On December 10, 2020, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry ...
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021. At its core, the regulatory rule freeze requires all pending final rules to be delayed at least 60 days in order for the Biden administration to review and opine on the necessity and scope of affected rules. During this delay period, the administration may review, revise, and possibly rescind federal administrative rules ...
The U.S ...
Fresenius Medical Care North America (FMCNA), a provider of products and services for people with chronic kidney failure, has agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules ...
On September 17, 2012, the Department of Health and Human Services (“HHS”) announced a $1.5 million settlement with the Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates Inc. (“MEEI”) for potential violations of the HIPAA Security Rule ...
On December 28, 2018, the Department of Health and Human Services (HHS), in partnership with the Health Sector Coordinating Council (HSSC), published the “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (HICP Publication), which is a four-volume publication designed to provide voluntary cybersecurity practices to health care organizations of all types and sizes, ranging from local clinics to large health care systems ...
On April 26, 2021, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced on its OCR Security List Digest that OCR had been made aware of misleading postcards being sent to health care organizations. The postcards inform recipients that they must participate in a “Required Security Risk Assessment.,” It directs them to send their risk assessment to www.hsaudit.org, a non-governmental website marketing consulting service ...
On Jan. 15, 2019, the Department of Health and Human Services’ (HHS) Office of Civil Rights (OCR) shared a bulletin published by the Office of the Assistant Secretary for Preparedness and Response, Critical Infrastructure Protection Public-Private Partnership (ASPR CIP) regarding a number of vulnerabilities identified in Microsoft Windows operating systems, which if not addressed, pose significant a threat to the environment. On Jan ...
Restrictions on the placement of High in Fat, Salt and Sugar (HFSS) food in prominent locations (in store and online) are now in force with restrictions on volume price promotions delayed until October 2023. What is in force? We discussed the new measures on HFSS food including restrictions on volume offers and new rules on placement and promotion in our previous article ‘Further restrictions on HFSS (high in fat, salt or sugar) foods are coming’ ...
Last Wednesday (July 26), the Federal Court of Appeal (FCA) handed down its highly awaited decision on the patentability of computer-implemented inventions (software patents). In Canada (Attorney General) v. Benjamin Moore & Co. (2023 CAF 168), the FCA rejected the test proposed by the Intellectual Property Institute of Canada (IPIC) in the first instance decision, Benjamin Moore & Co. c. Canada ...
The COVID-19 spread in Indonesia has caused several institutions in Indonesia to make certain adjustments, including in to hearings in district courts. On 23 March 2020, the Supreme Court issued Circular Letter No. 1 of 2020 on Guidance for the Implementation of Work during the Prevention of the Spread of Corona Virus Disease 2019 (COVID-19) within the Supreme Court and the other Courts, as was later amended by Circular Letter No ...
"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 ...
