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Regulations and Standards for Medical IT Networks & Connected Med Devices


Increasing numbers of traditional medical devices are being connected to information technology networks at hospitals and other health delivery organizations. At the same time, many home-use and consumer technologies are being deployed for patient care. The resulting wide-ranging and complex networks are covered by a patchwork of regulations. If you are a hospital IT professional or work with medical technologies that are networked or connected to the cloud, this symposium will provide insight on current thinking from the FDA and emerging international standards in this space.




8:00 AM Registration and Continental Breakfast

9:00 AM Welcome and Introductions

9:10 AM Overview of Regulations & Standards for Connected Devices; Geetha Rao; Triple Ring Technologies

9:30 AM Key-Note: Risk-Management for Medical Electrical Equipment – A journey from ISO 14971 via IEC[masked] to IEC[masked]; Oliver Christ; Prosystem USA

10:30 AM Responsibility Agreements – IEC[masked] the basis for future Health IT-Projects in hospitals; Geetha Rao, Oliver Christ

11:10 AM Coffee Break

11:30 AM Interoperability & Security Requirements for Medical Devices – lessons learned with wireless technologies; Sherman Eagles; Software CPR

12:30 PM Lunch

1:30 PM Requirements for “Stand-alone Software” as a Medical Device IEC[masked] “Health Software” & IEC 62304 “SW-Lifecycle”; Sherman Eagles; Software CPR

2:15 PM Liability concerns arising from the Integration of Medical Devices into IT Networks; Simone McCormick; Murphy, Pearson, Bradley & Feeney

3:00 PM Coffee Break

3:30 PM An Overview of HIPAA, FCC and FTC Regulations for Mobile Health IT in US; Mavis Yee, Jason Gonzalez; Nixon Peabody

4:15 PM Panel Discussion: Future Regulatory Frameworks for Health IT and Connected Medical Devices; Moderator: Geetha Rao; Triple Ring Technologies

4:55 PM Closing Remarks


5:00 PM Refreshments and Networking

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  • Nick D.

    Great speakers, food and drinks were more than fine, networking environment was friendly.

    May 30, 2013

  • Geetha R.

    Looking forward to seeing many more of you at this event. Please feel free to forward the invitation.

    May 23, 2013

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