Latest Updates

Blog: New ED Audit Guide Updates Requirements Concerning Third-Party Servicers

As discussed in our previous posts, the Department of Education’s new Audit Guide establishes new audit requirements applicable to for-profit schools and to compliance audits of third-party servicers that administer “any aspect” of the… more

Maybe the Yacht Was the Tip-Off

If you’re a surgical device distributor and you want to reward a surgeon for using your products on Medicare and Medicaid patients, you may want to choose a reward that’s less conspicuous than a yacht. That’s one lesson in the recent… more

IRS, PBGC and DOL Provide Additional Hurricane Relief

The IRS issued an announcement paralleling the relief granted to Hurricane Harvey victims to those in Florida affected by Hurricane Irma. Announcement 2017-13 (the “Announcement”) relaxes hardship distribution standards for employees… more

CFPB Provides Some Clarity on Alternative-Data Models Through No-Action Letter

On September 14, 2017, the CFPB issued a no-action letter – the first one ever issued by the agency – to a marketplace lender, stating that the agency had no present intention to take enforcement or supervisory action against the… more

Federal Education Secretary Announces Plans to Revamp Title IX Directives

The U.S. Department of Education recently announced plans to “revoke or rescind” current guidance addressing enforcement of Title IX. Secretary Betsy DeVos said earlier this month the department plans to review and overhaul guidance… more

European Commission paper on Brexit and IP

The European Commission has released a position paper on “Intellectual property rights (including geographical indications)” giving us the first indication of how the Commission will approach the Brexit negotiations with the UK… more

European Court Provides Further Clarity on Employee Monitoring

The September 5, 2017, decision of the Grand Chamber of the European Court of Human Rights (ECHR) in Barbulescu v Romania (Barbulescu) has interrupted a recent trend toward limiting privacy in the European workplace. The Barbulescu… more

As Medical Food Industry Grows, So May FDA Scrutiny

On September 1, the United States Food and Drug Administration (FDA) issued a Warning Letter to ND Labs, Inc. of Lynbrook, New York, regarding its LPS Cherry, Liquid Fiber Flow, and Nana Flakes 'medical food' products. The Warning… more

OFCCP Offers More Hurricane Relief

On the heels of the exemption for Hurricane Harvey contractors, and given the additional widespread destruction caused by Hurricane Irma, the federal government has extended a deadline affecting federal contractors and subcontractors… more

False Claims Act Relators Be Warned: Rule 54’s Taxable Costs Award Lies Ahead for the Overeager Relator

In a published opinion last week, the Fifth Circuit sent a reminder to would-be False Claims Act (“FCA”) relators that they better think carefully before filing suit because while they may be seeking treble damages, they may ultimately… more

Reviewing the Justices’ Voting Records in Death Penalty Appeals, 1990-2010 (Part 2)

Yesterday, we reviewed the individual Justices’ voting records in death penalty cases for the years 1990 through 1999. Today, we’re looking at the Justices’ voting records for the years 2000 through abolition in 2010… more

Losses Caused by Hurricanes: Are You Covered?

This hurricane season represents the first time in the history of record keeping that two Category 4 or higher hurricanes, Harvey and Irma, have struck the U.S. mainland in the same year. Within a month, Hurricanes Harvey and Irma… more

Some May Come and Some May Go: FDARA Brings Changes to User Fees and Other FDA Programs

On August 18, 2017, the President signed the FDA Reauthorization Act of 2017 (FDARA), which revises and extends several of FDA’s user fee programs. The user fee programs establish filing fees for various application types and other… more

Does the NAD’s Capillus Decision Baldly Contradict the FDA?

On September 12, the NAD released its decision in its review of the Capillus82 hair growth device (Case #6107). This case is unusual in that it addressed a challenge to a prescription-only medical device, and related closely to the… more

Europe Launches a New Cybersecurity Agency with Regulatory Authority

On 13 September 2017 the European Commission (“Commission” or “EC”) published a set of initiatives strengthening the EU cybersecurity strategy, mainly including: - A proposal for a “Cybersecurity Act”, consisting of a new regulation… more

Alert: M&A Lessons Learned from the Blocked Chinese Acquisition of Lattice Semiconductor

Last week, President Trump issued an Executive Order prohibiting the acquisition of Lattice Semiconductor Corporation (Lattice), a US computer chip manufacturer, by a Chinese investor. The president's order blocking the transaction was… more

