Health Level Seven is balloting the following candidate standards/documents before the May 2006 working group meeting. Comments received in response to these ballots will be discussed at the next HL7 working group meeting, which convenes May 7-12, 2006 in San Antonio, TX.

· Claims Attachments Additional Information Specifications

· Structured Documents

· Version 2.6

· Version 3.0

For Comment Only Ballots (included in the Version 3 section of this document)

· HL7 Development Framework

· HL7 Version 3 Standard: Immunization, Release 1

· HL7 Version 3 Standard: Personnel Management, Release 1, Human Resource/Regulatory Topics

· HL7 Version 3 Standard: Personnel Management, Release 2

· HL7 Version 3 Standard: Clinical Statement Pattern, Release 1

· HL7 Version 3 Standard: Specification and Use of Reusable Information Constraint Templates, Release 1

A section is devoted to each below.

NOTE: Each ballot document has a unique Ballot ID that can be found in the text for each ballot document below. Updated ballot spreadsheets for commenting will be available on the balloting website at the time the ballots open.

The membership is also reminded that ANSI rules dictate that all individuals who were in a membership ballot pool MUST be included in the initial ballot pool when the same document goes out for a subsequent membership ballot. Thus, if a document is going out for a 2^nd membership level ballot, all individuals who were in the ballot pool for the 1^st membership ballot are automatically subscribed as members of the ballot pool for the 2^nd membership ballot. If you do not wish to continue being in that ballot pool, please use the ballot site (see URL below) to remove yourself.

Ballot Open/Close Dates

All ballot pools in this document will open and close for voting on the following dates. If there is an exception to that for a specific pool, alternate dates will be provided.

Scheduled ballot open date: March 26, 2006

Scheduled ballot close date: April 29, 2006

Ballot Pool Signup

To sign up for any ballot pool, point your browser to http://www.hl7.org/ctl.cfm?action=ballots.home

The following document pools have been withdrawn from balloting for this cycle:

· HL7 EHR System Functional Model, Release 1

· v2.6 Messaging

· HL7 Version 3 Standard: Implantable Device Cardiac – Follow-up Device Summary, Release 1

· HL7 Version 3 Standard:  Scheduling, Release 2

The following documents have changed since the original pool announcement:

· HL7 Version 3 Standard: Claims and Reimbursement: Predetermination-Authorization Interactions, Release 1 had a unique ballot ID change from V3_CR_PAI_R1_C1_2006MAY to V3_CR_R3_PAI_R1_C1_2006MAY.

· HL7 Version 3 Standard: Clinical Genomics, Release 1 (1^st DSTU Update) had a unique ballot ID change from V3_CG_R1_D1_2006MAY to V3_CG_R1_U1_2006MAY.

· HL7 Version 3 Standard: Clinical Statement Pattern, Release 1 changed from committee ballot to for comment only. This required a unique ballot ID code change.

· HL7 Version 3 Standard: DICOM Composite Object References Common Message Element Types (CMET), Release 1 (1^st committee ballot) will be balloted as a subset of the HL7 Version 3 Standard: Common Message Element Types, Release 5 (5^th committee ballot) pool; see specifically CMETs numbered COCT_MT830110 (A_DicomSequence minimal) and COCT_MT830120 (A_DicomCompositeObjectReference minimal).

· HL7 Version 3 Standard: Specification and Use of Reusable Information Constraint Templates, Release 1 changed from DSTU ballot to for comment only. This required a unique ballot ID code change.

· HL7 Version 3 Standard: Personnel Management, Release 1: Human Resource/Regulatory Topics had a unique ballot ID change from V3_PM_R1_O2_2006MAY to V3_PM_ RNR_R1_O3_2006MAY

· HL7 Version 3 Standard:  Clinical Statement Pattern, Release 1had a unique ballot ID change from V3_CS_R1_O1_2006MAY to V3_CS_R1_O2_2006MAY.

· HL7 Version 3 Standard: Public Health Reporting – Public Health Investigation Request, Release 1 has been moved from the Patient Care TC section to the RCRIM TC secion of the document.

