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ENABLING BUILD OF DIGITAL HEALTH APPS AGAINST REGULATORY STANDARDS FOR MEDICAL USE

能够根据医疗用途监管标准构建数字健康应用程序

基本信息

批准号：
103868
负责人：
金额：
$ 70.73万
依托单位：
MIOTIFY LTD
依托单位国家：
英国
项目类别：
Collaborative R&D
财政年份：
2017
资助国家：
英国
起止时间：
2017 至无数据
项目状态：
已结题

来源：
https://gtr.ukri.org/projects?ref=103868
关键词：
ENABLING BUILD DIGITAL HEALTH APPS

项目摘要

The Internet of Things has created an explosion of data generating and collecting devices that is transforming all aspects of our lives. Healthcare is no exception, and the opportunity to ensure that whatever data is available can be used to inform the way healthcare is delivered has never been greater. However, the availability of connected clinical data does not necessarily translate into use to inform a clinical decision: any interpretation of this data for a medical purpose falls under strict regulations for software based medical devices, which is designed to protect patient safety, but compliance is currently expensive and complex to achieve. This project demonstrates proof of concept of our software tool kit to enable innovators to harness the potential of connected clinical data, enabling it to be transformed into actionable information to inform clinical decisions. Our platform can be used by many people designing connected apps for specific clinical indications or patient pathway, in a variety of settings, and will guide the inputs and provide the traceability to aid their compliance for regulatory submissions for software classified as a medical device (SaMD), quickly and cost effectively. This will open up new possibilities for service creators to build connected digital health solutions that will be fit for the purpose of enabling remote monitoring and improved self-care; transforming healthcare as we know it.

物联网创造了数据生成和收集设备的爆炸式增长，正在改变我们生活的各个方面。医疗保健也不例外，确保任何可用数据都可用于告知医疗保健提供方式的机会从未如此之大。然而，连接的临床数据的可用性并不一定转化为用于告知临床决策：出于医疗目的对该数据的任何解释福尔斯都受到基于软件的医疗器械的严格规定的约束，该规定旨在保护患者安全，但目前实现合规性既昂贵又复杂。该项目展示了我们的软件工具包的概念验证，使创新者能够利用互联临床数据的潜力，将其转化为可操作的信息，为临床决策提供信息。我们的平台可供许多人在各种环境中为特定临床适应症或患者路径设计连接应用程序，并将指导输入并提供可追溯性，以帮助他们快速且经济高效地遵守归类为医疗器械（SaMD）的软件的监管提交。这将为服务创建者提供新的可能性，以构建连接的数字健康解决方案，这些解决方案将适合实现远程监控和改善自我护理的目的;改变我们所知道的医疗保健。