Sittig Dean F, Wright Adam
Center for Healthcare Quality & Safety, McWilliams School of Biomedical Informatics, University of Texas Health Science Center at Houston, Houston, Texas, USA.
Informatics-Review LLC, Lake Oswego, Oregon, USA.
J Healthc Risk Manag. 2023 Oct;43(2):37-47. doi: 10.1002/jhrm.21553. Epub 2023 Jul 24.
Following the American Recovery and Reinvestment Act in 2009, use of electronic health records (EHRs) has become ubiquitous. Accordingly, one should expect most medical professional liability cases to involve review of patient records produced from EHRs. When questions arise regarding who was involved in care of a patient, what they knew and when, or the meaning, completeness, integrity, validity, timeliness, confidentiality, accuracy, or legitimacy of data, or ways that the EHR's user interface or automated clinical decision support tools may have contributed to the alleged events, one often turns to the EHR and its audit log. This manuscript discusses lines of defense incorporated into the design, development, implementation, and use of EHRs to ensure their integrity and the types of EHR transaction logs (e.g., audit log) that exist. Using these logs can help one answer questions that often arise in medical malpractice cases. Finally, there are "best practices" surrounding EHR audit logs that health care organizations should implement. When used appropriately, EHRs and their audit logs provide another source of information to help hospital risk managers, legal counsel, and EHR expert witnesses to investigate adverse incidents and, if needed, prosecute or defend clinicians and/or health care organizations involved in the patient's care.
2009年《美国复苏与再投资法案》颁布之后,电子健康记录(EHR)的使用变得十分普遍。因此,可以预料到大多数医疗职业责任案件都会涉及对电子健康记录所生成的患者记录的审查。当出现关于谁参与了患者护理、他们知道什么以及何时知道、数据的含义、完整性、准确性、有效性、及时性、保密性、正确性或合法性,或者电子健康记录的用户界面或自动化临床决策支持工具可能对所称事件有所促成的方式等问题时,人们往往会求助于电子健康记录及其审计日志。本文讨论了纳入电子健康记录的设计、开发、实施和使用过程中以确保其完整性的防御措施,以及现有的电子健康记录交易日志(如审计日志)的类型。使用这些日志有助于回答医疗事故案件中经常出现的问题。最后,医疗保健机构应当实施围绕电子健康记录审计日志的“最佳实践”。如果使用得当,电子健康记录及其审计日志可提供另一信息来源,以帮助医院风险管理人员、法律顾问和电子健康记录专家证人调查不良事件,并在需要时对参与患者护理的临床医生和/或医疗保健机构进行起诉或辩护。