Report: Employees Cited As Prime Cause Of Data Breaches At Small, Mid-sized Companies

For small and medium-sized businesses, the most dangerous cyberthreat may come from within. IT industry publication TechRepublic reports that a newly released study by Keeper Security and the Ponemon Institute suggests careless… more

Farewell to a Repo Man and Using Laconic Persuasion as a CCO

The life of a Repo Man is always intense… That was one of the greatest lines from one of the greatest movies from one of the greatest laconic actors of all time. Of course it was Harry Dean Stanton who died over the weekend. Along… more

Your Daily Dose of Financial News

The Systemic Risk Council—a heady group of “former top financial regulators, regulators, policymakers and academics”—is warning that the rollback of Dodd-Frank and other financial regulators could lead to bank failures and destabilize… more

[Video]Day 10 Of Innovation in Compliance-Improvisation in Compliance

How can you change the perceptions around compliance in your organization? With the Justice Department requirement, set out in the Evaluation of Corporate Compliance Programs, to more fully operationalize your compliance program, do… more

What are Trademarks?

Here at Winstead, we are fortunate enough to have two lawyers that were selected for inclusion in The Best Lawyers in America® 2018 in Trademark Law, Stan Moore and Cathryn Berryman. Before answering the question What are Trademarks?… more

What Effect Will the New Revenue Recognition Standard Have on M&A?

The Financial Accounting Standards Board's new revenue recognition standard is expected to have wide-ranging effects on M&A transactions. The new revenue recognition standard under GAAP will be applicable to public companies for annual… more

#CAUTION: FTC Ramps Up Enforcement of and Education on Social Media Influencer Disclosure Requirements

In 2017, being a “social media influencer” can mean big bucks. Companies are increasingly eager to pay individuals with large social media followings substantial sums to promote products in the hopes of reaching millions of potential… more

China’s ‘One Belt, One Road’ Initiative Creates Opportunities and Regulatory Challenges

In a time of shifting opinions on the benefits of globalization, China’s “One Belt, One Road” initiative (OBOR) offers an unexpected bright spot for multinational companies able and willing to participate in this… more

USCIS Reinstates Premium Processing for H-1B Cap Subject Petitions

USCIS announced on Monday, September 18, 2017, that it will immediately accept premium processing requests of all H-1B visa petitions subject to the Fiscal Year (FY) 2018 cap. H-1B cap petitions filed in April 2017, requesting a start… more

Recent Trends on the U.S. Doctrine of Equivalents

U.S. courts have long recognized that a product or process which does not literally infringe a patent can nevertheless infringe under the "doctrine of equivalents" if it is equivalent to the claimed invention. The percentage of patent… more

The publication of the Macron ordinances

The long-awaited reform of French employment law is now on track. The French government (the "Government") presented five draft ordinances outlining the different topics and related modifications that should be formally ratified by the… more

The Rise of Managed Care Audits and Reimbursement Demands in the Wake of the ACA

If the summer of 2017 demonstrated anything, it is that health care remains a complex and contentious industry. One of its many complications stems from the natural tension between health care providers and health care insurers as to… more

Supreme Court Declines to Resolve Circuit Split on Debt Recharacterization

On August 10, 2017, the U.S. Supreme Court rescinded the grant of certiorari in PEM Entities LLC v. Levin on the grounds that review had been “improvidently granted.” The case seemingly provided a perfect vehicle to resolve the circuit… more

The Trump threat to 401(k) and the reality of it

When Donald Trump was elected President last November, there were quite a few people who promised gloom and doom as if it was the end of our republic. Despite the tweets and the drama, that really hasn’t panned out yet. Many in the… more

How Much Circumstantial Evidence is Enough for Spoliation Sanctions?

