Communications & Media Science, Computers & Technology Health

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Health Update - November 2015

Best Practices for Using Social Media in Healthcare: Maximizing Impact, Mitigating Risk - Editor's note: In a generation more likely to seek health information online than see a doctor, social media is playing an...more

FDA Invites Genome Scientists to Come Play in the precisionFDA “Sandbox” - NGS Technologies Take Center Stage at Agency Campus

On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public workshops engaged presenters and audience members on various...more

HIPAA Lessons from the Warner Chilcott Settlement

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations...more

HIPAA and Text Messaging

Text messaging is pervasive. Doctors and other health care providers, covered entities, and business associates currently use (and embrace) the technology. Texting is easy, fast and efficient. It doesn’t require a laptop...more

FCC Clarifies the Requirements for Sending Wireless Calls and Text Messages to Patients

The Federal Communications Commission ("FCC") recently clarified questions surrounding wireless patient calls and text messages, and the requirements of the Telephone Consumer Protection Act (“TCPA”). The TCPA protects...more

State Law Obstacles to the National Distribution of eHealth Medical Devices Directly to Consumers

The latest and greatest eHealth medical devices directed to consumers are technologically advanced and consumer-friendly. They have the capacity to diagnose certain health conditions and generate treatment plans and...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

Health Care and Life Sciences Practice Newsletter

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

NLRB Extends Its Email Rule to the Health Care Workplace

The National Labor Relations Board (Board) continues its scrutiny of employer policies—this time striking down an email policy designed to ensure that health care employees provide patient care without distraction. UPMC, 362...more

Parties Continue to Challenge the FCC’s July 2015 Declaratory Ruling and Order

On September 4, 2015, both Vibes Media, LLC and Rite Aid Hdqrtrs. Corporation filed petitions for review of the FCC’s July 10, 2015 Declaratory Ruling and Order with the United States Court of Appeals for the District of...more

FCC Clarifies TCPA Exemptions for Health Care Calls

In 1991, Congress passed the Telephone Consumer Protection Act (“TCPA”), which was enacted to protect the privacy interests of consumers by placing restrictions on unsolicited contacts from automated telephone calls,...more

Clarification on the TCPA’s Exemption for Health Care-Related Calls

The Declaratory Ruling and Order issued by the Federal Communications Commission (“FCC”) July 10, 2015, clarified several sections of the Telephone Consumer Protection Act (“TCPA”), including addressing a petition filed by...more

FCC Releases Guidance on Autodialing and Pre-Recorded Voice Calls to Wireless Phone Numbers

This past July, the Federal Communications Commission (“FCC”) released a ruling (the “Ruling”) interpreting the Telephone Consumer Protection Act (“TPCA”) restrictions on certain communications to wireless telephone numbers....more

Telemedicine or just a gadget for fitness addicts? Mobile Health Apps and the law

Mobile health (mHealth) apps are becoming more and more popular. Back in 2013, more than 97,000 health apps were already on the market. According to the European Commission (EC), this figure now amounts to around 100,000...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs

The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more

FTC Staff Comment Encourages FDA to Reevaluate its Current Approach to Regulating Homeopathic Products

On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory...more

Central District of California "Discontinues" Much of Plaintiffs' Experts' Testimony in Cymbalta "Discontinuation Symptoms" Case

“I’m not a doctor, but I play one on TV” – shorthand for “I am pretending to know what I’m talking about, but I really don’t.” We have blogged frequently about experts inclined to such pretense and about courts’ varying...more

FDA is “Keeping up with Kardashians’” Social Media Posts

On August 7, 2015, the FDA sent a warning letter to drug maker, Duchesnay, over Kim Kardashian’s endorsement of its pills for morning-sickness. Kardashian had made an Instagram and Facebook post which vouched for the...more

Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more

Mobile Health Devices and Cybersecurity: Federal Guidance for Management of Threats in Medical Devices

New Technology = New Threats - With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating. The...more

Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more

Life Sciences Companies and Free %$&*@# Speech

Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has...more

FDA Update: New guidance released on mobile medical devices, medical devices data systems

Mobile devices, including cell phones and tablets, have had a major impact on the practice of medicine, how patients interact with their doctors, receive or implement treatments, as well as how software developers view the...more

Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination

In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more

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