COVID Laboratory Testing Investigations
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more
Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more
The U.S. Department of Health and Human Services (HHS) announced on July 14, 2020 that it is distributing rapid point-of-care diagnostic test instruments and tests to all 15,400 nursing homes throughout the country to...more
On January 2, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule entitled, Confidentiality of Substance Use Disorder Patient Records. The final rule makes changes to the SAMHSA...more
On November 27, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Pediatric Information for X-ray imaging Device Premarket Notifications. The guidance outlines FDA’s rationale regarding information that...more