Claims Attachments Additional Information Specifications

The Attachments Special Interest Group announces the formation of a ballot group for the following document listed below.  Note: This document describes how to exchange healthcare attachment data using the HL7 Additional Information Specification Implementation Guide Release 2.1, based on HL7 CDA Standard Release 1.0 (ASIG document CDAR1AIS0000R021).

· Additional Information Specification 0010: Drug Prior Authorization Attachment, Release 1 - Based on the HL7 Clinical Document Architecture, Release 1.0 (CDAR1AIS0010R010) (1^st informative ballot) -- This document defines the content for sending a Drug Prior Authorization attachment and includes all the appropriate LOINC values. Is has been developed for use with the Medicare Modernization Acts' ePrescribing process. (Unique Ballot ID: ASIG_INFOSPECS_DPAA_R1_I1_2006MAY)

Version 3 Messaging

The Clinical Decision Support Technical Committee announces the formation of a ballot group for the following document:

· HL7 Version 3 Standard: Infobutton Application, Release 1 (1^st DSTU ballot) –The Infobutton standard defines the format for messages between clinical information systems and electronic health information resources from which knowledge might be requested.  (Unique Ballot Id: V3_INFOBUTTON_R1_D1_2006MAY)

The Electronic Health Record Technical Committee and the Services Oriented Architecture SIG announce the formation of a ballot group for the following document:

· HL7 Version 3 Standard: Resource Location and Updating Service (RLUS), Release 1 (1^st committee ballot) –Resource Location and Updating Service (RLUS) Functional Model Specification describes an interface through which healthcare participants can share information for the benefit of the patient's health outcomes as well as their individual business goals. RLUS will provide a transparent means of locating and accessing health data regardless of underlying data structures, security concerns, or delivery mechanisms.  (Unique Ballot Id: V3_RLUS_R1_C1_2006MAY)

The Financial Management Technical Committee announces the formation of a ballot group for the following document:

· HL7 Version 3 Standard: Claims and Reimbursement:  Predetermination-Authorization Interactions, Release 1 (1st committee ballot) – The goal of the NeCST project in Canada was to create a new suite of Predetermination-Authorization combination interactions that better reflects the business flow process in Canada. This new set of interactions will eliminate the requirement to submit multiple interactions (the predetermination followed by the authorization) thereby streamlining the business flow process.

Note: The existing Predetermination message requests and responses will be used; therefore, no new R-MIMs or MTs are necessary. All materials are to be prepared by the Canadian NeCST project.  (Unique Ballot Id: V3_CR_R3_PAI_R1_C1_2006MAY)

The Infrastructure and Messaging Technical Committee announces the formation of ballot groups for the following documents:

· HL7 Version 3 Standard: Transport Specification – ISO 9660-Compliant Removable Media, Release 1 (1^st committee ballot) –This document defines an implementation technology specification (ITS) for ISO 9660-compliant (e.g., CD, flash) removable media.  (Unique Ballot Id: V3_TRANSPORT_ISO9660MEDIA_R1_C1_2006MAY)

· HL7 Version 3 Standard: Shared Messages, Release 3 (2^nd committee ballot) –The shared messages domain contains Message Types and Interactions that are shared and used by the various clinical and administrative domains.  Changes in this release extend the domain based on various discussions held within the INM committee, and by the COMT proposals adopted since the release of COMT R2 (proposals 904, 906, 908, 909 and 962 – see documents page of the INM committee on the HL7.org web site).

(Unique Ballot Id: V3_MT_R3_C2_2006MAY)

The Medical Records/Information Management Technical Committee announces the formation of ballot groups for the following documents:

· HL7 Version 3 Standard: Medical Records/Information Management, Release 1 (1^st membership ballot) – The DSTU has been updated to the current RIM and has had the status code removed from the parent document. (Unique Ballot ID: V3_MR_R1_M1_2006MAY)

· HL7 Version 3 Standard: Medical Records/Information Management, Release 2 (1^st DSTU ballot) – Information regarding queries has been added to the current DSTU. (Unique Ballot ID: V3_MR_R2_D1_2006MAY)

The Modeling & Methodology Technical Committee announces the formation of ballot groups for the following documents:

