Medical Device Data Sharing with Enterprise Health Systems 180313

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Meeting Information

Device guidance project Meeting Minutes		Date: 2018-03-13 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	Nictiz
y	Marti Velezis	USP
y	Greg Staudenmaier	USP
y	Kathleen Connor	USP
y	Jayme Welty
y	Neelima	Cerner

Agenda

Agenda Topics

1. scope
2. FHiR resources that will be profiled for this IG.
   1. Device, including the harmonized UDI pattern developed by the UDI Project and possible harmonization with medication AIDC barcode/RFID tracking at the point of care. VA has made great progress in patient safety by using barcode medication administration at the point-of-care. For this IG we would like to leverage the known and successful workflow used in the field.
   2. Procedure -references Condition, Practitioner. Encounter, and , of course, Patient.
   3. Based on our Connectathon work we identified MedicationAdministration , Medication, Location- optional resources for self-injection device and other home device
   4. For specialties, we would like to focus on orthopedics/joint replacement/prosthetics and cardiology implant, Other specialties? Womens' health?
3. planning

Minutes

Minutes/Conclusions Reached:

1. Scope of project, DAM overview
   1. How differs from UDI, Med Dev projects?
   2. Use of devices in context of point-of-care procedure; how device is documented.
      1. implants
      2. community centers; device back to VA
      3. Question: identify specialties with special interest (eg ortho, cardio)
      4. Not to rework device or device source of data
      5. Focus on capturing device identification in context of procedure (implants, used by, med admin)
      6. latest use case: self-injectables (procedure: start, stop using device)
      7. also a device qualifying implantables: implantable tags. Implant can self-identify, or augmented.
         1. tag may also identify sites/morphologies irrespective of device. auto capture of user, time, place, dose, etc.
2. ballot contents
   1. Ballot: Cross-paradigm IG + DAM additions
   2. FHIR profiles, V2
      1. Include provenance
      2. suggest example profiles for FHIR pub - Q# next steps
3. next steps
   1. review existing use cases week of 3/13: Team (https://gforge.hl7.org/gf/project/dcmmd/frs/)
   2. Confirm boundary with UDI DAM: Ioana, Marti. 3/16
   3. Add 2 use cases to DAM: Ioana 3/19
   4. 3/20 meeting - review new use cases
      1. review point of care procedure workflow examples. prioritize ortho, then cardio
   5. 3/26 present to PC
   6. 3/27 last meeting before submission
4. Note: This schedule is quite aggressive.

Meeting Outcomes

Actions Team: review DAM Ioana & Marti: meet on DAM boundary Ioana: add use cases to DAM; notify team

Next Meeting/Preliminary Agenda Items Review DAM. Bring comments. Time permitting, review example artifacts

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