The use of marijuana in patient care has undergone widespread growth and acceptance nationwide. Thirty-three states and the District of Columbia have laws authorizing the use of marijuana in some form. Two of those states – Utah and Missouri – joined that list this past mid-term cycle, as voters passed initiatives authorizing the use of medical marijuana. Others, such as Kentucky and Virginia, have pending legislation seeking to authorize the use of medical marijuana ...
In June 2022, at one of the annual meetings of the Employment, Social Policy, Health and Consumer Affairs (“EPSCO”) Council, health ministers expressed their concerns regarding the legislative transition to Regulation (EU) No 2017/745 of the European Parliament and of the European Council of 5 April 2017 on medical devices (“MDR”) and to Regulation 2017/746 of the European Parliament and of the European Council of 5 April 2017 on in vitro diagnostic medical devi
You’ve read the qualifying language before: across the country, construction projects are being impacted by the COVID-19 pandemic. We thought it important to prepare guidelines to assist contractors in navigating the situation from a risk management perspective. The situation is dynamic and will change quickly. A one-size-fits-all solution does not exist, and this global challenge continues to evolve. What works today may not address tomorrow’s needs ...
On August 25, 2020, Board Resolution No. 003-2020-EF/68.0 was published in the Official Gazette “El Peruano”, approving the “Guidelines for the State's response to the potential impacts of the COVID-19 pandemic on Public Private Partnership projects” (the “Guidelines”) ...
During 2017-2018, the Federal Antimonopoly Service of Russia (“FAS”) paid close attention to advertisements of OTC medicines and considered large number cases of violations of advertising legislation by pharmaceutical companies. At the end of 2018, FAS in collaboration with the Association of International Pharmaceutical Manufacturers and other market players, established a guideline on recommended advertising of OTC medicines (“Guideline”) ...
Why is H-1B Filing Season Important? This is the only time of year (with minor exceptions indicated below) U.S. Citizenship and Immigration Services (USCIS) accepts H-1B specialty worker petitions for the next fiscal year, which begins Oct. 1, 2020 ...
Overview Following the enactment of Law No. 33 of 2014 on Guarantees for Halal Products (“Law 33/2014”), its implementing regulation, Government Regulation No. 31 of 2019 (“GR 31/2019”), was recently issued and came into effect on 3 May 2019. In principle, Law 33/2014 requires that all products imported, distributed or traded in Indonesia be certified halal in accordance with Islamic principles ...
Our Approach Haynes and Boone, LLP believes employers should determine the degree to which outside assistance is required in meeting their obligations under HIPAA’s privacy rules. Some groups are offering, at substantial fixed fees, turnkey packages for HIPAA privacy compliance. We do not think, however, that is the most efficient or economical way for many employers to address their responsibilities under the privacy rules ...
We would like to inform you about several important news items, in the pharmaceutical industry, at the beginning of 2021. The Rules of registration and assessment of medicines for medical use in the EAEU come into force According to the Decision of the Eurasian Economic Commission Council (“EEC”), dated November 3rd 2016 No ...
Increased deal activity is likely in Australia's health and aged care sector in 2016, driven by:• investment interest from China• Australian players targeting outbound opportunities through joint ventures and partnerships; and• consolidation in the aged and home care services areas.Rapidly ageing populations across our region are driving demand for high quality health care, especially in countries such as China and Japan ...
The recent Winter Olympic Games and the conclusion of the Six Nations rugby were just two of many sporting events, large and small, that have been welcoming back fans (in accordance with local laws and restrictions) over the last several weeks. As we continue to live with COVID-19, it is crucial that organisers of sporting and other events are aware of health and safety requirements and their duty of care towards attendees ...
Agricultural and rural settings present significant health and safety risks, which must be carefully managed and mitigated by employers and landowners operating in the sector. The Health and Safety Executive’s (HSE) annual report into workplace fatal injuries (published on 6 July 2022) disclosed that, of the 123 workers killed in work-related accidents across the United Kingdom in 2021/22, 22 deaths occurred in the agriculture sector ...
