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FDA Issues Final Guidance on Postmarket Cybersecurity
  • Morgan Lewis & Bockius LLP
  • USA
  • January 10 2017

On December 28, 2016, FDA issued a final guidance titled "Postmarket Management of Cybersecurity in Medical Devices" (Final Guidance). A draft


The Evolution of Digital Health
  • Fenwick & West LLP
  • USA
  • January 6 2017

The digital health industry has grown into a well-defined sector that attracts billions of investment dollars each year. Fenwick startup partner


FDA Releases Guidance on Cybersecurity and Medical Devices
  • Reed Smith LLP
  • USA
  • January 6 2017

The FDA represents the latest federal agency to show a focus on cybersecurity issues with the release December 28 of new guidance. While the prospect


New FDA Guidance Addresses Medical Device Cybersecurity for the Internet of Things
  • Holland & Hart LLP
  • USA
  • January 5 2017

In 2017, numerous cybersecurity concerns relating to the Internet of Things (“IoT”) will emerge. IoT “refers to the ability of everyday objects to


On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance
  • Hogan Lovells
  • USA
  • January 4 2017

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories -


US FDA Issues Guidance on Postmarket Management of Cybersecurity in Medical Devices
  • Pearl Cohen Zedek Latzer Baratz
  • USA
  • January 2 2017

The US Food and Drug Administration (FDA) has published guidance informing of the FDA's recommendations for managing postmarket cybersecurity


21st Century Cures Act: Key Provisions of Interest to DrugDevice Clients
  • Reed Smith LLP
  • USA
  • December 27 2016

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Cures Act). It is hoped that provisions in the new bill, and the $6


Blood Pressure App Maker Settles FTC Charges Alleging Inaccurate App Readings
  • Winston & Strawn LLP
  • USA
  • December 21 2016

Aura Labs, Inc. recently settled charges with the FTC for alleged deceptive claims that its app, Instant Blood Pressure, provided blood pressure


President Obama Signs 21st Century Cures Act into Law, Exempting Certain Types of Medical Software from FDA Regulation
  • Hogan Lovells
  • USA
  • December 16 2016

On Tuesday, December 13, President Obama signed into law the 21st Century Cures Act. That Act previously passed both houses of Congress with


21st Century Cures Act’s Effect on Pharmaceutical and Biotechnology Industries
  • Morgan Lewis & Bockius LLP
  • USA
  • December 15 2016

The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and