Weber Jens H, Costa Oscar
University of Victoria, Victoria, BC, Canada.
AMIA Jt Summits Transl Sci Proc. 2020 May 30;2020:693-702. eCollection 2020.
Interoperability between heterogenous (health) IT systems relies on standards, which are communicated to system vendors in the form of so-called conformance profiles. Clinical information systems are often subjected to mandatory conformance testing and certification prior to being admitted into the health information exchange (HIE). The requirements specified in conformance profiles are therefore instrumental for ensuring the correctness and safety of the emerging HIE network. How can we ensure the quality and safety of conformance requirements themselves? We have adapted a system-theoretic hazard analysis method (STPA) for this purpose and applied it to an industrial case study in British Columbia, the Clinical Data eXchange (CDX) system. Our results indicate that the method is effective in detecting missing and erroneous constraints.
异构（健康）信息技术系统之间的互操作性依赖于标准，这些标准以所谓的一致性概要文件的形式传达给系统供应商。临床信息系统在被纳入健康信息交换（HIE）之前，通常要经过强制性的一致性测试和认证。因此，一致性概要文件中规定的要求对于确保新兴的HIE网络的正确性和安全性至关重要。我们如何确保一致性要求本身的质量和安全性呢？我们为此采用了一种系统理论危害分析方法（STPA），并将其应用于不列颠哥伦比亚省的一个工业案例研究——临床数据交换（CDX）系统。我们的结果表明，该方法在检测缺失和错误的约束方面是有效的。
