Diao James A, Venkatesh Kaushik P, Raza Marium M, Kvedar Joseph C
Harvard Medical School, Boston, MA, USA.
NPJ Digit Med. 2022 May 11;5(1):61. doi: 10.1038/s41746-022-00604-x.
Due to its enormous capacity for benefit, harm, and cost, health care is among the most tightly regulated industries in the world. But with the rise of smartphones, an explosion of direct-to-consumer mobile health applications has challenged the role of centralized gatekeepers. As interest in health apps continue to climb, national regulatory bodies have turned their attention toward strategies to protect consumers from apps that mine and sell health data, recommend unsafe practices, or simply do not work as advertised. To characterize the current state and outlook of these efforts, Essén and colleagues map the nascent landscape of national health app policies and raise several considerations for cross-border collaboration. Strategies to increase transparency, organize app marketplaces, and monitor existing apps are needed to ensure that the global wave of new digital health tools fulfills its promise to improve health at scale.
由于医疗保健在造福、危害和成本方面具有巨大影响力，它是世界上监管最严格的行业之一。但随着智能手机的兴起，直接面向消费者的移动健康应用程序激增，挑战了集中把关者的角色。随着对健康应用程序的兴趣持续攀升，国家监管机构已将注意力转向保护消费者免受挖掘和销售健康数据、推荐不安全做法或根本无法按宣传效果运作的应用程序影响的策略。为了描述这些努力的现状和前景，埃森及其同事描绘了国家健康应用程序政策的新领域，并提出了一些跨境合作的考虑因素。需要采取提高透明度、组织应用程序市场和监测现有应用程序的策略，以确保新的数字健康工具全球浪潮兑现其大规模改善健康状况的承诺。
