prescribed by the doctor and then reimbursed by health insurance. When an app becomes a DiGA app, it has to be reimbursed. In the past, innovators had to negotiate reimbursement with each health insurance company separately, and there are over 100 health insurance companies in Germany.
In August 2022, there were 35 applications in the DiGA repository. In order to be among them, ProCarement team is currently working with the regulator BfArM, which needs to approve the study design of applications applying to be listed as DiGA apps.
When assessing an application for DiGA, BfArM examines the manufacturer's information on, among other things, security, performance, data protection, medical quality and interoperability of the DiGA as well as the scientific evidence of its positive supply effect.
“We started our study in April 2022. We currently have 100 patients for the study with an objective to include 500 patients in the upcoming months. Due to regulations, it's not allowed to publish any study results before end of 2023. I can share that we already finished a pre-study last autumn with 70 patients here in Nuremberg. We showed a very positive effect on health status, quality of life, self-care of patients, as well as health literacy as. This is one of the most decisive parts of all these studies where we tried to show and measure guideline conformity of the physicians and patients which will, in the end, have a massive effect on adherence and with that, very positive health benefits,” explains Jörg Trinkwalter, the Managing Director at ProCarement.
Next step: France
In June, a research paper published in the Journal of medical internet research revealed the clinical robustness of digital health startups. The US researchers assessed the clinical robustness ob 224 US startups with an average age of 7.7. These companies were scored from 1-10 based on their clinical robustness, and only 20% received a score of 5 or more, and 44% had a clinical robustness score of 0.
Funding and clinical robustness across various clinical areas.
Source: ©Sean Day, Veeraj Shah, Sari Kaganoff, Shannon Powelson, Simon C Mathews. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 20.06.2022.
“Startups in Europe need to fulfill a lot of regulatory requirements in order to have a chance to get reimbursement. DiGA requires a CE certification Class I or II, it requires scientific pre-studies, it requires strict data protection according to GDPR, and you also need to be ISO 27001 certified for data protection. What is more difficult from my perspective are all aspects in terms of interoperability here in Germany and Europe. Here in Germany, we still have a lot of proprietary software systems in the clinics, with very limited open interfaces. This has a massive impact on usability for healthcare professionals, but also for patients,” comments Jörg Trinkwalter.
Procarement is participating in the current cohort of the EIT Health DiGinovation program. The Diginovation program links start-ups with an international consortium to accelerate the reimbursement of digital health apps in Europe. This will help the company speed up the reimbursement process for the French market.
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Questions addressed:
Heart failure is a gradual weakening of the heart. It prevents the heart from pumping as blood well as it should and can gradually cause kidney damage or failure, liver damage, heart rhythm, and heart valve problems. There are various apps on the market for heart Failure risk scoring, apps for patients to record symptoms and manage medications, and apps with educational materials. ProCarement offers you this tailor-made solution for setting up telemedical centers (TMZ) to enable better care for heart failure patients. Can you explain in a little bit more detail what you are managing?
How many doctors and patients are you currently working with? The company is only three years old.
What was your development pathway: how did you get to your first customers?
You are currently running a study to collect medical benefits and positive healthcare effects of app-based, guideline-compliant patient support. How far along is the study, how many patients will be included, and when do you anticipate you will be able to present results?
What does the current research say about the impact of digital health interventions on heart failure? What concrete results can you share with us?
In June, research was published in the Journal of medical internet research about the clinical robustness of digital health startups. The US researchers assessed the clinical robustness ob 224 US startups with an average age of 7.7. These companies were scored from 1-10 based on their clinical robustness; and only 20% received a score of 5 or more, and 44% had a clinical robustness score of 0. What trends are you observing in Europe in terms of clinical robustness?
As the digital health market matures, we see increasing demands for clinical validation of applications. You are MDD certified and are working towards the MDR certification. From your perspective: how did you approach certification? (what is required, what were the steps in your case…)
You participated in the DiGinnovation Programme, which helps startups through the reimbursement processes of digital health apps in Europe. How did this program help you? The challenge with Europe is that each country has specific requirements on top of the European legislation.
Does MDR certification come before national legislation? Or can you get reimbursement without MDR?
You are targeting German-speaking countries. Can you outline what differences in reimbursement requirements have come across so far?
How is the DiGinnovation program helping you on the reimbursement journey?
What would you advise companies that have not yet undergone the MDR certification process?
