Wearable sensors with possibilities for data exchange: Analyzing status and needs of different actors in mobile health monitoring systems. (January 2020)

• Record Type: Journal Article
• Authors: Muzny, Miroslav; Henriksen, Andre; Giordanengo, Alain; Muzik, Jan; Grøttland, Astrid; Blixgård, Håvard; Hartvigsen, Gunnar; Årsand, Eirik
• Is Part Of: International journal of medical informatics. Volume 133(2020)
• Publication Date: 2020-01
• Subjects: API Application Programming Interface -- CE Conformité Européene -- CPAP Continuous positive airway pressure -- DIY Do-It-Yourself -- eHealth Electronic Health -- EHR Electronic Health Records -- EMR Electronic Medical Record -- FDA Food and Drug Administration -- GDPR General Data Protection Regulation -- GSR Galvanic skin response -- GATT Generic Attribute Profile -- HIPPA Health Insurance Portability and Accountability Act -- IMU Inertial Motion Unit -- mHealth Mobile health -- NFC Near field communication -- PHR Personal Health Record -- PHI Protected Health Information -- Precert Digital Health Software Precertification -- REST Representational State Transfer -- SIG Special Interest Group -- SpO2 Peripheral capillary oxygen saturation -- USB Universal Serial Bus; Wearable device -- Health monitoring -- Data exchange -- Sensors -- mHealth -- EHR -- pHR -- Health data aggregators; Medical informatics -- Periodicals; Information science -- Periodicals; Computers -- Periodicals; Medical technology -- Periodicals; Medical Informatics -- Periodicals; Technology, Medical -- Periodicals; Computers; Information science; Medical informatics; Medical technology; Electronic journals; Periodicals; Electronic journals; 610.285
• DOI: 10.1016/j.ijmedinf.2019.104017
• Languages: English
• ISSNs: 1386-5056

Abstract

Highlights: Few wearable devices support transfer of data via local wired or wireless connection Access to data is often disabled due to missing verification of data prediction models or unsatisfactory regulatory requirements Only a small number of devices have been CE marked (class II or above) or are FDA approved A relatively small percentage of devices support smartphone health platforms for import of user-captured data Abstract: Background: Wearable devices with an ability to collect various type of physiological data are increasingly becoming seamlessly integrated into everyday life of people. In the area of electronic health (eHealth), many of these devices provide remote transfer of health data, as a result of the increasing need for ambulatory monitoring of patients. This has a potential to reduce the cost of care due to prevention and early detection. Objective: The objective of this study was to provide an overview of available wearable sensor systems with data exchange possibilities. Due to the heterogeneous capabilities these systems possess today, we aimed to systematize this in terms of usage, where there is a need of, or users benefit from, transferring self-collected data to health care actors. Methods: We searched for and reviewed relevant sensor systems (i.e., devices) and mapped these into 13 selected attributes related to data-exchange capabilities. We collected data from the Vandrico database of wearable devices, and complemented the information with an additional internet search. We classified the following attributes of devices: type, communication interfaces, data protocols, smartphone/PC integration, connection to smartphone health platforms, 3 rd party integration with health platforms, connection to health care system/middleware, type of gathered health data, integrated sensors, medical device certification, access to user data, developer-access to device, and market status. Devices from the same manufacturer with similar functionalities/characteristics were identified under the same device family . Furthermore, we classified the systems in three subgroups of relevance for different actors in mobile health monitoring systems: EHR providers, software developers, and patient users. Results: We identified 362 different mobile health monitoring devices belonging to 193 device families. Based on an analysis of these systems, we identified the following general challenges: Few systems have a Conformité Européene (CE) marking class II or above, or approval from the US Food and Drug Administration (FDA) Few systems use the standardized Bluetooth Low Energy GATT profile for wireless transfer of health data Few systems support health middleware Approximately 30% of the device families provide the user access to the source data. However, only 16% allow the transfer of data through direct communication with the device (i.e., without using a proprietary cloud-based service) Conclusions: Few of the identified mobile health monitoring systems use standardized, open communication protocols, which would allow the user to directly acquire sensor data. Use of open protocols can provide mobile health (mHealth) application developers an alternative to proprietary cloud services and communication tools, which are often closely integrated with the devices. Emerging new types of sensors, often intended for everyday use, have a potential to supplement health records systems with data that can enrich patient care.