HL7 Procedures for Taking Standards Through the iso ballot Process




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HL7 Procedures for Taking Standards Through the ISO Ballot Process
ISO, like HL7, manages its work via Work Groups. You can view the ISO Work Group names by opening the ISO Work Groups document.
Each HL7 standard that is promoted by HL7 to ISO for approval is sponsored by one of the ISO Work Groups and moves through the ISO ballot process based on the ISO/HL7 Pilot Project Agreement. The basic steps for securing ISO approval of an HL7 document are provided below:



  1. New Work Item Proposal (NWIP) Ballot (90 days) – The purpose of the NWIP is to ensure that there is enough interest in the HL7 standard by the countries that participate in ISO to merit the time and effort required to take it through the ballot process. To be successful, at least five (5) participating countries must agree to take part in the ballot and to volunteer experts from their country to assist with development of the standard.

  • Don Lloyd is responsible for formatting the HL7 specification in the ISO required format and forwarding that to ISO in time for this ballot. HL7 Work Groups shall not submit HL7 documents directly to ISO.

  • Ballot length: 90 days; ballot open and close dates are established by ISO. The ballot is controlled at the ISO level in Geneva. ISO countries vote in the ballot; individual HL7 members do not vote.

  • Once ISO opens the NWIP Ballot, HL7 will announce the ballot to its International Affiliates, encouraging them to engage in the ISO process for this ballot.

  • To pass, at least five (5) ISO participating countries must vote yes and identify an expert to work to work on the standard, and 2/3 of the combined affirmative and negative votes must be affirmative. Negative votes are allowed but those countries that submit a negative vote shall not participate on the expert panel.

  • At the end of the NWIP Ballot, Audrey Dickerson will send the ballot results (pass/fail, vote tally, the names of the countries that responded to the ballot, and any comments that were received on the Introductory Ballot) to ISOJIC@HL7.org. Lynn Laakso will post the results of the ballot to the ISO/JIC ballots page .

  • If the document passes the NWIP Ballot, it moves to Draft International Standard (DIS) ballot. If the vote fails, the document may be withdrawn or re-balloted at the same level.

  • If comments were received during the NWIP ballot, Don Lloyd will forward them to the sponsoring HL7 Work Group for review and response. Technical comments will likely be substantive and will require another normative ballot by HL7. This reballot may occur during NWIP Ballot, if required, or it may occur during the DIS Ballot, if the document moves to that phase.



  1. Draft International Standard (DIS) Ballot (5 months) – The purpose of the DIS ballot is to allow the participating countries to review the proposed standard in depth and return their comments, suggestions and corrections. If the NWIP ballot produced comments that required substantive changes to the proposed standard, the updated document will also be balloted by HL7. In this instance HL7 maintains its 30-day ballot cycle and ballots the document during the last 30 days of the 5 month DIS ballot so that the ISO and HL7 ballots end concurrently.

  • If formal comments were received during the NWIP Ballot, the sponsoring HL7 Work Group should use its normal procedures to reconcile comments submitted during the Introductory Ballot and make any required changes to the standard. The HL7 Work Groups shall return the responses and/or the updated document to Don Lloyd.

  • Don Lloyd will format the updated HL7 document (if there is one) in the ISO required format and forward it, along with the reconciled comments, to Audrey Dickerson before the opening of the DIS ballot.

  • DIS Ballot length: 5 months (150 days); ballot open and close dates are established by ISO. The ballot is controlled at the ISO level in Geneva. ISO “P” members vote in the ballot; individual HL7 members do not vote.

  • The HL7 ballot on this material, if one is required, will occur during the final 30 days of the DIS ballot. Following the current HL7 procedures, Don Lloyd will announce this ballot 30 days in advance and HL7 members sign up for the ballot pool and vote in the typical fashion. Normal rules for passing an HL7 ballot apply to the HL7 ballot on the same material (if such a ballot is required). The Ballot designation is incremented by .1 (i.e., EHR, R1 would become EHR, R1.1)

  • To pass the ISO DIS ballot, at least 2/3 of the returned votes from ISO “P” members must be affirmative. Abstentions are allowed; comments must accompany negative votes.

  • At the end of the DIS Ballot, Audrey Dickerson will send the ballot results (pass/fail, vote tally and comments that were received) to ISOJIC@HL7.org. Lynn Laakso will post the results of the ballot to the ISO/JIC ballots page .

  • If the ballot passes with 100% affirmative votes, the ballot is completed and proceeds to step 4, Publication. If the document passes with less than 100% approval, it advances to FDIS ballot. If the vote fails, the document may be withdrawn or re-balloted at the same level.

  • Don Lloyd will forward comments returned during the DIS Ballot to the sponsoring HL7 Work Group for review and response. Technical comments will likely be substantive and will require another normative ballot by HL7. All formal comments submitted during the DIS Ballot must be addressed by HL7. Informal comments may be addressed at a later time.



  1. Final Draft International Standard (FDIS) Ballot (60 days) – The FDIS ballot serves as a final ballot on the document, which is publication ready. While comments may be submitted on an FDIS ballot, the document will not be updated based on those comments. If the DIS ballot produced comments that required substantive changes to the proposed standard, the updated document will also be balloted by HL7. In this instance HL7 maintains its 30-day ballot cycle and ballots the document during the last 30 days of the 2 month FDIS ballot so that the ISO and HL7 ballots end concurrently. If no substantive changes resulted from the DIS Ballot, the participating ISO countries will participate in the ISO ballot; HL7 members do not vote.

  • If formal comments were received during the DIS Ballot, the sponsoring HL7 Work Group should use its normal procedures to reconcile comments submitted during the NWIP Ballot and make any required changes to the standard. The HL7 Work Groups shall return the responses and/or the updated document to Don Lloyd.

  • Don Lloyd will format the updated HL7 document (if there is one) in the ISO required format and forward it, along with the reconciled comments, to Audrey Dickerson before the opening of the FDIS ballot.

  • Ballot length: 2 months (60 days); ballot open and close dates are established by ISO. The ballot is controlled at the ISO level in Geneva. ISO countries vote in the ballot; individual HL7 members do not vote.

  • The HL7 ballot, if one is required, will occur during the final 30-days of the FDIS ballot. Following the current HL7 procedures, Don Lloyd will announce the HL7 ballot 30 days in advance of the balloting opening and HL7 members will sign up for the ballot pool and vote in the typical fashion. Normal rules for passing an HL7 ballot apply to the HL7 ballot on the same material (if such a ballot is required).

    • To pass the FDIS ballot, 2/3 of the returned affirmative and negative votes from ISO countries must be affirmative. Abstentions are allowed; comments must accompany negative votes. If the vote fails, the document may be withdrawn or re-balloted at the same level.

    • At the end of the FDIS Ballot, Audrey Dickerson will send the ballot results (pass/fail, vote tally and comments that were received) to ISOJIC@HL7.org. Lynn Laakso will post the results of the ballot to the ISO/JIC ballots page .



  1. Publication – Once the document passes the required ISO ballots, it is deemed an ISO standard. ISO performs the final edit and is responsible for publication of the approved standard. Once the final ISO document is available, Audrey Dickerson will notify HL7 by sending a note and the ISO document to ISOJIC@HL7.org


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