CLINICAL SOFTWARE QUALITY REVIEW PROCESS

描述(摘自申请摘要)：1996年7月，FDA呼吁 以讨论医疗软件法规。作为回应，一个财团 致力于通过信息改善医疗保健的组织 技术制定了负责任的监测建议 系统。提出的一项主要建议是监测临床 软件系统应尽可能放在地方一级，并且 这种监测应通过本地临床软件流程进行 与软件供应商合作的质量委员会(CSP-QC)。 这个项目的具体目标有两个。首先，测试 建立特定机构CSP-QC的可行性：1)作为一种可行的 替代FDA对医疗软件的监管，2)提供更多便利 可靠和集成的医疗计算和3)监督软件选择， 开发和实施，以确保质量和问题解决。 第二，制定和完善一种广泛适用的方法 在普通医疗计算社区内建立CSP-QC。四 机构，每个机构都有不同的临床计算系统和 不同的培训和病人护理策略将参与其中。这个 参与机构之间的差异将使我们能够核实 CSP-QC的概念在多种环境中都是可行的，并将 帮助确保方法的通用性和健壮性，即 发展起来的。 拟议中的项目意义重大。没有全国性的 在期望或职能方面的标准，供地方审查和 监控复杂的临床软件系统。CSP-QC将监控 机构选择供应商的产品或开发的程序 并将重点放在安全性、有效性、可靠性、 货币和安全。参与机构将计划、分享和 与LDS医院共同发展他们的活动 作为协调中心。CSP-QC将评估(正在进行的 基础)现有的医疗计算系统和所有新的软件开发 和收购。CSP-QC对软件相关政策和活动的影响 将会被评估。使用CSP-QC来确保 将对医疗软件的质量进行评估。A普遍适用 将制定和运行CSP-QC的方法。(注： 在与审查员会面时，CSP-QC被指定为 软件监督委员会或SOC。)

DESCRIPTION (taken from application abstract): In July 1996, the FDA called for discussion of medical software regulations. In response, a consortium of organizations dedicated to improving health care through information technology developed recommendations for responsible monitoring of such systems. A primary recommendation made was that monitoring of clinical software systems should be placed at the local level wherever possible, and that this monitoring should occur through local Clinical Software Process Quality Committees (CSP-QC's) in conjunction with software vendors. The specific aims of this project are twofold. First, to test the feasibility of having institution-specific CSP-QC's: 1) serve as a workable alternative to FDA regulation of medical software, 2) facilitate more reliable and integrated medical computing and 3) oversee software selection, development, and implementation to ensure quality and problem resolution. Second, to develop and refine a widely applicable methodology for instituting CSP-QC's within the general medical computing community. Four institutions, each with different clinical computing systems and with diverse training and patient care strategies will participate. The differences between the participating institutions will allow us to verify that the concept of CSP-QC's is workable in multiple environments and will help ensure the generalizability and robustness of the methodology that is developed. The proposed project is highly significant. There are no national standards, in terms of expectations or function, for local review and monitoring of complex clinical software systems. The CSP-QC's will monitor procedures by which an institution selects vendors' products or develops local software and will focus on the safety, efficacy, reliability, currency, and security. Participating institutions will plan, share, and evolve their activities in conjunction with each other, with LDS Hospital acting as the coordinating center. CSP-QC's will evaluate (on an ongoing basis) existing medical computing systems and all new software development and acquisition. CSP-QC impact on software-related policy and activities will be evaluated. The general feasibility of using CSP-QC's to ensure the quality of medical software will be assessed. A generally applicable methodology for instituting and operating CSP-QC's will be developed. (n.b. At the time of the meeting with reviewers, the CSP-QC's were designated as Software Oversight Committees or SOC's.)