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Health Level Seven International

Health Level Seven International® invites you to take part in the regular cycle ballot openings for balloting HL7 candidate standards and documents for the September 2019 ballot cycle. 

The candidate standards and other documents described in this announcement are balloting prior to HL7's September 2019 Working Group Meeting (WGM). Comments received from consensus group members will be addressed at that WGM running September 14-20, 2019 in Atlanta GA USA.


Ballot Period Open/Close Dates

Voting for consensus group members in most ballots in this document will open and close on the following dates.  Exceptions for a specific ballot are listed with that ballot description.


Ballot Open Date: Friday, August 9, 2019

Ballot Close Date: Monday, September 9, 2019

Consensus Group Enrollment Period

Consensus Group Enrollment Period is now closed

Important Note:  Consensus group signup closes when ballot voting begins.

Changes from the initial announcement are identified in the Update to Ballot Announcement for September 2019 Ballot Cycle  document released when this ballot cycle opens.

All those engaged in balloting should be informed that any subsequent ballot of material previously balloted at the normative level will supersede all previous ballots. Any votes or comments from previous ballots will not count towards the new normative ballot; for any comments to be considered again, voters will need to cast a new ballot with comments.


The grid below provides the name of the sponsoring and co-sponsoring Work Group(s) announcing the ballot opening for the ballot listed. Those interested in ballots for a certain attribute can sort the grid: by Work Group, or by product family for example.

Work GroupProject IDBallot NameFamilyBallot IterationBallot DescriptionLast BallotedUnique Ballot ID
Arden Syntax1479HL7 Arden Syntax: Implementation Guide, Release 3ARDEN 1st Informative BallotThe Arden Syntax IG describes the history, structure and use of the Arden Syntax in implementing clinical decision support. R2 of this implementation guide is an updated version of R1 that addressed issues related to knowledge sharing and interoperability. R3 adds new chapters and sections to R2 regarding use of a standard data model in Arden; use of Arden in an SOA; and representation of business processes in Arden.Since the last ballot of this material in 2019SEP , the following changes have been made: HL7_ARDEN_R3_I1_2019SEP
Biomedical Research and Regulation1425HL7 FHIR® Implementation Guide: CDISC Lab Semantics, Release 1FHIR 1st STU BallotClinical trials routinely exchange lab data between labs, contract research organizations, and trial sponsor companies. In some cases that lab data is supplied through a FHIR message. CDISC has a standard for lab data (called CDISC LAB). This IG provides a mapping between the FHIR format and the CDISC LAB format.Since the last ballot of this material in 2019SEP , the following changes have been made: This is the first releaseFHIR_IG_CDISC_LAB_R1_D1_2019SEP
Clinical Decision Support1505HL7 FHIR® Implementation Guide: Clinical Guidelines, Release 1FHIR 1st STU BallotThis implementation guide is a multi-stakeholder effort to use FHIR resources to build shareable and computable representations of the content of clinical care guidelines. The guide focuses on common patterns in clinical guidelines, establishing profiles, conformance requirements, and guidance for the patient-independent, as well as analogous patterns for the patient-specific representation of guideline recommendations.Since the last ballot of this material in 2019SEP , the following changes have been made: The initial ballot combines experience gained from multiple guideline representation projects, including Opioid Prescribing Support, Chronic Kidney Disease Management, Antenatal Care, HIV/HBV Screening, Prevention, and Treatment, and Immunization Decision Support.FHIR_IG_CPG_R1_D1_2019SEP
Clinical Decision Support1493HL7 FHIR® Implementation Guide: Documentation Templates and Payer Rules (DTR), Release 1- US RealmFHIR 1st STU BallotThe Documentation Templates and Rules (DTR) Implementation Guide (IG) specifies how payer rules can be executed in a provider context to ensure that documentation requirements are met. The IG is a companion to the Coverage Requirements Discovery (CRD) IG, which uses CDS Hooks to query payers to determine if there are documentation requirements for a proposed medication, procedure or other service.Since the last ballot of this material in 2019SEP , the following changes have been made: This ballot incorporates comments received from the informative May ballot.FHIR_IG_DTR_R1_D1_2019SEP
Clinical Genomics1050HL7 Domain Analysis Model: Clinical Genomics, Release 1HL7 2nd Informative BallotThis HL7 CG Information Model (IM) was developed in support of the Domain Analysis Model, recently published by this WG. The IM is not yet complete, but is ultimately intended to provide common semantics of the CG domain and will inform the development of WG artifacts and specifications. The purpose of this ballot is to solicit broad feedback on the portions of the IM that have stabilized and will form core portions of future modeling work.Since the last ballot of this material in 2014SEP , the following changes have been made: The original document produced by this PSS, which was last balloted in 2014, has been deprecated. Advances in the CG domain and in related modeling projects motivated a fresh look at this project.HL7_DAM_CG_R1_I2_2019SEP_WITHDRAWN
Clinical Information Modeling Initiative1430HL7 CIMI Logical Model: Analysis Normal Form (ANF), Release 1HL7 1st Informative BallotThis ballot will contain a White Paper describing ANF patterns, guidelines and how they provide value to both clinicians and model implementation projects.Since the last ballot of this material in 2019SEP , the following changes have been made: Initial ReleaseHL7_CIMI_LM_ANF_R1_I1_2019SEP
Clinical Interoperability Council1363HL7 FHIR® Implementation Guide: Breast Cancer Data Radiology Reporting, Release 1- US RealmFHIR 1st Comment-Only BallotThis Ballot proposes a set of FHIR Profiles that specify a hybrid structured and unstructured Breast Radiology Reporting covering all relevant modalities and techniques.

