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Dinsmore & Shohl LLP | October 2018

In response to questions regarding the legality of Cannabidiol (CBD) oil products, the State of Ohio Board of Pharmacy (Board) announced that only licensed and operating Medical Marijuana Control Program dispensaries may sell CBD oil products. In June, the Board announced the award of 56 provisional medical marijuana dispensary licenses. All of those provisional licensees will have six months to comply with operational requirements in order to obtain a certification of operation (COO) ...

Simonsen Vogt Wiig AS | October 2018

On 1 January 2020, the maximum allowable sulfur content of marine fuels will be drastically reduced from the current 3.50% to 0.5% m/m. 2020 is rapidly approaching, but is the shipping industry really prepared? In this article, we provide an overview of the regulations and the main alternatives for compliance that shipowners and operators are faced with. Introduction On 1 January 2020, the maximum allowable sulfur content of marine fuels will be drastically reduced from the current 3.50% to 0 ...

Dinsmore & Shohl LLP | October 2018

On September 20, 2018, the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced settlements with three Boston hospitals for disclosing Protected Health Information (PHI) to ABC News documentary filmcrews.[i] In total, the hospitals paid OCR $999,000 to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule ...

Shepherd and Wedderburn LLP | September 2018

Not-for-profit Reforesting Scotland’s "Thousand Huts" campaign has spearheaded the regrowth of the hutting community, previously almost entirely eradicated by increasingly strict building regulations. The new Building (Miscellaneous Amendments) (Scotland) Regulations 2017 sets out the framework for ecologically sustainable hut development. What is a Hut? A hut must be a single storey building used as recreational accommodation ...

Hanson Bridgett LLP | September 2018

The California Court of Appeal recently upheld a lower court decision that, as we previously discussed, expanded the scope of the "public trust doctrine" to include groundwater. In Environmental Law Foundation v. State Water Resources Control Board, the appellate court held that agencies permitting groundwater pumping must consider how pumping may harm "public trust interests ...

ENS | September 2018

Background The legal and philosophical aspects relating to the concept of “ownership” with respect to human biological material of various kinds has been hotly debated ...

Hunton Andrews Kurth LLP | August 2018

The Occupational Safety and Health Administration (“OSHA”) issued a final rule to “Improve Tracking of Workplace Injuries and Illnesses, “ which requires employers to electronically submit their injury and illness records to OSHA.  Specifically, establishments with 250 or more employees must annually submit their Forms 300, 300A, and 301.  And, establishments with 20 to 249 employees must annually submit their Form 300A ...

MinterEllison | August 2018

"The global healthcare deal frenzy is set to continue for at least another 18 months as technology giants including Amazon, strategic players and private equity firms step up their fight for limited assets ...

Hanson Bridgett LLP | July 2018

In the Loop: With the Hanson Bridgett Government Group     Not long ago, the state of California suffered through a crippling six-year drought, and water conservation was the name of the game. But California’s last two winters have been wetter, and water conservation feels a lot less urgent when the stuff is literally falling from the sky ...

Veirano Advogados | July 2018

Resolution number 217/2018 was published in the Brazilian PTO’s Official Bulletin number 2470, and amends Resolution number 80/2013, which refers to the fast-track examination for patent applications related to products, pharmaceutical processes, equipment and materials related to public health, aiming to accelerate patent applications considered strategic to the Brazilian Public Healthcare System ...

As the Trump administration is pushing forward on its deregulatory agenda and, in particular, its efforts to improve the Endangered Species Act (ESA) and its implementation by the US Fish and Wildlife Service (FWS) and National Marine Fisheries Service (NMFS) (together, the Services), the Supreme Court is poised to hear a landmark case on designation of critical habitat under the ESA that could provide some guideposts for the Services’ new regulations ...

On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy ...

Haynes and Boone, LLP | July 2018

Proposition 65 is a 1986 California right-to-know law requiring businesses to provide “clear and reasonable” warnings of potentially harmful exposures to chemicals appearing on the growing list maintained by California’s Office of Environmental Health Hazard Assessment (“OEHHA”) ...

Hanson Bridgett LLP | July 2018

The Affordable Care Act ("ACA") is alive and well, despite renewed legal challenges and the elimination of the “individual mandate” beginning next year. While the Tax Cuts and Jobs Act reduced the tax penalty for individuals who don’t have health coverage to $0, effective for 2019, employers continue to be subject to penalties for failing to comply with certain ACA rules ...

Carey | July 2018

In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164” ...

Dinsmore & Shohl LLP | July 2018

On June 28, 2018, Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Alex M. Azar III announced the ninth year of the national health care fraud takedown. The takedown resulted in the largest government action against health care fraud, which involved more than 600 defendants from over 50 federal districts. The targeted fraud schemes accounted for more than $2 billion in false billings ...

Lavery Lawyers | June 2018

Artificial intelligence technologies are extremely promising in healthcare.1 By examining, cross-referencing and comparing a phenomenal amount of data.2 AI lets researchers work more quickly at a lower cost3 and facilitates doctors’ decision-making with regard to diagnosis, treatment and choice of prescription. The integration of AI into the healthcare field can take various forms:4 Management of electronic medical records (e.g ...

Hanson Bridgett LLP | June 2018

This week, the U.S. Department of Labor (DOL) issued final rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer group or association to provide health coverage for their employees ...

Hanson Bridgett LLP | June 2018

On June 5, I wrote about the suspension of the California End of Life Option Act (“EOLOA”) in the wake of Ahn v. Hestrin and several related court proceedings in May.  On Friday, June 15, the Fourth District Court of Appeal determined that the EOLOA will in fact remain enforceable pending further proceedings. Thus, eligible Californians who have requested end-of-life drugs in accordance with the EOLOA may continue with the process described in that law ...

The Corps Struggles to Balance Competing Constitutional and Statutory Duties Federal agencies must often balance competing policy concerns and legal requirements. This process may be difficult and fraught with intense public feedback, and frequently results in litigation. The U.S. Army Corps of Engineers (the Corps) has found itself in the hot seat over how it manages the nation’s rivers, pitting its obligations under the Endangered Species Act (ESA) against private property rights ...

Dinsmore & Shohl LLP | June 2018

In 2016, West Virginia had the highest death rate in the country from drug overdoses—primarily caused by opioids—at 52.0 for every 100,000 people.[1] The state was on track to exceed that number in 2017.[2] Seeking to enact policies that not only curb but reverse this upward trend, the West Virginia Legislature introduced a number of bills during the 2018 Regular Legislative Session that sought to address this disturbing epidemic. One of these, S.B ...

Hanson Bridgett LLP | June 2018

A New Development on the Subject (Update as of June 15th) Click Here to Read »   A flurry of rulings during the last two weeks of May has generated enormous confusion regarding the status of California's two-year-old End of Life Option Act ("EOLOA"), the law that allows a terminally ill adult with a six-month prognosis to obtain aid-in-dying drugs from a physician, subject to numerous safeguards ...

Karanovic & Partners | June 2018

The first upscale exploration of oil and gas in Montenegro started in 1914, when King Nikola Petrovic approved the National Assembly's decision for oil exploration around Lake Skadar. The first well in the area of Crmnica dates back to 1922 - although it produced nothing of significance. In later researches of the Montenegrin offshore, the existence of geological structures with the potential for hiding hydrocarbon deposits was confirmed ...

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