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 Dec. 22, 2020, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol (CBD) products.[i] CBD is the primary non-psychotropic compound in Cannabis sativa plant. The FDA stated the companies who were served warning letters illegally marketed CBD products for the treatment or prevention of medical conditions, including COVID-19 ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Physician-Self Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the OIG Final Rule and the CMS Rule, collectively the Final Rules) will become effective ...
Coming to Grips with Hospital Price Transparency – DC Circuit Rejects American Hospital Association’s Effort to Invalidate Price Transparency Requirements Rule Since 2010, Section 2718(e) of the Public Health Service Act has required hospitals to establish and publish annually “a list of the hospital’s standard charges for items and services provided by the hospital ...
The City and County of San Francisco (SF) issued a COVID-19 surge-related travel and quarantine order (Quarantine Order) on Dec. 16, 2020, and an updated Shelter-In-Place Order (SIP Order) on December 9 (updated Dec. 30, 2020). Under those orders, every person who enters SF after having been outside the Bay Area within the last ten days must quarantine for 240 hours from the time of arrival in SF. However, two exceptions apply to those working on construction projects in SF ...
The underlying dispute relates to the MV «Cheshire» incident in 2017, where a cargo of fertiliser was subject to a major decomposition incident. The fertiliser that was carried on the vessel was damaged, and the vessel was declared a total loss. In February 2020, Oslo District Court ruled in favour of the cargo interests, holding the carriers liable for the cargo loss (approx. USD 25 million) (TOSLO-2017-180657-1). The carriers have appealed the judgement ...
The most recent changes to the Stark Physician Self-Referral Law (Stark) and the Anti-Kickback Statute (AKS), described previously here, create a new lexicon and framework to guide healthcare providers from payment for volume-based services to payment for value-based healthcare. These value-based rules go into effect on January 19, 2021 ...
For several years, pursuant to the Food Drug and Cosmetic Act and Federal Trade Commission Act,[i] the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued joint warning letters to CBD companies alleging labeling claims they made are false or misleading. According to the agencies, the claims being made by these CBD companies include assertions that their CBD products will treat or cure serious health conditions ...
The State of Ohio Board of Pharmacy (OBP) is required to adopt a resolution specifying the required types of credentials for the responsible person of each business type of (i) terminal distributors of dangerous drugs and (ii) distributor of dangerous drugs. Only individuals who meet the credentials specified may be the responsible person for that type of business. On Jan ...
The regulatory change proposed by the Department of Health and Human Services (HHS) in the recent HIPAA Notice of Proposed Rulemaking (NPRM) is another step toward HHS’s objective to encourage a patient-centric healthcare environment. The HIPAA NPRM proposes to tilt the balance of protecting privacy and facilitating the availability of information toward loosening restrictions on disclosures of patient information ...
The Court of Protection is a specialist Court, focussing solely on supporting vulnerable individuals. This past year has acutely highlighted the needs of those most vulnerable in our society and their dependency on others to help manage their affairs. The Court has had to adjust its practices in order to ensure that help and solutions are found for those lacking capacity with minimal delay ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Final Rule and the CMS Final Rule, collectively the Final Rules) ...
If parents cannot agree whether their children should be vaccinated, they can make an application under Section 8 of the Children Act 1989 to ask a judge to determine the issue. In M v H (Private Law Vaccination) [2020], the mother objected to the parties' two children aged six-years-old and four-years-old being given routine childhood vaccines in accordance with the NHS vaccination schedule ...
The United States’ Centers for Disease Control and Prevention (CDC) has issued an order that will take effect on January 26, 2021, requiring all arriving international airline passengers to provide proof of a negative COVID test taken within three days of the flight’s foreign departure. For those who have had it, the CDC will require proof of recovery ...
The U.S. Department of Health and Human Services (HHS) just announced that Provider Relief Fund Program (PRF) recipients will now be required to submit reports regarding their use of these funds later than previously announced. The previous deadline was February 15, 2021. Currently, a specific new timeline was provided, but HHS is encouraging providers to register to receive updates ...
The second HIPAA settlement of 2021 is the first traditional enforcement action of the year. And, it’s a big one. Traditionally, OCR enforcement has been triggered by breaches. In 2020, however, we saw a significant increase in a sub-set of Privacy Rule enforcement arising out of the U.S. Department of Health and Human Services’ Office for Civil Rights’ (OCR) patient “Right of Access” initiative ...
This is the first in our series of articles in which we will look at how Brexit and the EU-UK trade deal impacts research and development. In July 2020, the Government published its Research and Development Roadmap, which sets out the UK’s ambitious long-term objectives for investment in science and research to deliver economic growth and societal benefits across the UK ...
Effective Jan. 26, 2021, all air passengers traveling to the United States will be required to get a viral test for current infection within the three days before their flight to the U.S. is scheduled to depart, and provide written documentation of their laboratory test results (paper or electronic copy) to the airline ...
On January 20, 2021, Supreme Decree No. 8/2019 of the Ministry of the Environment was published in the Official Gazette, setting forth collection and valorization goals and other associated obligations for tires in order to prevent the generation of such wastes and to promote their reuse, recycling or other types of recovery, in the context of Law 20,920 on Extended Producer Responsibility. Regulated object: tires This decree is applicable to tires introduced into the market ...
Article PDFJust when businesses thought they had figured out their Proposition 65 compliance strategies, the State of California, through the Office of Environmental Health Hazard Assessment (OEHHA), has proposed a substantial change that will drastically limit the use of the short-form safe harbor warning first authorized in 2018 ...
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 ...
CONGRESS PASSES TRADEMARK MODERNIZATION ACT LEGISLATION In December 2020, the U.S. Congress took action that will have a significant effect on brand holders. At the end of the year, Congress passed the Trademark Modernization Act (“TMA”) that, inter alia, provides additional tools to the USPTO to respond to the rise in improper behavior in trademark filings including filing fraudulent claims of use ...
Two federal cases in the Northern District of Ohio recently reached very different conclusions on whether the state’s COVID-19 shutdowns of restaurants permit valid claims for business interruption insurance coverage. Reviewing essentially the same facts and policy provisions, one court found for the insurer, holding no coverage to exist. The other found for the policyholder, awarding coverage. The opposite results will no doubt lead to further upcoming appellate activity in Ohio ...
When Alabama’s Legislature convenes for its annual session on February 2, lawmakers will once again be asked to consider a bill that would provide certain Alabamians with access to medical cannabis ...
