Differential Analysis on Changes in Medical Device Software
医疗器械软件变化差异分析
基本信息
- 批准号:1160603
- 负责人:
- 金额:$ 6万
- 依托单位:
- 依托单位国家:美国
- 项目类别:Standard Grant
- 财政年份:2012
- 资助国家:美国
- 起止时间:2012-10-01 至 2014-09-30
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
This project is a collaboration under the NSF-FDA Scholar-In-Residence (SIR) program. Software increasingly is used in safety-critical medical devices. Given the safety-critical nature of software controlling medical devices, regulatory agencies are endowed by the government with authority to allow only software meeting with high standards of quality to be put into use. For example, the US Food and Drug Administration (FDA) prohibits a medical device from being marketed unless it can be reasonably trusted as safe and effective. Moreover, if a device on the market is reported to fail and cause health consequences to patients, the FDA has the right to take corrective actions, such as post-market reviews of the device to find the root cause of the failure. As medical device technology evolves, so does the software upon which the technology often relies. Changes in device software, after it has been approved or cleared by the FDA, may compromise the safety of that device. Assessing the safety of such changes presents special challenges to regulators at the FDA. To address these challenges in the context of regulation at the FDA, the research develops differential analysis techniques using the technology of dynamic symbolic execution to assess the effects of software changes on device safety. The research explores new techniques for addressing unique requirements and challenges posed by differential analysis in the context of FDA regulation. These techniques also advance the fundamental state of the art in differential analysis. Among the broader impacts of the project includes integration of the research into education programs and enhancement of teaching and research infrastructure.
该项目是NSF-FDA驻校学者(SIR)计划下的合作项目。软件越来越多地用于安全关键型医疗设备。鉴于控制医疗器械的软件的安全性至关重要,政府授权监管机构仅允许符合高质量标准的软件投入使用。例如,美国食品和药物管理局(FDA)禁止销售医疗器械,除非可以合理地相信其安全有效。此外,如果市场上的器械被报告失败并对患者造成健康后果,FDA有权采取纠正措施,例如对器械进行上市后审查,以找到失败的根本原因。随着医疗器械技术的发展,该技术通常依赖的软件也在发展。在FDA批准或许可后,器械软件的变更可能会损害器械的安全性。评估这些变化的安全性对FDA的监管机构提出了特殊的挑战。为了解决FDA监管背景下的这些挑战,该研究开发了使用动态符号执行技术的差异分析技术,以评估软件变更对器械安全性的影响。该研究探索了新技术,以解决FDA法规背景下差异分析所带来的独特要求和挑战。这些技术也推进了差分分析的基本技术水平。该项目的更广泛影响包括将研究纳入教育计划,并加强教学和研究基础设施。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Laurie Williams其他文献
Allergen Removal and Transfer with Wiping and Cleaning Methods Used in Retail and Food Service Establishments
- DOI:
10.4315/jfp-20-025 - 发表时间:
2020-07-01 - 期刊:
- 影响因子:
- 作者:
Binaifer Bedford;Girvin Liggans;Laurie Williams;Lauren Jackson - 通讯作者:
Lauren Jackson
Regression Test Selection for Black-box Dynamic Link Library Components
黑盒动态链接库组件的回归测试选择
- DOI:
10.1109/iwicss.2007.8 - 发表时间:
2007 - 期刊:
- 影响因子:0
- 作者:
Jiang Zheng;Laurie Williams;Brian P. Robinson;Karen Smiley - 通讯作者:
Karen Smiley
Attackers reveal their arsenal: An investigation of adversarial techniques in CTI reports
攻击者暴露他们的武器库:CTI 报告中对抗技术的调查
- DOI:
10.48550/arxiv.2401.01865 - 发表时间:
2024 - 期刊:
- 影响因子:0
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Md. Rayhanur Rahman;S. Basak;Rezvan Mahdavi;Laurie Williams - 通讯作者:
Laurie Williams
“I Am a Nice Person When I Do Yoga!!!”
“当我做瑜伽时,我是一个好人!!!”
- DOI:
- 发表时间:
2014 - 期刊:
- 影响因子:2
- 作者:
A. Ross;M. Bevans;E. Friedmann;Laurie Williams;Sue A. Thomas - 通讯作者:
Sue A. Thomas
Paving a Path for a Combined Family of Feature Toggle and Configuration Option Research
为功能切换和配置选项研究组合系列铺平道路
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- 发表时间:
2024 - 期刊:
- 影响因子:4.4
- 作者:
Rezvan Mahdavi;Sameeha Fatima;Laurie Williams - 通讯作者:
Laurie Williams
Laurie Williams的其他文献
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{{ truncateString('Laurie Williams', 18)}}的其他基金
Collaborative Proposal: SaTC: Frontiers: Enabling a Secure and Trustworthy Software Supply Chain
协作提案:SaTC:前沿:实现安全可信的软件供应链
- 批准号:
2207008 - 财政年份:2022
- 资助金额:
$ 6万 - 项目类别:
Continuing Grant
SaTC: CORE: Small: Risk-based Secure Checked-in Credential Reduction for Software Development
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- 批准号:
2055554 - 财政年份:2021
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Standard Grant
SHF: Small: Detecting the 1%: Growing the Science of Vulnerability Detection
SHF:%20小型:%20检测%20the%201%:%20增长%20the%20科学%20of%20漏洞%20检测
- 批准号:
1909516 - 财政年份:2019
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$ 6万 - 项目类别:
Standard Grant
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合作研究:DarkSide-20k:使用低放射性氩直接探测暗物质的全球计划
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1812480 - 财政年份:2018
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EAGER: Cognitive modeling of strategies for dealing with errors in mobile touch interfaces
EAGER:处理移动触摸界面错误策略的认知建模
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1451172 - 财政年份:2014
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$ 6万 - 项目类别:
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EDU: Motivating and Reaching University Students and Professionals with Software Security Education
EDU:通过软件安全教育激励和影响大学生和专业人士
- 批准号:
1318428 - 财政年份:2013
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$ 6万 - 项目类别:
Standard Grant
CT-ER: On the Use of Security Metrics to Identify and Rank the Risk of Vulnerability- and Exploit-Prone Components
CT-ER:关于使用安全指标来识别和排名易受攻击组件的风险
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0716176 - 财政年份:2007
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$ 6万 - 项目类别:
Standard Grant
Academy for Software Engineering Educators and Trainers
软件工程教育者和培训师学院
- 批准号:
0542681 - 财政年份:2005
- 资助金额:
$ 6万 - 项目类别:
Standard Grant
CAREER: Test-Driven Development of Secure and Reliable Software Applications
职业:安全可靠的软件应用程序的测试驱动开发
- 批准号:
0346903 - 财政年份:2004
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$ 6万 - 项目类别:
Continuing Grant
ITWF: Collaboration through Agile Software Development Practices: A Means for Improvement in Quality and Retention of IT Workers
ITWF:通过敏捷软件开发实践进行协作:提高 IT 员工质量和留住员工的方法
- 批准号:
0305917 - 财政年份:2003
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$ 6万 - 项目类别:
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