Health Care Law News and Insights

Industry insiders can all agree that the U.S. Food & Drug Administration (FDA) regulates the use of medical devices. Most insiders agree that a medical device is any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part that is intended for...

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On April 17, 2023, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) that would modify the Standards for Privacy of Individually Identifiable Health Information (Privacy Rule) under the Health Insurance Portability and Accountability Act of 1996 and...

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In a unanimous decision yesterday, the U.S. Supreme Court, in an opinion written by Justice Thomas, ruled that the False Claims Act's ("FCA") scienter element refers to a defendant's knowledge and subjective beliefs - not to what an objectively reasonable person may have known or believed. The case, U.S. ex rel. Schutte...

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