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Gearing Up for Change: President-Elect Trump's Nominees to Head HHS and CMS, and their Views on the ACA, Medicare, and Medicaid
  • Hogan Lovells
  • USA
  • December 1 2016

On November 29, 2016, President-elect Trump announced Congressman Tom Price as his intended nominee for Secretary of Health and Human Services, and


Global Media and Communications Quarterly - Autumn 2016
  • Hogan Lovells
  • European Union, Global, USA
  • November 23 2016

Digital has been one very powerful manifestation of globalization, but like other globalization trends, policymakers are divided on who should govern


U.S. - Protecting IP in Digital Health deals
  • Hogan Lovells
  • USA
  • November 18 2016

Industry sources estimate that more than $4 billion worth of deals in digital health have been signed globally this year so far, as pharmaceutical


FDA Got An Earful: FDA’s Part 15 Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products
  • Hogan Lovells
  • USA
  • November 17 2016

Last week, FDA held a much-anticipated Part 15 public hearing seeking commentary on its regulation of speech about unapproved uses of approved


U.S. - Develop a digital health IP protection plan
  • Hogan Lovells
  • USA
  • November 16 2016

The digital health space is transforming health care with inventions that address complex medical challenges, such as wearable health-tracking devices


CMS Delays Addition of U.S. Territories to Medicaid Drug Rebate Program
  • Hogan Lovells
  • USA
  • November 15 2016

On 14 November 2016, the Centers for Medicare and Medicaid Services (CMS) released an interim final rule with comment period (IFR), effective 15


NIH's Clinical Trial Initiatives
  • Hogan Lovells
  • USA
  • November 15 2016

Over the past few months, the National Institutes of Health (NIH) has unveiled several policies that add to the long list of regulatory obligations


FDA Issues New Final Guidance on Medical Device Reporting Requirements
  • Hogan Lovells
  • USA
  • November 14 2016

On 8 November 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Reporting for


The Trump Transition Team Expands, and Takes Its First Steps In Forming the Players and Policies of the Trump Administration
  • Hogan Lovells
  • USA
  • November 11 2016

The last three days since the election has seen a frenzy of activity as the expanding team of President-elect Donald Trump has begun the process of


U.S. Election Outcomes
  • Hogan Lovells
  • USA
  • November 9 2016

Government Relations Alert The surprise election of Donald Trump as President and the near Republican sweep of contested U.S. Senate elections