PH+Reporting+Charter

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 * Proposal for the ONC S&I Framework Public Health Reporting Initiative Charter ||
 * **9/21/2011 ** ||

Table of Contents 1.0 Name of Activity 2.0 Background 3.0 Charge 4.0 Goal 5.0 Approach 6.0 Timeframe, Scope and Milestones 7.0 Possible Partners and Stakeholders 8.0 Value Statement 9.0 Target Outcomes 10.0 Risks Appendix A: Public Health Reporting Examples Appendix B: References Appendix C: Template for Proposed S&I Public Health Reporting Initiative

<span style="color: #000000; font-family: 'Arial','sans-serif';">1.0 Name of Activity
<span style="font-family: 'Arial','sans-serif';">We propose to name this ONC S&I Framework Initiative the **S&I** **Public Health Reporting Initiative**. This Initiative will be conducted by the Public Health Reporting Workgroup (PH-R WG).

<span style="color: #000000; font-family: 'Arial','sans-serif';">2.0 Background
<span style="font-family: 'Arial','sans-serif';">On February 17, 2009, the President signed the American Recovery and Reinvestment Act of 2009 (ARRA). This statute includes the Health Information Technology for Economic and Clinical Health Act of 2009 (the HITECH Act) that set forth a plan for advancing the Meaningful Use (MU) of health information technology (HIT) to improve quality of care and establish a foundation for health care reform. Two Federal Advisory Committees, Health IT Policy and Health IT Standards have been established under this legislation. In 2010 these Committees identified three types of public health reporting that were adopted for MU Stage 1 of the HITECH-funded CMS Incentive Program:


 * 1) <span style="font-family: 'Arial','sans-serif';">Capability to submit electronic **syndromic surveillance** data to public health agencies and actual transmission according to applicable law and practice.
 * 2) <span style="font-family: 'Arial','sans-serif';">Capability to submit electronic data to **immunization** registries of Immunization Information Systems and actual submission in accordance with applicable law and practice.
 * 3) <span style="font-family: 'Arial','sans-serif';">Capability to submit **electronic data on reportable** (as required by state or local law) **lab** **results** to public health agencies and actual submission in accordance with applicable law and practice.

<span style="font-family: 'Arial','sans-serif';">Since then both the HIT Policy Committee and HIT Standards Committee recognized that the three public health domains selected for MU State 1 represent just a few of several types of ongoing information exchange between clinical providers and public health agencies that occur on an ongoing basis, and that creating unique implementation guide for electronic data exchanges for each would impose long-term burdens on providers and agencies alike. Both suggested that simpler approaches to managing public health reporting be considered for future stages of Meaningful Use. <span style="font-family: 'Arial','sans-serif'; font-size: 14px;">[1]

<span style="font-family: 'Arial','sans-serif';">The Office of the National Coordinator for Health IT (ONC) issued regulations codifying standards for electronic health record (EHR) certification and to measure compliant performance by providers. <span style="font-family: 'Arial','sans-serif'; font-size: 14px;">[2] <span style="font-family: 'Arial','sans-serif';">ONC manages a Standards & Interoperability (S&I) Framework to leverage existing and new HIT standards and tools, and harmonization and implementation of standards specifications (implementation guides) to promote electronic health information exchange interoperability nationwide. In 2011, several S&I Framework Initiatives were established to address gaps in HIT standards selected for MU and guide standards-based products and certification including the L <span style="color: #000000; font-family: 'Arial','sans-serif';">aboratory Results Interface (LRI) Workgroup and its Public Health Laboratory Reporting Workgroup. <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 14px;">[3] <span style="color: #000000; font-family: 'Arial','sans-serif';"> These were formed to address inconsistencies in electronic laboratory reporting specifications.

<span style="color: #000000; font-family: 'Arial','sans-serif';">The Public Health Laboratory Reporting Workgroup recognized that additional information is needed for prompt assessment and response to reportable diseases, beyond that contained in the MU Stage 1 implementation guide for laboratory result reporting. Similar types of information are needed for many different types of public health reports. <span style="font-family: 'Arial','sans-serif';">During the ONC S&I Framework face-to-face meeting in Washington DC, June 14-15, 2011 the LRI Public Health Workgroup proposed establishing the Public Health Reporting Initiative within the ONC S&I Framework.

<span style="font-family: 'Arial','sans-serif';">The S&I Public Health Reporting Initiative is aimed to harmonize HIT standards and implementation guides for interoperable bi-directional communication between clinical care and public health entities for many different types of public health reporting. We anticipate producing practical implementation guide(s) for public health reporting for a selected number of use cases that could be extensible to many other public health use cases. Specifically, we aimed to have these implementation guides be ready for Stage 3 of the Meaningful Use incentive program (i.e., ready for approval during Federal fiscal year 2013 for use by Federal FY 2015).

