Legal Updates

E-LEGAL® ARTICLE 27 OF GDPR REPRESENTATIVE OF THE DATA CONTROLLER

Summary:

With the entry into force of the GDPR, it has become mandatory for entities established in third countries which process personal data of European citizens to appoint a representative in the European Union. The present article analyses the situations in which such designation is mandatory and the prerogatives of this representative. Read more…

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CMS Proposes to Reverse Course and Repeal Its Final Rule Expediting Medicare Coverage of Breakthrough Devices and Defining the Medicare “Reasonable and Necessary” Coverage Standard

On September 15, 2021, CMS published a proposed rule that would repeal a final rule that created an expedited pathway for Medicare coverage of breakthrough devices and established formal criteria for applying the “reasonable and necessary” standard for coverage in Section 1862(a)(1)(A) of the Social Security Act, which has been the basic standard for coverage since the inception of the Medicare program.[1]  CMS has set a short period for comments, and interested parties must submit comments by October 15, 2021.

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IRS Updates Employee Plans Compliance Resolution System

The Internal Revenue Service (IRS) issued in its Revenue Procedure 2021-30 an update to its Employee Plans Compliance Resolution System (EPCRS) on July 16, 2021, revising its correction programs for qualified retirement plans. The new guidance generally replaces and supersedes prior EPCRS guidance.

Updated EPCRS Highlights
Key updates and new features for plan sponsors and administrators include the following points, which are generally effective July 16, 2021 (except as otherwise noted). Read more…

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Builders’ Risk Insurance: Is Demolition Work Covered?

By Sarah Bouzo, from our Insurance Law Practice Group

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September 17, 2021 — On June 7, 2021, the Superior Court dismissed the action in L’Unique assurances générales inc. c. Intact Compagnie d’assurance, 2021 QCCS 2916, in concluding that the Builder’s Risk issued in favor of Intact’s insured did not apply.

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Ninth Circuit Decision Holds That California Law Addressing Mandatory Arbitration Agreements May Go Into Effect

Since the Supreme Court issued its seminal 2018 decision in Epic Systems Corp. v. Lewis, acknowledging that the Federal Arbitration Act (“FAA”) permits the use of arbitration agreements with class action waivers, many employers have implemented arbitration programs for their employees. Those arbitration programs have been aimed, in no small part, at avoiding the class and collective actions that have overwhelmed employers, particularly in California.

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Unpacking Averages: FDA Review Time for 510(k)s

In this column, in the coming months we are going to dig into the data regarding FDA regulation of medical products, deeper than the averages that FDA publishes in connection with its user fee obligations.  For many averages, there’s a high degree of variability, and it’s important for industry to have a deeper understanding.  In each case, we will offer a few preliminary observations on the data, but we would encourage a conversation around what others see in the data.

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​​​​​​​Missouri Now Requires Employers to Provide Leave and Accommodations for Victims of Domestic and Sexual Violence

On August 28, 2021, Missouri’s new Victims Economic Safety and Security Act (VESSA) took effect. The statute requires employers with at least 20 employees to provide employees who have experienced domestic or sexual violence with unpaid leave and reasonable safety accommodations. VESSA also requires qualifying employers to comply with employee notice obligations by October 27, 2021. Read more >>

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Video: Biden’s Employer Vaccine Mandate, NY HERO Act Safety Plans, Cannabis Cases – Employment Law This Week

As featured in #WorkforceWednesday:  This week, we focus on Biden’s six-pronged action plan towards combating COVID-19, which requires mandatory vaccination programs for a majority of employers.

Biden Announces Employer Vaccine Mandates

On September 9, President Biden announced that all federal agencies and contractors and employers with 100 or more employees in the private sector must mandate COVID-19 vaccination through a new Occupational Safety and Health Administration-enforced emergency temporary standard. The plan is estimated to impact two-thirds of the country’s workforce. Attorneys Kate Rigby and Adam Tomiak discuss how employers should prepare for compliance. To read more about the President’s plan, click here.

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Considering tax reduction planning? Take action now

If you have a net worth in excess of $12 million or have been considering tax reduction planning, please call your estate planning attorney as soon as possible. The opportunity to take advantage of the estate and gift tax exemptions at current levels and the benefits of grantor trust planning may disappear soon. Here is what you need to know. Read more…

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A Big Relief to Telecom Sector

As part of its comprehensive package for the Telecom Sector of the Country, the Government of India has announced 100 % Foreign Direct Investment (“FDI”) under the automatic route in the said sector. To date, investment was allowed in the Telecom Sector up to 49% via automatic route and any investment beyond 49% had to be routed through the government i.e., the approval of the Government was required to be obtained.

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