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Managing legal risks in health information exchanges: A comprehensive approach to privacy, consent, and liability.
Tariq K Alhasan

Health Information Exchanges (HIEs) are revolutionizing healthcare by facilitating secure and timely patient data sharing across diverse organizations. However, their rapid expansion has introduced significant legal and ethical challenges, particularly regarding privacy, informed consent, and liability risks. This paper critically assesses the effectiveness of existing legal frameworks, including Health Insurance Portability and Accountability Act (HIPAA) and General Data Protection Regulation (GDPR), in addressing these challenges, revealing gaps in their application within HIEs. It argues that current consent models fail to provide meaningful control for patients, while privacy protections are weakened by issues such as re-identification and jurisdictional inconsistencies. Moreover, liability in data breaches remains complex due to ambiguous responsibility among stakeholders. The study concludes that reforms are needed, including dynamic consent models, standardized liability frameworks, and enhanced data governance structures, to ensure secure, ethical, and effective data sharing. These changes are essential to fostering patient trust, improving healthcare delivery, and aligning with Sustainable Development Goal (SDG) 3-ensuring healthy lives and promoting well-being for all.

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引用次数: 0
Integrating enterprise risk management to address AI-related risks in healthcare: Strategies for effective risk mitigation and implementation.
Gianmarco Di Palma, Roberto Scendoni, Vittoradolfo Tambone, Rossana Alloni, Francesco De Micco

The incorporation of artificial intelligence (AI) in health care offers revolutionary enhancements in patient diagnostics, clinical processes, and overall access to services. Nevertheless, this technological transition brings forth various new, intricate risks that pose challenges to current safety and ethical norms. This research explores the ability of enterprise risk management as an all-encompassing framework to tackle these arising risks, providing both a forward-looking and responsive strategy designed for the health care industry. At the core of this method are instruments that together seek to proactively uncover and address AI-related weaknesses like algorithmic bias, system failures, and data privacy issues. On the reactive side, it incorporates incident reporting systems and root cause analysis, tools that enable health care providers to quickly address unexpected events and consistently improve AI implementation procedures. However, some application difficulties still exist. The unclear, "black box" characteristics of numerous AI models hinder transparency and responsibility, prompting inquiries about the clarity of AI-generated choices and their adherence to ethical benchmarks in patient treatment. The research highlights that with the progress of AI technologies, the enterprise risk management framework also needs to evolve, addressing these new complexities while promoting a culture focused on safety in health care settings.

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引用次数: 0
Humbled and honored 谦卑和荣幸。
Josh Hyatt DFASHRM, CPHRM, CPPS, HEC-C
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引用次数: 0
Streamlining incident reporting system: A lean approach to enhance patient and staff safety in a Middle Eastern prehospital emergency care setting 精简事件报告系统:在中东院前急救环境中提高患者和工作人员安全的精益方法。
Hassan Farhat PhD, Guillaume Alinier PhD, Farid Ahmad Sohail PhD, Emna Derbel MSc, Fatma Babay EP. Rekik BN, Rafik Khedhiri BSc, Ma Cleo Alcantara RN, Anish Varghuese MSc, Abraham Ranjith RN, Elizabeth Sidaya MSc, Moza Al Ishaq PhD, Loua Al Shaikh MBBS, James Laughton MBBS

Incident reporting in Emergency Medical Services (EMS) is vital for enhancing patient safety and system performance, but time constraints often impede efficient documentation. Hamad Medical Corporation Ambulance Service Group (HMCASG) implemented a streamlined “Occurrence, Variance, and Accident” (OVA) reporting system to address these challenges. This study evaluated the effectiveness of this system in reducing incident report completion time. A “Lean” approach was used to streamline the reporting process. Four-hundred eighty-two OVA reports (241 baseline, 241 post-intervention) submitted between September 13 and October 8, 2022, were analyzed. The time taken to complete an OVA report was measured. Statistical analyses included Student t-tests, bivariate regression, and a Shewhart control chart. The mean time to complete an OVA report decreased significantly from 328.9 to 145.09 seconds (p < 0.05). The Shewhart control chart visually demonstrated the intervention's impact, while regression analysis confirmed its significance (p = 0.007). The streamlined OVA reporting system significantly reduced reporting time, addressing the challenge of balancing incident reporting with emergency response availability. This lean-based approach enhanced operational efficiency, promoted risk reduction, and strengthened prehospital care's foundation for quality improvement.