· HL7 Version 3 Standard: Common Message Element Types, Release 5 (1^st membership ballot) –This document describes the models, message types, and other artifacts that are used to express common concepts in a single domain or across multiple modeling domains, known as CMETs. The following CMET is included in the ballot, which previously passed committee ballot in May 2005: 820000 (Artifact ID), A_PrincipalCareProvision (Name).  (Unique Ballot ID: V3_CMET_R5_M1_2006MAY)

· HL7 Version 3 Standard: Common Message Element Types, Release 5 (1^st DSTU ballot) –This document describes the models, message types, and other artifacts that are used to express common concepts in a single domain or across multiple modeling domains, known as CMETs. This ballot covers material previously balloted by Clinical Genomics.  The following CMET is included in the ballot, which previously passed committee ballot in May 2005: To Be Assigned (Artifact ID), A_Genotype (Name). (Unique Ballot ID: V3_CMET_R5_D1_2006MAY)

· HL7 Version 3 Standard: Common Message Element Types, Release 5 (5^th committee ballot) –This document describes the models, message types, and other artifacts that are used to express common concepts in a single domain or across multiple modeling domains, known as CMETs. The ballot covers new material, updated and revised material from Committee Ballot 4, and material intended to replace existing normative CMETs.

This ballot contains minor corrections and enhancements as a result of prior committee ballot feedback, as well as new material. The following CMETs are included in the ballot:

(Unique Ballot ID: V3_CMET_R5_C5_2006MAY)

· HL7 Version 3 Standard: Refinement, Constraint and Localization to Version 3 Messages, Release 3 (3^rd committee ballot) –This version updates the language regarding conformance, clarifies constraint and refinement rules, and updates localization allowances. (Unique Ballot ID: V3_CONFORM_R3_C3_2006MAY)

· HL7 Version 3 Standard: Specification and Use of Reusable Information Constraint Templates, Release 1 (2^nd for comment only  ballot) – This document will specify the representation and implementation of reusable constraint patterns (templates) that can be applied to Version 3 static information models, including V3 messages and V3 CDA documents. These patterns are designed to be applied at the time that a document or message instance of the constrained model is being produced. This version addresses most of the questions raised when the document was published as draft for comment.  (Unique Ballot ID: V3_TEMPLATESPEC_R1_O2_2006MAY)

· HL7 Development Framework, Release 1 (2^nd for comment only ballot) – This document represents Requirements Analysis and Specification Modeling updates to the HL7 Development Framework. M&M intends to ballot and recommend the HDF Chapters for implementation as the “released” methodology document once they successfully go through the review process. The updates include:

· Roles and responsibilities for requirements analysis and specification modeling

· Quality criteria for specifications

· Dynamic Model details added to Specification Modeling

· Example for requirements analysis and specification modeling (annexes)

(Unique Ballot ID: HDF_R1_O2_2006MAY)

The Modeling & Methodology Technical Committee and the Templates and Conformance SIGs announce the formation of a ballot group for the following document:

· HL7 Version 3 Standard: Data Type Specialization Constraints, Release 1 (1^st committee ballot) –This document describes the expression of HL7 Version 3 constraints that restrict datatypes, resulting in datatype flavors which are applicable to a specific region, project or other localization. It will discuss methods to document the flavors, and assert their use in models and instances. This document was previously balloted for comment only in September 2005 and January 2006. Comments and recommendations from those ballots have been incorporated into this document. (Unique Ballot ID: V3_ DTFCONSTRAINTS_R1_C1_2006MAY)

The Orders and Observations Technical Committee announces the formation of ballot groups for the following documents:

· HL7 Version 3 Standard: Clinical Genomics, Release 1 (1^st DSTU Update) – The Clinical Genomics SIG has developed specifications that were recently approved as a DSTU. In this announcement we start the balloting of the first update of the specs based on feedback we got from our early adopters of the approved DSTU. This update includes revisions of the Genotype model and the Family History model, as well as a new model for describing multiple genetic loci like haplotypes, genetic profiles, gene expression panel or a set of DNA/protein variations data in fulfillment of a single genetic test order. This is the first update of the HL7 Clinical Genomics DSTU specifications. (Unique Ballot ID: V3_CG_R1_U1_2006MAY)

