PH+Reporting+Documents

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Reference Materials / Related Artifacts
Please add any reference materials for the Public Health Reporting Initiative to consider in the scope of its work. You may also email Lindsay Brown at lrbrown@cdc.gov to notify the Initiative of a reference.

**Description & Link:** This document presents the work products developed by the reportable conditions surveillance workgroup. This project engaged public health practitioners in examining and redesigning surveillance processes to accommodate and leverage standards‐based information flows from electronic laboratory reporting (ELR) and electronic health record (EHR) systems. The document is intended as both a roadmap and a tool for moving public health toward acquiring information systems that will support the work of reportable conditions surveillance effectively and efficiently. Read more at Redesigning Public Health Surveillance in an eHealth World. || **Description & Link:** This document is the Case Report Standardization Workgroup (CRSWg) proposal for the second version of the common core data elements for case reporting and laboratory result reporting, which was combined to standardize its representation and meaning for both use cases. To view, click on provided by the Council of State and Territorial Epidemiologists (CSTE). || || to read more. || for more. ||
 * **Date** || **Reference** ||
 * 6/1/12 || **Title:** Redesigning Public Health Surveillance in an eHealth World
 * 5/14/11 || **Title:** Common Core Data Elements (Appendix C)
 * 3/16/12 || **Title:** Electronic Submission of Animal Adverse Events HL7 Individual Case Safety Report (ICSR)
 * Description & Link:** The purpose of this document is to provide step by step directions to assist users, reporters, and technical staff in completing a well formed HL7 XML Individual Case Safety Report (ICSR) message for animal drug Adverse Event Reports (AER) and manufacturing/product defects messages. These submissions are intended to be sent electronically to the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) through the FDA Electronic Submissions Gateway (ESG) and upon reception they will be processed by CVM’s Adverse Event System. To read more, go to
 * 3/16/12 || **Title:** eMDR - electronic Medical Device Reporting Health Level Seven (HL7) Individual Case Safety Report (ICSR) Implementation Specifications (June 9, 2010/Food and Drug Administration / Center for Devices and Radiological Health)
 * Description & Link:** The eMDR project enables reporters to voluntarily submit medical device adverse event reports (MDRs) electronically. eMDR will accept electronic medical device reports via two options, one designed for low-volume reporting (infrequent or few reports) and one designed for high-volume reporting (frequent or numerous reports). This guide, divided into two sections, provides general information on the project and technical information and implementation details. To learn more, click on [[file:siframework/ICSRImplTechSpecv1_1Release08032010.doc|ICSRImplTechSpecv1_1Release08032010.doc.]] ||
 * 3/16/12 || **Title:** HL7 Version 3 Standard: Individual Case Safety Report, Release 1
 * Description & Link:**This Individual Case Safety Report (ICSR) captures information about adverse events and product problems that are reported to public health, patient safety/quality improvement organizations or regulatory agencies. The ICSR message supports reporting from a variety of sources such as consumers, hospitals, contract research organizations, clinicians or pharmaceutical product and medical device manufacturers. Go to
 * 3/16/12 || **Title:** Guidance for Industry: Pharmacovigilance of Veterinary Medicinal Products. Data Elements for the Submission of Adverse Event Reports. VICH GL42 - Draft Guidance. Food and Drug Administration / Center for Veterinary Medicine
 * Description & Link:** The scope of this guidance document is to describe the specific data elements to be used for the submission and exchange of spontaneous adverse event reports (AER) between marketing authorization holders (MAH) and regulatory authorities (RA). Go to Guidance for Industry
 * 3/16/12 || **Title:** FDA eSubmitter User Manual. Document version 5.1. Febuary 5, 2012. Food and Drug Administration
 * Description & Link:** The Food and Drug Administration (FDA) eSubmitter tool is a program that allows participants to electronically complete and submit information for various products to participating Centers. This tool is intended to automate the current paper submission process, allowing for quicker completion once users are accustomed to the software, as well as speed up the filing process with FDA. To read more, go to FDA eSubmitter Guide. ||
 * 3/16/12 || **Title:** Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide Data Elements and Message Specification. Version 3.01, Revision June 16, 2011
 * Description & Link:** This document is a guide fir implementing requirements for the electronic transmission of ICSRs. To read more, click on ICSR Implementation Guide. ||
 * 4/19/12 || **Title:** HL7 Implementation Guide for CDA Release 2: IHE Health Story Consolidation, Release 1
 * Description & Link:**The audiences for this implementation guide are the architects and developers of healthcare information technology (HIT) systems in the US Realm that exchange patient clinical data. To view the document in its entirety, click on HL7 Implementation Guide for CDA Release 2: IHE Health Story Consolidation, Release 1. ||
 * 4/19/12 || **Title:** Implementation Guide for Immunization Messaging
 * Description & Link:** This document represents the collaborative effort of the American Immunization Registry Association (AIRA) and the Centers for Disease Control and Prevention (CDC) to improve inter‐system communication of immunization records. To read more, go to Implementation Guide for Immunization Messaging. ||
 * 4/19/12 || **Title:** PHIN Messaging Guide for Syndromic Surveillance (March 2011)
 * Description & Link:** This guide was produced and developed through the efforts of a project designed to specify a messaging guide for the Syndromic Surveillance. Visit PHIN Messaging Guide for Syndromic Surveillance to learn more. ||
 * 4/19/12 || **Title:** HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1
 * Description & Link:** This guide is designed for use by analysts and developers who require guidance on data elements and components of the HL7 Version 2.5.1 ORU Unsolicited Observation Message relative to the Lab Results Interface (LRI) initiative. Users of this guide must be familiar with the details of HL7 message construction and processing. This guide is not intended to be a tutorial on that subject. To view, go to HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface. ||

