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HTMLSingapore: Opportunities for Medical Innovation
Lisa W. Clark, Michelle Ranello; Duane Morris LLP;
Legal Alert/Article
July 8, 2014, previously published on June 24, 2014
In addition to mobile health opportunities in the United States, tremendous potential for growth exists throughout the world, including in Southeast Asia. Singapore in particular is working to become a leader in healthcare innovation. It welcomes innovators and companies from around the world to...

 

HTMLIs One Really Better Than Many? The Unified Medical Staff Conundrum
Wakaba Y. Tessier; Husch Blackwell LLP;
Legal Alert/Article
July 8, 2014, previously published on July 1, 2014
The Centers for Medicare & Medicaid Services (CMS) published its final revisions (“Final Rule”) to the Medicare Conditions of Participation (CoPs) on May 12, 2014. Among other things, CMS proposed to revise its current interpretation of the hospital medical staff composition at 42...

 

HTMLUSPTO Extends Deadline to Comment on Subject Matter Eligibility Analysis
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
July 7, 2014, previously published on June 26, 2014
Yesterday at BIO’s session entitled “Patent-Eligibility from the Trenches: Practical Implications of the Supreme Court’s Prometheus (Mayo) and Myriad Decisions” a panel of experts and an engaged audience discussed the controversial USPTO “Guidance for Determining...

 

HTMLA “Virtual Merger” is Underway between Chicago-Area Alexian Brothers Health System and Adventist Midwest Health
Eric A. Klein; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
July 4, 2014, previously published on June 25, 2014
Chicago-area Alexian Brothers Health System and Adventist Midwest Health signed a non-binding letter of intent to form a joint operating company, a collaboration commonly referred to as a virtual merger. As Alexian brings five hospitals to the agreement and Adventist brings four, the health systems...

 

HTMLOIG Warns of Anti-kickback Statute Violations in Laboratory Payments to Referring Physicians
McDonald Hopkins LLC;
Legal Alert/Article
July 4, 2014, previously published on June 30, 2014
On June 25, 2014, the Office of Inspector General (OIG) issued a special fraud alert entitled “Laboratory Payments to Referring Physicians” which deals specifically with laboratories paying compensation to physicians and group practices for blood specimen collection, processing and...

 

HTMLIs the DOJ FCPA Enforcement Hegemony Dead?
Alexandra M. Gorman, Michael K. Loucks; Skadden, Arps, Slate, Meagher & Flom LLP;
Legal Alert/Article
July 3, 2014, previously published on June 26, 2014
For nearly 15 years, the United States has had the worldwide corruption enforcement stage to itself, reaping billions of dollars in fines and settlement payments from companies that have acknowledged engaging in bribery in foreign countries. That monopoly, however, may soon end. In a report...

 

HTMLFirst-Half Activity Energizes US Capital Markets in 2014
David J. Goldschmidt, Stacy J. Kanter, Phyllis G. Korff, Michael J. Zeidel; Skadden, Arps, Slate, Meagher & Flom LLP;
Legal Alert/Article
July 3, 2014, previously published on June 26, 2014
The U.S. equity and debt markets experienced a strong first half of the year. In the first quarter, the U.S. IPO market was the busiest since 2000, more than doubling the number of IPOs from the same period last year. The second quarter was nearly as active, bringing the year-to-date total to 134...

 

HTMLAn Update from the Federal Trade Commission
Helen J. Kim, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
July 2, 2014, previously published on June 24, 2014
The interplay between the Affordable Care Act (ACA), Accountable Care Organizations (ACOs), and antitrust has been a matter of great moment for several years. It has been an issue in litigation such as the Federal Trade Commission’s (FTC) St. Luke’s case. Recently, in a conference,...

 

Adobe PDFTime Running Out to File Comments on OIG Proposed Rulemaking That Gives OIG Limitless Time to Exclude Providers
Laura F. Laemmle-Weidenfeld, Heather M. O'Shea, Stephen G. Sozio, Heidi Ann Wendel; Jones Day;
Legal Alert/Article
July 1, 2014, previously published on June 24, 2014
Statutes of limitation serve an essential purpose in ensuring that claims are timely pursued before evidence becomes stale, and that parties can manage their affairs without a cloud of potential liability hanging over them indefinitely. These purposes apply with particular force in the context of...

 

HTMLFDA Issues Draft Guidance for Medical Device Data Systems
Leslie J. Levinson, Michaela ("Kayla") Tabela; Edwards Wildman Palmer LLP;
Legal Alert/Article
July 1, 2014, previously published on June 2014
On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance to inform manufacturers, distributors, and other entities that FDA does not intend to enforce compliance with the agency’s 2011 regulations governing medical device data systems (MDDS) subject to 21 CFR...

 


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