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Reed Smith
 
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Tel: +1 412 2883131
Fax: +1 412 2883063
Reed Smith Centre, 225 Fifth Avenue
Pittsburgh
PA 15222
United States
By Debra McCurdy
The OCR is requesting public input on reforms to HIPAA privacy and security rules to promote care coordination and the health system's transformation to value-based health care while protecting the privacy and...
By Rachel B. Weil
It took us more than a week, but we finally put away the last serving pieces from last week's family Hanukkah celebration.
By Gerard Stegmaier, John Feldman, Karl E. Herrmann, Jennifer Driscoll
Companies that employ algorithms, machine learning and artificial intelligence (AI) in their day-to-day business may face increased attention from federal antitrust and consumer protection regulators in the future.
By Stephen J. McConnell
Contrary to rumor, we are not on the verge of changing our name to the Filter Device Litigation blog. True, we are now on a several consecutive weeks run of sharing ...
By Jennifer Driscoll, Karl E. Herrmann
On November 13–14, the Federal Trade Commission (FTC) held hearings on "Competition and Consumer Protection in the 21st Century."
By Michelle Yeary
Today's case is not our usual fare. But we've never seen this kind of appeal succeed before, so we're going to spare a few minutes for something a little odd but important.
By James Beck
The FDA has recently released a proposed rule "to establish requirements for the medical device De Novo classification process" provided in 21 U.S.C. §360c(f)(2). FDA
By Gail Daubert, Debra McCurdy
Responding to longstanding industry criticisms, the Centers for Medicare & Medicaid Services (CMS) has announced a number of changes to the Healthcare Common Procedure Coding System (HCPCS) coding process for 2019.
By Steven Boranian
A federal court in Utah ruled the other day that it had no personal jurisdiction over a corporate parent, even though the plaintiffs alleged that the defendant subsidiary was the "alter ego"...
By John Feldman, Andrew Bernasconi
Over a spirited dissent, and in a 3-1 decision issued on November 14, the FTC Commissioners held that 1-800 Contacts violated Section 5 of the FTC Action ...
By Thomas Greeson, James F Hennessy
In a transmittal issued last week, the Centers for Medicare & Medicaid Services (CMS) extended newly-revised supervision rules for certain diagnostic tests paid via the Medicare Physician Fee Schedule ...
By Emily Hussey, Sung W. Park
On November 26, 2018, the FDA announced its intent "to modernize the FDA's 510(k) clearance pathway" by encouraging manufacturers to rely on newer (that is, 10 years old or less) medical devices ...
By James Beck
Late last month Bexis attended the annual ACI Drug and Medical Device Conference in New York. In between helping to lead the discussion in the pre-conference Defense Counsel War Room...
By Debra McCurdy
The Health Resources and Services Administration (HRSA) has announced that it will implement its January 5, 2017 340B drug pricing program rule on January 1, 2019.
By John Sullivan
Last year, we favorably cited Canary v. Medtronic, Inc. 2017 WL 1382298 (E.D. Mich. April 18, 2017), on two occasions, once to highlight its use of TwIqbal at the motion to dismiss stage...
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