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Mobile Health in the EU (part 1): introduction to mHealth and privacy laws
  • Hogan Lovells
  • USA
  • July 24 2015

The mobile Health (mHealth) sector is rapidly developing and revolutionising the healthcare market. More and more consumers share information such as


Fourth Circuit’s application of Stark Law and the False Claims Act in Tuomey II may invigorate calls for reform
  • Hogan Lovells
  • USA
  • July 24 2015

In its second opinion in United States ex rel. Drakeford v. Tuomey Healthcare System, Inc., the Fourth Circuit Court of Appeals affirmed a judgment


Latest version of 21st Century Cures would create new civil monetary penalties for fraud in HHS grants and contracts
  • Hogan Lovells
  • USA
  • July 9 2015

On 2 July, the House Energy and Commerce Committee released a "manager's amendment" to H.R. 6, the so-called 21st Century Cures legislation. Among


FDA releases new guidance on UDI direct marking requirements
  • Hogan Lovells
  • USA
  • June 30 2015

On June 26, 2015, FDA released a draft guidance document providing further clarification on the direct marking requirements associated with the


Supreme Court upholds federal health insurance subsidies
  • Hogan Lovells
  • USA
  • June 25 2015

Today, in a 6-3 ruling, the Supreme Court upheld the federal regulation that makes subsidies available to eligible individuals who purchase health


Supreme Court upholds federal health insurance subsidies
  • Hogan Lovells
  • USA
  • June 25 2015

Today, in a 6-3 ruling, the Supreme Court upheld the federal regulation that makes subsidies available to eligible individuals who purchase health


OIG issues new Advisory Opinion on donations to independent charitable foundation patient assistance programs
  • Hogan Lovells
  • USA
  • June 18 2015

Many manufacturers and providers donate to independent charitable foundation patient assistance programs (PAPs) that help financially needy patients


FDA publishes final guidance on physical attributes of generics
  • Hogan Lovells
  • USA
  • June 18 2015

FDA today published a final version of its guidance, "Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules," with only minor


340B Program: HRSA releases proposed rule on calculation of the ceiling price and imposition of civil monetary penalties on manufacturers
  • Hogan Lovells
  • USA
  • June 16 2015

Today, the Health Resources and Services Administration (HRSA) released a Notice of Proposed Rulemaking (NPRM) regarding the calculation of the 340B


CMS releases final rule for accountable care organizations in the Medicare Shared Savings Program
  • Hogan Lovells
  • USA
  • June 8 2015

On June 4, 2015, CMS issued a final rule updating the Medicare Shared Savings Program (MSSP). Under the MSSP, Accountable Care Organizations (ACOs