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Final FDA guidance clarifies distinction between medical device recalls and enhancements

  • Hogan Lovells
  • -
  • USA
  • -
  • October 20 2014

On 15 October 2014, the Food and Drug Administration (FDA) issued its final guidance clarifying the difference between medical device recalls and

340B program: PhRMA files court challenge to interpretive rule on orphan drug exception

  • Hogan Lovells
  • -
  • USA
  • -
  • October 14 2014

On Thursday, October 9, 2014, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit against the Department of Health and Human

Ninth Circuit upholds Alameda County’s safe drug disposal ordinance

  • Hogan Lovells
  • -
  • USA
  • -
  • October 10 2014

On September 30, 2014, a three-judge panel of the United States Court of Appeals for the Ninth Circuit unanimously affirmed the U.S. District Court

Department of Health and human services Office of Inspector General proposes new anti-kickback safe harbors and exceptions to civil monetary penalties statute

  • Hogan Lovells
  • -
  • USA
  • -
  • October 8 2014

On 1 October 2014 the Department of Health and Human Services Office of Inspector General (OIG) published a proposed rule that would create three

340B program: Health Resources and Services Administration (HRSA) issues proposal to collect manufacturer data; comments due by Dec. 1, 2014

  • Hogan Lovells
  • -
  • USA
  • -
  • October 2 2014

On Tuesday, September 30, 2014, the Health Resources and Services Administration (HRSA), which administers the 340B program, published a Federal

OCR and NIST host conference and provide insights on safeguarding health information

  • Hogan Lovells
  • -
  • USA
  • -
  • October 1 2014

Government officials emphasized the importance of risk analysis and risk management in safeguarding PHI at the Seventh Annual "Safeguarding Health

OIG report and Special Advisory Bulletin identify vulnerabilities in copay coupon processing

  • Hogan Lovells
  • -
  • USA
  • -
  • September 25 2014

Completing a project identified in its last two work plans, on 19 September 2014 the Office of Inspector General for the U.S. Department of Health

As business associate agreements amendment deadline approaches, OCR discusses upcoming HIPAA audits

  • Hogan Lovells
  • -
  • USA
  • -
  • September 18 2014

The 2009 HITECH Act mandated that the U.S. Department of Health and Human Services Office for Civil Rights ("OCR") conduct periodic audits of covered

National Health IT week at the FCC

  • Hogan Lovells
  • -
  • USA
  • -
  • September 16 2014

This week the Federal Communications Commission's (FCC's) CONNECT2HEALTHFCC Task Force, a group formed in March 2014 that is focused on using

NIH issues rules on Genomic Data Sharing

  • Hogan Lovells
  • -
  • USA
  • -
  • September 16 2014

On August 27, 2014, the National Institutes of Health (NIH) issued a new Genomic Data Sharing (GDS) Policy, which replaces the current genome-wide