<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">In the context of this Charter we use the term “**public health reporting**” to describe sending, receiving or retrieving patient-level or population level information for the purpose of public health interventions including surveillance and other legitimate functions. In addition to cases of infectious and chronic disease and poisoning this may include reports of newborn screening, effectiveness and safety reporting like adverse drug or device events, drug and biologics, registration of births and deaths, and exchanges with various public health registries (e.g., immunization registries, blood lead registries and others). Such reports should also be capable of being aggregated in the population-level reports (either prior to or after transmission as appropriate) and may contain de-identified information needed for communication between local, state and federal agencies.

<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">An initial case report is defined as a type of public health reporting that contains initial notification of an occurrence or it may contain specific information about what occurred. A classic example of initial case report is a report about occurrence or suspected case of a "notifiable" disease by a practitioner to local, state or federal public health agencies.[4] In the context of this Initiative, we will use this term to describe initial reporting from clinical electronic health record (EHR)systems to public health agencies on a public health occurrence (event) for all use cases, e.g., maternal and child health, injuries, immunization, chronic diseases and other public health programs (domains).

//<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">Please note that a more concise definition of “public health reporting” including the types (classes) of the reports (e.g. //<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">initial case report //and others) and reporting processes used for public health reporting and bi-directional communication will be defined by the Public Health Reporting Initiative’s Work Group when formed. Please see Appendix A for examples of individual- and population-level public health reports by programs/domains.//

<span style="font-family: 'Arial','sans-serif';">This document describes the Charter of the proposed S&I Public Health Reporting Initiative. We anticipate broader review of the Charter by public health and clinical care organizations to solicit their input in the specific activities under this Initiative described below.

<span style="color: #000000; font-family: 'Arial','sans-serif';">3.0 Charge
<span style="font-family: 'Arial','sans-serif';">The S&I Public Health Reporting Initiative will develop and implement a standardized approach to electronic public health reporting from EHR systems to local, state and federal public health programs that addresses the needs of several different reporting use cases, with the long-term goal of reducing the difficulty (to both providers and public health agencies) of implementing electronic versions of the broad spectrum of public health reporting.

<span style="font-family: 'Arial','sans-serif';">There are well-defined specifications being established for the three Stage 1 public health objectives (laboratory reporting, immunization and syndromic surveillance), using HL7 2.x implementation guides. As a result, the emphasis of the Initiative will not be creating new specifications for these domains. Also, there is no an expectation that providers would need to abandon Stage 1 guides in Stage 3. The Initiative will focus on harmonizing existing specifications for these three domains with other public health reporting use cases into a new, more universal implementation guide, e.g., by harmonizing data sets and information exchange standards (message-based and document-based) across domains.

<span style="font-family: 'Arial','sans-serif';">The Initiative will examine several reporting use cases that share similar business processes, information exchange requirements and data requirements. The Initiative will then select and harmonize HIT standards, develop harmonized implementation guide(s), establish reference implementations for standards testing, certification criteria, and processes for these use cases to be considered for Stage 3 of Meaningful Use.

<span style="font-family: 'Arial','sans-serif';">In addition, the Initiative will identify a few sites to pilot test artifacts from this Initiative including the deployment of certified HIT products to enable interoperability of EHRs and public health information systems. The public health domains to be considered may include but are not limited to the:


 * <span style="font-family: 'Arial','sans-serif';">Maternal and child health (e.g., early hearing detection and intervention (EHDI); vital records)
 * <span style="font-family: 'Arial','sans-serif';">Communicable diseases (e.g., public health laboratory (PH-Lab) data exchanges for public health case reporting and preparedness)
 * <span style="font-family: 'Arial','sans-serif';">Chronic disease (e.g., cancer, diabetes)
 * <span style="font-family: 'Arial','sans-serif';">Immunization
 * <span style="font-family: 'Arial','sans-serif';">Injury
 * <span style="font-family: 'Arial','sans-serif';">Occupational health (e.g., silicosis, work-related injury)
 * <span style="font-family: 'Arial','sans-serif';">Adverse event reporting (drugs, biologics, devices, tobacco, foods)
 * <span style="font-family: 'Arial','sans-serif';">Medical countermeasures and emergencies
 * <span style="font-family: 'Arial','sans-serif';">Surveillance (e.g., syndromic surveillance, biosurveillance, surveillance administered by FDA), and
 * <span style="font-family: 'Arial','sans-serif';">Other.

<span style="font-family: 'Arial','sans-serif';">We believe that harmonization and streamlining of the reporting constructs using HIT standards will help address healthcare providers and EHR vendors concerns about the need to accommodate competing reporting requirements and different standards adoption approaches across public health agencies.

//<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">Please note that the list of programs/domains included in the Public Health Reporting Initiative, the scope of work under each program/domain (e.g., domain-specific use cases, domain-specific //<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">initial case reports//, selected HIT standards and other), the use case and HIT standards selection and harmonization across domains will be defined by members of the Public Health Reporting Initiative when formed.//

<span style="color: #000000; font-family: 'Arial','sans-serif';">4.0 Goal
<span style="font-family: 'Arial','sans-serif';">The goal of the S&I Public Health Reporting Initiative is to harmonize HIT standards and implementation guides for bi-directional interoperable communication between clinical care and public health entities for selected use cases.

