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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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