· HL7 Version 3 Standard: Laboratory, Release 1 (9^th committee ballot) – The Laboratory domain comprises the models, messages, and other artifacts that are needed to support messaging related to laboratory tests, or observations. This ballot includes changes agreed to during ballot resolution for committee ballot 8. The material in this ballot constitutes Release 1 of the Laboratory Domain. In general, the Lab SIG implemented changes to resolve issues from committee ballot 8. This includes the following:

· Revisions to storyboards to better reflect use of Lab messaging.

· Additional descriptions of the layout of the various Lab Domain topics.

· Added description of the Lab order fulfillment process.

· Correct various trigger event state machine diagrams.

· Update DMIM and RMIMs to align with the Clinical Statement pattern and the OO generic Order Model.

· Update DMIM and RMIM Walkthroughs to reflect model changes.

· Add trigger events and interactions to support messaging for trackers.

· Added diagrams showing how microbiology results report should be implemented.

· Added new RMIMs to support simplified payloads for accept/reject messages.

(Unique Ballot ID: V3_LB_R1_C9_2006MAY)

· HL7 Version 3 Standard: Medication, Release 1 (2^nd committee ballot) –The Medication domain provides common medication constructs (through CMETS) for use by other HL7 TC/SIGs and provides messaging support for drug knowledge base queries. This release expands on the previous iteration by refining the materials presented in the Committee Level 1 ballot, by harmonizing interactions and RMIMs and ensuring that materials reflect the UV (universal) realm. (Unique Ballot ID: V3_ME_R1_C2_2006MAY)

· HL7 Version 3 Standard: Pharmacy, Release 1 (2^nd  committee ballot) – The Pharmacy domain includes support for Prescribing, Dispensing and Administration messages, as well as Rx status management, active medications and patient Rx queries. This release expands on the previous iteration by refining the materials presented in the Committee Level 1 ballot, by harmonizing interactions and RMIMs and ensuring that materials reflect the UV (universal) realm. (Unique Ballot ID: V3_RX_R1_C2_2006MAY)

The Orders and Observations TC and the Public Health and Emergency Reporting Special Interest Group announce the formation of a ballot group for the following document:

· HL7 Version 3 Standard: Immunization, Release 1 (2^nd for comments only ballot) – The Immunization domain provides message support to communicate the administration of immunizations. This iteration includes refinements to the materials presented in the previous ballot, harmonizes interactions and RMIMS and ensures that materials reflect the UV (universal) realm. (Unique Ballot ID: V3_IZ_R1_O2_2006MAY)

The Orders and Observations, Patient Care and Structured Documents Technical Committees announce the formation of a ballot group for the following document:

· HL7 Version 3 Standard: Clinical Statement Pattern, Release 1 (2^nd for comments only ballot) – The Clinical Statement pattern provides the foundation from which various specialized and constrained clinical statements can be derived. Various updates are included to reflect the harmonization discussions with the different stakeholders. (Unique Ballot ID: V3_CS_R1_O2_2006MAY)

The Patient Administration Technical Committee announces the formation of ballot groups for the following document:

· HL7 Version 3 Standard: Patient Administration, Release 2 (1^st committee ballot) – Patient Administration Version 3 Release 2 Committee 1 defines query messages and interactions for the Person and Patient registries. 

This iteration includes the following content:

· Revised Person query interaction for Find Candidates Query. Although this content passed Membership during the January 2006 ballot cycle, the Technical Committee is withdrawing the previous Query By Person Demographics message and balloting revised content.

· New Patient query interactions for Get Patient Demographics Query, Find Candidates Query, and Find Associated Identifiers Query.

(Unique Ballot ID: V3_PA_R2_C1_2006MAY)

The Patient Care Technical Committee announces the formation of ballot groups for the following documents:

· HL7 Version 3 Standard: Care Provision, Release 1 (3^rd DSTU ballot) – This document describes the information structures and vocabulary used to communicate information pertinent to the supervision, management, and custody of living subjects, devices, geographic sites, and other physical entities by a responsible care provider. This domain supports multiple specifications appropriate to referrals and record communications supporting collaboration and the continuity of care between care providers. 