This ballot further explores several alternate strategies for expressing cross cutting needs for providing structural context such as Sections for Findings, Impressions and Recommendations.
Since the last ballot of this material in 2019SEP , the following changes have been made: N/A - This is the initial ballot.FHIR_IG_BREAST_RADIOLOGY_R1_O1_2019SEP
Clinical Interoperability Council1509HL7 FHIR® Implementation Guide: Minimal Common Oncology Data Elements (mCODE), Release 1 - US RealmFHIR 1st STU BallotThis IG specifies a core set of common data elements for cancer that is clinically applicable in every electronic patient record with a cancer diagnosis. It is intended to enable standardized information exchange among EHRs/oncology information systems and reuse of data by other stakeholders (e.g. quality measurement, research).Since the last ballot of this material in 2019SEP , the following changes have been made: N/A - This is the initial ballot. FHIR_IG_MCODE_R1_D1_2019SEP
Clinical Interoperability Council1391HL7 Domain Analysis Model: Common Clinical Registry Framework, Release 2- US RealmHL7 1st Informative BallotThe Domain Analysis Model describes common data elements specifically tobacco and nicotine use that have been collected and harmonized across clinical data registries.Since the last ballot of this material in 2019SEP , the following changes have been made: The changes include a set of common data elements that includes a subset of Tobacco Data Elements. The Tobacco Data Elements was originally derived from the“Smoking Status” data element within the USCDI. This data element has been rigorously reviewed by subject matter experts within clinical, public health, and informatics realms and harmonized with existing quality measurement value sets.HL7_DAM_CCRF_R2_I1_2019SEP
Clinical Quality Information1125HL7 FHIR® Profile: Quality, Release 1 - US RealmFHIR 4th STU BallotQI-Core FHIR profiles provide a physical model for core elements of the Quality Information and Clinical Knowledge (QUICK) logical model. The QUICK model, derived from QI-Core, provides a uniform way for clinical decision support and quality measures to refer to clinical data. QI-Core defines a set of FHIR profiles with extensions and bindings needed to create interoperable, quality-focused applications. Since the last ballot of this material in 2019SEP , the following changes have been made: This QI-Core STU 4 ballot will update the QI-Core content to FHIR STU 4 and US Core STU 4 and provide additional guidance identified during implementation consideration. FHIR_QICORE_R1_D4_2019SEP
Conformance1396Version 2 Conformance Methodology, Release 1V2X-Related 1st Comment-Only BallotThis specification provides the rules and documentation requirements for profiling HL7 v2 base message definitions. It also provides guidance on how to assemble a set of message profiles to satisfy the requirements of a set of use cases documented in an implementation guide. A goal is to provide specifiers and implementers the mechanisms to define requirements in a clear and precise manner. The intent is to update the conformance methods used and to separate conformance from the base standard.Since the last ballot of this material in 2019SEP , the following changes have been made: N/AV2_CONFORM_R1_O1_2019SEP
Financial Management1490HL7 FHIR® Implementation Guide: Prior-Authorization Support (PAS), Release 1- US RealmFHIR 1st STU BallotA FHIR-based B2B process to allow implementers to use existing IT infrastructure resources for exchanging prior authorization. Existing business agreements can also be reused.
The goal is to define FHIR based services to enable provider, at point of service, to request authorization (including all necessary clinical information to support the request) and receive immediate authorization.
The assumption is that this use case will leverage the ASC X12N 278 and 275 for compliance with HIPAA.
Since the last ballot of this material in 2019SEP , the following changes have been made: NoneFHIR_IG_PAS_R1_D1_2019SEP
Financial Management1515HL7 FHIR® Implementation Guide: Payer Coverage Decision Exchange, Release 1 - US RealmFHIR 1st STU BallotThis FHIR-based specification supports the exchange of specific coverage/treatment decisions from one payer to another to allow for continued coverage of specific treatments without needing to repeat the review and authorization process that creates a burden for the provider, patient, and the payer. Since the last ballot of this material in 2019SEP , the following changes have been made: noneFHIR_IG_PCDE_R1_D1_2019SEP
Financial Management1489HL7 FHIR® Implementation Guide: Payer Data Exchange (PDex) Payer Network, Release 1 - US RealmFHIR 1st STU BallotThis guide will define the exchange methods and interoperability "standards" and specific use of FHIR resources to support Health Plan member-authorized exchange of healthcare directory and pharmacy directory information for members and third-party applications.
It may also support an unsecured exchange of directory information (depending on final detailed requirements).

