German healthcare market is one of the biggest in Europe and worldwide with EUR 457 billion yearly put into the domain and growth at a rate of 5.4 percent over the past five years.
Recently, new rules and legislation were presented in the country with the Digital Healthcare Act, and they introduced a new field: Digital Health Apps (DiGA). Now applications can be prescribed in the way medicine was previously prescribed to a patient by clinicians.
As a company that developed many software products for the German healthcare market, we decided to explore DiGA, its significance, benefits for patients and software developers, new challenges, and the future it holds for healthcare in Germany.
What’s DiGA, and What Value It Holds For App Designers
DiGA stands for Digital Health Applications (Digitale Gesundheitsanwendungen in German). It is a term used to describe mobile applications and software programs that support and contribute to medical treatment, diagnostics, and patient management.
These applications are specifically developed to meet the specific requirements of the German healthcare system and have undergone thorough evaluation processes to guarantee their safety, efficiency, and quality. From the time the legislation act has been accepted digital healthcare apps should be prescribed by doctors, just as they prescribe medications. DiGA oversees and regulates all medical devices and digital technologies, dictating the guidelines for the distribution and usage of these health technologies among patients in the country.
What Does it Mean to App Developers?
In the German healthcare system, prescribed medications and digital health applications are covered and financed by the German healthcare system or insurance, rather than being the financial responsibility of the patient.
This means that if an app is listed on the approved DiGA Directory, doctors throughout the country can start prescribing it, and the German healthcare system will cover the costs associated with using the application. Once your app is added to the DiGA Directory, it allows you to enter the “big boys game” in the healthcare market, transitioning from targeting health-conscious individuals and entities to reaching a wider audience encompassing the general population.
DiGA: The Regulatory Framework
The regulatory framework for DiGA was implemented in Germany in 2020. The evaluation and approval of these applications fall under the responsibility of the Federal Institute for Drugs and Medical Devices (BfArM). To be acknowledged as a DiGA, an app must fulfill specific criteria established by the Federal Office for Social Security (BAS).
For an app to be recognized as a DiGA, it must serve a medical purpose, undergo a favorable benefit-risk assessment, demonstrate measurable health benefits, and adhere to data protection regulations.
Additionally, DiGAs are required to seamlessly integrate into the existing healthcare infrastructure and provide user-friendly interfaces.
Benefits of DiGa Apps for Patients
First and furthermost, DiGa should be convenient for both clinicians and patients. It should bring benefits to all the parties, and it does, in the following ways:
Improved Patient Care
Digital Health Applications (DiGAs) hold the promise of improving patient care through personalized health management, medication reminders, and the monitoring of vital signs. DiGA applications enable patients to access crucial health information, track their progress, and receive guidance on treatment plans, empowering them to actively participate in their well-being.
Efficient Disease Management
DiGAs assist healthcare professionals in managing chronic diseases and promoting preventive care. By facilitating remote monitoring, enabling early symptom detection, and prompt intervention, these apps reduce the burden on healthcare facilities. Additionally, DiGA apps improve patient outcomes and reduce the risk of complications from diseases.
Higher Accessibility
Digital Health Apps are very accessible: anyone with a smartphone can get one. Patients have access to such functions as appointment scheduling, or telemedicine consultations. Virtual consultations allow people to get check-ups from any location and reduce costs by decreasing healthcare facilities’ admission.
Opportunities That Health Data Integration Brings
Digital apps approved by German regulators should be available for integration with Electronic Healthcare Records systems and other software. The seamless flow of data enables healthcare providers to make better-informed decisions, get more for less-obvious insights after looking into patient health trends, and adjust their treatment plans accordingly.
App’s Path to Glory (Being Approved to DiGA Directories)
So the German healthcare system is ready to prescribe the app (i.e. increase its users’ volume), and also to pay for patients’ expenses for using the app. That creates a unique go-to-market strategy for international companies. Does it matter, where is your company based to enter the German market of DiGA? There’s quite a set of steps you need to take, but the initial developer can be from any part of the world.
