The European Council has just adopted a new dual-use regulation. The new dual-use regulation is a recast of the current dual-use regulation and aims, among other things, to modernize European export controls in a number of areas. The regulation is directly applicable in all EU Member States and is expected to enter into force in 2021. In this Insight, Plesner's export control specialists outline the main changes resulting from the new dual-use regulation ...
The Office of Inspector General (OIG) has issued a favorable advisory opinion addressing an investment in an ambulatory surgery center (ASC) made by a health system, certain physicians employed by the same health system, and a management company. OIG Advisory Opinion No. 21-02 is the first advisory opinion since 2009 to provide guidance on ASC investments and related safe harbors to the Anti-Kickback Statute ...
Before going into the details of the proposal it should be mentioned that the actual rules of the proposal were not presented in the revised budget. The government stated that they aim to present the rules in the budget for 2022. The rules will also be subject to a hearing round and since the scheme constitutes state aid in accordance with the rules in the EEA Agreement, they will also require notification to and approval from ESA before implementation ...
For Mental Health Awareness Week, Caroline Watson, head of Shoosmiths Family Law team, offers practical advice on looking after your emotional wellbeing if you’re going through a divorce or a separation. When someone close to you dies, it’s generally accepted that there are five stages of grief: shock, denial, anger, bargaining, depression and acceptance. Some psychiatrists say that the emotional stages of a relationship breakdown are the same ...
By: Carol K. Lucas At a time when many are questioning the continued utility and viability of the corporate practice of medicine ban, California may be doubling down. On May 3, 2021, the California Senate Health Committee approved SB-642, the stated purpose of which is to protect medical decision-making from lay control. The bill is currently pending in the California Senate. Assembly Bill AB-705 is a substantially identical bill in the California Assembly ...
Electronic signature in employment documents The first set of amendments provided by the new normative act introduce expressly the possibility of concluding the individual employment agreement or addenda thereof using the qualified electronic signature or the advanced electronic signature, accompanied by the electronic time stamp or the qualified electronic time stamp and the qualified electronic seal of the employer ...
On May 5, 2021, the U.S. Department of Labor (DOL) officially withdrew from the Trump-era rule for classifying workers as independent contractors. This withdrawal has been anticipated since President Joe Biden assumed his role, and was official on May 6. The DOL is expected to publish a Final Rule in the Federal Register within the coming days. Trump-Era Independent Contractor Test Contrary to FLSA Purpose and Intent On Jan ...
On April 30, 2021, the U.S. Food and Drug Administration (FDA) announced it was revoking a policy related to new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The FDA stated that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs ...
More than three years after initial publication, the State Medical Board of Ohio's proposed revisions to its light-based device (laser) rules are now advancing toward possible enactment, as the Medical Board has announced amendments to the proposal and scheduled public rules hearing for May 17, 2021 ...
The Ohio Board of Pharmacy recently announced it will award up to an additional 73 dispensary licenses across Ohio. Dispensary licenses will be awarded through an application and lottery process that is expected to be finalized during the spring or summer of 2021. This expansion will bring the total number of dispensary licenses in Ohio to 130 and is expected to ameliorate patient dissatisfaction with regards to the price of medical marijuana products and lack of equal access ...
Dispute ResolutionThreshold to Commence Winding Up Proceedings RaisedBy the Federal Government Gazette Notification No. 4159 dated 22 March 2021, the amount of indebtedness required to commence winding up proceedings under section 466(1)(a) has been fixed at RM50,000.00 with effect from 1 April 2021.This means that a creditor may only commence winding-up proceedings against a debtor company where the debtor company has failed to satisfy a debt owed to the creditor exceeding RM50,000 ...
Those of us who grew up in the 70’s or 80’s may recall the excitement of Marty McFly wandering around in the then distant future of October 2015. Yes, 2015. Just over 5 years ago. ‘Where are the flying cars?!?’, you might be forgiven for asking. ‘And why don’t our Hover Boards, you know, hover?’ It's a common theme. George Orwell’s 1984 never happened as predicted and there’s no Big Brother watching us from a screen on the wall ...
The impact of the pandemic can be seen across all sectors of society but those who are disabled have been particularly affected, not least because employees with an underlying disability are likely to have been identified as clinically extremely vulnerable and told to shield for considerable parts of the last year. Being away from the workplace and separated from colleagues has left many feeling insecure ...
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 ...
Unpacking the Economic Aid Act and American Rescue Plan Act: Consolidated First Draw PPP Interim Final Rule, New First Draw PPP Loans, and Increases to First Draw PPP Loans On January 6, 2021, the Small Business Administration (the “SBA”) and the Department of Treasury released an Interim Final Rule called “Business Loan Program Temporary Changes; Paycheck Protection Program as Amended by Economic Aid Act” (sometimes referred to as the “Consolidated First D
On January 6, 2021, the Small Business Administration (the “SBA”) and the Department of Treasury released an Interim Final Rule called “Business Loan Program Temporary Changes; Paycheck Protection Second Draw Loans” (“Second Draw Rules”). These rules announced the implementation of section 311 of the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act (the “Economic Aid Act”) ...
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 ...
Background Disqus is an American company offering online public comment sharing services. These services were previously used by various Norwegian online newspapers. The Data Protection Authority has investigated whether Disqus has been sharing information about the users of the comment sections with marketing companies, without the knowledge of neither the users nor the owners of the online newspapers, and in breach of the GDPR ...
The pandemic has, if nothing else, demonstrated how much more needs to be done in the battle against climate change. Despite the worldwide economic slowdown and travel ban resulting from coronavirus, global carbon dioxide emissions reduced by just 6% (approximately 2.3bn tonnes) in 2020. But both governments and industry are responding to the challenge, however, with a renewed sense of urgency and collaborative spirit ...
To support our IHL community, on 21 April we hosted our latest webinar on “Fraud” where we discussed the recent upsurge in fraud due to home working, general awareness of fraudulent activity and what businesses can do to protect themselves. Here are the key takeaways: What types of fraud are you seeing at the moment? The world is a turbulent place right now, and therefore the perfect time for fraud and illicit activity to thrive ...
Last spring, many businesses did the unthinkable. In response to the spread of Covid-19 and subsequent stay-at-home orders, they seemingly overnight deployed fully remote workforces. Then everyone breathed a sigh of relief upon realizing that a fully distributed workforce ... works. As it turns out, cybercriminals were among those most eager to take advantage of distributed workforce arrangements ...
As part of its 2022 Inpatient Prospective Payment System (IPPS) Proposed Rule for Acute Care Hospitals, the Centers for Medicare and Medicaid (CMS) is proposing an increase for Medicare fee-for-service payment rates to acute care hospitals by 2.8 percent, or $3.4 billion in Fiscal Year (FY) 2022.[[1]] Hospitals hoping to receive the payment increase must successfully participate in the Hospital Inpatient Quality Reporting Program and be meaningful electronic health record users ...