Since the last ballot of this material in 2019SEP , the following changes have been made: None.FHIR_IG_PDex_PLAN_NET_R1_D1_2019SEP
Orders and Observations1335HL7 FHIR® Implementation Guide: LOINC – IVD Test Code (LIVD) Mapping, Release 1FHIR 1st STU BallotThe LOINC-IVD Test Code Mapping (LIVD) Implementation Guide provides suggested mappings by a manufacturer of the IVD test codes used by their device(s) to most likely LOINC codes. Based on context of specimen, test result, and other considerations, the IVD Test Code may map to a different LOINC code. The implementation guide describes the FHIR resources necessary to publish a catalog of one or more devices and their IVD Test Code mappings that may be specific to one or more manufacturers.Since the last ballot of this material in 2019SEP , the following changes have been made: The document has been updated to include ballot dispositions from the prior ballot, as well as two connectathon sessions, thus can be reviewed in full as the first STU ballot.FHIR_IG_LIVD_R1_D1_2019SEP
Orders and Observations1450Reaffirmation of HL7 Version 3: Laboratory; Result, Release 1V3 1st Normative BallotThis is a re-affirmation of the HL7 Version 3: Laboratory Results R1 that is comprised of the models, messages, and other artifacts that are needed to support messaging related to the results or observations association with laboratory tests. It currently supports the results of laboratory testing of any type of specimen, including human, animal, and environmental. Since the last ballot of this material in 2019SEP , the following changes have been made: There are no changes.REAFF_V3_LAB_RESULT_R1_N1_2019SEP
Patient Care1525HL7 FHIR® Implementation Guide: International Patient Summary, Release 1FHIR 3rd STU BallotAn International Patient Summary (IPS) document is an electronic health record extract containing essential healthcare information about a subject of care. It is specifically aimed at supporting the use case scenario for ‘unplanned, cross border care’, but it is not limited to it. It is intended to be international, i.e., to provide generic solutions for global application beyond a particular region or country.Since the last ballot of this material in 2019SEP , the following changes have been made: a. Scope slightly revised:
- extended beyond the cross border case
- no longer limited to the IPS document. The FHIR profiles the IPS document is composed of provides in fact a set of minimal, non-exhaustive, specialty-agnostic and condition-independent profiles potentially reusable beyond the IPS document scope.