<span style="color: #000000; font-family: 'Arial','sans-serif';">5.0 Approach
<span style="font-family: 'Arial','sans-serif';">The following approaches will guide implementation of this Initiative:

<span style="font-family: 'Arial','sans-serif';">I. Approach the creation of the implementation guide(s) so as to minimize unnecessary modification of EHRs and their certification by harmonizing with other ONC-certification criteria and other S&I Framework activities like the Transfer of Care (TOC) Initiative and others. <span style="font-family: 'Arial','sans-serif';">II. Approach the creation of the implementation guide(s) in a way to maximize its future extensibility and re-usability to other public health reporting use cases. <span style="font-family: 'Arial','sans-serif';">III. Minimize unnecessary impact on established MU Stage 1 public health reporting objectives while potentially simplifying such reporting in the future. <span style="font-family: 'Arial','sans-serif';">IV. Enable bi-directional communication as needed for public health reporting use cases. <span style="font-family: 'Arial','sans-serif';">V. Approach the creation of the implementation guide(s) so as to account for the needs of subsequent inter-jurisdictional communication (e.g. transfer of cases between jurisdictions and national notification requirements) and population-level reporting. <span style="font-family: 'Arial','sans-serif';">VI. Facilitate future certification of public health information systems that are interoperable with ONC-certified EHRs.

<span style="font-family: 'Arial','sans-serif';">The S&I Public Health Reporting Initiative is in alignment with the following ONC HIT Strategic Plan’s goals (2011-2015)<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">[5]


 * <span style="font-family: 'Arial','sans-serif';">Goal 2: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT
 * <span style="font-family: 'Arial','sans-serif';">Goal 5: Achieve Rapid Learning and Technological Advancement (Lead the creation of a learning health system to support quality, research, and public and population health)

<span style="color: #000000; font-family: 'Arial','sans-serif';">6.0 Timeframe, Scope and Milestones
<span style="font-family: 'Arial','sans-serif';">The Initiative will operate starting October 2011 through December 2013. At first, the Initiative will focus on initial //individual-patient reporting// from electronic health record-systems (EHR- systems) to public health agencies (local, state and federal). This Initiative will strive to deliver its products for timely consideration of the HIT standards Committee during FY 2013.

<span style="font-family: 'Arial','sans-serif';">The specific milestones are:
 * 1) **//<span style="font-family: 'Arial','sans-serif';">Select 3-5 use cases //**<span style="font-family: 'Arial','sans-serif';"> as examples of public health reporting. At first, we will focus on the initial case report (individual patient-level reporting) from EHR- systems to local/state/federal public health agencies
 * 2) **//<span style="font-family: 'Arial','sans-serif';">Harmonize business processes, functional requirements //****<span style="font-family: 'Arial','sans-serif';"> //and data requirements// **<span style="font-family: 'Arial','sans-serif';">(data sets (data elements)and value sets) for selected use cases based on the **initial case** report
 * 3) <span style="font-family: 'Arial','sans-serif';">Conduct **//HIT//** **//standards selection and harmonization//** for selected use cases**//,//** e.g., data standards (e.g., SNOMED CT, LOINC, X12); information exchange standards (e.g., HL7 V2.x, HL7 CDA) and others (e.g., identifier standards, privacy and security standards, Public Health Information Network (PHIN) standards and PHIN architecture). Existing HIT standards and profiles will be examined for suitability. New or altered standards will be requested as needed from Standards Development Organizations (SDOs). See Appendix C: Charter Template for examples of relevant HIT standards
 * 4) Develop **//implementation guide(s)//**for selected use cases for interoperable communication between EHRs and public health information systems.<span style="font-family: 'Arial','sans-serif';"> To extent appropriate, harmonize the implementation guides for MU Stage 1 public health objectives with these guides for bi-directional communication. Harmonize to extent appropriate the guides with those of Transition of Care and other S&I Initiatives as well as Public Health Information Network (PHIN) and Nationwide Health Information Network (NwHIN) Initiatives
 * 5) <span style="font-family: 'Arial','sans-serif';">Provide **//recommendations and criteria//** for the development of reference implementations (test methods and tools) that can be used to support pilot implementations based upon the specific use cases produced under this Initiative
 * 6) <span style="font-family: 'Arial','sans-serif';">Consider the need for and approaches to HIT standards-based certification of public health information systems. This may include recommending **//certification criteria//** for public health information technology and **//public health information systems certification//** processes through PHIN and/or other national certification entities.