紧急医疗服务(EMS)中的事件报告对于提高患者安全和系统性能至关重要,但时间限制往往阻碍有效的记录。哈马德医疗公司救护车服务组(HMCASG)实施了一个简化的“发生、差异和事故”(OVA)报告系统来应对这些挑战。本研究评估了该系统在减少事件报告完成时间方面的有效性。采用了“精简”方法来精简报告程序。分析了2022年9月13日至10月8日期间提交的482份OVA报告(241份基线报告,241份干预后报告)。测量完成OVA报告所需的时间。统计分析包括学生t检验、双变量回归和Shewhart控制图。完成OVA报告的平均时间从328.9秒显著减少到145.09秒(p
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引用次数: 0
Creation of root cause analysis and action (RCA2) standard work by a multidisciplinary team to prevent harm, reduce bias, and improve safety culture 创建一个多学科团队的根本原因分析和行动(RCA2)标准工作,以防止伤害,减少偏见,并改善安全文化。
Donise Musheno MS, RN, CPHQ, Mary Harnish MSN, RN, CPPS, Justin Roberts DO, Andrew Smokowicz MHA, CPHRM

This project aimed to (1) develop a multidisciplinary team to rapidly conduct event analysis, (2) create tools to standardize event communication, (3) expand resiliency support provided to staff, and (4) decrease cycle time between event occurrence and action implementation. A multidisciplinary team was created to investigate safety events. The team developed standard work including key stakeholder notification of the event, a huddle to facilitate immediate mitigation of risk, staff resiliency support, a consistent interview approach, analysis of investigation data, and an accountability meeting to ensure consensus on steps required to prevent future harm. Sustainability is hardwired through ongoing monitoring of metrics. The baseline data collection period was January 2020 through December 2022 (n = 41) and the intervention period was January 2023 through December 2023 (n = 25). First interview time was reduced from 2 days (SD = 2.38) to 1 day (SD = 1.20, p < 0.0001). Mean event finalization decreased from 31 (SD = 13.75) to 13 days (SD = 6.75, p < 0.001). Staff nervousness score decreased from 32.40 pre-interview to 13.96 post-interview (p < 0.001) on a 100-point analog scale. Non-fall related safety events decreased from an average of 10.5 per year between July 1, 2021–June 30, 2023 to a total of 6 between July 1, 2023–June 30, 2024 (p = 0.05).

该项目旨在(1)建立一个多学科团队来快速进行事件分析,(2)创建标准化事件沟通的工具,(3)扩大向员工提供的弹性支持,以及(4)缩短事件发生和行动实施之间的周期时间。成立了一个多学科小组来调查安全事件。该小组制定了标准工作,包括通知主要利益攸关方事件、召开会议以促进立即减轻风险、为工作人员提供复原力支持、采用一致的访谈方法、分析调查数据,以及召开问责会议以确保就预防未来伤害所需的步骤达成共识。通过对指标的持续监控,可持续性是根深蒂固的。基线数据收集期为2020年1月至2022年12月(n = 41),干预期为2023年1月至2023年12月(n = 25)。首次访谈时间从2天(SD = 2.38)减少到1天(SD = 1.20, p
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引用次数: 0
Case law update 法规和条例规定医院在提供急诊服务方面负有不可委托的义务,无论医院是通过自己的工作人员履行这些义务,还是与作为独立承包商的医生签订合同履行这些义务。
Christopher J. Allman JD, CPHRM, DFASHRM, Maggie Neustadt JD, CPHRM, FASHRM
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引用次数: 0
Haddon matrix model: Application to workplace violence in a hospital setting Haddon矩阵模型:应用于医院环境下的工作场所暴力。
Della J. Derscheid PhD, APRN-BC, MS, RN, Christopher Meyer BSN, RN, Judith E. Arnetz PhD, MPH, PT