b. Better alignment with jurisdictional requirements / profiles (e.g.Argonaut/US Core).
FHIR_IG_IPS_R1_D3_2019SEP
Public Health1511HL7 CDA® R2 Implementation Guide: National Healthcare Safety Network (NHSN) Healthcare Associated Infection (HAI) Reports for Long Term Care Facilities (HAI-LTCF-CDA), Release 1- US RealmCDA 1st STU BallotThese IGs will support electronic submission of HAI data to the National Healthcare Safety Network (NHSN). The intent of this project is to establish an electronic submission standard that is vendor-neutral that leverages LTCF existing workflows and eliminates duplicate documentation. This project will work with LTCF EHR vendors to identify data elements for use in the NHSN HAI surveillance definition. Since the last ballot of this material in 2019SEP , the following changes have been made: This is the first time this document as gone to ballot, therefore there are no substantive changes since the last ballot. CDAR2_IG_HAI_LTCF_R1_D1_2019SEP
Public Health1002HL7 CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), Release 1 STU Release 3 – US RealmCDA 4th STU BallotThe goal of this project is to develop an HL7 Clinical Document Architecture (CDA) Implementation Guide for representing data collected by the CDC NCHS within the Division of Health Care Statistics (DHCS). The data are collected through three surveys of ambulatory, inpatient, and outpatient care services in the United States: the National Ambulatory Medical Care Survey (NAMCS), the National Hospital Care Survey (NHCS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS). Since the last ballot of this material in 2019SEP , the following changes have been made: Update the IG based on implementer feedback and to more closely align with USCDI requirementsCDAR2_IG_NHCS_R1_D4_2019SEP
Public Health1511HL7 FHIR® R4 Implementation Guide: NHSN Healthcare Associated Infection (HAI) Reports for Long Term Care Facilities (HAI-LTCF-FHIR), Release 1- US RealmFHIR 1st STU BallotThese IGs will support electronic submission of HAI data to the National Healthcare Safety Network (NHSN).  The intent of this project is to establish an electronic submission standard that is vendor-neutral that leverages LTCF existing workflows and eliminates duplicate documentation. This project will work with LTCF EHR vendors to identify data elements for use in the NHSN HAI surveillance definition. Since the last ballot of this material in 2019SEP , the following changes have been made: This is the first instance of this IG being balloted therefore there are no substantive changes.FHIR_HAI_LTCF_R1_D1_2019SEP
Public Health1342HL7 FHIR® Implementation Guide: Clinical Decision Support for Immunizations, Release 1 - US RealmFHIR 2nd STU BallotThe Immunization Decision Support Forecast (ImmDS) use case covers the exchange of data between a system seeking a patient evaluated history and forecast and the clinical decision support engine capable of providing that history and forecast. Today, this layer is not standardized and leads to several unique/proprietary interfaces which are costly to implement. The scope of this implementation guide is to create a standard interface layer between the initiating system and the CDS engine.Since the last ballot of this material in 2019SEP , the following changes have been made: This updated ballot now is based on FHIR R4, including support for the new ImmunizationEvaluation resource. It also has enhanced use case and guidance information.FHIR_IG_CDS_IMMUNIZATION_R1_D2_2019SEP
Security1492HL7 Guidance: Basic Provenance for C-CDA and FHIR, Release 1 - US RealmHL7 1st Informative BallotSpecify functional and technical guidance on what constitutes basic “provenance”. This guidance should inform future implementations of the data class identified in the US Core Data for Interoperability published by the Office of the National Coordinator.

