Medical Device Data Sharing with Enterprise Health Systems 180327

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Meeting Information

Device guidance project Meeting Minutes		Date: 2018-03-27 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	George Dixon
y	J.-Uwe Meyer
	Kathleen Connor
	Jayme Welty
y	Neelima Chennamaraja

Agenda

Agenda Topics

1. Comments on ballot drafts
2. Plan

Minutes

Minutes/Conclusions Reached:

1. DAM
   1. No further comments received on DAM
   2. still soliciting (Comments to Ioana), up to deadline on 4/1
2. Guidance
   1. to be shared today
   2. soliciting feedback
   3. Context diagram discussion: a key orientation tool
   4. Comments solicited on best way to help readers orient themselves
3. Example artifacts
   1. to be shared today
   2. soliciting feedback

Meeting Outcomes

Actions Ioana: distribute guidance document Team: review DAM & guidance; provide comments by weekend

Next Meeting/Preliminary Agenda Items Next meeting in Köln for ballot reconciliation

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