Reference Materials - Data Exchange Models
include component="page" wikiName="siframework" page="PHRI Exchange Model Reference Documents"

Working Documents

 * **Artifact Name** || **Status** || **Notes** ||
 * [[file:siframework/S&I_PHReporting_Definitions20111102.xlsx|S&I_PHReporting_Definitions20111102.xlsx]] || N/A || Working draft of initiative definitions ||
 * [[file:siframework/20111102Definitions.pptx|20111102Definitions.pptx]] || N/A || Initial set of artifact and workgroup labels for S&I novices. ||
 * [[file:siframework/cv-PH ReportingStandardizationFramework-10-12-11.ppt|cv-PH ReportingStandardizationFramework-10-12-11.ppt]] ||  || Cindy Vinion's suggested revisions to the Framework ppt ||
 * [[file:siframework/S&I PHR Roadmap&CallSchedule_2011_RMafter call.pptx|S&I PHR Roadmap&CallSchedule_2011_RMafter call.pptx]] || N/A || Phase 1 and Phase 2 Roadmap and Call Schedule ||
 * [[file:siframework/SI PHReporting-UseCaseSelectionCriteria-09-28-11REV.doc|SI PHReporting-UseCaseSelectionCriteria-09-28-11REV.doc]] || N/A || Criteria for selecting use cases for the Initiative ||
 * [[file:siframework/S&I_PHreporting_UseCaseSelectionCriteria.xlsx|S&I_PHreporting_UseCaseSelectionCriteria.xlsx]] || Open || Criteria for selecting use cases for the Initiative ||
 * [[file:siframework/PHReporting Workgroup Options 09-21 v2.pptx|PHReporting Workgroup Options 09-21 v2.pptx]] || N/A || Presentation on Work Group Options (N. Lipskiy) ||
 * [[file:siframework/Comment on List of Potential Workgroups for S&IPHRInitiative.docx|Comment on List of Potential Workgroups for S&IPHRInitiative.docx]] || N/A || Comments on Potential Work Groups (S. Foldy) ||
 * [[file:siframework/PH Reporting Timeline.ppt|PH Reporting Timeline.ppt]] || N/A || Timeline for Meeting Dates and Deliverables ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_FINAL.pdf|PH_Reporting_Initiative_Charter_FINAL.pdf]] || N/A || Final Charter submitted to ONC. ||