<span style="font-family: 'Arial','sans-serif';">In addition, during 2012-2013 we will work on **//Developing a Roadmap//** for

<span style="font-family: 'Arial','sans-serif';">a. **//<span style="font-family: 'Arial','sans-serif';">Extending //**<span style="font-family: 'Arial','sans-serif';"> the implementation guide(s) to additional public health and patient safety use cases where appropriate; and to create <span style="font-family: 'Arial','sans-serif';">new specifications appropriate for different public health report classes (e.g., Case Investigation, Case Management (Care <span style="font-family: 'Arial','sans-serif';">Plans),Quality Measures reports and others)

<span style="font-family: 'Arial','sans-serif';">b. **//<span style="font-family: 'Arial','sans-serif';">Aligning //**<span style="font-family: 'Arial','sans-serif';"> public health, patient safety and clinical objectives in MU (Stages 2 and 3) with regards to HIT standards, e.g., Transition <span style="font-family: 'Arial','sans-serif';">of Care and others initiatives

<span style="font-family: 'Arial','sans-serif';">c. **//<span style="font-family: 'Arial','sans-serif';">Harmonizing //**<span style="font-family: 'Arial','sans-serif';"> HIT standards (vocabulary and terminology standards, information exchange standards, privacy and security <span style="font-family: 'Arial','sans-serif';">standards, identifier standards, functional and business process standards) between clinical care and population health systems <span style="font-family: 'Arial','sans-serif';">beyond the Meaningful Use Stage 1 objectives

<span style="font-family: 'Arial','sans-serif';">d. **//<span style="font-family: 'Arial','sans-serif';">Incorporating //**<span style="font-family: 'Arial','sans-serif';"> public health and patient safety needs in the ONC S&I Framework with regards to standards development, <span style="font-family: 'Arial','sans-serif';">harmonization, testing and certification, e.g., utilizing NwHIN and PHIN capabilities for public health systems testing and certification

<span style="font-family: 'Arial','sans-serif';">e. **//<span style="font-family: 'Arial','sans-serif';">Deploying //**<span style="font-family: 'Arial','sans-serif';"> standard-based certified HIT applications in public health agencies and for patient safety reporting.

<span style="font-family: 'Arial','sans-serif';">The participants of this Initiative will also provide domain/subject matter expertise as needed to the ONC FACA Committees, e.g., HIT Standards Committee and HIT Policy Committee as well as participate in the review of the ONC documents relevant to the scope of this Initiative.

<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">In the __first three months__ (Fall 2011) the S&I Public Health Reporting Initiative will focus on:


 * 1) **<span style="font-family: 'Arial','sans-serif';">Building a Consensus **<span style="font-family: 'Arial','sans-serif';"> on Public Health Reporting Definitions (e.g., classes of reports and reporting processes) a) to help identify the use cases with class(es) of reports that have overlapping business processes and information requirements and b) unify data exchange models
 * 2) **<span style="font-family: 'Arial','sans-serif';">Building a Consensus **<span style="font-family: 'Arial','sans-serif';">on Public Health Reporting HIT Standardization Framework to include planning for deployment of certified standards-based HIT solutions
 * 3) **<span style="font-family: 'Arial','sans-serif';">Assessing Various S&I Initiatives **<span style="font-family: 'Arial','sans-serif';"> in which public health has to be involved and designate representatives to these initiatives
 * 4) **<span style="font-family: 'Arial','sans-serif';">Selecting Priority Use Cases & Establishing Timeline **<span style="font-family: 'Arial','sans-serif';"> for short-term (ready by December 2013) and longer-term harmonization and testing of standards and specifications for public health reporting,
 * 5) **<span style="font-family: 'Arial','sans-serif';">Developing a Detailed Work plan **<span style="font-family: 'Arial','sans-serif';">for the Initiative activities in 2012-2013.
 * 6) __<span style="font-family: 'Arial','sans-serif';">Identifying Risk Mitigation techniques for items listed under Section 10.0 Risks __

//<span style="font-family: 'Arial','sans-serif';">Please note that the list of activities and the timeline proposed in this document are subject to change pending approval by ONC S&F Framework and the availability and agreement between the relevant agencies to sponsor and/or engage in the work effort. //

<span style="color: #000000; font-family: 'Arial','sans-serif';">7.0 Value Statement
<span style="font-family: 'Arial','sans-serif';">By utilizing commonalities of the business needs, functional requirements for information systems and data categories across various public health programs (domains), S&I Public Health Reporting Initiative enables a structured uniform approach for:

<span style="font-family: 'Arial','sans-serif';">1) engaging the public health and patient safety communities into the HIT standardization efforts, i.e., standards harmonization, testing, standards-based products certification and deployment <span style="font-family: 'Arial','sans-serif';">2) harmonizing business needs and functional requirements for developing HIT standards and <span style="font-family: 'Arial','sans-serif';">3) enabling development and deployment of interoperable HIT solutions

<span style="font-family: 'Arial','sans-serif';">This approach allows information exchanges within the larger clinical-public health enterprise, thus meeting the goal of delivering better and safer care and protecting the public from health threats.

<span style="color: #000000; font-family: 'Arial','sans-serif';">8.0 Target Outcomes
<span style="font-family: 'Arial','sans-serif';">The targeted outcomes for the implementation of the proposed activity:
 * <span style="font-family: 'Arial','sans-serif';">Harmonized requirements and standards for public health and patient safety reporting for selected use cases within MU Stages
 * <span style="font-family: 'Arial','sans-serif';">Harmonized implementation guides for public health reporting for selected use cases
 * <span style="font-family: 'Arial','sans-serif';">Unified approach for public health and patient/product safety reporting between clinicians and public health agencies at all levels of government
 * <span style="font-family: 'Arial','sans-serif';">List of PH priorities (business cases) and a Roadmap for HIT standardization for public health and patient/product safety reporting between clinical care and public health agencies
 * <span style="font-family: 'Arial','sans-serif';">List of public health programs for inclusion into MU and S&I Framework Initiatives for Stage 3

<span style="color: #000000; font-family: 'Arial','sans-serif';">9.0 Risks
<span style="font-family: 'Arial','sans-serif';">The following are the risks, challenges and potential obstacles to the success of the S&I Public Health Reporting Initiative activities.

