Differential Analysis on Changes in Medical Device Software

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。

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.