"Prepared for distribution at the Health Care and Life Sciences Law 2014 Program, New York City, October 24, 2014"--Page 5. "#48141"--Spine. Includes bibliographical references and index.
Contents:
Medical device data systems, Medical image storage devices, and medical image communications devices: Draft guidance for industry and food and Drug Administration Staff (Draft guidance) / FDA accepts first biosimilar application under new approval pathway (July 29, 2014) / Nathan Brown -- Mobile medical applications: Guidance for industry and Food and Drug Administration Staff ( September 25, 2013) U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for biologics Evaluation and Research -- Medical device data systems, Medical image storage devices, and medical image communications devices: Draft guidance for industry and food and Drug Administration Staff (Draft guidance) / Department of Health and Human Services, Food and Drug Administration -- Standards for the interoperable exchange of information for tracing of human, finished, prescription drugs, in paper or electronic format; Establishment of a public docket (Docket No. FDA-2014-N-0200) / U.S. Food and Drug Administration -- FDASIA health IT report: Proposed strategy and recommendations for a risk-based framework (April 2014) / The Office of the National Coordinator for Health Information Technology -- Title II of Drug Quality and Security Act: Drug supply chain security / U.S. Food and Drug Administration -- Drug Supply Chain Security Act (DSCSA) implementation plan / U.S. Food and Drug Administration -- Standards for the interoperable exchange of information for tracing of human, finished, prescription drugs, in paper or electronic format; Establishment of a public docket (Docket No. FDA-2014-N-0200) / Department of Health and Human Services, Food and Drug Administration -- Repealing and replacing the SGR (February 6, 2014) / The Center for Medicare & Medicaid Innovation -- FDA issues two draft guidance documents concerning internet/Social media platforms / Scott D. Danzis -- Guidance for industry: Fullfilling regulatory requirements for postmarking submissions of interactive promotional media for prescription human and animal drugs and biologics (Draft guidance, January 2014) / Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), center for biologics evaluation and research (CBER), Center for Veterinary medicine (CVM) -- Repealing and replacing the SGR (February 6, 2014) / The House Committee on Energy & Commerce and Ways & Means and the Senate Committee Finance Staff Preliminary design for an Oncology-Focused Model / The Center for Medicare & Medicaid Innovation -- A toolkit for Health Care Boards / Laura F. Laemmie-Weidenfeld, Jones Day -- Hospital value-based purchasing program: Frequently asked questions (March 9, 2012) / Centers for Medicare and Medicaid Services -- CMS has a variety of quality reporting and performance programs (PowerPoint Slides) / James Poyer -- Alleged FCA violations commonly asserted against health care entities / Nathan Brown -- Second circuit recognizes significant first amendment protections for off-label promotion / Scott D. Danzis -- New health care delivery models: State regulatory challenges (August 25, 2014) / Ellen L. Janos -- Recommended compliance resources / Health Care Fraud Prevention and Enforcement Action Team (HEAT), Office of Inspector General (OIG) -- A toolkit for Health Care Boards / Laura F. Laemmie-Weidenfeld, Jones Day -- CMS voluntary self-referral disclosure protocol (OMB Control number: 0938-1106) / Laura F. Laemmie-Weidenfeld, Jones Day. OIG Compliance Program Guidance for Pharmaceutical Manufacturers / Laura F. Laemmie-Weidenfeld -- Publication of the OIG's compliance program Guidance for Medicare+Choice organizations offering coordinated Care Plans / Laura F. Laemmie-Weidenfeld, Jones Day -- Publication of the OIG compliance program guidance for hospitals / Laura F. Laemmie-Weidenfeld, Jones Day -- OIG supplemental compliance program guidance for hospitals / Laura F. Laemmie-Weidenfeld, Jones Day -- Guidance for submitting a contractor self-disclosure (April 2014) -- OIG's provider self-disclosure protocol (Updated, April 17, 2013) / Laura F. Laemmie-Weidenfeld, Jones Day -- CMS voluntary self-referral disclosure protocol (OMB Control number: 0938-1106) / Laura F. Laemmie-Weidenfeld, Jones Day.
This resource is supported by the Institute of Museum and Library Services under the provisions of the Library Services and Technology Act as administered by State Library of Iowa.