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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

FTC Urges FDA to Reconsider Homeopathic Regulatory Framework

In a comment filed last Friday, the Federal Trade Commission (FTC) responded to its sister-agency’s request for comments by urging the Food and Drug Administration (FDA) to reconsider how homeopathic drugs are regulated. As...more

FTC Resolves Case Against “Melanoma Detective” App Marketer

The FTC announced late last week that it resolved its case against the final defendant, Avrom Lasarow, in the “Melanoma Detective” app matters. The FTC alleged that claims that the apps could detect and diagnose melanoma in...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

One Small Step for Amarin & One Giant Leap for Pharmaceutical Companies? - Only Time Will Tell

Friday’s ruling in Amarin Pharma, Inc. v. United States Food & Drug Administration is a monumental event. It signals the dawn of a new era for prescription drug promotion....more

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more

Blog: Kim Kardashian Drug Endorsement Results in FDA Warning Letter

The U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a Warning Letter this week to Duchesnay, Inc. related to celebrity Kim Kardashian’s social media posts on Instagram, Twitter and...more

Health Care Entities Get Clarity from FCC on Telephone Communications

The health care industry is in the midst of rapid change as governments fight rising health care costs, providers look to comply with myriad new regulations, and technology continues to take a more prominent role in the...more

The FCC's TCPA Regulatory Ruling Imposes Tighter Call Restrictions

Last month, the Federal Communications Commission (FCC) released a long awaited declaratory ruling and order, FCC 15-72, addressing several petitions which sought clarification of or exemptions from Telephone Consumer...more

NIST Issues Draft Guidance for Mobile Health Data

With health care breaches constantly on the rise, increasing access to electronic health records (EHRs) from mobile devices, and more prevalent “shadow” cloud use, health care organizations are getting a bit of help from the...more

Guest Post - Just the Fax, Ma’am

While Bexis is on vacation, here is a guest post to take up some of the slack. Our guest blogger today is Henry Pietrkowski, a partner in Reed Smith's Chicago office. This one's a little different. It's about the impace of...more

FCC Ruling Addresses Robocalls by Health Care Providers

Mintz Levin’s Communications Practice recently released a Communications Advisory discussing a Declaratory Ruling and Order released by the Federal Communications Commission (FCC). The ruling clarified and expanded the reach...more

US Federal Communications Commission’s Recent Order Expands Potential Liability under the Telephone Consumer Protection Act for...

“This Order will make abuse of the TCPA much, much easier. And the primary beneficiaries will be trial lawyers, not the American public.” That’s what FCC Commissioner Ajit Pai had to say in his dissent from the FCC’s recent...more

A Couple of Law Review Articles We Actually Like

The last couple of times we’ve commented on new law review articles, we haven’t liked what we’ve seen very much. We’re gluttons for punishment, however, and this time we were rewarded. We found a couple of recent law review...more

FCC Order Creates New TCPA Challenges for Companies

As previously reported, the Federal Communications Commission recently approved a Declaratory Ruling and Order (the Order) addressing a number of petitions that requested the FCC clarify its interpretations of the Telephone...more

The Sixth Circuit Further Defines “Advertisement” Under the Telephone Consumer Protection Act

Last month, in a case of first impression, the Sixth Circuit Court of Appeals issued an opinion finding that unsolicited faxes intended strictly for informational purposes were not “advertisements” and therefore not...more

“Ain’t Wastin’ Time No More”* — Doctors, Vets, and Lawyers in the Antitrust Crosshairs

Supreme Court Decision in North Carolina State Board of Dental Examiners v. Federal Trade Commission Prompts Legal Challenges to State Professional Boards - Earlier this month a Texas federal district court judge granted a...more

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

FCC Uses Industry Requests for TCPA Clarity to “Close Loopholes” and “Empower Consumers” Rather Than to Afford More Than Token...

The Federal Communications Commission (FCC) adopted a Declaratory Ruling and Order that resolves 19 petitions for declaratory ruling, one rulemaking petition and one petition for clarification, all arising out of an upsurge...more

FCC Approves TCPA Clarifications that Increase Potential for Liability

The Federal Communications Commission, in a divided vote, approved an order clarifying several long-simmering Telephone Consumer Protection Act (TCPA) issues. While the order has not been officially released, the...more

Federal Court Enjoins Texas Medical Board from Enforcing More Stringent Telemedicine Rules

On April 10, 2015, the Texas Medical Board (the “Board”) voted to adopt stricter regulations governing the practice of telemedicine, which were scheduled to go into effect June 3, 2015 (the “Revised Regulations”). The Board...more

Teladoc successful in thwarting new Texas telemedicine rules

We previously reported on the new telemedicine regulations adopted by the Texas Medical Board (Board), which requires that patients be seen face-to-face or in person to establish a physician-patient relationship in order to...more

All Eyes on Homeopathics: FTC Workshop Signals Targeted Regulatory Scrutiny of Homeopathic Products

On Tuesday, the Federal Trade Commission “FTC” announced it will be hosting a workshop in September to evaluate advertising for over-the-counter homeopathic products. Homeopathy is an alternative medicine practice dating back...more

Partners HealthCare Hit with Phishing Expedition Exposing 3,300 Patient Records

Late last week, Partners HealthCare announced that it notified approximately 3,300 patients of a security breach involving a hacking incident where intruders accessed medical and personal information of patients....more

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