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Category Archives: Hospitals

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U.S. Senate passes bill requiring prescription drug ads to include prices (updated)

Update (9/18/2018): Last week, as the U.S. House of Representatives was reconciling its spending bill for the Health and Human Services Department (HHS) with the amendment package passed by the U.S. Senate that is discussed below, House Republicans declined to adopt S.Amdt. 3964, which would have provided HHS with $1 million to issue rules requiring pharmaceutical companies to list prices

Hogan Lovells Issues Sponsored Research Alert on Proposed Changes to Federal Policy for Protection of Human Subjects

Hogan Lovells has issued a Sponsored Research Alert outlining a Notice of Proposed Rulemaking (NPRM) issued by the U.S. Department of Health and Human Services (HHS) that seeks to amend the U.S. Government’s policy on protection of human research subjects.  As the Alert describes: The NPRM would substantially change, in several respects, the regulatory framework with which universities and research

National Health IT Week at the FCC

This week the Federal Communications Commission’s (FCC’s) CONNECT2HEALTHFCC Task Force, a group formed in March 2014 that is focused on using broadband deployment to accelerate the adoption of advanced healthcare technologies, is joining more than 400 other public and private organizations in recognizing National Health IT Week (NHIT week).  NHIT week is a series of

FDA Proposes Enforcement Discretion for Medical Device Data Systems, Medical Image Storage Solutions, and Medical Image Communications Devices

In a 20 June 2014 draft guidance, the Food and Drug Administration (FDA or Agency) proposed that, once the guidance is finalized, the Agency would refrain from enforcement of all regulatory requirements for a subset of hardware and software that transfers, stores, converts, formats, and displays medical device data or medical imaging data, which would

FDA Health IT Initiatives: OpenFDA and FDASIA Health IT Public Workshop

In the last month, the Food and Drug Administration (FDA) undertook two new steps related to Health IT in the United States While the FDA’s involvement in this area of technology remains very controversial, both projects sought to enhance collaboration with the Health IT industry. FDASIA Workshop First, on May 13-15, 2014, the FDA, Federal Communications Commission (FCC),

District Court blocks hospital acquisition of a physician practice, concluding that anticompetitive effects outweigh potential quality and efficiency gains from consolidation

In the first ever FTC-litigated challenge to a hospital system’s acquisition of a physician group, the U.S. District Court for Idaho ruled in favor of the plaintiffs (the FTC, Idaho Attorney General, and St. Alphonsus, a competing hospital system). The plaintiffs challenged St. Luke’s Health System’s acquisition of the Saltzer Medical Group, a 41-physician multi-specialty

FDA and Other Government Agencies Focus on Radio Frequency Wireless Technology in Medical Devices

On August 13, 2013, the Food and Drug Administration (“FDA”) issued final guidance on design principles for medical devices using radio frequency (“RF”) wireless technology that are implanted or worn on the body and that are intended for use in locations such as hospitals, homes, clinics, and clinical laboratories.  This guidance comes as the FCC

District Court applies Christian Doctrine, upholds hospitals as subcontractors subject to OFCCP anti-discrimination provisions

In a significant decision with implications beyond the healthcare industry, the D.C. District Court upheld a ruling by the U.S. Department of Labor’s Administrative Review Board (ARB) deeming three Pennsylvania hospitals government subcontractors subject to the Office of Federal Contract Compliance Programs’ (OFCCP) jurisdiction. UPMC Braddock v. Harris, No. 1:09-cv-01210-PLF (D.D.C. Mar. 30, 2013).