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FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as labeling
  • Hogan Lovells
  • USA
  • December 26 2018

On November 20, the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital


Medical Products & FDA: What to Watch for in 2019
  • Mintz
  • USA
  • December 4 2018

Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues


Inside track: Healthcare - 03 December 2018
  • Holding Redlich
  • Australia
  • December 3 2018

Medical information supplied by an unknown number of customers to Commonwealth Bank's insurance operation is made available to other arms of the bank


CMS Proposed Rule Would Expand Coverage of Telehealth Benefits Under Medicare Advantage
  • Jones Day
  • USA
  • December 3 2018

Earlier this year, Congress passed the Bipartisan Budget Act of 2018 ("BBA"), which expands coverage for telehealth in


Artificial Intelligence und Smart Devices - Ethik und Rechtsprechung in Zeiten der Digitalisierung
  • Taylor Wessing
  • European Union
  • December 2 2018

Smart Devices und Künstliche Intelligenz - das sind Buzzwords des Jahres. 2018 stand und steht ganz im Zeichen digitaler Innovationen. Ob Internet of


U.S. FDA Announces New Framework for Prescription Drug-Use-Related Software
  • Sidley Austin LLP
  • USA
  • November 28 2018

The U.S. Food and Drug Administration (FDA) issued a notice in the Federal Register last week requesting public comment on a proposed framework for


FDA announces planned modernization of 510(k) pathway and seeks a more active role in driving technological innovation
  • Hogan Lovells
  • USA
  • November 28 2018

On 26 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director


FDA Engages in Patient Engagement - How Will It Affect Medical Device Regulation?
  • Baker McKenzie
  • USA
  • November 28 2018

The Patient Engagement Advisory Committee (PEAC) to the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH or


FDA’s Refreshed Approach to Device Safety Would Require Major Changes to 510(k) Program
  • Mintz
  • USA
  • November 27 2018

On November 26, 2018, FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the


A feather in one’s app: why the UK could lead the way for medical app patents
  • Marks & Clerk
  • United Kingdom
  • November 27 2018

Apple’s recent announcement that it will be opening its health records application programming interface (API) will be big news for healthcare app