Are informed policies in place to promote safe and usable EHRs? A cross-industry comparison.
Are informed policies in place to promote safe and usable EHRs? A cross-industry comparison.
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是否制定了明智的政策来促进安全和可用的电子病历？
DOI：
10.1093/jamia/ocw185
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
Ratwani,RajM
中科院分区：
文献类型：
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作者：
Savage,EricaL;Fairbanks,RollinJ;Ratwani,RajM
目标：尽管国家协调员办公室（ONC）制定了联邦政策，以促进安全和可用的电子健康记录（EHR）产品，但电子健康记录的可用性继续使供应商感到沮丧，并对患者安全产生影响。本研究旨在比较三个联邦机构在可用性和安全性方面的政府政策，以及检查这些政策合规性的方法：ONC和ehr，联邦航空管理局（FAA）和航空电子设备，以及食品和药物管理局（FDA）和医疗设备。我们的目标是确定政策是否存在差异，如果存在差异，如何应用其他行业的政策和执行机制来优化EHR可用性。方法：我们使用公开可用的管理文件进行定性研究，以检查各机构在可用性和安全政策方面的异同。结果：政策审查和分析揭示了每个机构的可用性政策中的几个一致性。这三个机构在可用性标准和政策执行机制方面出现了重大差异。FAA和FDA着眼于可用性过程的证据，与ONC相比，在测试最终产品时，FAA和FDA的规定更多，而ONC依赖于认证，规定较少。讨论：跨行业的可用性政策的比较说明了ONC和其他联邦机构之间的主要区别。这些差异可能会导致与电子病历相关的可用性挑战。结论：我们的分析突出了其他行业的可用性和安全政策的重要领域，这些领域可以更好地为ONC的电子病历政策提供信息。
Objective:Despite federal policies put in place by the Office of the National Coordinator (ONC) to promote safe and usable electronic health record (EHR) products, the usability of EHRs continues to frustrate providers and have patient safety implications. This study sought to compare government policies on usability and safety, and methods of examining compliance to those policies, across 3 federal agencies: the ONC and EHRs, the Federal Aviation Administration (FAA) and avionics, and the Food and Drug Administration (FDA) and medical devices. Our goal was to identify whether differences in policies exist and, if they do exist, how policies and enforcement mechanisms from other industries might be applied to optimize EHR usability.Method:We performed a qualitative study using publicly available governing documents to examine similarities and differences in usability and safety policies across agencies.Results:The policy review and analysis revealed several consistencies within each agency’s usability policies. Critical differences emerged in the usability standards and policy enforcement mechanisms utilized by the 3 agencies. The FAA and FDA look at evidence of usability processes and are more prescriptive when it comes to testing final products as compared to the ONC, which relies on attestation and is less prescriptive.Discussion:A comparison of usability policies across industries illustrates key differences between the ONC and other federal agencies. These differences could be contributing to the usability challenges associated with EHRs.Conclusion:Our analysis highlights important areas of usability and safety policy from other industries that can better inform ONC policies on EHRs.