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Health Securities

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

The Life Sciences Report - Winter 2018

Life Beyond FDA Clearance or Approval: The Reimbursement Challenge - To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more

Episode 20 -- Data Security and Privacy

by Michael Volkov on

Companies face increasing challenges from management and protection of data from hackers and breaches of sensitive commercial and personal data.  Recent headlines have underscored the threats to companies from such breaches. ...more

HIPAA Enforcement Update

by Locke Lord LLP on

With respect to enforcement, the Department of Health and Human Services, Office for Civil Rights (OCR) announced two Settlement Agreements to resolve allegations of HIPAA violations between May and October of 2017. Neither...more

Focus on ERISA - Tax Reform Includes Benefits and Compensation Provisions

by Dechert LLP on

On December 22, 2017, the tax reform bill, informally known as the Tax Cuts and Jobs Act (the “Act”), was signed by President Trump. As we noted in our prior OnPoint (available here) with respect to earlier versions of the...more

FDA Considers Approval Pathway for Medical Devices to Unilaterally Cross-Reference Marketed Drug Products

by King & Spalding on

Would Not Require Collaboration by the Drug Sponsor; FDA Requests Comments on Potential Approach - The Food and Drug Administration (FDA) requests comment on a potential approval pathway for “ devices referencing drugs”...more

FCPA Compliance Report-Episode 362-Brian Platz

by Thomas Fox on

In this episode, I visit with Brian Platz who discusses blockchain and his new company Fluree, a new Public Benefit Corporation that has introduced a scalable blockchain database for decentralized applications. ...more

Michigan Strikes Back . . . In Pennsylvania

by Reed Smith on

A (relatively) long time ago in a state not so far away, the Michigan Legislature enacted the Michigan Product Liability Act. It contained a provision providing the manufacturers of FDA-approved drugs with immunity from...more

CVS Health to Acquire Aetna

On December 3, 2017, CVS Health, a giant in the retail pharmacy industry, announced plans to acquire Aetna. Aetna is one of the largest medical insurers in the nation, servicing approximately 46.7 million people. Under the...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

Breakingviews on Broadcom’s threat to Qualcomm’s board in the form of a slate of 11 director nominees for the company it has, so far, unsuccessfully attempted to purchase....more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

Here’s the inside scoop on “Sheltered Harbor,” a “doomsday project” from US banks that they hope will “prevent a run on the financial system should one of them suffer a debilitating cyberattack.” The gargantuan voluntary...more

Compliance into the Weeds-Episode 60, Cardinal Health and Joint GC-CCO Role

by Thomas Fox on

In this episode, Matt Kelly and I take a deep dive into the Cardinal Health corporate governance imbroglio. In it, a disgruntled shareholder, the Teamsters Pension fund brought a motion to have the CEO stripped of his title...more

Under The Dome: Inside The Maine State House

by Pierce Atwood LLP on

Legislature Sustains Governor's Veto of Marijuana Implementation Legislation - On Monday, November 6, the Legislature met for the second day of the Special Session to take up the Governor’s veto of the marijuana...more

Digital Health Report - Fall 2017

Digital health is the convergence between healthcare, genomics, and digital technologies. It is a fast-growing sector with important implications for individuals and institutions alike. Whether it is hospitals and health...more

Conditional Optimism or Securities Fraud? Appellate Court Affirms Dismissal of Class Action against Biopharmaceutical Company;...

by Arnall Golden Gregory LLP on

On August 22, 2017, the United States Court of Appeals for the First Circuit (the “Court”) affirmed the dismissal of a securities fraud class action against Sarepta Therapeutics, Inc. (the “Company”), a biopharmaceutical...more

ERISA Newsletter - Third Quarter 2017

by Proskauer Rose LLP on

Editor's Overview - As we have observed on other occasions, the ERISA class action plaintiffs' bar has, for several years now, honed in on 401(k) plan fiduciaries and their decisions to select and retain investment options...more

SuperVision - Labor & Employment Law Insights - September 2017

...This issue of SuperVision is dedicated to questions our friends and clients may have regarding insurance and benefit topics. While not a common part of the Labor & Employment field, Spilman prides itself on having...more

When Plaintiff Conduct Matters

by Reed Smith on

We previously addressed the in pari delicto doctrine, whereby a plaintiff injured in the course of his or her criminal conduct cannot recover for those injuries. We specifically examined this doctrine’s most common...more

Global Privacy & Cybersecurity Update Vol. 15

by Jones Day on

UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Comments on Improvements to IoT Device Security - On June 19, the Federal Trade Commission ("FTC") submitted comments to a working group organized by the...more

Japan Legal Update - Volume 28 | July 2017

by Jones Day on

Labor - Japanese Supreme Court Decision on Overtime Payments to Doctors - In a court case in which a doctor employed by a health care corporation sought extra pay for overtime and late-night work (collectively, "overtime"),...more

Employee Benefits Developments - August 2017

by Hodgson Russ LLP on

The Employee Benefits practice group is pleased to present the Benefits Developments Newsletter for the month of August, 2017. Affordable Care Act – “I’m not dead yet!” - The Patient Protection and Affordable Care Act...more

Payment Reform: Moving at the Speed of Trust

by Epstein Becker & Green on

An August 14 meta-analysis of payment reform evaluations by Len Nichols and others offers health care investors a sobering appraisal of the success to-date of a range of payment reforms initiated by the Centers for Medicare &...more

The Ball is in the SEC’s Court: What Health Care Borrowers Can Do While Waiting on Changes to Rule 15c2-12

by Foley & Lardner LLP on

On March 1, 2017, the Securities and Exchange Commission (SEC) issued Release No. 34-80130 (the Release) proposing several amendments to its Rule 15c2-12 (the Rule) that would add two new events to the list of events that...more

Health Care Market Intelligence Private Equity Summary Report - July 2017

by Benesch on

A Look Back at the First Half of 2017... At the midpoint of 2017, deal data suggests deal volume (both PE and M&A) continues to trend downward – a trend that started in 2016 – however, despite this, deal values are...more

WPI Insider Briefing: After ACA "Repeal and Replace" Effort Fails, What's Next For Employers on Health Care and Other Workplace...

by Littler on

Last month began with significant momentum but long odds that Senate Republicans would pass legislation repealing and replacing the Affordable Care Act (ACA). In the early hours of July 28, GOP efforts came to a screeching...more

Bristol-Myers Squibb: The Aftermath

by Morrison & Foerster LLP on

Last month, the U.S. Supreme Court clarified the scope of specific personal jurisdiction in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty., 137 S. Ct. 1773 (2017) (“BMS”). Mass tort defendants...more

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