· A re-organization of the ballot pool:

o Movement of many domain storyboards and activity diagrams to a separate requirements analysis pdf

o Movement of much explanation and guidance to a separate pdf

· Enhancement of formal walk-throughs of models

· Alignment with changes in Clinical Statement Pattern as the Pattern has been evolving

· Creation of new Topics for:

o Allergies and Adverse Reactions

o Medical Conditions

o Clinical Observations

o Professional Services

(Unique Ballot ID: V3_PC_R1_D3_2006MAY)

The Personnel Management Technical Committee announces the formation of ballot groups for the following documents:

· HL7 Version 3 Standard: Personnel Management, Release 2 (1^st for comment only ballot) – The Personnel Management Technical Committee will submit its first for comment only ballot for the Organization Topic, Release 2 and the first for comment only ballot for the Provider Topic, Release 2.  This document provides support for audit data additions to the normative Provider and Organization messages as determined to support registry messaging.  The ballot includes audit data modifications to the normative Release 1 Provider and Organization messages based on the current work done in this area. The PM TC has gone back to for comment only while work on the audit methodology is finalized.  (Unique Ballot ID: V3_PM_R2_O1_2006MAY)

· HL7 Version 3 Standard: Personnel Management, Release 1: Human Resource/Regulatory Topics (3rd for comments only ballot) – The Personnel Management TC will submit a third draft for comment ballot for the Human Resource Topic, Release 1 and the Regulatory Topic, Release 1. This ballot includes additional storyboard and RMIM clarifications. (Unique Ballot ID: V3_PM_ RNR_R1_O3_2006MAY)

The Publishing Technical Committee announces the formation of a ballot group for the following document:

· HL7 Version 3 Publishing Facilitator's Guide, Release 1 (1^st informative ballot) – The Version 3 Publishing Facilitator’s Guide presents an overview of the Publishing Process, the tools that are used to create the content, and some guidance on creating consistent and correct content. The goal of the Guide is to provide the information needed to create a consistent Version 3 Standard that conforms to HL7 Modeling and Methodology practices and uses appropriate tooling. Section 3 on narrative content has been expanded to include relevant rules and conventions on using SHALL/SHOULD/MAY. Additional clarifications on the cast of characters for Storyboards have been added. Additional comments from the past ballot reconciliation has been used to clarify content, remove redundancies and create a more usable document. (Unique Ballot ID: V3_PUBGUIDE_R1_I1_2006MAY)

The Regulated Clinical Research Information Management Technical Committee announces the formation of ballot groups for the following documents:

· HL7 Version 3 Standard: Periodic Reporting of Clinical Trial Laboratory Data, Release 2 (1^st DSTU ballot) – Pharmacogenomics data have been added to this release of the Period Reporting of Clinical Trial Laboratory Results standard. These additions will allow the message to be used to transmit sequence and micro-array based pharmacogenomics data (and the significant findings, genotypes and phenotypes derived from the raw data) between laboratories, pharmaceutical companies and regulatory agencies involved in a regulated clinical research study.  This iteration includes minor typographical corrections in the storyboard, two Act name changes in the RMIM, and the substitution of the Clinical Genomics SIG Genotype CMET for the identical IMET in the Committee Balloted RMIM. (Unique Ballot ID: V3_RT_CTLAB_R2_D1_2006MAY) 

· HL7 Version 3 Standard: Patient Safety: Generic Incident Notification, Release 1 (1^st DSTU ballot) –Generic Incident Notification is a generalized notification report format used for unintended, expected or unexpected incident(s) that could have or did lead to harm for one or more patients receiving health care services.

This message can be implemented within a healthcare institution for localized reporting or for reporting to regional or national authorities. Anonymous reporting is allowed to protect the patient / staff's privacy. A separate ballot document will be submitted at a later date for the Root cause and Underlying factors Message (RUM).

