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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 ...

Haynes and Boone, LLP | September 2018

Eduardo Corzo, a Counsel in Haynes and Boone’s Mexico City office who focuses on maritime and shipping law, contributed to a new legal guide titled, “Getting the Deal Through – Shipping 2019.” Eduardo wrote the chapter that covers shipping as governed by the law of Mexico. Each chapter in the guide covers key issues such as ship registrations and mortgages, maritime liens, and responsibilities and liabilities of the shipping company ...

ENSafrica | 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 ...

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 ...

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) ...

Haynes and Boone, LLP | October 2018

Classic Maritime Inc. v Limbungan SDN BHD & Anor [2018] EWHC 2389 (Comm) This case arose out of a dispute relating to the correct interpretation of an “exceptions clause” which excused non-performance of a contract in circumstances that are usually described asforce majeure ...

Waller | October 2018

Late last month,  the U.S. Drug Enforcement Administration (DEA) issued a final order placing FDA-approved drugs that contain cannabidiol (CBD) derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in Schedule V of the Controlled Substances Act of 1970 (CSA). Schedule V of the CSA includes drugs such as Robitussin and Lyrica ...

Garrigues | October 2018

The Spanish Tax Agency published on their webpage an information notice by the Customs and Special Taxes Department with the intention of “enabling interested parties to comply with their tax and customs obligations” as it regards the arrival and departure of recreational craft from the customs territory of the Union ...

MinterEllison | October 2018

Information is critical to the conduct of health and medical research. Much of the time the information relates to individuals. Higher education institutions regularly collect, use, disclose and hold information, including health information, for research purposes ...

Dykema | October 2018

Cryptocurrencies have captured the imaginations of individuals and emerging businesses drawn to their potential to serve as alternative stores of value, to reduce transaction costs by eliminating intermediaries. Most notably in popular culture and media - to provide eye-catching opportunities for speculative investing ...

Dinsmore & Shohl LLP | October 2018

In a rare bipartisan and bicameral compromise, Congress has passed the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” shortened to the “SUPPORT Act.” The bill was signed by President Trump on October 24, 2018 ...

Simonsen Vogt Wiig AS | October 2018

Shipowners often face the decision as to which flag they should fly on their vessel. Several factors may influence the choice of flag. The shipowner's decision as to which flag they should fly on their vessel must be made when an owner is: registering a new build; changing flag in connection with a sale and purchase transaction; or concluding a bareboat contract ...

Dinsmore & Shohl LLP | November 2018

Today the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (NPRM) that will end HRSA’s delays in implementing a January 5, 2017 final rule concerning 340B drug price calculations and civil monetary penalties (CMPs) against manufacturers who knowingly and intentionally overcharge 340B covered entities for 340B drugs (the Final Rule) ...

Simonsen Vogt Wiig AS | November 2018

The value of the car is no longer merely associated with the car body, its engine or other material parts. Substantial value is found in the knowledge that controls the car – knowledge that does not only steer the car, but which may form the basis for maintenance and repairs planning, computing insurance premiums or indicating who is liable in the case of damage ...

Dinsmore & Shohl LLP | November 2018

Recently, the Ohio Department of Medicaid (ODM) proposed the adoption of Ohio Administrative Code 5160-1-32.1 (the Proposed Rule), which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA privacy rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...

Dinsmore & Shohl LLP | November 2018

In the last quarter of 2018, the Office of the Inspector General (OIG) announced that ImmediaDent of Indiana, LLC (ImmediaDent), which operates nine dental care practices, and Samson Dental Partners, LLC (SDP), which provides administrative support to Immediadent, have agreed to pay the United States and the state of Indiana $5.1 million to resolve allegations that they improperly billed Indiana’s Medicaid program ...

Dinsmore & Shohl LLP | November 2018

On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects ...

Dykema | November 2018

Obviously, they are all natural disasters that climate scientists believe will increase in severity and intensity in the coming years. And they are all events that nursing homes and assisted living facilities (and all Medicare/Medicaid certified health care providers) are legally required to prepare for in order to protect their residents and patients. More pointedly, though, they are all events which the U.S ...

Dinsmore & Shohl LLP | November 2018

In a letter to state Medicaid directors on Nov.13, 2018, the Secretary of the U.S. Department of Health and Human Services, Alexander Azar, announced a new demonstration opportunity that will allow states to provide improved care for adults with a serious mental illness (SMI) and children with serious emotional disturbance (SED) ...

Dinsmore & Shohl LLP | November 2018

The deadline for meeting the previously issued nursing home compliance mandate is approaching. The Centers for Medicare & Medicaid Services (CMS) issued the mandate in 2016 and gave facilities three years to become compliant. On November 28, 2019, skilled nursing facilities (SNF) and nursing homes will be required to adopt and implement a compliance program as a condition for participation in Medicare and Medicaid ...

A&L Goodbody LLP | November 2018

Ireland is a key global hub for aviation finance and leasing, having almost 50 years' experience in the sector. Recent reports forecast that the Irish aviation sector will see growth of over 20 per cent in aircraft assets from 2016 to 2021. Aviation finance and leasing is a global industry with investment into Ireland mainly coming from the US, Europe and Asia. Ireland’s aviation finance and leasing sector was a 'disruptive' industry in Ireland long before the term was even coined ...

Dykema | December 2018

Increased federal oversight may be on the horizon for skilled nursing facility involuntary transfers and discharges. The Office of Inspector General (OIG) included in its 2019 Work Plan reviewing SNFs’ involuntary transfers and discharges, focusing on reviewing whether State agencies have effectively investigated and enforced proper transfer and discharge procedures ...

Dykema | December 2018

Medicare and Medicaid certified nursing homes are frequently required to pay fines (called “civil money penalties” or “CMPs”) to the U.S. Centers for Medicare and Medicaid Services (“CMS”) when government surveyors find them out of compliance with the Requirements for Participation for Long-Term Care Facilities. It is not uncommon for CMS to assess CMPs in the hundreds of thousands of dollars ...

Hanson Bridgett LLP | December 2018

Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...

Dinsmore & Shohl LLP | December 2018

On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway.  In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway ...

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