<span style="font-family: 'Arial','sans-serif';">Public Health Community Support (Readiness for Change):


 * __<span style="font-family: 'Arial','sans-serif';">Supporting e-Health Initiatives. __<span style="font-family: 'Arial','sans-serif';"> With the involvement of public health in various discussions about EHR-based information exchanges in the past 10 years, the risk of the public health community not supporting the need for making its information systems interoperable across public health and with clinical systems is low as long as funding and leadership support is available
 * __<span style="font-family: 'Arial','sans-serif';">Facing Technical Challenges. __<span style="font-family: 'Arial','sans-serif';"> Today public health is challenged with how to make the legacy systems interoperable. With the growing understanding of public health informatics and the role of HIT standards, the public health community is long ready for a coordinated approach towards the use of interoperable HIT solutions when available
 * __<span style="font-family: 'Arial','sans-serif';">Automated Detection of Public Health and Patient Safety Events. __<span style="font-family: 'Arial','sans-serif';"> Currently very few, if any, machine-processable solutions for reportable conditions and patient safety reporting are available. Also, the high variance of regulation between states and among federal agencies in different domains further complicates implementation of automated reporting. Every effort should be made to support development of a national knowledgebase of reportable condition/events definitions and jurisdictional requirements

<span style="font-family: 'Arial','sans-serif';">Meaningful Use of HIT:
 * __<span style="font-family: 'Arial','sans-serif';">Siloed Approach. __<span style="font-family: 'Arial','sans-serif';"> MU rules today encourage a siloed approach of electronic exchanges of EHR-Ss with public health. Today, the ongoing MU implementations for MU-selected public health programs/domains (syndromic surveillance, laboratory reporting, immunization) are often conducted without taking into account public health and patient safety information exchanges for other programs/domains. Today’s rule making and HIT certification processes create a risk of promoting duplication of data submission to public health from EHR-Ss for non-MU domains
 * __<span style="font-family: 'Arial','sans-serif';">Data Requirements. __<span style="font-family: 'Arial','sans-serif';"> Public health sometimes has data requirements that extend beyond those typically collected or maintained for clinical use. Some public health functions will be impacted by the gaps in data collected “in the field”

<span style="font-family: 'Arial','sans-serif';">IT Standards Readiness:
 * __<span style="font-family: 'Arial','sans-serif';">HIT Standards for Public Health and Patient Safety __<span style="font-family: 'Arial','sans-serif';">. Standards Development Organizations (SDOs) are mainly focused on developing standards for clinical needs. The limited efforts for developing public health and patient safety HIT standards may keep public health behind clinical care with regards to available standards-based HIT solutions. There are particular concerns regarding the very limited portfolio of testing tools for standards-based public health HIT solutions. Certification capabilities have not been well defined for EHR-S and public health information systems to support public health requirements. Deploying HIT applications without proper testing and certification of their ability to support interoperability standards poses a high risk of those systems not being interoperable in the long run. Public health may not interoperate with clinical care if it lags too far behind the national HIT standardization.

<span style="font-family: 'Arial','sans-serif';">Funding:
 * __<span style="font-family: 'Arial','sans-serif';">HIT Standardization __<span style="font-family: 'Arial','sans-serif';">: Very limited funding is provided today for participation of public health stakeholders in national HIT standardization efforts, including the development of a national knowledgebase of reportable condition/event definitions and jurisdictional requirements. Without proper funding broader development and harmonization of HIT standards for various public health programs are at risk
 * __<span style="font-family: 'Arial','sans-serif';">Deployment of Standard-based HIT Products __<span style="font-family: 'Arial','sans-serif';">: Very limited funding is provided today for the deployment of standards-based HIT solutions in public health. Without proper funding the upgrades of legacy public health information systems to utilize certified standards-based HIT solutions for various public health programs are at risk

<span style="font-family: 'Arial','sans-serif';">Other:
 * __<span style="font-family: 'Arial','sans-serif';">Scope Challenge __<span style="font-family: 'Arial','sans-serif';">: With many diverse public health programs to choose from, there is a danger that this project will broaden its scope too quickly at the expense of a thorough treatment of the subject matter areas within its initial scope.

