Current Science on Consumer Use of Mobile Health for Cardiovascular Disease Prevention: A Scientific Statement From the American Heart Association.
Current Science on Consumer Use of Mobile Health for Cardiovascular Disease Prevention: A Scientific Statement From the American Heart Association.
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DOI：
10.1161/cir.0000000000000232
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发表时间：
2015-09-22
期刊：
影响因子：
37.8
通讯作者：
American Heart Association Publications Committee of the Council on Epidemiology and Prevention, Behavior Change Committee of the Council on Cardiometabolic Health, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, Council on Quality of Care and Outcomes Research, and Stroke Council
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文献类型：
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作者：
Burke LE;Ma J;Azar KM;Bennett GG;Peterson ED;Zheng Y;Riley W;Stephens J;Shah SH;Suffoletto B;Turan TN;Spring B;Steinberger J;Quinn CC;American Heart Association Publications Committee of the Council on Epidemiology and Prevention, Behavior Change Committee of the Council on Cardiometabolic Health, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, Council on Quality of Care and Outcomes Research, and Stroke Council
1158流通2015年9月22日生物医学工程、医学和健康相关科学。允许实时收集数据的移动设备越来越普遍，使研究人员能够评估各种情况下的多种行为，从而为干预措施的发展提供信息，以促进行为改变。技术支持的行为健康干预措施旨在使个人参与预防或管理疾病的健康行为，它们导致了卫生实践的根本变化。17 .除了允许更频繁和方便地以社区为基础评估健康参数外，这些以技术为媒介的工具还支持消费者之间以及消费者与保健提供者之间的健康信息交流，促进保健决策，并鼓励积极的健康行为，包括自我管理和促进健康。18,19因此，移动医疗技术正变得越来越普遍，其使用将继续增长，20这与医学研究所关于增加卫生技术设计和测试的呼吁是一致的。21 .移动设备的普及为利用信息和通信技术提供最先进的医疗和保健服务提供了改善健康结果的机会。由于智能手机多种多样的功能和先进的计算特性，它通常被认为是袖珍电脑。除了这些可以提供信息和通信的设备外，还有可穿戴式传感器，可以短时间或长时间佩戴，监测活动或生理变化（如运动、心率、睡眠）。这些传感器可以实时提供数据，也可以将数据保存到设备中，以便以后上传和查看。美国食品和药物管理局负有监督医疗器械安全性和有效性的公共卫生责任。然而，这只适用于受监管医疗设备的附属应用程序（例如，诊断疾病的应用程序）。许多移动应用程序不是医疗设备，这意味着它们不符合《联邦食品、药品和化妆品法案》第201 (h)节对设备的定义，美国食品和药物管理局也没有对它们进行监管。一些移动应用程序可能符合医疗设备的定义，但由于它们对公众构成的风险较低，美国食品和药物管理局打算对这些设备行使执法自由裁量权。目前市场上的大多数移动健康应用程序都符合这两点
1158 Circulation September 22, 2015 biomedical engineering, and medicine and health-related sciences. 16 Mobile devices that permit collection of data in real time are increasingly ubiquitous, enabling researchers to assess multiple behaviors in various contexts and thus inform the development of interventions to prompt behavior change. Technology-supported behavioral health interventions are designed to engage individuals in health behaviors that prevent or manage illness, and they have led to fundamental changes in health practices. 17 In addition to permitting more frequent and convenient community-based assessment of health parameters, these technology-mediated tools support the exchange of health information among consumers and between consumers and health providers, enable health decision making, and encourage positive health behaviors, including self-management and health promotion. 18, 19 Consequently, mHealth technologies are becoming more prevalent, and their use will continue to grow, 20 consistent with the Institute of Medicine’s call to increase the design and testing of health technologies. 21 The ubiquity of mobile devices presents the opportunity to improve health outcomes through the delivery of state-of-theart medical and health services with information and communication technologies. 22 Because of their diverse capabilities and advanced computing features, smartphones are often considered pocket computers. 16 In addition to these devices that can inform and communicate, there are wearable sensors that can be worn for short or extended periods and monitor activity or physiological changes (eg, exercise, heart rate, sleep). These sensors can provide data in real time or save the data to a device for later uploading and review.The US Food and Drug Administration has a public health responsibility to oversee the safety and effectiveness of medical devices. However, this applies only to applications (apps) that are accessory to regulated medical devices (eg, apps that diagnose a condition). Many mobile apps are not medical devices, meaning that they do not meet the definition of a device under section 201 (h) of the Federal Food, Drug, and Cosmetic Act, and the US Food and Drug Administration does not regulate them. Some mobile apps may meet the definition of a medical device, but because they pose a lower risk to the public, the US Food and Drug Administration intends to exercise enforcement discretion over these devices. Most of the mHealth apps on the market at this time fit into these 2