App Prescriptions: Top 5 Challenges for Digital Healthcare Application (DiGA) Providers

In this article, Ivan Pantykin, Vice President, Healthcare & Life Sciences, DACH, outlines certain challenges that DiGA providers need to keep in mind if they want their product to be certified and reimbursed.
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By Ivan Pantykin
Vice President, Healthcare and Life Sciences, Europe
App Prescriptions: Top 5 Challenges for Digital Healthcare Application (DiGA) Providers

When it comes to innovation in the healthcare sector, Germany is leading the pack. Following the implementation of the Digital Healthcare Act (DVG, 2019), digital health applications (DiGAs) are becoming an integral part of the country’s healthcare ecosystem. Now, the 73 million people insured by Germany’s statutory healthcare plan will be able to benefit from this digital health initiative.

In order to have their application approved as a DiGA, companies need to go through the BfArM (The Federal Institute for Drugs and Medical Devices) approval process. However, the BfArM process is complex — in addition to meeting the listed requirements, providers need to struggle with not so obvious challenges to make sure that their product is eligible for prescription. Based on DataArt’s experience of developing DiGAs for our clients in Germany, we have collected the top 5 challenges that your company should keep in mind as it looks to jump into the fast-growing market of digital health apps.

1. Integration with Insurance Companies

DiGAs are designed to be reimbursed by insurance companies, which allows more patients to get access to quality digital healthcare. Therefore, DiGA providers need to integrate with insurance companies’ software. However, most insurers’ application programming interfaces (APIs) are not able to handle the necessary integration and often require DiGA providers to deal with issues that arise. At some point in the future, all insurance companies, or intermediary companies that aggregate integrations with different insurance companies at one single point, will fix these issues. But today, it is essential that DiGA providers learn to manage the technical issues themselves. As a result, many choose to hire a third-party service with expertise in insurance integrations.

2. Data Center Compliance

Unlike in the United States., patient data in Germany cannot be stored with popular cloud providers like AWS, GCP, or Microsoft Azure. That’s because, in accordance with the German law, data that is collected by DiGAs can not be transferred outside the EU. This means that BfArM will not approve a digital healthcare application if it uses a data center based in the U.S. DiGA providers that use U.S. cloud providers or data centers must migrate to local data centers.

Oftentimes, this is more extensive than transferring all data from one provider to another. Digital applications are often tightly integrated with a cloud provider’s services, especially when it comes to authentication, analytics, and other data operating mechanisms. Consequently, migrating this data is a significant effort that can transform a digital health application’s architecture. With this in mind, health app providers often look to make their applications cloud-agnostic, which means that the applications can be moved seamlessly between cloud platforms.

3. Interoperability

Interoperability is an essential feature of digital health applications. DiGAs must integrate with all parties involved in the healthcare ecosystem, including hospitals, pharmacies, physicians and therapists, and insurance companies. At the same time, patients need to have full control over their data.  The DiGA certification process requires health apps to present health data using FHIR (Fast Healthcare Interoperability Resources), an open, internationally recognized interoperability standard for patient data exchanges. Currently, a lack of guidelines regarding the structure of patient data elements in a FHIR profile makes this task difficult to fulfill. As a result, many DiGA providers consult with a technology partner that has experience implementing solutions using FHIR. Interoperability is a significant challenge, but a successful implementation can result in a highly-competitive and compatible DiGA product.

4. Data Protection and Data Security

For healthcare apps, patient data protection is often a challenge. Health information is extremely sensitive and highly vulnerable to cyberattacks. Germany’s Federal Ministry of Health requires DiGA providers to use data security and data protection tools at all times. To ensure data protection and security, BSI (Office for Information Security) has developed guidelines that rely on confidentiality, integrity and availability. Additionally, BSI has come up with regulations that ensure DiGAs meet requirements for information security. This includes security regulations that govern usage, architecture, source code, third-party software, encryption and authentication, data protection, and security regulations associated with patient data. It is essential for DiGA providers to understand the potential threats to data privacy and learn how to address them.

5. UI/UX

Since DiGAs are patient-facing apps, their interface should be user friendly. The role of UI/UX of health applications has long been recognized by digital health providers. However, when designing a DiGA, companies need to consider several additional factors. Like any app, DiGAs must be usable and accessible. But these applications must also be clear and intuitive, so that patients can easily control the app. Providers should keep in mind that DiGAs are not aimed at primary or preventative care and usually serve those with a specific condition. In many cases, DiGAs will be used by the elderly, children, or those with serious developmental conditions. As a result, each DiGA needs to be developed according to the needs of the specific patient user group.

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