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The regulation of cosmetic interventions in the UK: toothless rhetoric or industry overhaul?

This Reed Smith client alert looks at the UK government’s response to the independent review of the regulation of cosmetic interventions in the UK. The key issues In recent years, cosmetic procedures have become widely...more

FDA Seeks Comments for Revised Draft Guidance Regarding the Distribution of Publications Discussing Off-Label Uses of...

The Food and Drug Administration (FDA) released a draft guidance that revises its 2009 guidance on Good Reprint Practices. The draft guidance reflects FDA’s current thoughts on this important topic that impacts drug and...more

FTC Settles Case With Medical Transcription Company

The Federal Trade Commission (FTC) recently announced that it had settled its data privacy case against medical transcription firm GMR Transcription Services, Inc. (GMR) following allegations that GMR had failed to adequately...more

FDA Revises Draft Guidance Concerning Distribution of Scientific and Medical Publications for Drug and Device Manufacturers

Updating policies established in a 2009 Guidance, the Food and Drug Administration (FDA) has released a draft version of a proposed 2014 Guidance addressing the use of medical publications in promoting "off label" uses of...more

Some Things Better Left Unshared: Social Media and Medical Identity Theft

The Washington Post recently published an article reminding individuals not to tweet or otherwise share information concerning their medical conditions on social media, warning that disclosing such information publicly “is...more

Advertising Law - Feb 13, 2014

FTC Drives Car-Related False Ad Suit to Settlement - The Federal Trade Commission recently settled charges with Nissan North America and its advertising agency over deceptive advertising for the Nissan Frontier pickup...more

In with the New, Part III: 2014 Privacy, Advertising and Digital Media Predictions

Boston-based litigation partner Matt Turnell shares his predictions about class action litigation under the Telephone Consumer Protection Act (TCPA) and Electronic Communications Privacy Act (ECPA) in 2014 and Boston-based...more

U.S. Privacy and Data Protection: 2013 Year in Review and a Look Ahead to 2014

In Boston, we celebrated Data Privacy Day (January 28) by presenting “U.S. Privacy and Data Protection: 2013 Year In Review and a Prediction of What’s to Come in 2014” for participants in an IAPP KnowledgeNet. Our panel of...more

Google’s Breach of Canadian Privacy Rules

In a recent decision released by the Canadian Privacy Commissioner (PIPEDA Report of Findings #2014-001), the commissioner investigated a complaint that Google pitched ads to an individual based on medical information that he...more

Oh Canada! Google Settles Health-Related Behavioral Advertising Claims

The Office of the Privacy Commissioner of Canada (OPC) announced on January 15, 2013, that it reached a settlement with Google over the use of health information in behavioral advertising. The case involving a complaint that...more

Is Using Health Information For Interest-Based Advertising Really Off-Limits?

As was widely reported, on January 15, 2013, the Office of the Privacy Commissioner of Canada (OPC) issued a Report of Findings regarding interest-based advertising or online behavioural advertising through Google’s AdSense...more

23andMe Named in Class Action Lawsuit

Things are getting worse for genetic diagnostics company 23andMe. On the heels of receiving a Warning Letter from the FDA over its Personal Genomic Services (PGS) test (see "FDA Threatens Agency Action Against 23andMe Over...more

The Online Marketer’s Guide To Privacy

I’ve hesitated to write this post because the law is always changing and you can’t cover it all in one blog post (thank goodness for linking). I did a presentation to the Houston Interactive Marketing Association this week...more

Can A State Impose Civil Penalties On A Drug Or Device Company For Using A Federally-Approved Label?

Overview - States have increasingly brought actions under Medicaid fraud or consumer protection statutes seeking civil penalties and restitution from the makers of prescription drugs. Many top-selling drugs have been...more

New FCC Rules to Protect Telephone Consumers from Autodial/Robocalls

On October 16, 2013, new Federal Communication Commission rules took effect to further protect consumers under the Telephone Consumer Protection Act of 1991 (TCPA). See 47 U.S.C. § 227; 47 C.F.R. § 64.1200. The changes...more

Telemarketing: HIPAA Can Reverse the Charges Under the TCPA

The Telephone Consumer Protection Act (TCPA) generally limits automatically dialed and prerecorded telemarketing calls to wireless and residential phones. In the past, healthcare providers and other "advertisers" could rely...more

Offering health care solutions at consumers' fingertips? What you should know about FDA regulation of mobile medical apps

Over two years after the Food and Drug Administration issued draft guidance on “mobile medical applications,” the agency recently issued its greatly anticipated final guidance. As FDA considered comments from stakeholders...more

FDA Issues Long-Awaited Final Guidance on Mobile Medical Applications

Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients. On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more

FDA Issues Final Guidance on Mobile Medical Apps: “De-Regulatory” Move Helps Clarify Certain Key Questions, But Leaves Others Open

On September 25, 2013, the Food and Drug Administration (FDA) issued its long-awaited final guidance on health-related software applications intended for use on mobile devices. Under the guidance, FDA will regulate only those...more

Request for Comments on Risk-Based Regulatory Framework for Health IT

An interagency working group – composed of the Food and Drug Administration (FDA), Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communications Commission (FCC) – is seeking...more

FDA Issues Two Warning Letters for Social Media Use: FDA Does Not Approve of “Liking” Consumer Claims and Targets Website Search...

In 2009, the U.S. Food and Drug Administration (FDA) announced that it intended to release a guidance document explaining how it will regulate industry’s use of social media to advertise products or communicate with...more

Getting the Best Medical Care: a Newsletter from Patrick Malone - April 2013

In This Issue: - A Magician Speaks Out About Fooling People - Science Is the Tortoise... - ...Alternative Medicine Is the Hare - Resources for Sorting Fact from Fiction - Recent Health Care News You Should...more

South Carolina Court Holds No Coverage for Blast Fax Case Under E&O Policy

In its recent decision in BCS Ins. Co. v. Big Thyme Enters., 2013 U.S. Dist. LEXIS 20051 (D.S.C. Feb. 14, 2013), the United States District Court for the District of South Carolina had occasion to consider whether an alleged...more

“But what is it, Doc?” – Health Care Professionals under Professionals under Regulation 1924/2006

Changes in the epidemiological profile in Western countries during the last three decades have shown an increasing trend in the development of non-transmissible chronic diseases in the adult population. Nutrition-related...more

Abbott Labs to Pay $1.6 Billion to Settle Consumer Protection and Misbranding Claims

Abbott Laboratories (Abbott), an Illinois company, will pay over $1.6 billion in penalties to the federal government and several states related to its alleged illegal promotion of the prescription drug Depakote for off-label...more

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