20151023 OO FHIR conCall
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|HL7 OO on FHIR (for Orders and Observations)
Call in details:
|Date: 2015-10-22 |
2015 - 02:00 PM (Eastern Time, GMT -04 DST)
|Chair:||Note taker(s): EH:|
|Quorum = chair + 4||no|
|Co chairs||Riki Merrick||Rob Hausam||Lorraine Constable||Patrick Lloyd||Ken McKaslin||Hans Buitendijk|
|Fhir Editor/Facilitator||Eric Haas|
|Bill Gregory - Pfizer||Rob Hausam||Eric Haas|
Agenda and Notes
- Roll Call
- Agenda Check
- Discussion Topics
- Device 
- HL7 Whitepaper on UDI
- Mapping to UDI and MU 2015
- Spreadsheet mapping across standards and MU
- Review guidance in notes and element comments and whether need to clearly point to what gos where in core or leave it to profile since I am unclear on whether the 6 parts are US Realm specific.
- Do we need a resource for HCT/Ps or create an extension for the DIN?
- MU mentions additional stuff that patients will have access to. - Extension candidates?
- Mapping to UDI and MU 2015
§ 170.315 2015 Edition health IT certification criteria. ... (pp 515ff) (14) Implantable device list. (i) Record Unique Device Identifiers associated with a patient’s Implantable Devices. (ii) Parse the following identifiers from a Unique Device Identifier: (A) Device Identifier; (B) The following identifiers that compose the Production Identifier: (1) The lot or batch within which a device was manufactured; (2) The serial number of a specific device; (3) The expiration date of a specific device; (4) The date a specific device was manufactured; and (5) For an HCT/P regulated as a device, the distinct identification code required by 21 CFR1271.290(c). (iii) Obtain and associate with each Unique Device Identifier: (A) A description of the implantable device referenced by at least one of the following: (1) The “GMDN PT Name” attribute associated with the Device Identifier in the Global Unique Device Identification Database. (2) The “SNOMED CT® Description” mapped to the attribute referenced in paragraph (a)(14)(iii)(A)(1) of this section. (B) The following Global Unique Device Identification Database attributes: (1) “Brand Name”; (2) “Version or Model”; (3) “Company Name”; (4) “What MRI safety information does the labeling contain?”; and (5) “Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437).” (iv) Display to a user an implantable device list consisting of: (A) The active Unique Device Identifiers recorded for a patient; and (B) For each active Unique Device Identifier recorded for a patient, the description of the implantable device specified by paragraph (a)(14)(iii)(A) of this section. (C) A method to access all Unique Device Identifiers recorded for a patient. (v) For each Unique Device Identifier recorded for a patient, enable a user to access: (A) The Unique Device Identifier; (B) The description of the implantable device specified by paragraph (a)(14)(iii)(A) of this section; (C) The identifiers associated with the Unique Device Identifier, as specified by paragraph (a)(14)(ii) of this section; (D) The attributes associated with the Unique Device Identifier, as specified by paragraph (a)(14)(iii)(B) of this section. (vi) Enable a user to change the status of a Unique Device Identifier recorded for a patient.
Updated based on OO on FHIR discussion 20151022
*8925 add UDI string HRF formats to Identifer type codes (None) None *8929 extensions for GUDID data elements (None) None *5985 Suggest that if a UDI is present that it alone be recorded, and other values be recorded when there is not UDI present (Eric Haas) Not Persuasive *5507 Jan 2015 Ballot Comment #444 (Leslie Tompkins) Not Persuasive with Mod *8926 Provide Clearer guidance for UDI components (None) Persuasive *8927 Clarify Device scope in introduction (None) Persuasive *5623 scope and boundary between device and b/t/o, (Eric Haas) Persuasive with Mod *7254 2015May core #373 - UDI doesn't identify repository/jurisdiction (Paul Knapp) Persuasive with Mod In Person *8928 W5 Mapping and reordering of device (None) Persuasive with Mod
QA issues: possible assignments
AOB (Any Other Business)
|Actions (Include Owner, Action Item, and due date)|
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