Regulations and Standards for Medical IT Networks & Connected Med Devices
Details
ABOUT THE SYMPOSIUM
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.
DISCOUNT REGISTRATION: $80 with Partner Affiliation (ASQ, RAPS, SVFORUM. HTF, B2DG)
REGULAR REGISTRATION: $95
SYMPOSIUM AGENDA
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 60601-1 to IEC 80001-1; Oliver Christ; Prosystem USA
10:30 AM Responsibility Agreements – IEC 80001-2-6 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 82304-1 “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