Health Care Law News and Insights

Monkeypox—Do Employers Need To Worry?

Published: Jun 13, 2022
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Several cases of monkeypox has now been found in the United States. We do not yet know whether employers will need to worry about monkeypox in the context of their workforces and workplace, but it may be wise to be informed. Monkeypox is a viral illness that has symptoms including...

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3 Things You Need To Know About The FDA’s New Software As A Medical Device (SaMD) Guidance

Published: Jun 06, 2022
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The FDA recently released a draft guidance for what documentation sponsors should include in premarket submissions for software-based products. The new guidance is an update to the current guidance, which is from 2005, and it has important information for anyone operating in the digital health space. In addition to BrightInsight's...

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Public Health Emergency Likely To Remain In Place, At Least For Now

Published: May 23, 2022
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On Monday, May 16, the Department of Health and Human Services (HHS) passed a self-imposed 60-day deadline to notify states that they did not plan to extend the Public Health Emergency (PHE), which has been in place since Jan. 31, 2020. HHS most recently extended the PHE for 90 days...

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