Chelsea M. Rutherford
Subscribe to Chelsea M. Rutherford's PostsChelsea M. Rutherford focuses her practice on corporate, transactional and regulatory matters affecting a wide range of clients in the health care and life sciences industries. Read Chelsea M. Rutherford's full bio.
New York AG Settlement with App Developers Serves as a Warning for the Need for Evidence-Backed Commercial Claims
By Chelsea M. Rutherford and Jennifer S. Geetter on Apr 5, 2017
Posted In Advertising & Marketing, Big Data, Consumer Protection, Data Privacy, Ecommerce, Electronic Contracting, Mobile Apps, Telehealth, Text Messaging
On March 23, 2017, the New York Attorney General’s office announced that it has settled with the developers of three mobile health (mHealth) applications (apps) for, among other things, alleged misleading commercial claims. This settlement highlights for mHealth app developers the importance of systematically gathering sufficient evidence to support their commercial claims. Read the full...
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What You Need to Know about Changes to the Common Rule
By Bernadette M. Broccolo, Chelsea M. Rutherford, Jennifer S. Geetter, Jiayan Chen and Lisa Mazur on Feb 10, 2017
Posted In Data Privacy, General Interest, Uncategorized
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 repositories and use of those repositories for secondary research. All stakeholders involved in federally funded research should be aware of the...
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HHS Finalizes Overhaul of Federal Human Subjects Research Protections
By Chelsea M. Rutherford and Jennifer S. Geetter on Jan 18, 2017
Posted In Data Privacy, General Interest, Uncategorized
On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.” These are the first revisions to the Common Rule since its original enactment in 1991, and have been in progress since HHS...
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OMB Reviewing Common Rule Overhaul
By Chelsea M. Rutherford and Jennifer S. Geetter on Jan 6, 2017
Posted In Data Privacy, General Interest, Uncategorized
On January 4, 2017, the Department of Health and Human Services (HHS) submitted a draft final rule to amend the federal human research regulations to the Office of Management and Budget (OMB). These regulations, often referred to as the Common Rule, were originally developed in 1991 and have been adopted by multiple federal departments and...
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