//<span style="font-family: 'Arial','sans-serif';">Please note that in the first phase of the S&I Public Health Reporting Initiative (2011-2013) we propose to focus on individual level reporting from EHR to public health agencies focusing in initial case report. // =__<span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 14px;">Not engaging in this PH-Reporting Initiative __<span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 14px;">: The risks of not engaging all interested stake holders and continuing the siloed approach of public health related data exchange, be it due to program isolation in the public health realm or the incentivized direction of MU, will leave all public health entities behind, as more and more of their partners will become unable to support the multitude of requested formats and vocabulary. =

<span style="color: #000000; font-family: 'Arial','sans-serif';">Appendix A: Public Health Reporting Examples
<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">The concept of Public Health Reporting encompasses data exchanges on individual cases/events (individual level) and aggregated cases/events (population level) under the following reporting hierarchy: <span style="font-family: 'Arial','sans-serif'; font-size: 14px;">1) Reporting from EHR-systems and consumers to local/state/federal agencies <span style="font-family: 'Arial','sans-serif'; font-size: 14px;">2) Reporting from local and state agencies to federal agencies, and from observational data systems to federal agencies.

<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">Specific examples of Public Health Reporting under this hierarchy are provided below. [The Initiative will <span style="font-family: 'Arial','sans-serif';">initially focus on //individual-patient reporting// from electronic health record-systems (EHR- systems) to public health agencies (local, state and federal) <span style="font-family: 'Arial','sans-serif'; font-size: 14px;">.


 * <span style="font-family: 'Arial','sans-serif'; font-size: 14px;">1) Reporting from EHR and consumers to local/state/federal agencies **

//<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">Examples of the PH Programs //<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">: Communicable diseases (Lab and Case report), Chronic Diseases (Cancer), Immunization, Early Hearing Detection and Intervention (EHDI), Vital Records (VR), AHRQ Patient Safety Network, FDA Product Adverse Event (AE) Reporting (device, drug, biologics and vaccines, tobacco, food), FDA Device/Disease Registry, Occupational health (e.g., silicosis, work-related injury)
 * <span style="font-family: 'Arial','sans-serif'; font-size: 13px;">Individual Case **<span style="font-family: 'Arial','sans-serif'; font-size: 13px;"> **Reporting**
 * //<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">Purpose //**<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">: Care Coordination (Notification of Event for Care/Program Planning, Care Delivery/Transfer of Care, Decision Support on the Case basis)

//<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">Purpose //<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">: Quality of Clinical/PH intervention, PH Surveillance and Decision Support on Hospital/Jurisdiction Basis //<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">Examples //<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">: Geocoded Interoperable Population Summary Exchange (GIPSE) Reports, Syndromic Surveillance, Hospital Reporting to PH Agency, Occupational health (e.g., silicosis, work-related injury)
 * <span style="font-family: 'Arial','sans-serif'; font-size: 13px;">Population-Level (Aggregate) Reporting **<span style="font-family: 'Arial','sans-serif'; font-size: 13px;"> **on a Number of Cases,**


 * <span style="font-family: 'Arial','sans-serif'; font-size: 14px;">2) Reporting between local, state agencies and federal agencies, and between observational data systems and federal agencies **

//<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">Purpose //**<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">: **<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">Notification of Individual Cases //<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">Examples //<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">: Bioterrorism Agents (Categories A,B, and C), Biosurveillance (Biosense – de-identified cases), FDA Product Safety AE reporting (device, drug, biologics and vaccines, tobacco, food)
 * <span style="font-family: 'Arial','sans-serif'; font-size: 14px;">Individual Case **<span style="font-family: 'Arial','sans-serif'; font-size: 14px;"> **Reporting**

//<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">Purpose //<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">: Quality of Clinical/PH intervention, PH Surveillance and Decision Support on Federal Level, Health Statistics, Research //<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">Examples //<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">: Injuries, Immunization, Communicable and Chronic Diseases, EHDI, VR, FDA Sentinel, Professional Organization Reporting to FDA, Medical Countermeasures and Emergencies, Response Network and Surveillance (eLEXNET/[6]FERN[7], LRN[8]), Adverse Event Reporting from Hospitals to Manufacturers and to FDA (devices, drugs, tobacco, biologics), Occupational health (e.g., silicosis, work-related injury)
 * <span style="font-family: 'Arial','sans-serif'; font-size: 13px;">Population-Level (Aggregate) Reporting **<span style="font-family: 'Arial','sans-serif'; font-size: 13px;"> **on a Number of Cases,**

<span style="color: #000000; font-family: 'Arial','sans-serif';">Appendix B: References
<span style="font-family: 'Arial','sans-serif';">Examples of documents to be reviewed under the Public Health Reporting Initiative (in alphabetical order): <span style="font-family: 'Arial','sans-serif';">8. ONC S&I documents 14
 * 1) <span style="font-family: 'Arial','sans-serif';">Agency for Healthcare Research and Quality (AHRQ). Common Formats Project<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">[9]
 * 2) <span style="font-family: 'Arial','sans-serif';">Agency for Healthcare Research and Quality (AHRQ). Registries for Evaluating Patient Outcomes: A User Guide.
 * 3) <span style="font-family: 'Arial','sans-serif';">HITSP Interoperability Specification (IS) #11: Public Health Case Reporting<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">[10]
 * 4) <span style="font-family: 'Arial','sans-serif';">HL7 Public Health Reporting Domain Analysis Model
 * 5) <span style="font-family: 'Arial','sans-serif';">HL7 Public Health Functional Profile<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">[11]
 * 6) <span style="font-family: 'Arial','sans-serif';">IHE Public Health Reporting Integration Profile<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">[12]
 * 7) <span style="font-family: 'Arial','sans-serif';">HL7 Service-Aware Interoperability Framework.<span style="font-family: 'Arial','sans-serif'; font-size: 14px;">[13]