The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released the Health Care Fraud and Abuse Control Program Annual Report. The 2018 Report highlighted key enforcement areas and policy considerations. The Health Insurance Portability and Accountability Act of 1996 established a national Health Care Fraud and Abuse Control Program (the Program) under the direction of the Attorney General and the Secretary of HHS ...
On July 9, 2021, President Joe Biden signed a wide-ranging executive order entitled “Promoting Competition in the American Economy.” One key element of the executive order is to address noncompete covenants that the White House characterized as stifling competition between companies. Section 5(g) encouraged the FTC to draft rules which seek to “curtail the unfair use of non-compete clauses and other clauses or agreements that may unfairly limit worker mobility ...
April 12, 2022 By: Mary H. Rose Health care providers who received Provider Relief Funds under the CARES Act during Period 1 (April 10, 2020 to June 30, 2020) were required to use the funds by June 30, 2021 and submit a report to the Health Resources and Services Administration (HRSA) regarding use of the funds by September 30, 2021. On March 10, 2022, HRSA sent notices to approximately 10,000 providers who failed to meet the report deadline ...
With yet another recent uptick in COVID-19 cases, the need for additional health care practitioners in the state of Ohio continues to grow. Recognizing that this shortage will not be resolved in the near future, the Ohio General Assembly has eliminated another barrier for physicians with a prior history involving a substance use disorder to seek licensure in Ohio ...
A reputation for counterfeiting, poor quality control, ever-changing and inconsistent application of regulations and the challenges of ensuring that development does not unduly prejudice the welfare of the general population - this description of China’s pharmaceutical industry is representative of much that is good, bad and challenging in China’s recent regulatory and economic development ...
Recent events, including the investigations into Facebook’s handling of its users’ personal data, have highlighted the realization that personal data is, in today’s world, one of the most valuable resources for any business and that businesses not only collect and store their customers’ personal data but also use and even sell it for profit ...
Report of the Department of Banks and Financial Institutions Health Emergency - BCRA Communication “A” 7048: adjustments to the national payment system. Yesterday, the Central Bank of the Argentine Republic (BCRA) issued Communication "A" 7048 (the " Communication "), through which certain adjustments were established on the national payment system. The Communication was issued in accordance with the provisions of Decree No ...
ALERT Hospital May Be Excluded For Physician Recruiting On May 8, 2006 the OIG announced that it intends to exclude San Diego-based Alvarado Hospital from participation in Medicare, Medicaid and all other federal health care programs because of payments the Hospital made under relocation agreements involving placement of newly-recruited physicians in established physician practices ...
Healthcare Hazards Involving Medical Records During Bankruptcy Companies in the healthcare industry face many unique challenges when undergoing a bankruptcy, including challenges arising due to the federal and state law framework governing the use and disclosure of medical information. In February 2018, the U.S. Department of Health and Human Services (HHS) announced that it had reached a settlement with the receiver appointed to liquidate the assets of Filefax, Inc ...
Should States Embrace Telehealth Parity? Parity in telehealth is the notion that health services provided via telehealth technology should be treated equally as health services provided face-to-face. This is consistent with coverage parity, which requires payors to provide the same level of insurance coverage for patient encounters and services, while payment parity (a.k.a ...
View the February 2017 Health Law Vitals Newsletter PDF. Final Guidance Sheds Light on Medical Device Reporting Requirements In November 2016, the U.S. Food and Drug Administration issued a final guidance on medical device reporting for manufacturers ("Final MDR Guidance") ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was reevaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities.The bills reawakened a debate about the pros and cons of POHs ...
View a PDF of the November 2017 edition of the Haynes and Boone Health Law Vitals newsletter. FDA Improving Regulatory Oversight of Stem Cell Therapies and Regenerative Medicine Products Regenerative medicine is a burgeoning interdisciplinary research field aiming to offer new therapies that replace or regenerate human cells, tissues, or organs with the goal of restoring or establishing normal function ...
