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Medical Device Data Sharing with Enterprise Health Systems 180320
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Meeting Information
Device guidance project Meeting Minutes |
Date: 2018-03-20 Time: 9:00-10:00 ET | ||
Facilitator | Jay Lyle | Note taker(s) | Jay Lyle |
Attendee | Name | Affiliation | |
y | Jay Lyle | JP Systems / VA | |
y | Ioana Singureanu | ||
y | Marti Velezis | ||
y | Denise Downing | ||
Kathleen Connor | |||
y | Jayme Welty | ||
y | Neelima Chennamaraja | ||
Agenda
Agenda Topics
- Review 2 new use cases from 2017
- Review new use cases from 3/2018
- Confirm boundary with UDI ballot
- Review workflow examples
- Orthopedics
- Cardiology
- Plan 3/26 PC presentation
- Plan ballot content submission
Minutes
Minutes/Conclusions Reached:
- UDI project alignment
- UDI project interested in making sure this DAM does not get into hardware issues.
- No changes identified. This project will not address device component.
- No publication of UDI DAM this ballot.
- OO work may change device resource; this project will create profile for current version (STU3) of device resource.
- reflect changes to tracking implantable devices based on UDI project team feedback
- New document: renamed, leaving out "DCM"
- we'll ballot both DAM and guidance, not DAM embedded in guidance
- Ioana to clarify in document what's relevant for this ballot
- Contributors:
- Review DAM & guidance documents available here
- Ioana to incorporate into ballot document
Meeting Outcomes
Actions
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Next Meeting/Preliminary Agenda Items
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