Healthcare IT Evening Event: Connected Health Safety – Regulatory and Industry Challenge



  • Topic: Connected Health Safety – Regulatory and Industry Challenge
    (Note: Due to a scheduling conflict, the originally planned topic for January 23rd has been rescheduled to a later date.)

    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 recent FDA activity in this area and the complementary efforts of the Connected Health Safety Initiative, 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.


    6:30 - 7:00 p.m. Registration / Networking / Refreshments

    7:00 - 7:15 p.m. Announcements and Introductions

    7:15 - 8:30 p.m. Presentation and Discussion

    8:30 - 8:45 p.m. Wrap-up / Networking