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HEALTH E-SERVICE PLATFORM

Health eServices is composed of industry-based health information technology practitioners and noted academic researchers. We are highly experienced in health IT, data exchange standards, compliance assessment, and testing.

We seek to help entities resolve challenging technologies, policies, and regulatory issues involved with effective sharing of client health information. We seek to provide comprehensive guidance on data standards, regulatory requirements, and sustainable technology practices.

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FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States

An FDA Safety Communication

Nathan E Botts 0 3585 Article rating: No rating

The U.S. Food and Drug Administration (FDA) is warning health care providers and people with diabetes of risks associated with use of devices for diabetes management unauthorized for sale in the U.S., whether used alone or along with other devices. These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use. Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death.

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