Essén Anna, Stern Ariel D, Haase Christoffer Bjerre, Car Josip, Greaves Felix, Paparova Dragana, Vandeput Steven, Wehrens Rik, Bates David W
House of Innovation, Stockholm School of Economics, Stockholm, Sweden.
Harvard Business School, Harvard University, Boston, MA, USA.
NPJ Digit Med. 2022 Mar 18;5(1):31. doi: 10.1038/s41746-022-00573-1.
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.
商业科技领域存在大量且不断增长的数字健康应用程序（应用），这可能会让临床医生、患者和支付方感到困惑。因此，医疗保健系统面临的一个日益严峻的挑战是，帮助医疗从业者和患者识别安全有效的应用，以产生最大的健康效益，并指导支付方的覆盖范围决策。几乎所有发达国家都在尝试制定政策框架，以在这种背景下改善决策、患者护理和健康结果。本研究比较了九个国家目前正在制定/使用的针对健康应用的国家政策方法。我们使用二手数据，结合对政策和监管文件的详细审查，以及对数字健康政策领域关键人物和专家的访谈，来收集有关已实施和计划中的政策及举措的数据。我们发现，大多数方法旨在建立健康应用审批的集中渠道，尽管一些国家正在增加分散化元素。虽然所研究的国家采取了不同的路径，但在透明度、健康内容、互操作性以及隐私和安全等领域的要求方面，仍存在广泛的国际趋同。大多数国家市场上应用的数量之多，对临床医生和患者来说是一个挑战。我们对相关政策的分析确定了报销、安全以及隐私等领域的挑战，并表明在审批的操作化、实施和国际可转移性等领域需要更多的监管工作。在监管方面需要跨国努力，以便各国实现这些技术的益处。
