In this report, you will find a summary of two important decrees published yesterday in the Official Gazette. Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives By means of Executive Branch’s Decree No ...
The Minister of Health has issued Regulation No. 28 of 2013 on Affixing Health Warnings and Information on Tobacco Product Packaging which came into force on 12 April 2013, as a further implementation of Government Regulation No. 109 of 2012 on Control of AddictiveSubstances in the Form of Tobacco Products. The Regulation requires tobacco producers and importers to affix pictorial health warnings and health information on their tobacco products packaging ...
Regulators Expand Opportunities for Telehealth Services Under COVID-19 Shadow By: Phil Kim, Kayla Cristales, and Jennifer Kreick As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services ...
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 ...
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(FDA) announced that it was reevaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities.The bills reawakened a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 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") ...
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 ...
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 ...
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 ...
The Philippine Department of Labor and Employment (DOLE) recently issued guidelines to address safety and health issues faced by workers who, by the nature of their work, have to stand or sit for long periods. The DOLE noted that the wearing of high heeled shoes and/or standing at work for long periods or even frequent walking lead to health issues such as strain on the lower limbs, aching muscles, hazardous pressure on the hip, knee and ankle joints and sore feet ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 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 ...
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 ...
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 ...
On March 25, 2020, Governor Jim Justice signed into law House Bill 4925, which will take effect June 2, 2020. HB 4925 (W. Va. Code 18-2-25) provides that any student receiving home instruction pursuant to W. Va. Code 18-8-1(c), for at least one year proceeding the year proposing to be eligible, shall be eligible for participation in interscholastic athletic events and other extracurricular activities of public secondary schools serving the attendance zone in which the student lives ...
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 ...
The Advertising Standards Authority (ASA) has published an update to its guidance on misleading green claims that demonstrates its collaboration with the Competition and Markets Authority (CMA) and their joint commitment to protect consumers from 'greenwashing'. What are green claims? We discussed green claims and the ASA’s and CMA’s guidance in our previous article “Are your green claims compliant?” ...
Recent Federal Circuit Decision on Section viii Carve Outs and Inducement By C. Kyle Musgrove, Partner On November 1, 2010, a divided 2-1 panel of the Federal Circuit issued a decision in AstraZeneca LP v. Apotex, Inc. that addresses inducement of infringement in the context of a Section viii "carve out" under 21 U.S.C. § 355(j)(2)(A)(viii) and 21 C.F.R. § 314.92(a)(1) ...
