
Connecticut becomes the fifth state to pass a comprehensive privacy law. Are you prepared for state privacy law compliance required in 2023?
Continue Reading Where Is the Tipping Point – Comprehensive State Privacy Law Update
Thought Leaders on Laws and Regulations Affecting Health Care and Life Sciences
Connecticut becomes the fifth state to pass a comprehensive privacy law. Are you prepared for state privacy law compliance required in 2023?
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Continue Reading Where Is the Tipping Point – Comprehensive State Privacy Law Update
On Tuesday, August 24, 2021, California Attorney General Rob Bonta issued a guidance bulletin (the “Guidance”) to health care providers reminding them of their compliance obligations under California’s health data privacy laws, and urging providers to take proactive steps to protect against cybersecurity threats. This Guidance comes, in part, as a response to federal regulators…
On October 22, 2019, the Centers for Medicare and Medicaid Services (“CMS”) issued a Request for Information (“RFI”) to obtain input on how CMS can utilize Artificial Intelligence (“AI”) and other new technologies to improve its operations. CMS’ objectives to leverage AI chiefly include identifying and preventing fraud, waste, and abuse. The RFI specifically states…
On July 11, 2019, a Federal judge for the U.S. District Court for Maryland ruled that manufacturers and importers of products such as e-cigarettes and other electronic nicotine delivery systems (“ENDS”) have ten months to submit applications for marketing to the U.S. Food and Drug Administration (“FDA”). The ten-month deadline is applicable to new tobacco…
On February 27, 2019, Tennessee-based holding company Vanguard Healthcare, LLC (“Vanguard”), agreed to pay over $18 million to settle a False Claims Act (“FCA”) action brought by the United States and the state of Tennessee for “grossly substandard nursing home services.” The settlement stems from allegations that five Vanguard-operated facilities failed to do the following:…
On November 26, 2018, the U.S. Food and Drug Administration (“FDA”) announced the process for clearing most medical devices for marketing is being updated to incorporate changes the FDA laid out in an April draft guidance. For over forty years, most medical devices have entered the United States market through the 510(k) clearance process.…
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