<span style="color: #000000; font-family: 'Arial','sans-serif';">Appendix C: Template for Proposed S&I Public Health Reporting Initiative



 * <span style="font-family: 'Arial','sans-serif'; font-size: 18px;">Appendix D: List of Organizations that reviewed and support this Initiative: **
 * <span style="font-family: 'Arial','sans-serif';">Centers for Disease Control and Prevention (CDC), DHHS
 * <span style="font-family: 'Arial','sans-serif';">US Food and Drug Administration (US-FDA), DHHS
 * <span style="font-family: 'Arial','sans-serif';">Public Health Data Standards Consortium (PHDSC)
 * <span style="font-family: 'Arial','sans-serif';">Public Health Informatics Institute (PHII)
 * <span style="font-family: 'Arial','sans-serif';">North American Association of Central Cancer Registries (NAACCR)
 * <span style="font-family: 'Arial','sans-serif';">National Association of City and County Health Officials (NACCHO)
 * <span style="font-family: 'Arial','sans-serif';">Council of State and Territorial Epidemiologists (CSTE)
 * <span style="font-family: 'Arial','sans-serif';">National Birth Defects Prevention Network

<span style="font-family: 'Arial','sans-serif';">Selective statements of support received during Public Comment period:

<span style="font-family: 'Arial','sans-serif';">Council of State and Territorial Epidemiologists (CSTE): <span style="font-family: 'Arial','sans-serif';">Recognition of this area of activity will help ensure adequate nationwide engagement between a wide range of public health practitioners working in state and local health departments, the clinical community and the health information technology community. The Public Health Reporting Initiative under the ONC S & I Framework will help guide the public health enterprise in a complex and rapidly evolving environment. CSTE is fully supportive of the “development of a national knowledgebase of reportable conditions/events definitions and jurisdictional requirements”. This project has been identified as a need to further support public health reporting but due to a lack of dedicated resources and funding has not been completed; as such, we would strongly encourage the active funding of such efforts. Given the foundational importance of Public Health Reporting to all areas of public health, and the heightened pressures to modernize public health’s approach to information system design and use, CSTE endorses the recognition of the Public Health Reporting Initiative under the ONC S & I Framework and the development of use cases.

<span style="font-family: 'Arial','sans-serif';">The North American Association of Central Cancer Registries, Inc. (NAACCR): <span style="font-family: 'Arial','sans-serif';">The North American Association of Central Cancer Registries, Inc. (NAACCR) strongly supports this initiative and the inclusion of cancer registries.

<span style="font-family: 'Arial','sans-serif'; font-size: 13px;">[1] <span style="font-family: 'Arial','sans-serif';"> Letter of June 16, 2011 from HITPC chairs to the National Coordinator for HIT. <span style="font-family: 'Calibri','sans-serif'; font-size: 13px;">[2] <span style="font-family: 'Arial','sans-serif';">Meaningful Use Stage 1 Final Rule; Federal Registrar; [] <span style="font-family: 'Calibri','sans-serif'; font-size: 13px;">[3] <span style="font-family: 'Arial','sans-serif';">Office of National Coordinator for Health IT (ONC). Standards and Interoperability (S&I) Framework..The L <span style="color: #000000; font-family: 'Arial','sans-serif';">ab Results Interface (LRI) Workgroup’s Public Health Laboratory Reporting Sub-Workgroup. URL: <span style="font-family: 'Arial','sans-serif';">http://wiki.siframework.org/LRI+Public+Health+Lab+Results+WG <span style="font-family: 'Calibri','sans-serif'; font-size: 14px;">[4] <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13px;">Agency for Healthcare Research and Quality (AHRQ).Public health reporting. Technical Support of Network of Patient Safety Databases & Common Formats. Version 1.3; revised January 13, 2010 (working document). <span style="font-family: 'Arial','sans-serif'; font-size: 13px;">[5] <span style="font-family: 'Arial','sans-serif';"> Federal Health IT Strategic Plan 2011-2015. URL; [] <span style="font-family: 'Calibri','sans-serif'; font-size: 14px;">[6] <span style="font-family: 'Arial','sans-serif'; font-size: 13px;"> US Food //and// Drugs Administration (FDA). Electronic Laboratory Exchange Network (eLEXNET). URL: [] <span style="font-family: 'Calibri','sans-serif'; font-size: 14px;">[7] <span style="font-family: 'Arial','sans-serif'; font-size: 13px;">US Food and Drugs Administration (FDA). Food Emergency Response Network (FERN) URL;[] <span style="font-family: 'Calibri','sans-serif'; font-size: 14px;">[8] <span style="font-family: 'Arial','sans-serif'; font-size: 13px;">Centers for Disease Control and Prevention (CDC). Laboratory Response Network (LRN). URL: [] <span style="font-family: 'Arial','sans-serif'; font-size: 13px;">[9] Agency for Healthcare Research and Quality (AHRQ). Common Formats Project. URL: [] <span style="font-family: 'Arial','sans-serif'; font-size: 13px;">[10] <span style="font-family: 'Arial','sans-serif';"> Health Information Technology Standards Panel (HITSP) Interoperability Specification (IS) #11: Public Health Case Reporting. URL: http://www.hitsp.org/InteroperabilitySet_Details.aspx?MasterIS=true&InteroperabilityId=364&PrefixAlpha=1&APrefix=IS&PrefixNumeric=11 <span style="font-family: 'Arial','sans-serif'; font-size: 13px;">[11] <span style="font-family: 'Arial','sans-serif';"> HL7 Public Health Functional Profile. URL: [] <span style="font-family: 'Arial','sans-serif'; font-size: 13px;">[12] <span style="font-family: 'Arial','sans-serif';"> Integrating the Healthcare Enterprise (IHE).Quality, Research and Public Health Committee. Public Health Reporting Integration Profile. URL: http://www.ihe.net/Technical_Framework/upload/IHE_QRPH_Suppl_PH-rpt_Rev1-0_PC_2011-06-17.pdf <span style="font-family: 'Calibri','sans-serif'; font-size: 14px;">[13] <span style="font-family: 'Arial','sans-serif';">HL7 Service-Aware Interoperability Framework. URL: [|www.hl7.org]14 S&I Wiki page at: http://wiki.siframework.org/Introduction+and+Overview

