We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 683

Health IT regulator updates guidance on privacy and security
  • Hogan Lovells
  • USA
  • May 27 2015

In an effort to help members of the health IT community better understand the federal laws relating to interoperability, the Office of the National


Recent first amendment rumblings
  • Hogan Lovells
  • USA
  • May 13 2015

Lately, there seems to be a palpable uptick in news related to FDA's regulation of off-label communications. Here are some of the developments we've


CEO media statements draw additional scrutiny
  • Hogan Lovells
  • USA
  • May 13 2015

The Food and Drug Administration (FDA) has issued a second enforcement letter regarding a pharmaceutical company executive's statements on television


FDA withdraws draft disease awareness guidance
  • Hogan Lovells
  • USA
  • May 12 2015

FDA announced last week that it was withdrawing numerous draft guidance documents including its 2004 draft guidance on disease awareness activities


Pioneer ACO Model achieves substantial savings; CMS decides to expand the CMMI Model for the first time
  • Hogan Lovells
  • USA
  • May 7 2015

On May 4, 2015, CMS announced that the Center for Medicare & Medicaid Innovation (CMMI) demonstration project, the Pioneer Accountable Care


Centers for Medicare & Medicaid Services (CMS) requests comments on national coverage of stem cell transplantation
  • Hogan Lovells
  • USA
  • May 6 2015

On April 30, 2015, CMS opened a 30-day comment period for aNational Coverage Analysis (NCA) on Stem Cell Transplantation. Currently, CMS has a


Recent FDA metrics show increase in reported violations from BIMO inspections
  • Hogan Lovells
  • USA
  • April 30 2015

The Food and Drug Administration (FDA) recently published annual bioresearch monitoring (BIMO) inspection metrics for fiscal year (FY) 2014. These


New OIG guidance for governing boards reaffirms expectation of active board compliance oversight
  • Hogan Lovells
  • USA
  • April 27 2015

On April 20, 2015, the Department of Health and Human Services Office of Inspector General (OIG), in conjunction with associations representing legal


New draft guidance outlines FDA’s key considerations in accepting foreign data
  • Hogan Lovells
  • USA
  • April 24 2015

On April 21, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Acceptance of Medical Device Clinical Data from Studies


EEOC proposes regulations on wellness program compliance with the ADA
  • Hogan Lovells
  • USA
  • April 17 2015

The U.S. Equal Employment Opportunity Commission (EEOC) announced yesterday that it will issue proposed regulations on Monday, April 20, to clarify