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Effects of Medical Device Regulations on the Development of Stand-Alone Medical Software: A Pilot Study

机译：医疗器械规则对独立医疗软件发展的影响：试点研究

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Background: Medical device regulations which aim to ensure safety standards do not only apply to hardware devices but also to standalone medical software, e.g. mobile apps. Objectives: To explore the effects of these regulations on the development and distribution of medical standalone software. Methods: We invited a convenience sample of 130 domain experts to participate in an online survey about the impact of current regulations on the development and distribution of medical standalone software. Results: 21 respondents completed the questionnaire. Participants reported slight positive effects on usability, reliability, and data security of their products, whereas the ability to modify already deployed software and customization by end users were negatively impacted. The additional time and costs needed to go through the regulatory process were perceived as the greatest obstacles in developing and distributing medical software. Conclusion: Further research is needed to compare positive effects on software quality with negative impacts on market access and innovation. Strategies for avoiding over-regulation while still ensuring safety standards need to be devised.

机译：背景：旨在确保安全标准的医疗器械规则不仅适用于硬件设备，还适用于独立的医疗软件，例如，移动应用程序。目标：探讨这些法规对医疗独立软件开发和分配的影响。方法：我们邀请了130名领域专家的便利样本参与了关于现行法规对医疗独立软件开发和分配的影响的在线调查。结果：21名受访者完成了调查问卷。参与者报告了对其产品的可用性，可靠性和数据安全性的轻微积极影响，而通过最终用户修改已经部署的软件和自定义的能力产生了负面影响。通过监管过程所需的额外时间和成本被认为是开发和分发医疗软件的最大障碍。结论：需要进一步研究，比较对软件质量的积极影响，对市场准入和创新产生负面影响。避免过度监管的策略，同时需要设计安全标准。

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《eHealth Conference》|2018年|xii 348 p. :|共8页
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Kathrin BLAGEO; David JUNGWIRTH; Daniela HALUZA; Matthias SAMWALD;
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1. Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive [J] . Mchugh M., Mccaffery F., Casey V. Software, IET . 2012,第5期

机译：软件过程改进，以帮助医疗器械软件开发组织遵守医疗器械指令的修订案
2. To what extent the medical device software regulations can be achieved with agile software development methods? XP-DSDM-Scrum [J] . Ozcan-Top Ozden, McCaffery Fergal Journal of supercomputing . 2019,第8期

机译：敏捷软件开发方法可以在多大程度上实现医疗器械软件法规？
3. Digital health – Software as a medical device in focus of the medical device regulation (MDR) [J] . KurtBecker, MyriamLipprandt, RainerR?hrig, Information Technology . 2019,第5a6期

机译：数字健康 - 软件作为医疗器械规则的重点（MDR）的医疗器械
4. Effects of Medical Device Regulations on the Development of Stand-Alone Medical Software: A Pilot Study [C] . Kathrin BLAGEO, David JUNGWIRTH, Daniela HALUZA, eHealth Conference . 2018

机译：医疗器械规则对独立医疗软件发展的影响：试点研究
5. The Use of Predicates in FDA Regulation of Medical Devices: A Case Study of Robotic Surgical Devices [D] . Lefkovich, Charlotte. 2018

机译：医疗器械FDA调节谓词的使用 - 以机器人外科手术装置为例
6. Software quality regulation under the Safe Medical Devices Act of 1990: hospitals are now the canaries in the software mine. [O] . V. M. Brannigan 1991

机译：根据1990年安全医疗设备法案的软件质量规定：医院现在是软件矿井中的金丝雀。
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Effects of Medical Device Regulations on the Development of Stand-Alone Medical Software: A Pilot Study

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