Mintz Levin

New Materials Help Covered Entities Comply with Nondiscrimination Rules

Last week, the Department of Health and Human Services (“HHS”) released new materials for covered entities to use to comply with Section 1557, the nondiscrimination provision of the Affordable Care Act. Section 1557 strengthens…more
| Civil Rights, Health

FDA Adjustment to Orphan Drug Review May Indicate Increased Scrutiny of Designations

In recent years, applications for orphan drug designations have flooded into FDA at a rapid pace, and this year appears to be no exception. Orphan drug applications received by FDA rose by approximately 30% over the previous…more
| Health, Science, Computers, & Technology

Renovating the Past, Constructing the Future: H.R. 5530

This is the fourth installment in a series examining five bipartisan bills advanced by the House Committee on Education and the Workforce on June 22, 2016 and approved by the full House of Representatives on July 11, 2016. While…more
| Education, Elections & Politics, Finance & Banking, Real Estate - Commercial

FDA Releases Draft Guidance on Codevelopment of Therapeutic Products and Screening Tests

On July 14, 2016, the U.S. Food and Drug Administration (the “FDA”) released draft guidance on the codevelopment of therapeutic products (such as pharmaceuticals) and companion tests that are used to determine if the therapeutic…more
| Health, Science, Computers, & Technology

CPSC Chairman Kaye and Commissioner Adler: Current Civil Penalties Approach Works

Yesterday, CPSC Chairman Elliot Kaye and Commissioner Robert Adler issued a lengthy joint statement vigorously defending the Commission’s current approach to civil penalties against various criticisms voiced by Commissioners Joe…more
| Civil Remedies, Consumer Protection, Products Liability

Pokémon Go in the Workplace: Oh Look There’s a Pikachu!

Did you know that the world is now inhabited by creatures called Pokémon? (Or maybe they’ve always been there?) Some run across the plains; others fly through the skies; and some live in the mountains….and some, yes, some, are…more
| Labor & Employment Law, Science, Computers, & Technology

FinTech Companies Face Big Privacy Challenges in 2016

According to the FBI, “there are only two types of companies: those that have been hacked and those that will be.” It does not take an actual data breach, however, for a company to be liable for its data security practices. In…more
| Antitrust & Trade Regulation, Consumer Protection, Finance & Banking, Privacy, Science, Computers, & Technology

Facebook v. Vachani – User Authorization Can Be Revoked By Service Providers

The U.S. Court of Appeals for the Ninth Circuit recently issued a decision that could have far reaching implications for the relationships between companies that provide online services, their customers or users, and third…more
| Business Torts, Commercial Law & Contracts, Communications & Media Law, Privacy, Securities Law

California Federal Court Reminds Employers That They Must Carefully Navigate Disability Accommodation Process

The obligation to accommodate a disabled employee is an ongoing one; a doctor’s note may not be a prerequisite to engage in the interactive process – those are two important lessons that employers should take away from a recent…more
| Civil Procedure, Civil Rights, Labor & Employment Law

FDA Deep Dive: Real Life Implications of FDA NEST Program Explored

In our Israel Connect Summer 2016 edition we summarized the FDA’s post-market surveillance data programs, including the NEST program designed to consolidate and analyze real-world device data once a device is legally…more
| Health, International Law & Trade, Science, Computers, & Technology

House Passes GE Labeling Bill; Obama Expected to Sign

As a parting act before its seven-week recess, the House last Thursday passed by a vote of 306-117 Senator Pat Roberts’s (R-KS) legislation (S.764) requiring the labeling of genetically engineered foods. Already approved by the…more
| Agriculture, Communications & Media Law, Conflict of Laws, Consumer Protection, Elections & Politics

FDA Reorganization Takes on Cancer Moonshot and Other Initiatives

On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016 State…more
| Administrative Law, Elections & Politics, Health, Science, Computers, & Technology

Expanding Access and Encouraging Health Care: H.R. 5529

This is the third installment in a series examining five bipartisan bills advanced by the House Committee on Education and the Workforce on June 22, 2016. The original post briefly summarizing all five bills was posted in…more
| Education, Elections & Politics, Health

The Department of Labor’s 2016 Final Fiduciary and Conflict of Interest Regulations: Amendments to Prohibited Transaction Exemption 84-24 for Transactions Involving Insurance Agents and Brokers (and Others)

This post continues our examination of the Department of Labor’s suite of final fiduciary and conflict of interest regulations. Our previous posts discussed the newly expanded definition of “investment advice fiduciary”; the…more
| Finance & Banking, Labor & Employment Law, Securities Law

Dutch Foundation Dismissed for Inadequate Safeguarding of Members’ Interests

On June 29, 2016, the Dutch Court of East Brabant dismissed a foundation’s claims against Rabobank Group for alleged unlawful selling of interest rate swaps because it failed to meet the requirement of the Dutch Claim Code that…more
| Business Organizations, Business Torts, Civil Procedure, Finance & Banking, Securities Law
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