Approaching Compliance with Privacy Regulations Under the Health Insurance Portability and Accountability Act of 1996, including Final Modifications In 1996, Congress passed the Health Insurance Portability and Accountability Act (“HIPAA”). In 2000, the Department of Health and Human Services issued final regulations under HIPAA establishing privacy standards for certain individually identifiable health information ...
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has begun the pilot phase of HIPAA privacy and security audits of health care providers, health insurers and health care clearinghouses (“covered entities”) to assess HIPAA compliance efforts. Up to 150 covered entities will be subject to the initial audits, to be conducted by KPMG, LLP, the OCR audit contractor ...
With the passing of April 14, 2003, large health plans (those with more than $5,000,000 in annual receipts) became subject to the privacy regulations issued under the Health Insurance Portability and Accountability Act (HIPAA). However, more HIPAA deadlines loom on the horizon ...
Amidst continuing COVID-19 concerns, regulators issued certain waivers of HIPAA requirements and penalties as well as additional guidance applicable during this public health emergency. HIPAA Enforcement Discretion for Telehealth ...
October 6, 2021 By: Jennifer Guerrero While a remote work environment can provide many benefits to all of the parties involved, it also can present significant challenges for organizations that need to remain Healthcare Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health Act (HITECH) compliant ...
The Impact of Business Associate Rules Under the Final Privacy and Security Standards Presented at: Negotiating Technology Outsourcing Agreements Law Seminars International Seattle, Washington Introduction The Health Insurance Portability and Accountability Act of 1996, more commonly known as HIPAA, has brought many changes to the health care field, as well as our day-to-day lives ...
As the regulation system on human genetic resources ("HGR"), biosecurity and laboratory animals is experiencing continuous improvement, enforcement actions of the Ministry of Science and Technology ("the MOST") have become more active and tight in recent years ...
On October 26, 2022, the National Medical Products Administration ("NMPA") issued the newly revised Measures for the Administration of Drug Recalls ("the 2022 Measures") that has just been formally adopted. The former Measures for the Administration of Drug Recalls ("the 2007 Measures") was issued and implemented on December 10, 2007 ...
On May 9, 2022, National Medical Products Administration (NMPA) issued for public comments a draft revision (the “Draft Revision”) to the Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China (the “Regulations”). The public comment period ends on June 6, 2022. The Regulations were last revised and became effective in March 2019 ...
On June 1, 2023, China's Ministry of Science and Technology ("MOST") officially released the Implementation Rules for the Regulation of Human Genetic Resources Administration ("Implementation Rules"), which will come into effect on July 1, 2023 ...
On October 23, 2021, a second draft amendment to the Anti-Monopoly Law of the People’s Republic of China (the “Draft Amendment”) was issued for public comments following its review at the 31st meeting of Standing Committee of the 13th National People’s Congress (the “NPC”, the Chinese legislature). The public comment period ends on November 11, 2021 ...
On April 1, 2020, the U.S. Department of Labor (“DOL”) issued a temporary rule regarding the implementation of the emergency paid sick leave and Expanded Family and Medical Leave (“EFMLA”) requirements established by the recently enacted Families First Coronavirus Response Act (“FFCRA”). The DOL temporary rule covers significant ground in terms of delineating workers’ and employers’ rights and responsibilities under the FFCRA ...
The appointment of provisional liquidators by the Cayman Court is a powerful and valuable tool in the right circumstances. However, in a series of recent cases, the Court has underscored the high hurdles that must be met and emphasised that an order to appoint liquidators must always be viewed as a serious step that requires a heavy and onerous evidential burden on those who seek such orders ...
Two recent Supreme Court decisions concerning the First Amendment affect when the government can regulate speech. Dinsmore's Justin Burns and Brady Wilson wrote about the cases for Law360 Expert Analysis. An excerpt is below and the full PDF is above. Recent headlines from the U.S. Supreme Court focus on leaks, but City of Austin v. Reagan National Advertisements of Austin and Shurtleff v. City of Boston, two recent First Amendment decisions, are also worth noting ...
The High Court handed down the approved judgment on Monday 6 November 2023 in the case between Siemens Mobility Limited (“Siemens”) and High Speed Two (HS2) Limited (“HS2”) ...
For the first time, the Irish High Court has been asked to make a blocking order in regard to the illegal live streaming of Premier League games. Instead of watching Premier League games through legitimate and licensed services, some people were seeking to do so free of charge ...
The Quebec Court of Appeal confirmed the Superior Court’s decision, which dismissed the insured’s action in warranty against his liability insurer under his home owner’s policy. The insured alleged that the purchasers’ claim for reducing the purchase price due to a hidden defect was covered under the liability insurance policy. The Facts In April 2005, Plaintiffs, Bérubé and Marcil, purchased Johnston’s residence ...
On June 2, 2010, the Quebec Court of Appeal confirmed the Superior Court’s decision (per Justice Gill es Hébert), which dismissed the insured’s action in warranty against his liability insurer under his home owner’s policy. The insured all eged that the purchasers’ cl aim for reducing the purchase price due to a hidden defect was covered under the liability insurance policy.(1)THE FACTSIn April 2005, Plaintiffs, Bérubé and Marcil, purchased Johnston’s residence ...
On 14 June 2023, the European Parliament adopted its positionon the draft AI Act, which brings one step closer an EU regulation for generative AI and other AI systems. This blog gives the highlights of the current draft text, taking into account the newest amendments that have been proposed ...
On Friday, March 13, 2020, the Department of Health and Human Services (HHS) announced several waivers of existing Centers for Medicare and Medicaid (CMS) regulations pursuant to Section 1135(b) of the Social Security Act, including the waiver of certain Emergency Medical Treatment and Active Labor Act (EMTALA) obligations and Medicare conditions of participation during the COVID-19 pandemic ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a new fact sheet providing a compilation of all provisions through which a business associate may be held directly liable with the HIPAA Privacy, Security, Breach Notification, and Enforcement regulations (collectively the HIPAA Rules) ...
On November 26, 2012, the Department of Health and Human Services’ Office of Civil Rights (“OCR”) published guidance on the two methods for de-identifying protected health information (“PHI”) in accordance with the HIPAA Privacy Rule ...
The long awaited Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Regulation amendments (the “Changes”) to incorporate the changes made by Health Information Technologyfor Economic and Clinical Health (HITECH) in 2009 as part of the American Recovery and Reinvestment Act and by the Genetic Information Nondiscrimination Act (“GINA”) were recently released ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) proposed revisions to regulations issued under Section 1557 of the Affordable Care Act (ACA) (the Proposed Rule). The Proposed Rule would revise certain provisions of the current Section 1557 rule that federal courts have ruled as likely unlawful, and eliminate the requirement that covered entities publish non-discrimination notices and include taglines in foreign languages on all significant publications ...
On January 31, 2019, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced a proposed rule that would significantly change the federal Anti-Kickback Statute (AKS) regulatory safe harbors regarding prescription drug rebates and discounts ...
