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Health Communications & Media

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

Ninth Circuit En Banc Panel Holds that Central Hudson Survives Sorrell

by Reed Smith on

Last week we bashed a Ninth Circuit Daubert decision. We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the...more

HIPAA Settlements in April and May Highlight Key Compliance Concerns for OCR

by Williams Mullen on

After a break in March with no new settlement agreements, OCR returned in April and May with quite a few. The Health Care Data Aware Blog already posted about a $400,000 OCR settlement released April 12, 2017, which can be...more

Senate Proposes Expanded Use of Telehealth

On May 18, 2017, the Senate Finance Committee voted to move forward a bill entitled the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 (S870), which would increase access to...more

Blog: FDA Solicits Comments Regarding Two New Studies Related to Drug Promotion

by Cooley LLP on

The U.S. Food and Drug Administration (FDA) published two Federal Register notices today announcing its intent to study different aspects of drug promotion. In Docket No. FDA-2017-N-1315, the FDA solicited comments regarding...more

New HHS Cybersecurity Preparedness Checklist

by Carlton Fields on

The Department of Health and Human Services’ Office of Civil Rights (OCR) recently published a checklist to guide HIPAA-covered entities and business associates through an appropriate response to a ransomware or cybersecurity...more

Trump Administration Delays Yet Another Food Rule: Revised Nutrition Facts Label Paused Indefinitely

by Saul Ewing LLP on

On June 13, 2017, the U.S. Food and Drug Administration (FDA or the Agency) delayed indefinitely the Nutrition Facts and Supplement Facts Label and Serving Size rules (the Rules), which were set to go live on July 26, 2018...more

OCR Issues Checklist for Responding to Cyber-Attack

The Office for Civil Rights (OCR) recently released guidance entitled “My Entity Just Experienced a Cyber-attack! What Do We Do Now?” The Checklist is a practical tool for health care entities and outlines several steps to...more

Spelling Counts (Among Other Things): FDA Issues Warning Letters for Mistakes in Drug Listing

by Arnall Golden Gregory LLP on

Recently, the Food and Drug Administration issued two Warning Letters to pharmaceutical companies for failing to fulfill product listing obligations for what appear to be oversights. In the first letter issued at the end of...more

FDA Says Viewers Catch a Fleeting Glimpse; Can’t Hear What You’re Saying to Sponsor of Ad with Mismatched Audio and Visual Risk...

by Arnall Golden Gregory LLP on

Recently, FDA’s Office of Prescription Drug Promotion (OPDP) issued its first Untitled Letter of the year, citing a direct-to-consumer TV advertisement for a prescription weight- loss drug. According to OPDP, the ad made...more

FDA Announces Delay in Compliance Dates for Revised Nutrition Fact Requirements

by Kelley Drye & Warren LLP on

The FDA announced today that it was delaying implementation of the final rule promulgated in May 2016 that revised regulations governing Nutrition Facts labels on food and dietary supplements. The rule initially set a...more

FDA Announces Intent to Extend Compliance Date for Changes to Nutritional and Supplement Facts Labels and Serving Sizes – Federal...

Following last month’s announcement that the Food and Drug Administration (FDA or agency) had decided to delay the compliance deadline for the menu labeling regulations; yesterday, the agency announced its intent to extend...more

New legislation eases the way for telehealth providers in TX and signals increasing national alignment

by Dorsey & Whitney LLP on

New legislation recently signed into law in Texas paves the way both for digital health companies to expand, particularly direct-to-consumer (D2C) companies, and also potentially heralds an era of virtual care visits on a...more

Marketer In Hot Water for Inconspicuous TCPA Consent Language

by Klein Moynihan Turco LLP on

A recent decision issued by the United States District Court for the Northern District of Illinois has brought renewed emphasis to the importance of prominently displaying TCPA consent language in Internet marketing. In a...more

FDA Warns Against Products Claiming to Cure Cancer

by Fox Rothschild LLP on

The Food & Drug Administration (“FDA”) regulates cancer drugs and devices, both for use by humans and pets. Such drugs and devices must obtain FDA approval or clearance before they can be marketed or sold to consumers, so...more

FCC Amends NAL in Rural Healthcare Proceeding, Increases Proposed Fine

by Kelley Drye & Warren LLP on

In the first action of its kind, on June 7, 2017, the Federal Communications Commission (“FCC”) issued an amendment to a Notice of Apparent Liability for Forfeiture and Order (“NAL”), for alleged violations of the rules...more

HHS Releases Health Care Industry Cybersecurity Task Force Report

Last week, the Department of Health and Human Services (HHS) issued its “Report on Improving Cybersecurity in the Health Care Industry,” which is the culmination of a year-long effort on behalf of the Cybersecurity Task...more

Latest Updates To Ediscovery for Defendants Cheat Sheet

by Reed Smith on

This is our quasi-annual update to our cheat sheet about ediscovery for defendants. Essentially that means using discovery to obtain access to what plaintiffs have said about themselves, and their supposed injuries, on...more

“Fireball” Malware a Threat to Health Care Industry

A new report released by Check Point has security personnel working in the health care industry particularly concerned and they are warning their colleagues about the existence of “Fireball.”...more

OCR Issues Reminder on Security Incidents

Following the frequent and varied ransomware attacks on health care entities over the past few years, the Office for Civil Rights (OCR) published guidance last summer to the health care industry reminding it that a ransomware...more

Data Privacy + Cybersecurity Insider - June 2017

by Robinson & Cole LLP on

The American Institute of CPAs (AICPA), has released a risk management reporting framework intended to "establish a common, underlying language for Cybersecurity risk management reporting — almost akin to US GAAP or IFRS...more

Eighth Circuit Court of Appeals Affirms Dismissal of TCPA Claims on Grounds of Prior Express Consent

by Stinson Leonard Street on

In Zean v. Fairview Health Services, the U.S. Court of Appeals for the Eighth Circuit recently affirmed the district court's dismissal of a putative class action complaint under the Telephone Consumer Protection Act (TCPA)....more

Browsewrap Disclosure Held Insufficient to Constitute “Prior Express Written Consent” Even for a Healthcare-Related Call

by Dorsey & Whitney LLP on

Folks involved with selling health insurance, or anything else for that matter, and who rely upon browsewrap website terms might want to give Sullivan v. All Web Leads, Inc., No. 17-cv-1307, 2017 U.S. Dist. LEXIS 84232 (N.D....more

National Pharmacy Avoids TCPA Claim for Flu Shot Robocall under Health Care Rule Exemption

by Hinshaw & Culbertson LLP on

A judge in the Southern District of New York recently held that an automated, pre-recorded message sent on behalf of Rite Aid informing recipients to obtain a flu vaccine shot was exempted from the Telephone Consumer...more

Health System Paid $2.4 Million Settlement After Identification in a Press Release of a Patient Who Was Engaged in Fraud

by Dickinson Wright on

The U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced a $2,400,000 settlement with Memorial Hermann Health System (“MHHS”) to resolve an investigation of an unauthorized disclosure of...more

TCPA Class Action Tossed out After Hospital Provides Records Indicating Consent

Central Florida Regional Hospital (the Hospital) was released from a proposed class action last week for its alleged violations of the Telephone Consumer Protection Act (TCPA). The Hospital’s debt collector, Transworld...more

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Cybersecurity

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