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CLINICAL SOFTWARE QUALITY REVIEW PROCESS

临床软件质量审查流程

基本信息

批准号：
2883315
负责人：
REED M. GARDNER
金额：
$ 48.75万
依托单位：
IHC HEALTH SERVICES, INC.
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
起止时间：
1998-03-01 至 2003-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/2883315
关键词：
computer program /software computer system design /evaluation

项目摘要

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.)

描述（摘自申请摘要）：1996年7月，FDA呼吁讨论医疗软件法规。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发展的建议，负责监测这种系统. 提出的主要建议是监测临床软件系统应尽可能放在地方一级，应通过本地临床软件过程进行该监测质量委员会（CSP-QC）与软件供应商合作。该项目的具体目标有两个方面。首先，为了测试具有机构特定的CSP-QC的可行性：1）作为一个可行的替代FDA对医疗软件的监管，2）促进更多可靠和集成的医疗计算和3）监督软件选择，开发和实施，以确保质量和问题的解决。第二，制定和完善一个广泛适用的方法，在一般的医疗计算社区中建立CSP-QC。四每个机构都有不同的临床计算系统，各种培训和病人护理战略将参与其中。的参与机构之间的差异将使我们能够验证 CSP-QC的概念适用于多种环境，有助于确保方法的普遍性和稳健性，开发拟议的项目意义重大。没有国家在期望或功能方面的标准，供当地审查，监控复杂的临床软件系统。 CSP-QC将监测机构选择供应商的产品或开发本地软件，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医院一起发展他们的活动，作为协调中心。 CSP-QC将评估（持续进行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被评估。使用CSP-QC确保将评估医疗软件的质量。一个普遍适用的将制定建立和运行CSP-QC的方法。（注：在与审查员开会时，CSP-QC被指定为软件监督委员会（SOC）。