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HIPAA regulations for wearable devices


Covered entities and business associates should be well-aware of the OCR HIPAA audit program, particularly when Phase 2 has already been in place for several months now. More organizations are electing for cloud computing options, and may even start to implement wearable devices, in addition to other connected devices (i.e. medical devices, smartphones, tablets). There are key areas that covered entities and their business associates must focus on to ensure that they remain HIPAA compliant (HIPAA regulations) while also working toward staying innovative.

“ONC and other federal agencies have published guidance to help organizations determine what types of regulations are potentially applicable to them and their devices. For example, the Federal Trade Commission (FTC) has specific guidance on sharing consumer health information, as well as guidance for mobile health app developers. ONC also collaborated with the FTC, the Food and Drug Administration (FDA), and OCR to create an informative online tool for potential legal concerns with mobile application security. Developers can use the website to ensure that they are properly adhering to federal requirements. Along with guidance on how HIPAA regulations would potentially apply to mobile applications, the tool also highlights the FTC Act, the FTC’s Health Breach Notification Rule, and the Federal Food, Drug and Cosmetics Act (FD&C Act).” [1]

Telegenisys has already ensured that its devices and systems are managed as per HIPAA regulations and have been audited for and received certifications for ISO 9001:2005, ISO 27001:2005 and HIPAA compliance. Know more


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