On Monday, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released an online platform designed for use by developers of mobile medical applications (apps). The site allows users to submit questions regarding compliance with the Health Insurance Portability and Accountability Act (HIPAA) and to access […]
A letter from the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights to Rep. Peter DeFazio (D-Ore.) signals an intent to move forward with providing clearer regulatory guidance relating to the Health Insurance Portability and Accountability Act (HIPAA) rules addressing mobile health app developers. The letter, […]
On October 1 the US Food and Drug Administration (FDA) issued final guidance regarding cybersecurity for medical devices. The FDA guidelines urge device manufacturers to include safety controls on devices to prevent cyber threats and recommend manufacturers outline the necessary steps that will be taken if their devices are found to […]
The mobile medical application marketplace has developed into a $68 billion industry; however, the U.S. Department of Health and Human Services (HHS) has not yet updated guidance regarding the Health Insurance Portability and Accountability Act’s (HIPAA) application to app developers that collect and use sensitive personal data. In response to […]
We informed you earlier this week that the U.S. Food and Drug Administration’s (“FDA”) long awaited final guidance on mobile medical applications was released. We have now published a Cooley Alert that analyzes the final guidance in greater detail. The Cooley Alert is available at: http://www.cooley.com/FDA-issues-final-guidance-regarding-mobile-medical-applications.
While the FDA has yet to issue final guidance on mobile medical applications, the FDA recently issued final guidance on radio frequency (“RF”) wireless technology in medical devices (“wireless medical devices”). For comparison, the anticipated guidance on mobile medical applications is expected to address questions such as, “Will/How will mobile medical […]
Privacy concerns regarding mobile devices in health care are raising eyebrows and making headlines. The Telegraph reports that “health and fitness apps have been harvesting sensitive personal data and passing it on to insurance and pharmaceutical companies” although “apps companies . . . have denied that the information is personally […]