The aim of this study was to identify hospital-based workplace violence (WPV) risk factors with the Haddon Matrix Model (HMM) to determine its potential utility to conceptualize multiple risks for WPV events. This descriptive study utilized two independent convenience samples Data from behavioral emergencies (2014–2015) for patient violence (N = 192) and from health care staff (N = 380) 12-month violence survey responses (2015) in a Midwestern academic hospital were analyzed. Logistic regression examined patient features associated with physical violence. Survey questions pertained to employee, environment, and cultural factors associated with WPV; responses were examined with Chi-square and two-sample t-tests. Violence risk factors populated the 4 Haddon Matrix domains at pre-event time frames as Host (worker)-age/demographics, Agent (patient)-age/gender, Physical Environment-door/window structure, and Social Environment-worker safety. Risks at event time frames populated for Agent—behavior/delirium, and Physical Environment—event medication/patient identification. The Haddon Matrix identification of hospital violence risks indicates its utility as a comprehensive approach to workplace violence.

本研究的目的是利用Haddon矩阵模型(HMM)识别基于医院的工作场所暴力(WPV)风险因素,以确定其概念化WPV事件多重风险的潜在效用。本描述性研究使用了两个独立的便利样本,分析了中西部一家学术医院12个月暴力调查(2015年)中患者暴力行为急诊(N = 192)和医护人员(N = 380)的数据。Logistic回归分析了与身体暴力相关的患者特征。调查问题涉及与WPV相关的员工、环境和文化因素;采用卡方检验和双样本t检验对应答进行检验。在事件发生前的时间框架内,暴力风险因素填充了4个哈登矩阵域,分别是主人(工人)-年龄/人口统计学,代理人(病人)-年龄/性别,物理环境-门/窗结构和社会环境-工人安全。在agent -行为/谵妄和物理环境-事件用药/患者识别的事件时间框架上的风险。哈登矩阵对医院暴力风险的识别表明其作为一种全面的工作场所暴力方法的效用。
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引用次数: 0
Case law update 判例法更新。
Christopher J. Allman JD, CPHRM, DFASHRM, Maggie Neustadt JD, CPHRM, FASHRM
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引用次数: 0
Identification of patients on chronic prescription opioids at risk for opioid use disorder using pharmacy claims data 利用药房报销数据识别有阿片类药物使用障碍风险的长期处方阿片类药物患者。
Aleesha Jantzen Pharm.D., Scott Thomas Hall Pharm.D., Benjamin Lai MB BCh BAO, Julie L. Cunningham Pharm.D., Laura Odell Pharm.D., MPH

Using pharmacy claims data from a single commercial health plan to identify opportunities for opioid use disorder (OUD) focused screening and interventions communicated via targeted prescriber messaging. Participants included members ≥18 years using more than 90 morphine milligram equivalents (MMED) daily based on all opioid claims, had >1 paid claim for an opioid product, and had ≥90 days of total opioid therapy. Members were excluded with ≥1 claims for an oral chemotherapy agent (except methotrexate). Intervention was completed with a secure communication to the primary outpatient opioid prescriber that included resources for diagnosis, treatment, and best practices for opioid prescribing. The main outcome measure was any documented change to opioid use following the intervention. Seven hundred forty-five members were identified; a subset (n = 20) was further assessed, and all had identified OUD risk factors; providers were subsequently sent a communication. Sixteen providers acknowledged receipt and 11 patients (55%) had at least one documented intervention following communication receipt. Provision of targeted, evidence-based recommendations to providers for patients identified to be at risk of OUD from pharmacy claims data can result in increased recognition and intervention. Future efforts to explore feasibility of provider education detailing efforts and continued evaluation of efficacy are needed.

