背景:自COVID-19大流行以来,推动了人类社会的数字化转型,智能手表等可穿戴设备已经可以以连续和自然的方式测量生命体征;然而,个人数据的安全性和隐私性是扩大卫生专业人员在临床后续决策中使用这些数据的挑战。与欧洲通用数据保护条例类似,在巴西,LeiGeraldeProtealçãodeDados制定了处理个人数据的规则和准则,包括那些用于病人护理的,比如那些被智能手表捕获的。因此,在任何远程监控场景中,有必要遵守规章制度,使这个问题成为一个需要克服的挑战。
目的:本研究旨在建立一种数字解决方案模型,用于从可穿戴设备中捕获数据,并以安全,敏捷的方式将其用于临床和研究。遵循现行法律。
方法:根据巴西的LeiGeraldeProdçodeDados(2018)建立了一个功能模型,智能手表捕获的数据可以通过物联网匿名传输,然后在医院内识别。共选择80名志愿者进行为期24周的随访临床试验,分为2组,一组先前诊断为COVID-19的人和一组先前未诊断为COVID-19的人,以测量平台与设备的同步率以及智能手表在院外条件下的准确性和精确度,以模拟家中的远程监控。
结果:在一项为期35周的临床试验中,收集了>1120万条记录,没有系统停机时间;每分钟66%的连续搏动在24小时内同步(2天内79%,一周内91%)。在协议的极限分析中,氧饱和度的平均差异,舒张压,收缩压,心率为-1.280%(SD5.679%),-1.399(SD19.112)mmHg,-1.536(SD24.244)mmHg,和0.566(SD3.114)每分钟节拍,分别。此外,2个研究组在数据分析方面没有差异(既不使用智能手表也不使用黄金标准设备),但值得一提的是,COVID-19组的所有志愿者都已经治愈了感染,并且在日常工作生活中具有很高的功能。
结论:根据获得的结果,考虑准确性和精度的验证条件,并模拟医院外使用环境,本研究中建立的功能模型能够从智能手表中获取数据并匿名将其提供给医疗保健服务,它们可以根据法律进行治疗,并在远程监测期间用于支持临床决策。
BACKGROUND: Since the COVID-19 pandemic, there has been a boost in the digital transformation of the human society, where wearable devices such as a smartwatch can already measure vital signs in a continuous and naturalistic way; however, the security and privacy of personal data is a challenge to expanding the use of these data by health professionals in clinical follow-up for decision-making. Similar to the European General Data Protection Regulation, in Brazil, the Lei Geral de Proteção de Dados established rules and guidelines for the processing of personal data, including those used for patient care, such as those captured by smartwatches. Thus, in any telemonitoring scenario, there is a need to comply with rules and regulations, making this issue a challenge to overcome.
OBJECTIVE: This
study aimed to build a digital solution model for capturing data from wearable devices and making them available in a safe and agile manner for clinical and research use, following current laws.
METHODS: A functional model was built following the Brazilian Lei Geral de Proteção de Dados (2018), where data captured by smartwatches can be transmitted anonymously over the Internet of Things and be identified later within the hospital. A total of 80 volunteers were selected for a 24-week follow-up clinical
trial divided into 2 groups, one group with a previous diagnosis of COVID-19 and a control group without a previous diagnosis of COVID-19, to measure the synchronization rate of the platform with the devices and the accuracy and precision of the smartwatch in out-of-hospital conditions to simulate remote monitoring at home.
RESULTS: In a 35-week clinical
trial, >11.2 million records were collected with no system downtime; 66% of continuous beats per minute were synchronized within 24 hours (79% within 2 days and 91% within a week). In the limit of agreement analysis, the mean differences in oxygen saturation, diastolic blood pressure, systolic blood pressure, and heart rate were -1.280% (SD 5.679%), -1.399 (SD 19.112) mm Hg, -1.536 (SD 24.244) mm Hg, and 0.566 (SD 3.114) beats per minute, respectively. Furthermore, there was no difference in the 2
study groups in terms of data analysis (neither using the smartwatch nor the gold-standard devices), but it is worth mentioning that all volunteers in the COVID-19 group were already cured of the infection and were highly functional in their daily work life.
CONCLUSIONS: On the basis of the results obtained, considering the validation conditions of accuracy and precision and simulating an extrahospital use environment, the functional model built in this
study is capable of capturing data from the smartwatch and anonymously providing it to health care services, where they can be treated according to the legislation and be used to support clinical decisions during remote monitoring.