Digital therapeutics, or Digital Health Applications (DiGA), are apps for the detection, monitoring, treatment, or alleviation of medical conditions. The DiGA initiative is part of the 2019 Digital Healthcare Act (DVG) that sets the legal framework for doctors to prescribe DiGAs to the 73 million citizens insured with a statutory health insurer that reimburses their use, and has been recognised as a pioneering approach globally. To classify as a DiGA, apps that are CE-marked as Class 1 and 2a low risk medical devices must have successfully passed the Fast-Track assessment process by the Federal Institute for Drugs and Medical Devices (BfArM). The assessment appraises an app with regards to its safety, performance, data protection, information security, medical effectiveness, interoperability, its ability to bring positive health effects and advance the healthcare system, among other things.
The first DiGAs were authorised for use in October 2020, and now a total of 24 are approved (as of 29 Nov 2021). So far, 106 applications were submitted, of which six were rejected and 52 withdrawn – on the grounds of inappropriate study design (42%) and inapt systematic data evaluation (42%). Currently 24 apps are under review. The approved DiGAs cover a range of medical fields including: cancer (2); cardiovascular system (1); ears (1); hormones & metabolism (3); muscles & bones & joints (3); nervous system (3) and psyche (11).
Initially, DiGA developers stemmed from the startup domain, but interest from medtech and pharma companies – as well as industry associations is increasing. The majority (86%) of applications are “made in Germany”, with 10% of DiGA applicants based in other European countries and 4% in the US and New Zealand.
According to the health innovation hub (hih), a think-tank, and implementation supporter for the digitisation efforts of the German Federal Ministry of Health, doctors prescribed DiGAs around 50,000 times between October 2020 and November 2021. This was slightly below the hih’s expectations – though could be attributed to the time it takes to educate doctors on the use of these new tools.
Best practices must be shared, and opinion leaders need to be involved to drive up prescription numbers. The fact that some DiGAs are more commercially successful than others suggests that vendors must engage in marketing activities to familiarise doctors and patients with their products. DiGA developers have conceded that they had underestimated the effort it takes to commercialise them.
WHY IT MATTERS
The 2018 study ‘Smart Health Systems, International comparison of digital strategies’ examined to what extent 18 selected countries had digitised their healthcare delivery. The fact that the study ranked Germany in 17th place may have acted as a overdue wake-up call for action. The Federal German Health Minister, Jens Spahn, who assumed office in March 2018, has enacted a series of laws that advance the digitisation of healthcare delivery in Germany.
Despite the slow start compared to its European neighbours, Germany’s digitisation efforts leaped forward with the launch of DiGAs. There are several notable leading approaches. Firstly, apps can get prescribed and reimbursed, with the latter being dependent on an app’s ability to improve patient-relevant structures and processes in healthcare such as facilitating access to care or coping with illness-related difficulties in everyday life. However, DiGAs do not stand alone and are one piece in a digitally supported healthcare delivery ecosystem, with other elements such as electronic health records (EHR) and e-prescribing incorporated. Therefore, the BfArM emphasis on the interoperability of DiGAs is becoming increasingly important to ensure that the data captured via an app can be transferred into a patient’s EHR and integrated into doctors’ workflows.
Based on the positive reception of DiGAs, the Federal Health Ministry hopes that the range of medical conditions supported by DiGAs will continue to grow. Moreover, the DiGA-concept will be applied in the nursing field with the creation of the so-called digital nursing applications (DiPA) to be launched on 1 January 2022. Their aim is to assist organising and managing nursing tasks, especially with a view to support those looking after relatives at home. Additionally, DiGAs offer an opportunity to collect real-world data that can be used for population health management and research purposes to advance patient outcomes. However, these are cleatrly early days for DiGAs and the BfArM announced plans to tighten the certification process. There have also been calls to make DiGAs available to the ten million privately insured citizens.
THE LARGER CONTEXT
The German approach has inspired other countries to look closer at reimbursable apps. In October, French President Emmanuel Macron announced plans to replicate the DiGA reimbursement scheme and the hih has also reportedly had interest from North America and other European countries to integrate elements of the DiGA approach into their eHealth strategies. Representatives from Belgium, Denmark, Finland, France, Ireland, Luxemburg, Spain and Sweden spoke at a recent hih event in a joint effort to harmonise market access for reimbursable medical apps across Europe. As they all face similar challenges, they felt that the German DiGA approach was helpful and could be used as a template for their own respective efforts. They agreed to continue with multilateral talks, also on an EU-level.
ON THE RECORD
“There is a market for digital therapies. We did something very non-Germanic by trying something new and improving it at the same time in an agile way,” commented Dr Gottfried Ludewig, Head of Digitisation and Innovation, Federal Ministry of Health.
Dr Wiebke Löbker, Head of Innovation and Change Management, BfArM, emphasised that DiGas are part of a connected healthcare system: “Positive healthcare effects are important, but increasingly so is interoperability, so that data can be transferred to EHRs. There will be more future requirements regarding data transfer to enable a connected eHealth ecosystem.”
“DiGAs need to be integrated into the physicians’ workflows and included into EHRs. We need clear processes for DiGAs to be reimbursed from private insurers. Other countries are looking at Germany to copy the processes. Nobody thought this would be possible for Germany to become a leader in some eHealth respects,” said Nora Blum, Co-Founder, Selfapy.
Furthermore, Christian Oberlé, President, CNS, Luxemburg concluded: “Germany succeeded in a short time frame, which is inspiring. DiGAs create a dynamic that helps the digitisation of healthcare. This gives hope to others”.
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