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Results: 11-20 of 7,610

The writing’s on the wall: wise pharma companies will heed FDA warning in new draft guidance on data integrity cGMPs
  • DLA Piper LLP
  • USA
  • May 2 2016

FDA is again shining a spotlight on data integrity violations, announcing in a new draft Guidance for Industry: Data Integrity and Compliance with


Tips on Avoiding HIPAA Breaches for Patient-Employee Records
  • Fox Rothschild LLP
  • USA
  • May 2 2016

Our partner Elizabeth Litten and I were featured again by our good friend Marla Durben Hirsch in her article in the April 2016 issue of Medical


Privacy and Cybersecurity Update April 2016
  • Skadden Arps Slate Meagher & Flom LLP
  • European Union, USA
  • April 30 2016

Following its December announcement that a draft regulation had been completed, the European Parliament voted on April 14, 2016, to formally approve


Senate HELP Committee Approves 19 Bills on Medical Innovation as House Adds Directives to FDA's 2017 Appropriations Bill
  • Arnold & Porter LLP
  • USA
  • April 28 2016

On April 6, 2016, the Senate Committee on Health, Education, Labor and Pensions (HELP) voted to approve five bills on biomedical research, drug


Sweating the Small Stuff: Enforcement Trends Focusing on Day-to-Day Specialty Pharmacy Operations
  • Bass, Berry & Sims PLC
  • USA
  • April 28 2016

Astronomical settlements involving complicated manufacturer-specialty pharmacy (SP) relationships usually dominate the headlines and our attention


Follow the data: FDA addresses cGMPs for data integrity issues in Draft Guidance
  • Morgan Lewis & Bockius LLP
  • USA
  • April 28 2016

In recent years, issues involving the integrity of and controls around manufacturing data have become a significant concern for product sponsors and


The IMD Exclusion: Changes Now and Changes to Come
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • April 27 2016

On Monday, CMS finalized their long-awaited Medicaid managed care regulation. Deep in the regulation was a change to allow Medicaid reimbursement for


New York Presbyterian Hospital Settles OCR HIPAA Investigation
  • Ropes & Gray LLP
  • USA
  • April 27 2016

On April 21, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced a $2.2 million settlement with The New


HIPAA on the Small Screen: OCR Penalizes Unauthorized Patient Filming
  • Hall Render Killian Heath & Lyman PC
  • USA
  • April 27 2016

On April 21, 2016, the Department of Health and Human Services ("HHS") Office for Civil Rights ("OCR") announced a $2.2 million settlement with a New


LabMD’s Waiting Game: Lingering Questions over FTC’s Authority in Data Security Matters
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • April 27 2016

A contentious legal battle over data security between the Federal Trade Commission and LabMD, a small medical testing lab, is chronicled in the