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February 26, 2012

Mtg: Connected Health Safety â?? Regulatory and Industry Challenge

by @ 8:25 pm. Filed under ALL, BioEngineering, Electronics Design

TUESDAY February 28, 2012
SCV Product Safety Engineering Chapter
Speakers: Geetha Rao, Ph.D., VP Corp. Dev., Triple Ring Technologies; Marta Zanchi, Ph.D., Principal Consultant, Medinnovo
Time: Optional dinner at 5:15 PM at Honba Sushi; Presentation at 7:00 PM at U.L.
Cost: none
Place: Honba Sushi, 2587 North 1st St, San Jose; then Underwriters Laboratories Inc., 455 E. Trimble Rd, San Jose
RSVP: not required

Professional healthcare delivery is increasingly reliant on IT-networks that incorporate wired, wireless, or otherwise connected medical devices.? Separate from that, consumer technologies such as home-use diagnostics connected to cell phones are increasingly being used in healthcare application.? As these two trends converge, assuring patient safety and effectiveness is a significant challenge in the resulting wide-ranging, networked systems with complex inter-dependencies and multiple subsystem owners.? While the FDA regulates devices, the IT networks themselves are largely unregulated.? As these networks have added capabilities for real-time data exchange and remote monitoring, they have increasing impact on patient safety, clinical effectiveness, continuous availability of care, and security of both the networks and the medical devices.? Drs. Geetha Rao and Marta Zanchi will discuss FDA activity in this area and the complementary efforts of the Connected Health Safety Initiative (CHSI), a non-profit industry coalition which aims to develop a framework for collaborative management of safety, clinical effectiveness, and data security risks in connected healthcare systems.

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