News & Analysis as of

Safe Harbors

Two End-of-Year Federal Government Deadlines Approaching

by McNair Law Firm, P.A. on

Significant Changes to Online Copyright (DMCA) Safe Harbor and DoD Contractor Cybersecurity (NIST 800-171) Requirements Take Effect at the End of This Year. Important Change Affecting Digital Millennium Copyright Act...more

Schrems Redux: What's the Future for Transatlantic Data Transfers?

by Bryan Cave on

What Now? With its decision on Tuesday 3 October 2017 referring a preliminary question on the validity of the European Union’s “standard contractual clauses” (“SCC”) regime to the Court of Justice of the European Union...more

Copyright Office to DMCA service providers

by Dentons on

One of the best-known benefits of the Digital Millennium Copyright Act (DMCA) is the safe harbor from copyright infringement liability that it provides "online service providers", broadly defined in the statute as any...more

Should Your 401(k) Plan Go Safe Harbor?

by Ary Rosenbaum on

December 1 is pretty quickly going to be upon us, which reminds me that I have some notices to send out shortly. For those in the retirement plan business, we know December 1 marks the date that safe harbor notices have to be...more

December 31st Deadline to Re-Register a DMCA Designated Agent

by Miles & Stockbridge P.C. on

Online service providers have until December 31, 2017, to re-register a designated agent with the Copyright Office if they want to remain eligible for protection from copyright infringement liability under the Digital...more

European Court of Justice to Rule on Validity of Standard Contractual Clauses

On October 3, 2017, the High Court of Ireland issued its decision in Data Protection Commissioner vs Facebook and Schrems1 concerning the validity of the EU Standard Contractual Clauses (SCCs)—a mechanism used by a very large...more

HHS-OIG blesses product replacement program

by Dentons on

The federal health care program anti-kickback statute, 42 U.S.C. § 1320a-7b(b) (AKS), in addition to prohibiting payments for patient referrals, prohibits one party (such as a manufacturer) from providing anything of value to...more

EU Updates on Schrems II and the Privacy Shield

The current challenge to Facebook’s privacy practices in Ireland (“Schrems II”) may be coming to a head. You will recall that in Schrems I, the challenge to Facebook’s privacy practices led to a decision issued by the...more

Reform Comes to Australian Restructuring and Insolvency Law

by Morgan Lewis on

Two key changes made to Australian insolvency law enhance restructuring efforts in Australia and could improve outcomes for US investors. ...more

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

by Baker Ober Health Law on

A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

Following Biosimilar Trial, Jury Awards Amgen $70 Million for Pfizer’s Pre-Approval Infringement of Now-Expired EPO Patent

In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more

Ninth Circuit Establishes Rule for Mixed Statements under Reform Act’s Safe Harbor, in In re Quality Systems, Inc. Securities...

On July 28, the Ninth Circuit reversed the dismissal of a securities class action, and remanded to the Central District of California. In re Quality Sys., Inc. Sec. Litig., 865 F.3d 1130 (9th Cir. 2017). Quality Systems,...more

A Pending Supreme Court Ruling Can’t Create a Claim that Doesn’t Currently Exist

After hearing oral argument at confirmation on August 30, 2017, the bankruptcy court for the Western District of Pennsylvania issued a written opinion in In re rue21, inc., et. al., Case No. 17-22045-GLT (Bankr. W.D. Pa....more

You Can’t Ignore RESPA Section 8(c)

by Foley & Lardner LLP on

It’s been over a year since the Consumer Financial Protection Bureau (CFPB) turned the real estate settlement services industry on its head by announcing in its first ever administrative appeal that Section 8(c) of the Real...more

IRS Provides Safe Harbor for Inadvertent Normalization Violations

On September 7, 2017, the IRS issued Revenue Procedure 2017-47, which provides a safe harbor for regulated public utilities for inadvertent or unintentional uses of a practice or procedure that is inconsistent with the...more

Engaging in Political Activities? Know Your Safe Harbors and Stay Compliant

Interacting with public officials and public employees is necessary for many businesses and nonprofit organizations. No one should be discouraged from engaging public officials and public employees on public policy. In fact,...more

Safe harbour and ipso facto reforms pass through the Senate

by DLA Piper on

Another step has been taken towards the introduction of a safe harbour for directors of insolvent companies and limited stay on the operation of ipso facto clauses. Late on Monday evening, after some debate, the Senate passed...more

Time to Prepare for the End of the Year - Part One

by Poyner Spruill LLP on

The end of the year is rapidly approaching! To avoid costly penalties that can arise from inadvertent errors in the year-end rush, plan sponsors should begin talking with their service providers now about what must be done by...more

Your Digital Millennium Copyright Registration May Be About To Expire

Last November, we wrote about the Copyright Office’s decision to ditch its paper registration system for the Digital Millennium Copyright Act (“DMCA”) safe harbor and start a new online system completely from scratch. If you...more

When Speaking to Investors, Mix Facts with Predictions at Your Peril

The Private Securities Litigation Reform Act of 1995 protects “forward-looking statements”—that is, predictions about the future, at least when they are accompanied by “meaningful cautionary statements” that could cause the...more

Preparing for the New Massachusetts Equal Pay Law, Part I: Whether, When, and How to Conduct a Pay Equity Audit

The July 1, 2018, implementation date for the amendments to the Massachusetts Equal Pay Act (MEPA) is less than a year away. The amendments approved in 2016 will bring about substantial changes to the definition of...more

Bond-Financed Hospitals Must Apply New IRS Rules to Service Contracts

by McDermott Will & Emery on

After nearly two decades of restructuring service agreements to comply with Internal Revenue Service safe harbors, hospitals and other 501(c)(3) organizations are now subject to a new set of guidance and a single safe harbor...more

Virginia Supreme Court Rules on Subject-to-Tax Safe Harbor to the Royalty Addback

by Morrison & Foerster LLP on

In a 4-3 decision, the Virginia Supreme Court held that the subject-to-tax safe harbor to the royalty addback was ambiguous and applies only to the extent that the royalties are actually taxed by another state. In addition,...more

OIG’s Expanded Interpretation of Warranty Safe Harbor Portends Well for Value-Based Health Care

by Ropes & Gray LLP on

In a new advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) clarified the scope of the Anti-Kickback Statute (“AKS”) warranty safe harbor (the “Warranty Safe Harbor”). In...more

Delaware Passes Amendment to Data Breach Notification Law

by Wilson Elser on

For the first time since 2005, Delaware has amended its data breach notification law (DE Code Tit. 6, 12B-101-104). Whereas Delaware’s previous law only required companies to notify affected residents of a breach “as soon as...more

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Cybersecurity

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