JMIR mHealth and uHealth
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JMIR mHealth and uHealth · Jun 2020
Medical Device Apps: An Introduction to Regulatory Affairs for Developers.
The Poly Implant Prothèse (PIP) scandal in France prompted a revision of the regulations regarding the marketing of medical devices. The new Medical Device Regulation (MDR [EU]) 2017/745 was developed and entered into force on May 25, 2017. After a transition period of 3 years, the regulations must be implemented in all EU and European Economic Area member states. ⋯ In particular, rule 11 sets specific rules for the classification of medical device software and will be described in this paper. In comparison to the previous MDD, the MDR is more stringent, especially regarding the classification of health apps and software. The implementation of the MDR in May 2020 and its interpretation by the authorities will demonstrate how app and software manufacturers as well as patients will be affected by the regulation.
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JMIR mHealth and uHealth · Jun 2020
Case-Initiated COVID-19 Contact Tracing Using Anonymous Notifications.
We discuss the concept of a participatory digital contact notification approach to assist tracing of contacts who are exposed to confirmed cases of coronavirus disease (COVID-19); the approach is simple and affordable for countries with limited access to health care resources and advanced technology. The proposed tool serves as a supplemental contract tracing approach to counteract the shortage of health care staff while providing privacy protection for both cases and contacts. This tool can be deployed on the internet or as a plugin for a smartphone app. ⋯ The system will then automatically send a message to the contacts informing them of their contact status, what this status means, the actions that should follow (eg, self-quarantine, respiratory hygiene/cough etiquette), and advice for receiving early care if they develop symptoms. The name of the sender of the notification message by email or mobile phone can be anonymous or not. The message received by the contact contains no disease information but contains a security code for the contact to log on the platform to retrieve the information.
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JMIR mHealth and uHealth · Jun 2020
ReviewHospital Bring-Your-Own-Device Security Challenges and Solutions: Systematic Review of Gray Literature.
As familiarity with and convenience of using personal devices in hospitals help improve the productivity, efficiency, and workflow of hospital staff, the health care bring-your-own-device (BYOD) market is growing consistently. However, security concerns owing to the lack of control over the personal mobile devices of staff, which may contain sensitive data such as personal health information of patients, make it one of the biggest health care information technology (IT) challenges for hospital administrations. ⋯ The findings suggest that to optimize BYOD security management in hospitals, all 3 dimensions of the security process (people, policy, and technology) need to be given equal emphasis. As the nature of cybersecurity attacks is becoming more complex, all dimensions should work in close alignment with each other. This means that with the modernization of BYOD technology, BYOD strategy, governance, education, and relevant policies and procedures also need to adapt accordingly.
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JMIR mHealth and uHealth · Jun 2020
User Retention and Engagement With a Mobile App Intervention to Support Self-Management in Australians With Type 1 or Type 2 Diabetes (My Care Hub): Mixed Methods Study.
Mobile health apps are commonly used to support diabetes self-management (DSM). However, there is limited research assessing whether such apps are able to meet the basic requirements of retaining and engaging users. ⋯ The findings of this short-term intervention study suggested acceptable levels of participant retention and engagement with My Care Hub, indicating that it may be a promising tool for extending DSM support and education beyond the confines of a physical clinic.
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JMIR mHealth and uHealth · Jun 2020
A New System for Surveillance and Digital Contact Tracing for COVID-19: Spatiotemporal Reporting Over Network and GPS.
The current pandemic of the coronavirus disease (COVID-19) has highlighted the importance of rapid control of the transmission of infectious diseases. This is particularly important for COVID-19, where many individuals are asymptomatic or have only mild symptoms but can still spread the disease. Current systems for controlling transmission rely on patients to report their symptoms to medical professionals and be able to recall and trace all their contacts from the previous few days. ⋯ Data from the mini-program can also be merged with other data to predict epidemic trends, calculate individual and population risks, and provide recommendations for individual and population protection action. It may also improve our understanding of how the disease spreads. However, there are a number of unresolved questions about the use of smartphone data for health surveillance, including how to protect individual privacy and provide safeguards against data breaches.