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As the Prospect of a Vaccine Approaches, Business and Communications Challenges Are Just Around the Corner

Eye on FDA

Related to both of these first two questions – what sort of documentation will be necessary for an individual – either employee or customer – to present evidence of inoculation? What are the HIPAA and privacy implications, if any, related to all of these questions? But first there will be regulatory rites of passage.

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Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law Blog: Biosimilars

The gray box at the top of the document at this link shows the change in position. Second, absent some kind of contractual relationship between a provider and a manufacturer, a provider is generally immune from misbranding if the provider is not also selling a regulated product.