Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
On April 20, 2018, as anticipated, 17 federal departments and agencies (the “Agencies”) issued a notice of proposed rulemaking (“2018 NPRM”) in which the Agencies propose a six-month delay to the general compliance date for...more
The Department of Health and Human Services has taken a step toward harmonizing the complex regulatory requirements for federal human subjects research. Our Health Care Group breaks down the changes to the Common Rule due to...more
On Sept. 8, 2015, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM) to seek input on changes to the Federal Policy for the Protection of Human Subjects, otherwise known as...more
On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...more
The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more
On September 28, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) updating federal policy for the Protection of Human Subjects, more...more
Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more
On September 2, 2015, HHS issued the long-awaited Notice of Proposed Rulemaking (NPRM) on revisions to the rules governing federally-funded research involving individuals, commonly referred to as the Common Rule (Subpart A of...more
In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more
The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more