Health Consumer Protection Communications & Media

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Part I - TCPA: Regulatory - Calls By or on Behalf of the Federal Government

A number of organizations filed comments and/or reply comments regarding the National Consumer Law Center (“NCLC”)’s Petition for Reconsideration of the Broadnet Declaratory Ruling, which asks that the FCC reconsider its...more

FDA to Host Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Medical Products

On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The hearing is intended to...more

The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law....more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

Final Order against Practice Fusion Approved by FTC

On August 16, 2016, the Federal Trade Commission (FTC) approved the final order resolving its privacy complaints against Practice Fusion. The complaint alleged that Practice Fusion “misled consumers by soliciting reviews for...more

FDA Issues Final Guidance on General Wellness Products

On July 28, 2016, the United States Food and Drug Administration (FDA) finalized guidance stating that the agency does not plan to regulate “general wellness products,” including software applications, provided they present a...more

Hospital Text Messaging Rules Placed on Hold by Joint Commission

The Joint Commission, which accredits hospitals and other health care organizations, hit pause on its prior May 2016 announcement to allow secure text messaging in hospitals and other health care organizations. The use of...more

Congress Passes GMO Labeling Bill – Preempting State Labeling Laws

In response to recent state efforts to regulate the labeling of food products containing genetically modified organisms (GMOs), the U.S. House of Representatives, on July 14, passed S. 764, a Senate-initiated bill...more

Potassium Chloride Should Be Potassium Salt On Food Labels

On June 27, 2016, NuTek Food Science LLC filed a citizen petition with the U.S. Food and Drug Administration that, if granted, will provide great benefits to consumers by helping the FDA and the food industry in their efforts...more

PowerPoint Slides: Could My Company's Website Violate the Americans with Disabilities Act?

Under the Americans with Disabilities Act (ADA), places of public accommodation must ensure equal access to the goods and services they offer to disabled individuals. Is a company website subject to the ADA? The answer to...more

Webinar: Could My Company's Website Violate the Americans with Disabilities Act? [Video]

Under the Americans with Disabilities Act (ADA), places of public accommodation must ensure equal access to the goods and services they offer to disabled individuals. Is a company website subject to the ADA? The answer to...more

Advertising Law - June 2016

First Circuit Affirms Ruling Against Jerk.com - In a victory for the Federal Trade Commission, the First Circuit Court of Appeals affirmed a Commission ruling that website Jerk.com, a self-described reputation management...more

Health Law Pulse - June 2016

On May 9, 2016, a federal district court for the Middle District of Pennsylvania rejected a request from the Federal Trade Commission (FTC) for a preliminary injunction to enjoin the pending merger (Merger) between Penn...more

Facebook, Healthcare Provider Websites and HIPAA

In a class action Complaint filed in the Northern District of California on March 15, 2016, Kiesel Law LLP, on behalf of primary plaintiff Winston Smith and a potential class of others, alleges that Facebook received...more

Mobile App Compliance for Dummies: New Tool Helps Developers Understand Their Legal Compliance Requirements

In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool...more

Federal Agencies Provide User-Friendly Guidance on Compliance with Data Privacy Laws

How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil...more

Regulators Offer Guidance on Privacy and Security for Health App Developers

This month, the Federal Trade Commission (FTC) issued guidance on privacy and security best practices for health-related mobile apps, such as fitness apps connected with wearables, diet and weight loss apps, and health...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

A New Tool for Health App Developers to Navigate a Crowded Regulatory Field

As regulators seek to define their authority and the scope of their enforcement power, more health apps will continue to flood the marketplace and transform how patients are treated. As mobile health applications...more

You Can Pay Now or You Will Pay Later: FDA Issues a Warning Letter to a Pharmaceutical Company for a Misleading Patient Co-Pay...

On March 29, 2016, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to a pharmaceutical company for a patient co-pay assistance voucher that failed to include risk...more

Transfer of healthcare website information to Facebook alleged to be a HIPAA violation

Filed under the title of creative lawyering, a putative class action case has been filed against Facebook in federal court in Northern California alleging that health care providers and medical organizations have violated...more

Debt Collector for Affiliated Physician Group Can Rely on Patient Contact Consent Obtained by Hospital

Careful drafting of consent and information release provisions can ensure that providers and affiliated physicians and their debt collectors can contact patient cell phones using automatic telephone dialing systems or...more

Sixth Circuit Finds “Prior Express Consent” in Affirming Dismissal of TCPA Class Action against Healthcare Provider’s Debt...

The Sixth Circuit (the “Court”) recently sided with a defendant-debt collector in a putative class action in which the plaintiffs claimed that the defendant’s calls to their cell phones violated the Telephone Consumer...more

Creditor Can Obtain TCPA "Prior Express Consent" Through Intermediary, Sixth Circuit Rules

A creditor that received a consumer's cell phone number through an intermediary had the consumer's ''prior express consent'' under the Telephone Consumer Protection Act (TCPA) to receive calls from a debt collector, the U.S....more

FDA Targets CBD Products, Claims Made in Social Media

Last February, FDA issued three warning letters to companies marketing cannabidiol (CBD) products as dietary supplements. FDA reviewed the companies’ websites and concluded that claims that CBD products could treat...more

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