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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

Sixth Circuit Affirms Dismissal Of TCPA Claims Against Healthcare Providers’ Debt Collector

The Sixth Circuit recently affirmed the entry of summary judgment against plaintiffs who had not given their phone numbers to the debt collector that had called them or to the creditor to which they owed money. See Baisden v....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

Patients provide cell phone number to hospital, debt collection calls are okay under TCPA

The 6th Circuit upheld the 2014 Ohio federal court’s decision in Mais v. Gulf Coast Collections Bureau stating that two hospital patients who provided their cell phone numbers to the hospital where they sought treatment, in...more

Health Care Update - February 2016

Are Lawmakers and Stakeholders Ready for the Silver Tsunami? - Last week, the Congressional Budget Office (CBO) released a projection that shows Medicare enrollment will grow by more than 30 percent in the next decade...more

Do the Restrictions on Advertising with Nutrition and Health Claims also Apply to Communications Addressed Exclusively to Health...

The Court of Justice of the European Union (ECJ) will soon decide on the issue of whether the restrictions on promoting foodstuffs with nutrition and health claims also apply to communications addressed exclusively to health...more

Antitrust: “Doctor, Doctor, Give Me the News”* Court gives Teladoc some good news in its antitrust challenge to Texas Medical...

Back in April 2015, Teladoc, Inc., which provides U.S. board-certified doctors for consults via phone or online video, filed an antitrust challenge to stop a new Texas Medical Board (TMB) rule from taking effect that requires...more

Henry Schein Settles FTC Charges of Deceptive Advertising of Dentrix G5

Data encrypted in accordance with the Advanced Encryption Standard (“AES”) gives dentists a “safe harbor” in the event of certain breaches of patient information. However, those relying on Henry Schein’s Dentrix G5 software...more

Texas Medical Board Loses Bid for State Action Immunity

The Teladoc decision reinforces that state boards that are composed of market participants need to reassess how they are supervised if they seek shelter from antitrust scrutiny under the state action doctrine....more

Off-Label Promotion and Product Liability: Are Industry’s Recent Court Wins in One Space a Win in the Other?

The pharmaceutical industry has recently felt empowered and emboldened by recent litigation that would seemingly allow companies to distribute, proactively, information about unapproved uses, i.e., off-label, so long as the...more

NACDS Files Amicus Brief in Support of Petitioner Rite Aid in Consolidated Appeal of FCC’s TCPA Order

On December 2nd, the National Association of Chain Drug Stores, Inc. (“NACDS”) submitted an amicus brief in support of member organization and petitioner Rite Aid in the consolidated appeal of the FCC’s July 10, 2015...more

What is the TCPA and Why is it of Concern to Long Term Care Facilities?

The Telephone Consumer Protection Act (TCPA) was enacted in 1991 to protect consumers, especially cell phone consumers, from unwanted robocalls and texts. The Act applies to virtually any company that utilizes auto-dialing...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

FCC’s New Order Provides Some Guidance for Imaging Centers Placing Autodialed Calls to Patients

The Telephone Consumer Protection Act (“TCPA”) protects consumers from unwanted telephone calls and text messages by requiring a business to obtain prior express consent before placing autodialed or prerecorded voice calls to...more

U.S. to China Health Care Arrangements: New Rules for Medical Institution and Service Advertisements

As U.S. hospitals and health care providers continue to explore China’s market for international health care business opportunities, including telemedicine, they often consider providing services or products to consumers...more

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