Professor Freimut Schliess, Director of Science & Innovation, at the Profil Institut für Stoffwechselforschung GmbH, illustrates how dissipating initial scepticism of digital health technologies makes for a thrilling challenge for regulators, manufacturers and clinical researchers alike

The discussion about the digitalisation of healthcare and the benefits it can bring to patients and the sustainability of health systems is currently on everyone’s lips. On the other hand, there is scepticism regarding the prescription of digital health technologies (DHTs). Moreover, the high pressure on payers to reimburse the cost of DHTs for relevant patient

populations boosts the demand for high levels of evidence-based on a methodologically rigorous assessment of safety, medical effectiveness and costs. This presents thrilling challenges to regulators, manufacturers and clinical researchers, as most DHTs realise a Software-as-a-Service (SaaS) model with a mode of action that is fundamentally different from those of drugs and conventional medical devices.

In the European Union, a recent framework of evidence generation has been introduced by the new European Medical Devices Regulation 2017/745 (MDR). Alongside, specific requirements for achieving reimbursability were introduced in some countries, such as in Germany and the UK.

One of the main challenges brought by the MDR to digital health technologies is that many DHTs were upgraded to a higher class of device, which might lead to the need of a certification from a Notified Body and performance of clinical investigations that, in many cases, were not required before. It means higher costs and longer time to market. In Germany, the pathway towards reimbursement of digital health applications (DiGAs) requires comparative clinical investigations to be implemented in Germany to demonstrate either medical benefits or patient-relevant improvements of structure and processes in healthcare. The DiGA pathway is accessible solely for DHTs of class I and class IIa. Rather uniquely, the Federal Institute for Drugs and Medical Devices (BfArM) can grant a provisional eligibility for reimbursement for one year, if the clinical study proving a positive healthcare effect is going to be performed in parallel. User experiences collected during the provisional listing can complement the clinical trial outcomes. Thus, although the request for a clinical trial may be perceived as a challenge, this fast-track can provide manufacturers with competitive advantages as it facilitates earlier access to the German reimbursement market.

The National Institute for Health and Care Excellence (NICE) developed a fine-grained evidence standard framework for DHTs commissioned in the UK. The approach appears unique in closely balancing the risk-benefit ratio and the cost-intensity of an individual DHT with the level of evidence required to achieve eligibility for reimbursement. Best practice standards for high-level evidence generation include the conduct of comparative randomised controlled trials in a setting relevant to UK health and social care system. Further, DHT manufacturers are required to provide health economic analyses. For cost-intensive DHTs a cost-utility analysis should reveal whether higher costs could be justified by a corresponding gain in numbers of quality-adjusted life years.

Smart randomised controlled clinical trials

From a clinical research perspective, randomised controlled clinical trials (RCTs) are considered the golden standard for the evaluation of clinical effectiveness.

However, RCTs are sometimes hardly affordable for smaller DHT manufacturers, and outcomes do not always fully reflect real-world healthcare provision. One solution to this problem could be the combination of an RCT design with remote decentralised clinical trial (RDCT) elements: RCTs can be simplified by the usage of a study app, digital assessment tools complementing the DHT and virtual study visits. This not only could increase the external validity of RCTs, but also make them more affordable for smaller companies. Careful considerations with regard to a potential design of a mock DHT (placebo) and the impact of using an app per se on human behaviour are always necessary in order to enable an allocation as accurate as possible of trial outcomes to the intervention under investigation.

Smart RCT designs combining the risk-based approach (MDR) with dynamic approaches oriented to value-based healthcare (VBHC) payment models could pave the way for meeting the challenges of proving eligibility of DHTs for reimbursement. High-level evidence from rigorously designed pre-market RCTs accompanied by strong cost-utility analyses could justify the immediate reimbursement of cost-intensive devices for defined patient groups. In case the manufacturer could initially provide only lower levels of evidence, the device would be entitled of reduced reimbursement. If later subsequent PMCF activities, like post-market clinical investigations, and the continued collection of PROMs corroborate fulfilment of high performance, higher level of reimbursement would be applied.

Overall, Europe appears to be at the beginning of a good way to make DHTs an integral component of VBHC provision. A clear commitment of all stakeholders to high-level scientific evidence from pre-and post-marketing evaluations of clinical and process effectiveness, as well as a strong awareness for costs will help to dissipate initial scepticism and establish a wider acceptance of DHT usage in the management of diseases.


  • This article is part of the RealWorld4Clinic innovation project that develops, in compliance with the MDR 2017/745, a class III DHT for the remote cardiorespiratory health monitoring of heart failure patients and clinical trial participants.
  • RealWorld4Clinic is curated and financially supported by EIT Health, a network of best-in class health innovators that collaborates across borders and delivers solutions to enable European citizens to live longer, healthier lives. EIT Health is funded by the EIT, a body of the European Union.
  • The support of Tatiana Affini Dicenzo (Manager Science & Innovation at Profil Institute for Metabolic Research GmbH) in the creation of this article is greatly acknowledged.


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