Completed Documents
List of Agencies and Organizations to include in Outreach activities (Public Comment participation) Charter's Presentations to Public Health Audiences. || Click here to provide your comments. || || Lipskiy, & Anna Orlova. ||
 * **Artifact Name** || **Status** || **Notes** ||
 * [[file:2012CSTE_presentation_PHRI.pptx]] || Closed || Presentation delivered at the 2012 CSTE Annual Conference on the S&I Framework Public Health Reporting Initiative. ||
 * [[file:siframework/S&I PH Reporting - Draft WGs and Activities v1.xlsx|S&I PH Reporting - Draft WGs and Activities v1.xlsx]] || Closed || List of potential Work Groups and possible activities. ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_Draft_for Public Comments.pdf|PH_Reporting_Initiative_Charter_Draft_for Public Comments.pdf]] || Closed || Draft Charter for Public Comment ||
 * [[file:siframework/PHI Conference presentation discussion20110823.docx|PHI Conference presentation discussion20110823.docx]] || Closed || 2011 PHI Conference Session attendees discussion of use cases, scope, etc. ||
 * [[file:siframework/2011 PHI Conference E10 panel presentation 08-23-11 ONC Updates.pptx|2011 PHI Conference E10 panel presentation 08-23-11 ONC Updates.pptx]] || Closed || PowerPoint presentation given at the 2011 PHI Conference on Tuesday, August 23, 2011. ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_Draft_for Public Comments.pdf|PH_Reporting_Initiative_Charter_Draft_for Public Comments.pdf]] || Closed || Comment Period: August 19 - September 6, 2011 ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_Draft_081711.docx|PH_Reporting_Initiative_Charter_Draft_081711.docx]] || Closed || Updated Draft Charter ||
 * [[file:siframework/Charter Template_PH_Reporting_081711.pptx|Charter Template_PH_Reporting_081711.pptx]] || Closed || Updated Charter Template ||
 * [[file:siframework/Timeline and Outreach-08-11-11.ppt|Timeline and Outreach-08-11-11.ppt]] || Closed || Timeline for submitting Charter to ONC
 * [[file:siframework/Comments to Be Discussed at the Call on 8-10-11.doc|Comments to Be Discussed at the Call on 8-10-11.doc]] || Closed || Combined comments from participants on the PH Initiative Charter, version 7/22/2011 ||
 * [[file:siframework/Charter Template_PH_Reporting_080911.pptx|Charter Template_PH_Reporting_080911.pptx]] || Closed || Updated Draft Charter. ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_Draft_072711.docx|PH_Reporting_Initiative_Charter_Draft_072711.docx]] || Closed || This document was drafted by the Public Health WG leads. This document will be used to foster discussion among the community during the workgroup calls. The goal should be to provide a concise executive summary of the proposed initiative for the presentation to ONC. Any additional information can remain in a separate document as a point of reference but the group should focus on getting the scope right and highlighting the key points using the template provided.
 * [[file:siframework/Charter Template_PH_Reporting_072211.pptx|Charter Template_PH_Reporting_072211.pptx]] || Closed || Cllick here to provide your comments. ||
 * [[file:siframework/Charter Template_v5-PUBLIC HEALTH.pptx|Charter Template_v5-PUBLIC HEALTH.pptx]] || Closed ||  ||
 * [[file:siframework/Public Health WG Approach_07_25_11.docx|Public Health WG Approach_07_25_11.docx]] || Closed || Previous Versions:
 * [[file:siframework/Public Health WG Approach_07_25_11.docx|Public Health WG Approach_07_25_11.docx]] || Closed || Previous Versions:
 * Public Health Domain Related Lab Data Exchanges and Cases || Closed || This spreadsheet was updated before the FTF (Nikolay, Riki, Kosta). The workgroup members are encouraged to review this spreadsheet in detail. Please provide any comments and/or suggestions following the instructions on the page. ||
 * MU 1, MU2, MU3 & Beyond MU Context Diagrams || Closed || These diagrams were created during the FTF in June 2011 to capture the PH reporting relationships. To provide updates click the link and follow the instructions on the page. ||
 * [[file:siframework/Laboratory Results Interface Initiative-Public Health2.doc|LRI Public Health Overview]] || Closed || Updated scope document provided by Kosta Makrodimitris, Nikolay
 * [[file:DataHarmonizationProfile_02132013.docx]] || Closed || Consensus approved version of the Data Harmonization Profile ||

Proposals for Next Cycle
The user stories and documents in the table below include material of interest to the next cycle of the initiative work.
 * **Document** || **Date** || **Submitted By** ||
 * [[file:siframework/Use Case - Referrals From EMRs to Quitlines for Tobacco Use.doc|Use Case - Referrals From EMRs to Quitlines for Tobacco Use.doc]] || 4/9/12 || Thomas Land (thomas.land@state.ma.us) ||
 * [[file:siframework/Specialist Patient Initiator_32812.pdf|Specialist Patient Initiator_32812.pdf]] || 4/9/12 || Thomas Land (thomas.land@state.ma.us) ||
 * [[file:siframework/Primary Doctor Patient Initiator_32812.pdf|Primary Doctor Patient Initiator_32812.pdf]] || 4/9/12 || Thomas Land (thomas.land@state.ma.us) ||
 * [[file:siframework/Non Medical Group Patient Initiator_32812.pdf|Non Medical Group Patient Initiator_32812.pdf]] || 4/9/12 || Thomas Land (thomas.land@state.ma.us) ||
 * [[file:siframework/Hospital Patient Initiator_32812_Final.pdf|Hospital Patient Initiator_32812_Final.pdf]] || 4/9/12 || Thomas Land (thomas.land@state.ma.us) ||
 * [[file:siframework/CFS_Document.pdf|CFS_Document.pdf]] - Minimum data elements for research reports on CFS || 4/23/12 || Jason A Leonard et. al. via Riki Merrick ||

Access to Protected Content
Participation in this Initiative will require access to protected content. In support of the S&I Framework, HL7 has established a no-fee license granting participants access to this information.

Click here for step by step directions on how to access protected content.

If you are looking for the work products from the LRI Public Health Lab Results WG please click here.

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