Digital Health Apps in Germany – An Update on the DiGA Journey


Digital therapies, or digital health applications (DiGA), are applications for the detection, monitoring, treatment or mitigation of medical conditions. The DiGA initiative is part of the Digital Healthcare Act (DVG) of 2019 which defines the legal framework allowing doctors to prescribe DiGA to the 73 million citizens insured with a compulsory health insurer who reimburses their use, and has been recognized. as a pioneering approach on a global scale. To be classified as DiGA, applications that are CE marked as low risk Class 1 and 2a medical devices must have successfully passed the Expressway evaluation process by the Federal Institute for Drugs and Medical Devices (BfArM). The assessment assesses an application with regard to its security, performance, data protection, information security, medical efficiency, interoperability, ability to have positive health effects and to do advancing the health system, among others.

The first DiGAs were cleared for use in October 2020, and now a total of 24 are approved (as of November 29, 2021). So far 106 applications have been submitted, of which six have been rejected and 52 withdrawn – due to inappropriate study design (42%) and inadequate systematic data assessment (42%). Currently, 24 applications are under review. Approved DiGAs cover a range of medical fields including: cancer (2); cardiovascular system (1); ears (1); hormones and metabolism (3); muscles & bones & joints (3); nervous system (3) and psyche (11).

Initially, DiGA developers came from the startup field, but interest from medical and pharmaceutical technology companies – as well as industry associations is growing. The majority (86%) of applications are “made in Germany”, with 10% of DiGA applicants based in other European countries and 4% in the United States and New Zealand.

According to the Center for Health Innovation (hih), a think tank and supporter of the implementation of the German Federal Ministry of Health’s digitization efforts, doctors prescribed DiGAs approximately 50,000 times between October 2020 and November 2021. It was slightly below hih’s expectations. – but could be attributed to the time it takes to train doctors in the use of these new tools.

Best practices need to be shared and opinion leaders need to be involved to increase the number of prescriptions. The fact that some DiGAs are more commercially successful than others suggests that salespeople need to engage in marketing activities to familiarize physicians and patients with their products. The developers at DiGA have admitted to underestimating the effort required to bring them to market.

WHY IS IT IMPORTANT

The 2018 study ‘Intelligent health systems, The international comparison of digital strategies examined the extent to which 18 selected countries had digitized their healthcare delivery. The fact that the study ranks Germany in 17th place may have been a late call to action. German Federal Health Minister Jens Spahn, who took office in March 2018, has enacted a series of laws that advance the digitization of healthcare delivery in Germany.

Despite a slow start compared to its European neighbors, Germany’s digitization efforts surged with the launch of DiGA. There are several notable leading approaches. First, applications can be prescribed and reimbursed, the latter depending on an application’s ability to improve patient-relevant healthcare structures and processes, such as facilitating access to care or coping with challenges related to patient care. disease in everyday life. However, DiGAs are not stand-alone and as one in a digital healthcare delivery ecosystem, with other elements such as electronic health records (EHRs) and e-prescribing incorporated. Therefore, BfArM’s focus on DiGA interoperability becomes increasingly important to ensure that data captured through an application can be transferred to a patient’s EHR and integrated into physician workflows. .

Based on the favorable reception given to DiGAs, the Federal Ministry of Health hopes that the range of medical conditions covered by DiGAs will continue to expand. In addition, the DiGA concept will be applied in the field of nursing with the creation of digital nursing applications (DiPA) which will be launched on January 1, 2022. Their objective is to help organize and manage nursing tasks, in particular with a view to supporting people who take care of their loved ones at home. Additionally, DiGAs provide the ability to collect real-world data that can be used for population health management and research purposes to advance patient outcomes. However, these are clearly the first days for DiGAs and BfArM has announced its intention to toughen up the certification process. Calls have also been made to make the DiGA available to the ten million citizens who are privately insured.

THE BROADER CONTEXT

The German approach has inspired other countries to take a closer look at reimbursable applications. In October, French President Emmanuel Macron announced his intention to replicate the DiGA reimbursement system and hih was also reportedly interested in North America and other European countries in incorporating elements of the DiGA approach into their strategies. health online. Representatives from Belgium, Denmark, Finland, France, Ireland, Luxembourg, Spain and Sweden spoke at a recent hih event as part of a joint effort to harmonize the access to the reimbursable medical applications market across Europe. As they all face similar challenges, they felt that the German DiGA approach was useful and could be used as a model for their own respective efforts. They agreed to continue multilateral talks, also at EU level.

ON THE RECORD

“There is a market for digital therapies. We did something very non-Germanic, trying something new and at the same time improving it in an agile way, ”commented Dr Gottfried Ludewig, Head of Digitization and Innovation, Federal Ministry for Health.

Dr Wiebke Löbker, Head of Innovation and Change Management, BfArM, stressed that DiGas are part of a connected healthcare system: “The positive effects on healthcare are important, but the interoperability increasingly so, so that data can be transferred to the EHRs. There will be more future requirements regarding data transfer to enable a connected e-health ecosystem. “

“DiGAs need to be integrated into physician workflows and included in EHRs. We need clear processes for DiGAs to be reimbursed by private insurers. Other countries are looking to Germany to copy the processes. No one thought it would be possible for Germany to become a leader in some areas of eHealth, ”said Nora Blum, co-founder of Selfapy.

In addition, Christian Oberlé, President, CNS, Luxembourg concluded: “Germany has succeeded in a short period of time, which is inspiring. DiGAs create momentum that helps digitize healthcare. It gives hope to others ”.


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