How to evaluate health and medical apps in public health - what are alternatives to randomized controlled trials?
Felix Holl 2,3,4
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SOCIUM Research Center on Inequality and Social Policy, University of Bremen, Bremen, Germany
Leibniz ScienceCampus Digital Public Health Bremen, Bremen, Germany
DigiHealth Institute, Neu-Ulm University of Applied Sciences, Neu-Ulm, Germany
Institute for Medical Information Processing, Biometry, and Epidemiology, Ludwig Maximilian University of Munich, Munich, Germany
Charité–Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Health and Nursing Science, Berlin, Germany
Publication date: 2023-04-27
Popul. Med. 2023;5(Supplement):A644
How people monitor their health has changed drastically during the last years since the widespread accessibility of smartphones. Since then, thousands of apps have been developed to promote health and prevent diseases. They can also improve the patient’s autonomy and reduce the workload burden on health professionals. However, these apps can also have downsides, as their evidence is not always available. Instead, some studies discuss a gap in long-term evidence regarding health apps. To tackle this, many countries started to regulate medical apps (a subgroup of health apps) as mobile medical devices. In Germany, the Digital Healthcare Act has regulated the prescription and reimbursement for medical apps as digital health applications (DiGA) since October 2020. To be listed as a DiGA, medical apps must demonstrate positive medical benefits and patient-relevant structural and procedural improvements through suitable methods (e.g., randomized controlled trials (RCT)). While RCTs are considered the gold standard for evaluating causal relationships between tools and resulting health outcomes, they might not be suitable for the digital environment. Software (such as apps) is characterized by its evolving process at a rapid pace. This doesn’t work well with the average 5.5 years duration of an RCT with a strict study protocol. Additionally, such extensive research is expensive and nearly impossible to finance for health technology start-ups. This workshop will argue that RCTs have limitations when evaluating health or medical apps. We will introduce the participants briefly to the three core principles (3 talks, 5 minutes each) before discussing possible alternatives. To start, Laura Maaß will present the differences between health and medical apps and why differentiation is crucial when discussing their evidence. Building on this, Felix Holl will display the regulation of medical apps in Germany as DiGA and why Germany decided to use RCTs as the primary evaluation method. Lastly, Robert Hrynyschyn will explain why RCTs have limitations in evaluating health and medical apps and what alternatives exist. Once the participants gain insights into the problem, we will divide the audience into smaller groups to collect and prioritize the challenges for assessing health and medical apps during the development, evaluation, and implementation phases. The groups will then formulate solutions and assessment designs based on this Discussion. Finally, the group’s Results will be presented to the audience and discussed with the whole group. We will use the Results from the workshop for a white paper on alternative methods for assessing and evaluating health and medical apps to make the Results public to interested researchers and policy-makers outside this conference. Workshop Objectives: The workshop’s objective is to discuss the challenges of applying methods to digital health tools that weren’t designed to evaluate the digital environment. Together with the participants, we aim to find alternatives for RCTs as the new gold standard for assessing digital public health interventions. Workshop key questions: What public health challenges arise in using, evaluating, and regulating health and medical apps? How can those challenges be addressed to create a higher impact on healthcare systems?
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