GDPR Compliance is a Must
Any software business that operates in Europe and processes data has to be GDPR-compliant. This is EU data protection law and all companies with European customers are obliged to follow these guidelines. Being located elsewhere doesn’t free you from the need for these guidelines.
Elinext has experience in delivering GDPR-compliant custom software to its clients. Contact us to get a free quote on your healthcare project that would follow all the international guidelines and will become competitive in any European market.
File an Application to BfArM
There’s a special procedure for GDPR-compliant software to be included in the DiGa directory. BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) has the analog in the USA – FDA – and it treats digital apps the way the American Food and Drugs Administration examines new drugs before issuing the license.
Data requirements are not that strict for the apps, and there are no clinical trials, but everything else is quite similar.
Fast Track your DiGA Application
To support the DiGA initiative, the BfArM has implemented a fast-track process for application review.
This expedited process ensures that applicants receive a response within a timeframe of as little as 3 months. During the review, the regulator focuses specifically on the following aspects:
- Patient safety
- Performance of the app
- GDPR compliance for data protection
- Medical quality
- Evidence of positive outcomes from the application
The regulator has published a comprehensive guide on how to fast-track your DiGa approval. They focus on the compliance and safety of the app more than on anything else.
Ensure Integration with the National Health System and Insurance Companies
The healthcare system in Germany consists of private and public entities. There is a base level of care for all the citizens, and the general population is entitled to buy extra insurance for higher levels of care. All the hospitals (there are around 2,000 of them) in Germany can be broken down into public, charitable, and private. Digital health software must possess the capability to seamlessly integrate with numerous relevant hospitals (all types), health agencies, and insurance companies.
That way, the app will be prescribed very often, and the digital health company will get all the revenue. Once your app is deeply integrated into the health system, the cash flow will be big and imminent.
What’s Next for DiGa?
The idea of prescription medical apps is not new. FDA in the US often approves medical apps: i.e. Diabetes Manager by WellDoc, reSET-O (prescription digital therapeutic for patients with opioid use disorder), and NightWare (helps with PTSD).
International Interest in DiGAs
The concept of DiGAs has attracted attention beyond Germany. Other countries, including Austria and Switzerland, are exploring similar frameworks to regulate and integrate digital health applications into their respective healthcare systems, taking inspiration from the German model.
Startups and Innovation
The introduction of DiGAs has sparked a wave of innovation and startups in the digital health sector in Germany. Numerous entrepreneurs and developers are creating new applications to address unmet healthcare needs and contribute to the expanding DiGA ecosystem. Europe is known for having a vibrant startup ecosystem, and many digital health startups are developing solutions that now could be streamlined and prescribed via the DiGA protocol.
Potential for Research and Data Analysis
The data collected by DiGAs have the potential to contribute to medical research and population health studies. With proper privacy safeguards and ethical considerations, this data can be harnessed to gain insights into disease patterns, treatment effectiveness, and public health trends. While it doesn’t seem like the biggest source to feed machine learning algorithms at the moment, as the number of prescribed apps continues to grow, the ecosystem expands exponentially.
Conclusion
The introduction of Digital Health Applications (DiGAs) in Germany has brought significant advancements and opportunities to the healthcare sector. Integration with the German healthcare system, insurance companies, and relevant health agencies is essential for the success of DiGA apps. This integration allows for wider adoption, increased prescription rates, and payment coverage by the healthcare system.
Elinext is an experienced player in the software healthcare market, and we’ve been delivering custom products to clients for decades. That is partially because we know that compliance is a requirement that can’t be overlooked. We always keep a close look at all the new and existing requirements, and that allows us to guarantee our clients who’d like to streamline their app to DiGA standards, that their fast track to DiGA compliance will indeed take as little time and effort as possible.
