Szarfman Ana, Levine Jonathan G, Tonning Joseph M, Weichold Frank, Bloom John C, Soreth Janice M, Geanacopoulos Mark, Callahan Lawrence, Spotnitz Matthew, Ryan Qin, Pease-Fye Meg, Brownstein John S, Ed Hammond W, Reich Christian, Altman Russ B
U.S. Food and Drug Administration, Silver Spring, MD 20993 USA.
Independent Researcher, Rockville, MD 20855 USA.
Commun Med (Lond). 2022 Jul 18;2:86. doi: 10.1038/s43856-022-00148-x. eCollection 2022.
Easy access to large quantities of accurate health data is required to understand medical and scientific information in real-time; evaluate public health measures before, during, and after times of crisis; and prevent medical errors. Introducing a system in the USA that allows for efficient access to such health data and ensures auditability of data facts, while avoiding data silos, will require fundamental changes in current practices. Here, we recommend the implementation of standardized data collection and transmission systems, universal identifiers for individual patients and end users, a reference standard infrastructure to support calibration and integration of laboratory results from equivalent tests, and modernized working practices. Requiring comprehensive and binding standards, rather than incentivizing voluntary and often piecemeal efforts for data exchange, will allow us to achieve the analytical information environment that patients need.
要实时理解医学和科学信息、在危机发生前、期间和之后评估公共卫生措施以及预防医疗差错，就需要能够轻松获取大量准确的健康数据。在美国引入一个能够高效获取此类健康数据并确保数据事实可审计性、同时避免数据孤岛的系统，将需要对当前做法进行根本性变革。在此，我们建议实施标准化的数据收集和传输系统、为个体患者和终端用户设置通用标识符、建立一个参考标准基础设施以支持等效检测的实验室结果的校准和整合，以及现代化的工作实践。要求制定全面且具有约束力的标准，而不是激励自愿且往往零散的数据交换努力，这将使我们能够实现患者所需的分析信息环境。
