Tag Archives: Epstein Becker & Green

ILN Today Post

Epstein Becker Green Welcomes James J. Oh to Its Chicago Office

Epstein Becker Green (EBG) is pleased to announce that James J. Oh has joined as a Member of the Firm in the Employment, Labor & Workforce Management practice, in its Chicago office. Mr. Oh, who joins the firm from Littler, where he had served on its Board of Directors, represents employers in various industries, including financial services and insurance, in high-stakes employment cases across the country.

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ILN Today Post

Epstein Becker Green Maintains Its ISO 27001 Certification for 2nd Year, the Highest Accreditation for Information Protection and Security

Epstein Becker Green (EBG) is pleased to announce that, for the second year, it has attained ISO 27001 certification in Information Security Management.

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FDA’s New Year Resolution: Breakthrough Barriers and STeP Up Device Innovation

On December 18, 2018 the Food and Drug Administration (“FDA”) finalized guidance on its existing Breakthrough Device Program and announced plans for advancement of the Safer Technologies Program (“STeP”).  In the announcement, FDA Commissioner Scott Gottlieb emphasized the FDA’s efforts to promote innovation in medical devices that advance patient safety. This new medical device guidance could signal a year of opportunity for innovative medical device manufacturers that seek to advance patient safety.

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ILN Today Post

Suffolk County Enacts Law Banning Wage History Inquiries

On November 20, 2018, Suffolk County, New York’s Legislature passed the Restricting Information on Salaries and Earnings Act (“RISE Act” or “Act”). With limited exceptions, the Act will prohibit employers in Suffolk County with four or more employees from inquiring about or relying on a job applicant’s compensation history at any stage during the hiring process. Sponsored by County Executive Steve Bellone, the RISE Act amends the Suffolk County Human Rights Law. The Act will become effective on June 30, 2019.

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Marijuana Legalization Takes Another Step Forward in 2018 Elections

In the November 2018 mid-term elections, state ballot measures for the legalization of marijuana were approved in three states – Michigan, Missouri, and Utah – and rejected in one state – North Dakota.

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Mixed Results for Employers on Marijuana – Two Federal Courts Refuse to Find State Marijuana Laws Preempted by Federal Law

Two recent federal cases illustrate why employers – even federal contractors – must be cognizant of relevant state-law pronouncements regarding the use of marijuana (i.e., cannabis) by employees. While one case found in favor of the employer, and the other in favor of the employee, these decisions have emphasized that state law protections for users of medical marijuana are not preempted by federal laws such as the Drug-Free Workplace Act (DFWA). Employers must craft a thoughtful and considered approach to marijuana in the workplace, and in most cases should not take a zero-tolerance approach to marijuana.

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OCR Requests Comments on Ways to Modify HIPAA

On December 14, 2018 the Department of Health and Human Services, Office for Civil Rights (“OCR”) formally issued a Request For Information (“RFI”) seeking public input on “ways to modify the HIPAA Rules to remove regulatory obstacles and decrease regulatory burdens in order to facilitate efficient care coordination and/or case management and to promote the transformation to value-based healthcare, while preserving the privacy and security of PHI.”  OCR is seeking comments for a series of 54 different specific questions (many with additional subparts) corresponding to the following five major topic areas:  (1) the promotion of information sharing for treatment and care coordination; (2) the promotion of parental and caregiver involvement in addressing the opioid crisis and serious mental illness; (3) additional ways to remove regulatory obstacles and burdens to facilitate care coordination and promote value-based health care; (4) an effective means to implement the accounting of disclosures requirement of the HITECH Act; and (5) Notice of Privacy Practices operational practices.

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FDA to Overhaul Medical Device Approval Process

On November 26, 2018, the U.S. Food and Drug Administration (“FDA”) announced the process for clearing most medical devices for marketing is being updated to incorporate changes the FDA laid out in an April draft guidance. For over forty years, most medical devices have entered the United States market through the 510(k) clearance process. The 510(k) process offers an expedited approval process available only for products that are substantially equivalent to products already on the market (known as predicate devices). The FDA is considering no longer allowing sponsors to rely on predicates older than ten years and making public information about cleared devices that relied on predicates more than ten years old. In addition, the FDA intends to finalize guidance establishing an alternative 510(k) pathway with different criteria that reflect current technological principles.

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FDA Reexamining Communication Practices with Investigational New Drug Sponsors

On November 19, 2018, the FDA submitted a proposal to the White House Office of Management and Budget (OMB) to approve a review that will assess current communication practices between FDA review staff and Investigational New Drug (IND) sponsors.  The FDA has contracted with Eastern Research Group (ERG) to determine whether the current mode of communication between these parties needs to be adapted moving forward.  Depending on the results of this review, communication practices and requirements could be altered, which might have an effect on the IND application process. Possible modifications might occur that could assist in removing communication bottlenecks hindering approval timelines.

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IRS Extends Deadline for Furnishing 2018 Forms 1095 to Individuals and Good Faith Transition Relief

The Internal Revenue Service (“IRS”) has released Notice 2018-94, which extends the due date for furnishing the 2018 Form 1095-B and Form 1095-C to individuals from January 31, 2019 to March 4, 2019.

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