News & Analysis as of

Public Health Medical Devices Department of Health and Human Services (HHS)

Alston & Bird

Health Care Week in Review: House Committee on Oversight and Accountability Held a Hearing on PBMs; HHS Reorganizes Technology,...

Alston & Bird on

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

Alston & Bird

Health Care Week in Review: House Held a Markup of 23 Bills; Senators Announced a Proposal on Primary Care Payment Reform

Alston & Bird on

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

King & Spalding

FDA Publishes White Paper on Artificial Intelligence & Medical Products

King & Spalding on

On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more

MoFo Life Sciences

New Opportunities For Test Developers: Monkeypox Diagnostics

MoFo Life Sciences on

For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products....more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 22, Number 9. Privacy Briefs: September 2022

Report on Patient Privacy 22, no. 9 (September, 2022) - More than 92% of patients believe privacy is a right and their health data should not be available for purchase, according to a survey from the American Medical...more

Alston & Bird

Alston & Bird Health Care Week in Review - September 2020 #1

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Pillsbury Winthrop Shaw Pittman LLP

Understanding PREP Act Liability Protections in the Fight Against COVID-19

Answers to frequently asked questions on who is eligible for PREP Act protections, which products are covered, and what activities will be immunized. PREP Act guarantees of immunity are available to those who manufacture,...more

King & Spalding

CMS Releases Additional Section 1135 Waivers and Flexibilities to Assist the U.S. Healthcare System with COVID-19 Patient Surge

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On March 30, 2020, CMS issued additional Section 1135 blanket waivers to provide the American healthcare system with additional flexibility to respond to the COVID-19 pandemic. CMS is authorized under Section 1135 of the...more

McDermott Will & Emery

Detailed Summary of Federal Requirements for Production of Hand Sanitizing Products

To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have...more

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