Exploring Digitization of Health and Medical Data and Records Part Two
Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
The Evolution of Informed Consent in U.S. Courts
What patients misunderstand about their right of informed consent
New guidance released by the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) on April 1, 2024, clarified that hospitals will not be eligible for Medicare or Medicaid...more
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more
A New York State Supreme Court Justice recently ruled the state’s Covid-19 vaccine mandate for health care workers is “null, void and of no effect.” Justice Gerard Neri ruled the state overstepped its authority by...more
Welcome to the 14th issue of the 2021 edition of Unprecedented. Predictions of an end to the COVID-19 pandemic from even a few months ago have been called into question by the highly contagious Delta variant, with some...more
Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more
The CDC has issued new guidance focused on ensuring employees’ informed consent for COVID-19 testing in the workplace. This builds on earlier guidance the CDC issued regarding workplace testing programs last fall. Because...more
As employers continue to grapple with a safe return to the workplace, the U.S. Centers for Disease Control and Prevention (CDC) issued new guidance for businesses and employers on SARS-CoV-2 testing of employees, as part of a...more
As employers continue to grapple with a safe return to the workplace, on January 21, the U.S. Center for Disease Control and Prevention (CDC) issued new guidance for businesses and employers on SARS-CoV-2 testing of...more
Telehealth expanded dramatically in response to the COVID pandemic. Now that providers, patients, payers and public officials have seen the benefits, it is almost certain that telehealth will continue to play an increasingly...more
Conducting medical product clinical trials during the COVID-19 public health emergency presents unprecedented challenges. In light of the challenges presented by COVID-19, the Food and Drug Administration (FDA) issued...more
On June 3, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” with new information on the use of...more
On April 24, 2020, the FDA issued a Drug Safety Communication about the known side effects of hydroxychloroquine and chloroquine – the antimalarial drugs being used to treat Covid-19. These side effects include serious and...more
The federal government and several states have carved out legal immunities for providers treating COVID-19 patients on the front lines. These legal immunities, however, are temporary and in some cases narrowly drawn. In...more
Many sectors of the economy have ground to a halt in the effort to curtail the COVID-19 pandemic (the “Pandemic”), and the clinical research industry is not immune to the effects of these business shutdowns. While the...more