Alerts

The Office for Civil Rights (OCR) recently began its second round of audits of covered entities and business associates for compliance with the HIPAA Privacy Rule, Security Rule, and Breach Notification Rule (the “Phase 2” audits).

On Monday, the US Supreme Court sent a potential class action case back to the Ninth Circuit for reconsideration, marking an intermediary win for Spokeo Inc., which uses a “people search engine” to find, compile, and sell publicly available personal information.

The California Office of the Attorney General (OAG) recently released a report detailing a comprehensive analysis of the data breaches reported to the OAG between 2012 and 2015.

FDA announced Tuesday that it will begin reevaluating how it regulates the use of the term “healthy” on food labeling.

The Federal Trade Commission recently issued warning letters to companies whose mobile applications contain cutting-edge software that can monitor consumers’ television viewing habits.

The legally mandated paid sick leave landscape is ever-changing, with new leave laws and legislation developing at the state, federal, county, and city levels.

On May 6, 2016, CMS published in the Federal Register a request for comments on proposed revisions to the information to be collected pursuant to the CMS Voluntary Self-Referral (Stark) Disclosure Protocol (SRDP).

In March 2012, the Centers for Medicare & Medicaid Services (CMS) enhanced its Medicare enrollment screening for new and existing enrollees to the Medicare program. Providers not meeting CMS’s enhanced enrollment screening risk denial, revocation, or deactivation of Medicare billing privileges.

The FTC final order against a video game marketing company highlights that advertising partners must monitor influencer disclosures and performance.

Last September, we published an alert warning retailers of a looming expansion in the reach of Title III of the Americans with Disabilities Act that would impose requirements on e-commerce websites to make themselves more accessible to users with a wide variety of disabilities.

In fact, the House passed the DTSA by a vote of 410-2 on April 27, 2016, and today, May 11, President Obama signed it into law. The DTSA is codified at 18 U.S.C. 1836(b).

Texas Health and Human Services Commission (HHSC) has finally issued final regulations transitioning to the use of the National Average Drug Acquisition Cost (NADAC) to establish Medicaid ingredient cost reimbursement instead of utilizing manufacturer-reported prices.

FDA recently issued its final guidance on restaurant menu labeling intended to help restaurants and similar retail food establishments understand nutrition labeling requirements under the Federal Food, Drug, and Cosmetic Act that may apply to them.

The Defend Trade Secrets Act of 2016 was voted and approved on April 27, 2016 and is now on its way down Pennsylvania Avenue to the President’s desk for signing.

The Drug Enforcement Agency recently approved a first-ever randomized, placebo-controlled clinical trial to study the use of botanical (“whole plant”) marijuana (rather than an extract made thereof) to treat post-traumatic stress disorder in veterans.

In a surprising move that could dramatically impact government enforcement actions against life science companies, the health care industry, and government contractors, a federal board has increased federal False Claims Act penalties by more than 100 percent. 

Store credits not redeemable for cash are not unclaimed property under California’s Unclaimed Property Law.

A recent lawsuit filed against GNC serves as a reminder that companies need to ensure that prices listed as “regular prices” are substantiated.

The Department of Justice recently announced it has reached a more than $780 million settlement with Pfizer Inc. and its subsidiary Wyeth to resolve reported false pricing allegations.

Whether it is proprietary information regarding customers, pricing, sourcing, product design, or manufacturing methods, trade secrets provide a competitive edge in the market by virtue of the fact that it is not generally known.

Why does it matter? This seemingly inconsequential distinction may mean the difference between being able to prominently display your embroidered brand trademark on your jeans and being required to place a large “Made in China” marking next to the embroidered brand trademark.

Given the recent municipal bankruptcies and likelihood of more to come during the next recession, the author draws lessons from recent cases to determine what changes to Chapter 9 would be in the interest of the nation.

VA recently announced a significant policy change that will now require drug manufacturers to make drugs that are “covered drugs” under the Veterans Health Care Act (VHCA) available to the VA under the manufacturer’s Federal Supply Schedule (FSS) contract.

Arent Fox filed an amici brief on behalf of the Wisconsin Alumni Research Foundation, the Indiana University Research and Technology Corporation, and San Diego Intellectual Property Law Association. Our brief focused on the following three errors in the Federal Circuit’s rationale.