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U.S. Department of Health and Human Services

About FDA

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Research Project: Wireless Use in Medical Care

Rapid integration of wireless technology into all aspects of health care is occurring in areas such as Home Hospital Transport Rescue, Nursing homes, Doctor’s offices, Civilian and Military medical facilities.  Problems due to many simultaneous wireless signals include data and signal disruption and slow-down, loss of coexistence with other wireless technology and loss of personal information security. These are largely outside the scope of existing standards for medical electrical equipment. Information and tools are needed urgently to help provide the appropriate pathways for design, testing, deployment, and maintenance of safe, secure and reliable wireless healthcare. Issues to be addressed included Quality of Service (QoS), data integrity (e.g., data throughput, latency, and corruption), coexistence with other wireless equipment, and security of health records. One of the few tools available is the FDA draft Wireless Medical Device Guidance.  Immediate needs include more research, development of standards, other tools to evaluate coexistence and QoS.

A handheld wireless medical device in the center and 4 interfering
wireless sources around it. The interferers are a microwave oven,
handheld data phone, laptop computer, and Wi-Fi router.