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Wearable gizmos vs. medical devices: how companies can comply with FDA security recommendations
  • Kaye Scholer LLP
  • USA
  • July 16 2015

Kaye Scholer Counsel Helen Christakos, whose practice areas include intellectual property, technology and data security, discusses the U.S. Food and

New product liability and jurisdictional questions in e-health
  • Freshfields Bruckhaus Deringer LLP
  • Asia-Pacific, European Union, USA
  • June 2 2015

The increasing use of e-health products and services as a diagnostic and information tool raises various issues concerning potential liability if

Top 5 steps for medical device manufacturers to operationalize their cybersecurity programs
  • Kaye Scholer LLP
  • USA
  • May 25 2015

In an age where the critical infrastructure of almost every government, organization, and network depend on technology, cyber issues have quickly

FDA issues guidance documents on how it considers balancing premarket and postmarket data collection during PMA reviews in a bid to accelerate the approval of new breakthrough devices
  • Loeb & Loeb LLP
  • USA
  • May 7 2015

The regulator explains how it determines when it's appropriate to increase reliance on postmarket collection to reduce the extent of premarket

Mobile apps offer opportunity, challenges for health & beauty field
  • Shook Hardy & Bacon LLP
  • USA
  • April 1 2015

As devices plug more people into the "Internet of Things," there is a growing overlap between the world of smartphones, tablets and software, and the

Increased FTC enforcement as FDA deregulates low-risk health IT devices
  • Morgan Lewis & Bockius LLP
  • USA
  • March 25 2015

In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement actions against companies that make misleading promotional claims

Navigating litigation and tort liability risks for mobile health and health IT applications
  • Arnold & Porter LLP
  • USA
  • February 18 2015

In the last ten years, mobile applications ("apps") have become an integral part of daily life for people throughout the world. Manufacturers have

FDA issues final guidance eliminating regulatory controls on medical device data systems, imaging storage devices, and imaging communications devices
  • Ropes & Gray LLP
  • USA
  • February 11 2015

On February 9, 2015, the United States Food and Drug Administration (FDA) issued a final guidance document describing the Agency's intention not to

New guidance documents from FDA seek to clarify regulation for wellness devices and medical device accessories
  • Hall Render Killian Heath & Lyman PC
  • USA
  • February 10 2015

On January 20, 2015, the Food and Drug Administration (the "FDA" or "Agency") published two draft guidance documents designed to fulfill promises it

FDA finalizes guidance on medical device data systems
  • Hall Render Killian Heath & Lyman PC
  • USA
  • February 10 2015

On February 6, the Food and Drug Administration (the "FDA" or "Agency") released a finalized guidance (the "Guidance") informing the public that the