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Symposium on Changing Regulations and Standards for Medical Device Software and Health Information Systems

Date of Event: 
Friday, July 24, 2009 - 9:00am to 4:30pm
Location: 
Electrical Engineering and Computer Science Building

The University of Minnesota Software Engineering Center presents a Symposium on "Changing Regulations and Standards for Medical Device Software and Health Information Systems".

In this symposium, FDA representatives and industry leaders will provide an update on the status of standards used for medical device software and health information management systems and the current thinking of regulatory bodies regarding what they may require to evaluate the safety of these products.

Software is playing an ever increasing role in medical devices as the ability to collect and relate patient information promises improved health care delivery. The technology used to gather and manage this medical information is changing rapidly and its regulation is under discussion and revision. Software applications that are part of a medical device and that interact with a medical device must provide reliable interoperability to share information while maintaining patient safety and data privacy. Since these interconnected systems will include government organizations, they must also provide adequate security against malicious users while reliably performing their intended function.

One key element for the success of this new environment is the use of consensus standards, developed cooperatively by industry, regulators and users. Standards play a central role in regulation in the EU and the FDA is required by law to consider them in pre-market review of medical devices.

Agenda

9:00 - 9:15 Introduction, Overview, and Goals of Workshop
Mats Heimdahl (Professor and Director of U of M Software Engineering Center)
Sherman Eagles (SoftwareCSP)
9:15 - 10:15 International Standards and EU regulation of medical device software–an update
Sherman Eagles (SoftwareCSP)
10:15 - 10:45 Refreshment Break
10:45 - noon FDA’s plans for using medical device standards (Slides available after symposium)
Brian Fitzgerald, Deputy Director (FDA Office of Science and Engineering Laboratories)
Richard Chapman (FDA Office of Science and Engineering Laboratories)
noon - 1:00 Lunch
1:00 - 2:00 From Sensor to EHR: Charting a Course to Next Generation Applications
Todd Cooper (Breakthrough Solutions Foundry, Inc.)
2:00 - 2:45 The needs for security in medical devices and health information technology (pdf slides)
Brian Fitzgerald, Deputy Director (FDA Office of Science and Engineering Laboratories)
2:45 - 3:15 Refreshment Break
3:15 - 4:15 Emerging Requirements for Information Technology: A view from FDA (Slides available after symposium)
Richard Chapman (FDA Office of Science and Engineering Laboratories)
4:15 - 5:00 Panel Discussion with Speakers
Moderator: Mats Heimdahl
When:
Friday, July 24th, 2009, 9:00-17:00
Registration and continental breakfast start at 8:30.
Where:
University of Minnesota, Minneapolis Campus, Electrical Engineering and Computer Science Building
Cost:
$90. We will provide continental breakfast, coffee break, and symposium materials.
Registration:
We encourage all participants to pre-register since seating is limited.
On-Line Registration with Credit Card
Parking:
Park in the Washington Avenue Ramp