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FDA Publishes Redraft of 510(k) Third Party Review Program

USA - November 20 2018 Section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act codifies the 510(k) Third Party Review Program (3P Review Program), which authorizes…

Carolyn A. Alenci, Frederick R. Ball, Stephen M. Honig, Jennifer A. Kearns, Vicki G. Norton, Jiazhong (Jason) Luo, Ph.D., JOHANN YI-DER LIN, PH.D., Ryan Smith

PA Supreme Court Significantly Narrows Application of State’s Peer Review Protection Act

USA - April 27 2018 On March 27, 2018, the Pennsylvania Supreme Court held in a 4-3 decision that the Pennsylvania Peer Review Protection Act (“PRPA”) would not prevent…

Samantha Dalmass

New SAMHSA Rule Allows Disclosure of Patient Substance Use for Payment, Healthcare Operations

USA - February 1 2018 SAMHSA has finalized provisions relating to the disclosure of patient-identifying substance use information for payment and…

Erin M. Duffy

Hackers Unleash “Ransom” Attack on Health System, Forcing It to Shut Down Computer Systems

USA - March 29 2016 On March 28 MedStar Health, the largest health system in the Washington, D.C. area, shut down its computer systems, including its electronic health…

For both providers and private equity firms, payment reforms bring rewards

USA - March 14 2016 The impact of changing payment models on private equity investments in health care was the topic explored at a February 10 event co-hosted in New…