We’ve all heard, “It’s not whether you win or lose, but how you play the game.” But how you play the game is often a big part of ending up on the winning side in e-discovery. In today’s world, it has almost become normal that people… more

An English-Language Primer on Germany’s GDPR Implementation Statute: Part 1 of 5

Over the past year, the German government has been working on legislation to implement the EU’s General Data Protection Regulation (GDPR). On July 6, 2017, Germany did so by passing a statute titled the Data Protection Amendments and… more

Dow Takes its Gene Patents Row with Bayer to the Supreme Court to Avoid the $455 Million Arbitral Award

When a company agrees to arbitrate an international patent licensing agreement, the avenues for the appeal of the resulting arbitral award are very limited. Even the invalidity or expiration of the underlying patents may be… more

2017 Mid-Year Cross-Border Government Investigations and Regulatory Enforcement Review

Welcome to BakerHostetler’s 2017 Mid-Year Cross-Border Government Investigations and Regulatory Enforcement Review. This edition delivers news, analysis and insights into key developments in the cross-border investigations and… more

California Takes One Step Closer to Imposing Reporting Requirements and Public Shaming for Employer Pay Gaps

When we last checked in on AB 1209, the Gender Pay Gap Transparency Act, the proposed legislation was making its way through the California Senate. After making a few key amendments, the Senate passed the bill on September 7, 2017… more

You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter

Companies can’t sign quality agreements and then say “we’re done.” This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good… more

The Graham-Cassidy Bill: Evaluating the Latest ACA Repeal Measure

Last week, the Senate unveiled the Graham-Cassidy Bill, Republican legislators’ latest attempt to repeal the Affordable Care Act (ACA). Crafted by Sens. Bill Cassidy, R-LA, Lindsey Graham, R-SC, Dean Heller, R-NV, and Ron Johnson… more

Mind the Gap! Hurricanes may have significant impact on Gap coverage

Some estimates peg the number of cars flooded by Hurricane Harvey at more than a half million. So too, the number of flooded cars following Irma will be legion. This significant loss will likely lead to a significant number of… more

The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing what it… more

[Video]Compliance into the Weeds-Episode 54, Report from TEC 2017

In this episode, Matt Kelly returns to his journalism roots with a live report from TEC 2017, the Workiva user conference. We discuss some of the hot topics at the conference including possible repeal or modification of SOX sections… more

New Rules Promoting Free Cross Border Flow of Non-personal Data in the European Union

On September 13 the European Commission (“Commission” or “EC”) issued a proposal for a new Regulation on a framework for the free flow of non-personal data in the EU… more

FDA Issues Guidance on Use of Real-World Evidence for Medical Devices

On August 31, 2017, the Food and Drug Aministration issued a final guidance titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” In the guidance, which finalizes the agency’s July 2016 draft… more

Dealing with Disaster: Issues and Relief for Employee Benefit Plans

In the period following natural disasters such as Hurricanes Harvey and Irma, employer plan sponsors will be faced with any number of hardship-related employee benefit plan administration issues. Many of these involve critical… more

CRISPR: How will it change our lives?

CRISPR One giant breakthrough; a mass of complexities - The discovery and successful harnessing of the gene editing technology, CRISPR, promises to be one of the most significant breakthroughs of our age. But a complex series of… more

Energy Insider Interview Series: Questions for Independent Petroleum Association of America President and CEO Barry Russell

1. IPAA has long advocated for smart and responsible oil and gas development and remained at the forefront of the discussions shaping policy and regulations affecting the industry. What’s your take on the first six months of the Trump… more

Responding To SCDEW: The Payoff For Employers

There are several ways that employers can keep their unemployment insurance (UI) tax rate down. First, it is beneficial to learn how the South Carolina Department of Employment and Workforce (“SCDEW”) determines the employer’s… more

Registration For This Year's Diversity Lottery Program Starts On October 3, 2017: Here's What To Know

The U.S. State Department administered DV Lottery Program awards immigrant visas (green cards) to individuals hailing from countries with low rates of immigration to the United States. This year there are 50,000 DV visas available. The… more

Joy in Who-Ville? Playwright Wins Fair Use Copyright Dispute in Parody of “Grinch”

It’s not quite what Dr. Seuss envisioned: Kind-hearted and cheerful Cindy-Lou Who from the childhood classic “The Grinch That Stole Christmas” becomes a cynical adult who was thrown in prison after murdering her abusive husband, the… more

October 15th Deadline: Medicare Part D Notice Of Creditable (Or Non-Creditable) Coverage

UPDATED: September 19, 2017 – Employers who offer prescription coverage to any Medicare Part D eligible employees (whether or not retired), or Medicare Part D Medicare-eligible spouses or dependents, you must provide those individuals… more

Canadian Securities Regulators Clear a Path for Bitcoin Funds

The British Columbia and Ontario securities regulators have taken a leap forward in the regulation of bitcoin and other cryptocurrencies with the first registration of a fintech start-up, First Block Capital Inc., which intends to… more

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