HL7 RCRIM Working Group Meeting Minutes



Monday Q3

Attendees

|First Name |Last Name |Affiliation |E-mail Address |

|Michael |Brennan |Johnson and Johnson |mbrenna3@its. |

|William |Friggle |Sanofi Aventis |William.Friggle@sanofi- |

|Patricia |Garvey |FDA |patricia.garvey@fda. |

|Ed |Helton |NCI |heltone2@mail. |

|Allen |Hobbs |Kaiser Permanente |Allen.Hobbs@ |

|John |Kiser |Abbott Laboratories |john.kiser@ |

|Juli |Klemm |NCI |klemmj@mail. |

|Wayne |Kubick |CDISC |wkubick@ |

|Rebecca |Kush |CDISC |rkush@ |

|Vada |Perkins |FDA |vada.perkins@fda. |

|Mitra |Rocca |FDA |Mitra.Rocca@fda. |

|Mary Ann |Slack |FDA |maryann.slack@fda. |

|John |Speakman |NCI |john.speakman@ |

|Lise |Stevens |FDA |lise.stevens-Hawkins@fda. |

|Ed |Tripp |Edward S. Tripp and Associates |edward.tripp@ |

|Steve |Ward |Lilly |stw@ |

I. CDA IG (Patient Narratives) Ballot Reconciliation Mitra Rocca

Mead Walker

The summary of the balloting is in the table below.

|  |Aff. |Neg. |Abst. |NV |

|Affiliate |1 |0 |17 |0 |

|Consultant |1 |0 |5 |2 |

|Government/Non-Profit |9 |0 |1 |0 |

|Payor |0 |0 |1 |0 |

|Pharmaceutical |8 |1 |1 |2 |

|Provider |15 |17 |4 |2 |

|Vendor |0 |4 |12 |3 |

|Totals |34 |22 |41 |9 |

|% of Votes |32.08% |20.75% |38.68% |8.49% |

|Quorum |91.51% |

|Approval |34 |

The consolidated comments spreadsheet lists all votes cast and comments or reference to the uploaded comment spreadsheet.

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The spreadsheet below is a consolidation of all comments uploaded via spreadsheet and text document.

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The following was presented by Mitra

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Attached below is the standard with amendments

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Attached below is the reconciliation spreadsheet with comments as discussed at this quarter.

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The work group reviewed all negatives. Several resolutions require recommendations from Structured Documents. There was a discussion around the necessity for identifying an author considering the fact that there may be multiple ghost writers for narratives as well as the potential for the information to be system generated. We will discuss with SDWG and determine if a null flavor can be used for the author attribute.

Monday Q4 BRIDG

|First Name |Last Name |Affiliation |E-mail Address |

|Becky |Angeles |ScenPro |bangeles@ |

|Elaine |Ayres |NIH Clinical Center |eayres@ |

|Michael |Brennan |Johnson and Johnson |mbrenna3@its. |

|Julie |Evans |CDISC |jevans@ |

|William |Friggle |Sanofi Aventis |William.Friggle@sanofi- |

|Ed |Helton |NCI |heltone2@mail. |

|Joyce |Hernandez |Merck |joyce.hernandez@ |

|John |Kiser |Abbott Laboratories |john.kiser@ |

|Bron |Kisler |CDISC |bkisler@ |

|Juli |Klemm |NCI |klemmj@mail. |

|Wayne |Kubick |CDISC |wkubick@ |

|Rebecca |Kush |CDISC |rkush@ |

|Jason |Rock |Global Submit |jason.rock@ |

|Lisa |Schick |Scenpro, Inc. |lschick@ |

|Amnon |Shabo |IBM Research - Haifa |shabo@ |

|Koji |Shomoto |JPMA |jpma.denshi@ |

|Mary Ann |Slack |FDA |maryann.slack@fda. |

|Rik |Smithies |NPROGRAM Ltd |rik@nprogram.co.uk |

|John |Speakman |NCI |john.speakman@ |

|Ed |Tripp |Edward S. Tripp and Associates |edward.tripp@ |

|Mead |Walker |Mead Walker Consulting |dmead@ |

|Steve |Ward |Lilly |stw@ |

Note: there is a discussion with Structured Documents on patient narratives (HOSTED by SD) during the first half of the quarter for those interested.

I. LS DAM overview Juli Klemm

Juli presented the following

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This project grew out of caGIG® with the goal of static semantics of the domain of hypothesis driven and discovery research. Fifty six (56) of the 130 classes originate from BRIDG.

The Work Group discussed the fact that incorporating this into BRIDG then BRIDG scope will expand. Does this have an impact on RCRIM and does RCRIM need to revisit the use of BRIDG as its DAM.

The primary concern is will BRIDG be overburdened with the new content and therefore put future project work at risk?

II. BRIDG Update Becky Angeles

Becky presented the attached status update

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Project Scope statement needs to be updated. The current plans are out of sync with the HL7 PSS.

II. Publication of BRIDG Ballot outstanding - PBS Metrics Ed Tripp

Julie will manage the publication request.

III. HL7 and CDISC Relationship and IP Becky Kush

There has been a lot of discussion at the HL7 Board of Directors as how to deal with IP. Becky expressed that CDISC IP is free and open and CDISC wants to keep it that way.

We discussed the possibility of modeling the HL7/CDISC MOU based on the relationship of CDSIC and ISO.

There will be additional IP discussion at the Board meeting. Ed and Becky will report back on Wednesday at the business meeting.

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