On May 31, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released a Final Rule (the “Final Rule”) that withdraws the mandatory vaccination requirement for employees of CMS-certified healthcare facilities, which includes hospitals, critical access hospitals, long term care facilities, home health agencies, hospices, and ambulatory surgical centers ...
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 ...
May 31, 2023 By: Marissa Alkhazov Governor Jay Inslee signed HB 1047, Washington State’s Toxic-Free Cosmetic Act (the Act) into law on May 15, 2023. The Act bans some of the most concerning chemicals added into cosmetic and personal care products, including PFAS, phthalates, formaldehyde and formaldehyde releasing agents ...
On May 16, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a $350,000 settlement with MedEvolve, Inc., a practice and revenue cycle management and practice analytics software services company, to resolve alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”) regulations ...
As we gear up for the UK Covid-19 Inquiry’s first full public hearing on 13 June, here is a reminder of what has been covered to date, followed by a list of issues to be covered within the scope of the first (Module 1) investigation. Inquiry to date the Inquiry was formally established by the Chair (Baroness Heather Hallett) on 28 June 2022, at which time the final Terms of Reference were published by the Government (UK COVID-19 Inquiry: terms of reference - GOV.UK (www.gov ...
The hemp industry's explosive growth following the 2018 Farm Bill has produced a number of consequences, some intended and many more almost certainly never considered by lawmakers. The development of THC acetate ester (THCO), a synthetic substance created from hemp, almost certainly falls within the latter category. Recently, THCO has gained substantial popularity. In a Feb ...
The Chartered Institute of Personnel and Development (CIPD) has issued a report which provides guidance on supporting employees who are experiencing fertility issues. The report surveyed 300 workers who experienced difficulties with fertility while in employment within the last five years, as well as over 2,000 senior HR professionals and decision makers ...
In recent years, China is continuously exploring the regulations of LDT (Laboratory Developed Tests, as defined below). With the introduction of a series of new regulations, many outstanding multinational and local companies have participated in the research of LDT. At this stage, general provisions can no longer meet the demand of the practice of LDT industry ...
As highlighted in our previous article, the Infected Blood Inquiry’s first interim report established considerable liabilities in relatively short order, recommending that £100,000 be paid “without delay” to victims and partners bereaved by infections transmitted by blood transfusions and blood products. Sir Brian Langstaff, former High Court judge and current Chair of the Infected Blood Inquiry, released his second interim report on 5 April 2023 ...
May 15, 2023 By: Meghna Parikh The expiration of the COVID-19 Public Health Emergency (“PHE”) on May 11, 2023 could have created a “prescription cliff” leaving patients without access to controlled substances. During the PHE, telemedicine flexibilities allowed patients to have access to Schedule II and narcotic controlled substances via telemedicine without a prior in-person medical evaluation ...
The end of the COVID-19 public health emergency on May 11, 2023 has left many healthcare facilities confused about whether the vaccination mandate for Centers of Medicare and Medicaid Services (“CMS”) certified healthcare facilities still stands ...
The EU regulator has harmonized the maximum levels for tetrahydrocannabinol (THC) in hemp seeds throughout the Union within the food contaminants framework. This EU harmonization puts pressure on conservative national food laws such as the Belgian Royal Decree of 31 August 2021, which treats hemp seeds as a prohibited food.The situation in Belgium, however, is changing to better align it with EU law ...
The Pensions Regulator's General Code could be published any day now, but what is it, and why has it been so delayed? Back in March Charles Counsell, then CEO of the Pensions Regulator (TPR) confirmed in an interview with Pensions Age Magazine that the long anticipated consolidated code of practice would be published in the spring, under the new title of the “General Code” ...
Ohio lawmakers are considering a bill – House Bill 89 – that would bar medical, nursing, and other medical-professional students from performing pelvic, prostate, or rectal exams on anesthetized or otherwise unconscious patients without prior approval.[1] Intimate exams are used in clinical rotations as an opportunity for training, but opposition to the practice involving unconscious and uninformed patients has grown in recent years ...
Following the passage of House Bill 122 last year, the State Medical Board of Ohio (“Ohio Board”) has released final administrative rules governing the provision of telehealth services by Ohio physicians and certain other provider types.[i] The final rules, which became effective February 28, 2023, continue the recent trend of regulators, such as the Drug Enforcement Agency,[ii] largely reverting back to pre-pandemic telehealth restrictions ...
The U.S. Department of Health and Human Service’s Office of Civil Rights (“OCR”) has announced that several notifications of enforcement discretion issued during the COVID-19 public health emergency (“PHE”) will expire concurrently with the expiration of the PHE on May 11, 2023 at 11:59 PM ...
Ohio legislators are once again attempting to transform the state’s medical marijuana control program after a similar effort stalled out last year. Proponents of the proposed legislation, Senate Bill 9, seek to expand medical marijuana access to Ohioans and revamp the structure of the current program. The proposal would establish the Division of Marijuana Control (“DMC”) under the Department of Commerce ...
With the COVID-19 Public Health Emergency (PHE) set to end on May 11, 2023, federal agencies have published FAQs explaining how the end of the PHE will affect previously extended deadlines relating to COBRA, HIPAA special enrollment, and claims and appeals under group health plans. This article provides (i) a recap of the deadlines, (ii) rules of thumb for determining the deadlines, and (iii) tables more specifically addressing some of the most common deadlines that arise ...
Part of the fall-out of the COVID-19 pandemic is the condition labelled ‘long-covid’. This is still a relatively new condition that remains under study, but symptoms include extreme tiredness, shortness of breath, loss of smell and muscle aches. Some people experience further complications and suffer memory problems known as ‘brain fog,’ difficulty sleeping, dizziness, depression and anxiety ...
April 17, 2023 By: Meghna Parikh ALERT: Recent guidance from the Food and Drug Administration (“FDA”) clarifies a procedural issue for premarket submissions related to cybersecurity of medical devices and emphasizes the importance of collaboration between the FDA and medical device manufacturers. Providers using medical devices in their practice should pay attention to these rulings because they impacts the providers’ ability to educate and engage their patients ...
On March 31, 2023, Governor Andy Beshear signed Senate Bill 47 making medical marijuana use and sale legal in Kentucky, effective January 1, 2025. [i] Kentucky now joins at least 37 other states that have legalized medical marijuana. The newest piece of legislation comes on the heels of Governor Beshear signing two executive orders related to cannabis in November of 2022 ...
On March 22, 2023, the Centers for Medicare & Medicaid Services (“CMS”) updated its guidance and survey process for home dialysis services in nursing homes.[1] The updated guidance is based on comments, questions, and feedback received from state survey agencies, the dialysis community and other stakeholders since CMS initially issued guidance in 2018 ...
Shoosmiths’ Public Inquiries team is delighted to present a series of podcasts in respect of reflections and experiences of the COVID-19 pandemic. Hosted by Hayley Saunders and Alex Friston, we are delighted to be joined by a variety of speakers, each bringing something different to the table in relation to impacts, views and then thoughts towards the Public Inquiry, which is set to commence its first public hearings on 13 June ...
