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) ...
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 ...
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 ...
The oil and gas sector has seen significant changes over the past few years, led by a significant reduction in global oil prices. This has increased the focus on operational efficiency and more flexible ways of working collaboratively to alleviate the effects of protracted price deflation ...
On 18 October 2018, the Compensation for Occupational Injuries and Diseases Amendment Bill, 2018 was published for public comment. In terms of the Notice that accompanied the Bill, written representations on the proposed amendments may be furnished within 60 days of publication of the notice ...
Blockchain is a distributed ledger of data entries. The entries are processed and managed by a series of different computers, or ‘nodes’, which can be running on different servers. Every computer connected to the system keeps a copy of this ledger, meaning that different parties can view and manage the same information in real time. It also makes it exceptionally safe and secure. The energy sector has been relatively slow to adopt blockchain technology ...
The UKCS is the largest decommissioning market in the North Sea. There are around 475 fixed facilities, over 10,000 kilometres of pipeline and approximately 5,000 wells. These will all need to be decommissioned over the next 30 years, when they reach the end of their economic life, at an estimated cost of £59.7 billion ...
Feeling the heat: the draft Climate Change Bill, 2018 Earlier this year, the South African Minister of Environmental Affairs (the “Minister”) published the draft Climate Change Bill, 2018 for public comment. Since then, the Department of Environmental Affairs (“DEA”) has undertaken a road show across the country to solicit comments to the Bill and held further bilateral meetings with stakeholders earlier this year ...
Earlier this year, the Minister of Mineral Resources (the “minister”) published a notice amending Chapter 4 of the regulations relating to explosives, binding in terms of the Mine Health and Safety Act, 1996. The regulations will come into effect at the end of the 2018 year ...
Towards the end of 2018, the South African Minister of Mineral Resources, Gwede Mantashe (the “Minister”), published the Broad-Based Socio-Economic Empowerment Charter for the South African Mining and Minerals Industry, 2018 (the “2018 Mining Charter”). It is indicated that “implementation guidelines” are to be published in the near future. What follows is a summary of a few of the salient features of the 2018 Mining Charter ...
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 ...
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) ...
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 ...
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 ...
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 ...
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 ...
Earlier this year, the Ministry of Energy and Mineral resources ("MEMR") issued Press Release No. 00022/04/SJI/2018 to continue arranging dozens of overlapping regulations and permits ("Simplification"). So far, 90 regulations and 96 certifications/recommendation/permits ("Regulations") have started since 22 January 2018 ...
Earlier this year, the Minister of Energy and Mineral Resources (the “MEMR”) issued Regulation Number 10 of 2018 on The Second Amendment to Minister of Energy and Mineral Resources Regulation Number 10 of 2017 on the Principles of Power Purchase Agreements (“MEMR Reg 10/2018”) which came into effect on 13 February 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 ...
The Ministry of Energy published the General Administrative Rules on Social Impact Assessment of Projects in the Energy Sector (“Rules”). The Rules set forth requirements for drafting and filing an Assessment report, as well as the procedure for the issuance of a Resolution and Recommendations. After a 3-year public consultation process, on June 1st, 2018, the Rules were finally published on the Official Gazette of the Federation, entering into force on June 2nd ...
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 ...
The Mining Commission issued a public notice on 17 July 2018, calling for mining licence holders to submit their local content plans to the Mining Commission. The call is in line with the requirements of the Mining (Local Content) Regulations, 2018 (the “Regulations”) ...
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 ...
In recent years the European Commission has issued numerous regulations setting out various network codes and requirements aimed at improving the security of energy supply within the EU. As Denmark is a member of the EU these regulations are directly applicable in Denmark ...