The IG includes technical guidance for C-CDA 2.1, and US FHIR Core (based on R4).
Since the last ballot of this material in 2019SEP , the following changes have been made: N/AHL7_PROVENANCE_CCDA_FHIR_R1_I1_2019SEP
Security914HL7 Version 3 Standard: Privacy and Security Architecture Framework, Release 1V3 3rd Normative BallotPSAF Volume 3 Provenance has been substantially updates based on comments received during the January 2019 ballot. The primary change is its restructuring in accordance with HL7 Domain Analysis Model. This is the only volume in scope for this ballot.Since the last ballot of this material in 2019SEP , the following changes have been made: Complete update of previous PSAF Provenance work based on January comments and restructuring as a Domain Analysis Model.V3_PSAF_R1_N3_2019SEP
Services Oriented Architecture1436HL7 Health Services Platform (HSP) Marketplace, Release 2 STU 1V3 1st To Be Determined BallotThe Health Services Platform (HSP) Marketplace provides a vendor-agnostic specification for publication,
curation, discovery, and distribution of interoperable service implementations. This specification will be
completely agnostic to programming language/frameworks, database, and I/O technologies, as well as
support SMART-on-FHIR client applications that require on-site deployment
Since the last ballot of this material in 2019SEP , the following changes have been made: Additional clarification of Smart-on-FHIR support added with references to the FHIR specifications.
Added timezones to timestamp specifications as per ISO 8601.
Minor adjustments to spelling, terminology and punctuation.
GIThub references changed HL7 GIThub.
Discussion on Security issues clairified.
API to be published in machine-readable form
HL7_HSP_R2_D1_2019SEP
Services Oriented Architecture1420HL7 Model-based Transformation Service, Release 1HL7 1st STU BallotThis document provides a general platform independent Service Functional Model (SFM) specification for an HL7 model-based bi-directional transformation service with exemplary mappings illustrating typical. The scope of the SFM is limited to the exchange of data between a source and a target where the source and target are different HL7 Standards (V2, CDA, FHIR). Since the last ballot of this material in 2019MAY , the following changes have been made: Since the previous informative ballot, use cases and the Service Functional Model specification have been added along with additional mapping formalisations and exemplars.HL7_MODEL_XFORM_R1_D1_2019SEP_WITHDRAWN
Structured Documents1204HL7 CDA® R2 Implementation Guide: Personal Advance Care Plan Document, Release 1 - US RealmCDA 1st Normative BallotThis 2-vol. IG describes constraints on the CDA R2 standard. It establishes templates to support exchange of personal advance care planning directive information using the CDA standard. The designs for the Personal Advance Care Plan Doc are consistent and compatible with prior templates established in C-CDA for the Advance Directives section of a clinical summary document (i.e. CCD, Consult Note, Referral Summary, or Transfer Summary) and could be used to augment the C-CDA Care Plan Doc Temp.Since the last ballot of this material in 2019SEP , the following changes have been made: N/ACDAR2_IG_PERSADVCAREPLAN_R1_N1_2019SEP
Structured Documents976HL7 CDA® R2 Implementation Guide: Structured Form Definition Document, Release 1CDA 2nd Normative BallotThis ballot is for an implementation guide defining a Structured Form Definition Document for purpose of representing patient questionnaires as a structured document reusing and/or enhancing existing CDA templates where possible creating new CDA templates where necessary. Since the last ballot of this material in 2017JAN , the following changes have been made: This is the second Normative ballot for this document. The changes made to the document reflect the resolutions that were agreed to by the working group. Both substantive and non-substantive changes were made. As this is the second Normative ballot for this IG, the ballot comments are limited to only the substantive changes. The substantive changes were due to the following N1 comments: 1, 7, 11, 21, 25, 28, 29, 32, 33, 34, 35, 36, 37, 38, 39, 45, 46, 47. Comments during this second (N2) ballot are restricted to those (substantive) changes only. The corresponding final reconciliation spreadsheet can be found here: http://wiki.hl7.org/images/5/50/CDAR2_IG_SFDEFDOC_R1_N1_2017JAN_amalgamated_January042018-FINAL_Jan292019.xls CDAR2_IG_SFDEFDOC_R1_N2_WITHDRAWN


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