During the previous ballot cycle a number of comments were made, but these were of a less substantive nature than those received at the previous committee level ballot. Therefore, at a discussion between PSSIG and RCRIM, it was agreed that it was now appropriate for this message to go to DSTU level. Key updates since the last cycle are extensions to use cases, storyboards and scenarios. Domain definitions have been refined in accordance with feedback received from the SIG and TC. (Unique Ballot ID: V3_RR_GIN_R1_D1_2006MAY)

· HL7 Version 3 Standard: Regulated Product Submission, Release 1 (1^st DSTU ballot) – The goal of the Regulated Product Submission message is to facilitate the processing and the review of submissions. Accordingly, the Regulated Product Submission Refined Message Information Model captures all information required for the efficient processing and review of regulatory submissions.

Different product types have different table of contents; that is to say, different lists of topics that must be addressed within the submission. However, the general data layouts of all regulated products are the same. Therefore, the objective of the Regulated Product Submission message is to define one message structure that can be used for all regulated products. It is intended that this message will be used, worldwide, for regulated products, including but not limited to, foods, medical devices, human therapeutics, and veterinary medicine. It is important to note that the wide range of products that is contemplated leads to providing a generic structure for the actual specification. (Unique Ballot ID: V3_RP_R1_D1_2006MAY) 

· HL7 Version 3 Standard: Public Health Reporting – Public Health Investigation Request, Release 1 (2nd committee ballot) – The purpose of the Investigation Request topic is to document the artifacts necessary for a request from one public health organization to another to initiate a public health investigation. The Investigation Request topic includes the following changes: 

· Addition of a Investigation Promise as a response to an Investigation Request.

· Updates to the model to resolve ballot issues.

· Additional storyboards.

(Unique Ballot ID: V3_RR_PHIR_R1_C2_2006MAY)

The Structured Documents Technical Committee announces the formation of a ballot group for the following document:

· HL7/ASTM Implementation Guide for CDA Release 2 – Continuity of Care Document (1^st informative ballot) – This document represents a guide to implementing the ASTM Continuity of Care Record (CCR) as an HL7 Clinical Document Architecture (CDA) document. (Unique Ballot ID: CDAR2_IMPL_CCD_I1_2006MAY)

Alternate ballot open date: April 3, 2006

Alternate ballot close date: May 1, 2006

The Vocabulary Technical Committee announces the formation of a ballot group for the following document:

· HL7 Version 3 Implementation Guide: Using SNOMED CT, Release 1 (1^st DSTU ballot) – The scope of this implementation guide is to provide guidance for the use of SNOMED CT in the HL7 V3 Clinical Statement model. The intent is to guide implementers in the construction of instances.  To the extent that other HL7 V3 models share features with the Clinical Statement model, it will be possible to extrapolate these recommendations to other situations. While other code systems (such as LOINC or ICD9) may be required or even preferable in some situations, these situations are outside the scope of this guide.  Where a particular constraint profile requires the use of other code systems, that profile should complement and not contradict recommendations stated here. (Unique Ballot ID: V3_IMPL_SNOMED_R1_D1_2006MAY)

Balloting Procedure

HL7 members in good standing and others who are materially affected by the proposed standard and wish to participate in these ballots must join the respective ballot groups. This can be accomplished by going to http://www.hl7.org/ctl.cfm?action=ballots.home. Alternately, you can call the HL7 office at (734) 677-7777 and request that the Ballot Group Declaration Form be faxed or mailed to you. 

HL7 will conduct these ballots according to its procedure for electronic balloting. Individuals who sign up for the ballot group will not receive a paper copy of the document or a paper ballot. Instead, they will be notified by e-mail when the ballot package is available. They will download the document from the HL7 web server and will enter their votes and comments using the HL7 web server.

If a member of the ballot group does not have access to the technology being used, or if the person can demonstrate that using the electronic process creates a substantial hardship, he/she may request a paper copy of the ballot package and/or vote using a paper ballot. Because of the extra expense and time delays associated with paper ballots, HL7 does not intend to provide the alternative of using paper to members who have access to the technologies and have no substantial hardship associated with their use.

Comments resulting from this ballot will be discussed at the upcoming HL7 meeting, which convenes May 7-12, 2006 in San Antonio, TX.