利用来自单一商业健康计划的药房理赔数据,确定通过有针对性的处方信息进行阿片类药物使用障碍(OUD)重点筛查和干预的机会。参与者包括根据所有阿片类药物报销单每天使用超过 90 吗啡毫克当量 (MMED) 的≥18 岁的会员,有 >1 次阿片类药物产品的付费报销单,且阿片类药物治疗总天数≥90 天。口服化疗药物(甲氨蝶呤除外)报销次数≥1 次的成员不包括在内。通过与阿片类药物主要门诊处方者的安全通信完成干预,其中包括诊断、治疗和阿片类药物处方最佳实践的资源。主要结果指标是干预后阿片类药物使用的任何有记录的变化。共确定了 745 名成员;进一步评估了一个子集(n = 20),所有成员都有已确定的 OUD 风险因素;随后向医疗服务提供者发送了沟通信息。16 名医疗服务提供者确认收到了信息,11 名患者(55%)在收到信息后进行了至少一次记录在案的干预。向医疗服务提供者提供有针对性的循证建议,帮助他们从药房报销数据中识别出有 OUD 风险的患者,可以提高识别率和干预率。今后需要努力探索医疗服务提供者详细教育工作的可行性,并继续对其效果进行评估。
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引用次数: 0
Beyond error: A qualitative study of human factors in serious adverse events 超越错误:对严重不良事件中人为因素的定性研究。
Chenjerai Mujuru MBA, Carmelle Peisah MBBS, MD, FRANZCP

The field of healthcare quality and safety has been informed by the study of Human Factors contributing to adverse events. Hitherto, much of the study of Human Factors has been focused on a narrow lens of human error, identifying cognitive-based or knowledge-based errors and cognitive processes such as loss of situational awareness contributing to error. While these factors are important, this narrow approach fails to consider the complexity of relational and systemic factors that also contribute to adverse events. We aimed to explore the relational and systemic human factors, including shared clinician attitudes and behavior, that contribute to serious adverse patient events in a public health setting. The study, set in a metropolitan local health district in New South Wales, Australia, was conducted using a retrospective qualitative multi-incident content analysis design. Serious adverse event reviews (SAER) over 6 months (2022–2023) were subject to qualitative content analysis until data saturation was reached. Data saturation reached at 20 reports. Emergent themes related to human factors in serious adverse events included: (i) delays and inertia—with a subtheme of inertia of ageism; (ii) “All-or-nothing” approach to end-of-life care and planning; (iii) communication lapses; and (iv) implementation gap between standards and practice. Error-based incidents accounted for only 35% of the serious adverse events examined. The sample studied involved mostly (65%) male patients, with a mean age of 69 (70% aged >65), managed across the gamut of specialties, with the most common incident being the management of acutely deteriorating patients. In conclusion, there is more to Human Factors in adverse events than cognitive or knowledge-based error. While identifying and correcting errors is absolutely essential, we need adjunctive “soft measures” to address clinical attitudes, behaviors, and relationships in health care, particularly in increasingly complex, fraught, and stressful health care environments.

对导致不良事件的人为因素的研究为医疗质量和安全领域提供了信息。迄今为止,对人为因素的研究大多集中在狭义的人为错误上,认为认知错误或知识错误以及认知过程(如丧失情景意识)是导致错误的原因。这些因素固然重要,但这种狭隘的研究方法没有考虑到关系因素和系统因素的复杂性,而这些因素也是造成不良事件的原因。我们旨在探索在公共卫生环境中导致严重不良患者事件的关系和系统性人为因素,包括临床医生的共同态度和行为。这项研究以澳大利亚新南威尔士州的一个大都市地方卫生区为背景,采用回顾性定性多事件内容分析设计。对 6 个月(2022-2023 年)内的严重不良事件回顾(SAER)进行定性内容分析,直至数据达到饱和。20 份报告达到数据饱和。与严重不良事件中的人为因素有关的新主题包括(i) 延迟和惰性--副主题是年龄歧视的惰性;(ii) 临终关怀和规划的 "全有或全无 "方法;(iii) 沟通缺失;(iv) 标准和实践之间的执行差距。在所研究的严重不良事件中,错误事件仅占 35%。所研究的样本大多(65%)涉及男性患者,平均年龄为 69 岁(70% 年龄大于 65 岁),管理范围涉及各个专科,最常见的事件是对病情急剧恶化患者的管理。总之,不良事件中的人为因素不仅仅是认知或知识错误。虽然识别和纠正错误是绝对必要的,但我们还需要辅助性的 "软措施 "来解决医疗保健中的临床态度、行为和关系问题,尤其是在日益复杂、紧张和压力巨大的医疗保健环境中。
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引用次数: 0
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Journal of healthcare risk management : the journal of the American Society for Healthcare Risk Management
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