Health app policy: international comparison of nine countries’ approaches

Abstract

An abundant and growing supply of digital health applications (apps) exists in the commercial tech-sector, which can be bewildering for clinicians, patients, and payers. A growing challenge for the health care system is therefore to facilitate the identification of safe and effective apps for health care practitioners and patients to generate the most health benefit as well as guide payer coverage decisions. Nearly all developed countries are attempting to define policy frameworks to improve decision-making, patient care, and health outcomes in this context. This study compares the national policy approaches currently in development/use for health apps in nine countries. We used secondary data, combined with a detailed review of policy and regulatory documents, and interviews with key individuals and experts in the field of digital health policy to collect data about implemented and planned policies and initiatives. We found that most approaches aim for centralized pipelines for health app approvals, although some countries are adding decentralized elements. While the countries studied are taking diverse paths, there is nevertheless broad, international convergence in terms of requirements in the areas of transparency, health content, interoperability, and privacy and security. The sheer number of apps on the market in most countries represents a challenge for clinicians and patients. Our analyses of the relevant policies identified challenges in areas such as reimbursement, safety, and privacy and suggest that more regulatory work is needed in the areas of operationalization, implementation and international transferability of approvals. Cross-national efforts are needed around regulation and for countries to realize the benefits of these technologies.

What Intervention Elements Drive Weight Loss in Blended-Care Behavior Change Interventions? A Real-World Data Analysis with 25,706 Patients

“…Finally, clinical trials, especially randomized controlled trials, will need to be conducted to drive BBCI research and corroborate findings from real-world data analyses such as the study at hand. The resulting evidence base will be crucial to inform decision-making within the growing number of healthcare systems that embrace BBCI [ 45 ]. To conclude, this study adds to a growing body of research on the efficacy of BBCI for weight loss and documents their multifaceted impact per treatment phase in a real-world care setting.…”

Regulatory considerations to keep pace with innovation in digital health products

“…It is estimated that in 2020, over 90,000 new digital health apps were released, with the majority focused on “wellness management” 5 . As many apps in this space make claims that may be easily interpreted as medical 6 , understanding which apps are targeting wellness vs. formal medical management may not always be straightforward for clinicians and patients 7 . For example, an app offering CBT could fall outside the FDA’s scope if it aims to promote or encourage healthy … activities generally related to a healthy lifestyle or wellness , but the same app could qualify for enforcement discretion if it instead offers to help users maintain their behavioral coping skills by providing a “Skill of the Day” behavioral technique 8 .…”

Has the pandemic enhanced and sustained digital health-seeking behaviour? A big data interrupted time-series analysis of Google Trends

“…United Kingdom and Australia) and more digitally hesitant countries (e.g. United States) (9,10), thus providing a balanced representation of search behaviour across countries at various stages of digital health development.…”

“…We extracted weekly relative search volume data for Canada, the United States, the United Kingdom, New Zealand, Australia, and Ireland from 1 February 2019 to 1 August 2021 (n=780 country-weeks). The six countries were chosen because they share English as their dominant language and provide a varied representation in policy landscape regarding digital health (9,10). Google is used for 87% to 93% of the online search queries in the countries under study (32)(33)(34), meaning our data accurately captures the preferences of the population of the countries under study.…”

“…For instance, the design process of digital health solutions is indicative of which populations it will be able to reach and, equally importantly, what population groups will experience difficulties in accessing and using the tool (3,9). Policy environments are also vital to laying the foundation of how conducive a health system is to adopting a digital health solution and how health professionals are trained in the field of digital health (3,9,10). Finally, the readiness and willingness of digital health users are crucial elements in adopting digital health solutions (2,8).…”