For almost 30 years, hospitals and certain other health care organizations have been required to report to the National Practitioner Data Bank (NPDB) specified “adverse actions” regarding physicians and dentists that they employ, contract with, or have on staff.
On January 12, 2015, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a proposed regulation to revise the required warning statement for products containing chemicals listed by the state under Proposition-65 (Prop-65).
Most parties that enter into arbitration agreements do not expect their choice to be diminished by being forced to litigate in open court. This paramount deference to contractual freedom is a hallmark of US law as well as the practice in the United States Court of Appeals for the Second Circuit.
Your company has been asked by a customer to certify that its products manufactured in US plants are in compliance with “Buy American” requirements. How does your company respond?
The Food and Drug Administration (FDA) has just issued its long-awaited Draft Guidance on Current Good Manufacturing Practice (CGMP) Requirements for Combination Products.
In 2014, the Departments of State and Commerce implemented final rules that overhauled 11 United States Munitions List (USML) Categories. These changes have affected a wide range of industries.
Your company has been asked by a customer to certify that its products manufactured in US plants are in compliance with “Buy American” requirements. How does your company respond?
In a succinct eight-page opinion, the Supreme Court ruled unanimously last week that trademark “tacking” is a question of fact that should generally be decided by juries.
On January 16, 2015, Sens. Jerry Moran (R-KS) and Mark Warner (D-VA) introduced S. 181 (The Startup Act), which is meant to promote new business formation, especially in the information technology industry.
Recent guidance from Hong Kong’s Privacy Commissioner suggests that Hong Kong may be on the verge of implementing major new restrictions on the cross-border transfer of personal data.
Arent Fox expands Government Relations practice with addition of Senior Government Relations Director Alex Manning. Alex is joining the firm’s Washington, DC office and will advise clients on issues surrounding cybersecurity, privacy, data breaches, tax, trade policy, and immigration.
The beginning of 2015 brings implementation of The Joint Commission’s (TJC) newly rewritten Sentinel Events Policy (Policy) for hospitals. Released in late 2014, and effective January 1, 2015, the Policy clarifies and puts into operation new and revised definitions and expectations.
The Treasury Department’s Office of Foreign Assets Control and the Commerce Department’s Bureau of Industry and Security released their much-anticipated regulations governing trade with Cuba, and they were published in the Federal Register and became effective on January 16, 2015.
On January 15, 2015, the Federal Communications Commission’s (FCC) Notice of Proposed Rulemaking (NPRM) regarding the scope of its definition of “multichannel video programming distributors” (MVPDs) was published in the Federal Register.
On December 30, 2014, the Department of Health and Human Services Office of Inspector General (OIG) published its annual solicitation for the development and/or modification of safe harbor provisions under the Federal Anti-Kickback Statute.
The Massachusetts Department of Revenue recently issued a draft directive setting out what records must be kept for all vendors, retailers, and contractors using computerized point-of-sale systems.
Should you choose federal litigation or arbitration? In arbitration, parties to a dispute agree to submit the dispute for a decision to a neutral third party who is not a public official. Advantages include limited discovery while disadvantages include narrower grounds for appeal.
The Department of Health and Human Services Office of Inspector General posted Advisory Opinion No. 14-11 addressing a charitable foundation’s request to provide cost-sharing assistance to financially needy patients diagnosed with either Crohn’s disease or ulcerative colitis.
On January 6, 2015, Federal Trade Commission (FTC) Chairwoman Edith Ramirez delivered a speech discussing best practices for companies in the emerging market of the “Internet of Things,” which refers to the wireless interconnectivity of everyday devices, from home appliances to medical devices.
Late last week, eight days after the Terrorism Risk Insurance Act (TRIA) expired, the US House of Representatives and the US Senate overwhelmingly approved H.R. 26, legislation reauthorizing TRIA until the end of 2020.
In a precedential ruling, the Trademark Trial and Appeal Board of the US Patent & Trademark Office (USPTO) sustained an opposition by McDonald’s to the mark MCSWEET for pickled gourmet vegetables on the grounds that it infringed on and diluted McDonald’s famous family of “MC” for formative marks.
Canada’s Department of Foreign Affairs, Trade, and Development announced an enhanced Corporate Social Responsibility Strategy when it released a report entitled “Doing Business the Canadian Way: A Strategy to Advance Corporate Social Responsibility in Canada’s Extractive Sector Abroad.”
On December 30, 2014, Michigan Governor Rick Snyder (R), signed Public Law 414 into law, which excludes college athletes from the definition of “public employees” who are entitled to collectively bargain in Michigan.
Following up from the Executive Order 13685 which effectively banned US trade and investment with Crimea, the Department of the Treasury has just issued General License 5.
It will be interesting to see if the Rule survives the judicial, and perhaps even legislative, challenges it may face. If you have any questions about the Rule, please contact the authors of this post or the Arent Fox professional who handles your matters.