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
The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in...more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
On January 19, the CFPB issued Circular 2023-01 to affirm that companies offering “negative option” subscription services are required to comply with federal consumer financial protection laws. According to the Circular,...more
The off-label use of ketamine to treat anxiety, depression, and other behavioral health disorders —coupled with the COVID-19 telehealth era—has spurred the opening of virtual ketamine clinics nationwide. Some clinics offer a...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
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
Shortly after updating the related draft Questions and Answers document, the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed...more
The Massachusetts Board of Registration in Medicine (“BORIM”) recently finalized revisions to 243 CMR 2.00 (Licensure and the Practice of Medicine). These changes took effect on August 9, 2019. Because of the uncertainty...more
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule to amend its regulations to allow waiver or alteration of informed consent requirements in certain FDA-regulated clinical investigations...more