The authorities seem to have gone on the offensive on the issue of counterfeits. In the run-up to Christmas, the Department of Trade and Industry (DTI) has called on South Africans not to buy counterfeit goods, even if they are cheaper than the originals (as they invariably are) ...
"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 ...
On October 3, 2014 the Department of Health and Human Services, Office of Inspector General (“OIG”), released a proposed rule to add new safe harbors to the Anti-Kickback Statute (“AKS”) and to amend the definition of “remuneration” in the Civil Monetary Penalties (“CMP”) regulations. The OIG additionally solicited comments on same which must be submitted no later than 5 pm EST on December 2, 2014 ...
The coronavirus creates a situation for the world, for the Netherlands and for the Dutch health care that most of us have never experienced before. As the healthcare & life sciences market group, we are confronted with this event in various ways. In our business and private lives, but also mainly because we see what the impact is for our clients. We are very looking for the best way to deal with this ...
Courts nationwide have struggled for years with the question of when a subjective opinion is false under the False Claims Act. The Supreme Court’s decision to deny review of two cases involving health-care providers that had allegedly submitted false claims for payment based on subjective clinical judgment still leaves us without a uniform, national answer, says Nicholas A. Danella. The U.S ...
Healthcare Legislative Update - 78th Regular Session July 2003 © 2003 – Haynes and Boone, LLP Haynes and Boone, LLP 901 Main St., Suite 3100 Dallas, TX 75202 You have accessed the Healthcare Legislative Update for the 78th Regular Session of the Texas Legislature. This update has been compiled by the Health Care Section of Haynes and Boone LLP for use as a quick reference tool on topics that we believe that will be of interest to our clients and the healthcare industry ...
Last June 16, the Superior Court of Québec1 rendered a safeguard order in an injunction proceeding in favour of a health-care institution the purpose of which was to set conditions for the visits of the daughter of a user of the institution who was an incapable person lodged there, as well as her interactions with the user and the staff ...
On January 5, 2023, the Federal Trade Commission (“FTC”) issued a Proposed Rule that would prohibit employers from enforcing non-compete agreements against former employees, contractors, and other workers. Dinsmore & Shohl’s Labor and Employment Group’s legal alert on January 5, provides general information about the changes envisaged in the Proposed Rule ...
In the midst of a global pandemic, much attention and praise are rightfully being showered on healthcare and pharmaceutical providers. While the world watches with awe at the sacrifices that pharmaceutical and healthcare providers are making during this difficult time, government prosecutors too are watching—albeit for a different reason ...
The COVID-19 pandemic has presented many novel challenges and questions for employers, from administration of Families First Coronavirus Response Act (“FFCRA”) leave to managing performance of remote workers. For healthcare providers, these challenges and questions have been only one of many burdens of operating during a pandemic. As vaccines become more widely available, the pandemic raises new challenges, some unique to employers in the healthcare industry ...
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 ...
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") ...
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 ...
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 ...