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Comments
**PARTICIPANTS: Add attachments of your comments related to the Public Health Reporting Initiative, below!** Southern Nevada Health District || 9/6/2011 || Public Comments on Charter ||
 * **Name of Attachment** || **Creator** || **Creation** **Date** || **Comments** ||
 * **Comments Received By September 21, 2011** ||  ||   ||   ||
 * [[file:siframework/SI PHReporting-UseCaseSelectionCriteria-09-12-11REVslfcommentv.2.docx|SI PHReporting-UseCaseSelectionCriteria-09-12-11REVslfcommentv.2.docx]] || Seth Foldy || 9/18/2011 || Comment on Use Case Selection Criteria ||
 * **Comments Received by September 6, 2011** ||  ||   ||   ||
 * [[file:siframework/Comments on Proposal for the ONC SI Framework Public Health Reporting Initiative Charter-NIH-NLM.docx|Comments on Proposal for the ONC SI Framework Public Health Reporting Initiative Charter-NIH-NLM.docx]] || Alan Zuckerman || 9/6/2011 || Public Comment on Charter ||
 * [[file:siframework/Response to the proposal for ONC SI Framework Public Health Reporting Initiative_CSTE v3.doc|Response to the proposal for ONC SI Framework Public Health Reporting Initiative_CSTE v3.doc]] || Lisa Ferland || 9/6/2011 || Public Comment on Charter ||
 * [[file:siframework/Response to the proposal for ONC SI Framework Public Health Reporting Initiative_CSTE9-6-2011.doc|Response to the proposal for ONC SI Framework Public Health Reporting Initiative_CSTE9-6-2011.doc]] || John Middaugh
 * [[file:siframework/NAACCR comments on ONC PH Reporting Initiative_20110906.pdf|NAACCR comments on ONC PH Reporting Initiative_20110906.pdf]] || Lori Havener || 9/6/2011 || Public Comments on Charter ||
 * **Comments Received by August 3, 2011** ||  ||   ||   ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_Draft_072711-CIshikawa.docx|PH_Reporting_Initiative_Charter_Draft_072711-CIshikawa.docx]] || Charlie Ishikawa || 8/3/2011 || Comments on Draft Charter ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_Draft_072711-nha.docx|PH_Reporting_Initiative_Charter_Draft_072711-nha.docx]] || Noam Arzt || 8/3/2011 || Comments on Draft Charter ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_Draft_072711-nha-bbrand.docx|PH_Reporting_Initiative_Charter_Draft_072711-nha-bbrand.docx]] || Bill Brand || 8/3/2011 || Comments on Draft Charter ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_Draft_072711SDanos.docx|PH_Reporting_Initiative_Charter_Draft_072711SDanos.docx]] || Scott Danos || 8/3/2011 || Comments on Draft Charter ||
 * **Comments Received by August 10, 2011** ||  ||   ||   ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_Draft_080411_NL.docx|PH_Reporting_Initiative_Charter_Draft_080411_NL.docx]] || Nikolay Lipskiy || 8/4/2011 || Comments on Draft Charter ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_Draft_0727-2011-_FDA-AUG09.docx|PH_Reporting_Initiative_Charter_Draft_0727-2011-_FDA-AUG09.docx]] || Kosta <span style="font-family: 'Tahoma','sans-serif'; font-size: 13px;">Makrodimitris || 8/9/2011 || Comments on Draft Charter ||
 * [[file:siframework/Comments to Be Discussed at the Call on 8-10-11-bbrand.doc|Comments to Be Discussed at the Call on 8-10-11-bbrand.doc]] || Bill Brand || 8/9/2011 || Comments on Compiled Comments Document ||
 * [[file:siframework/Comments to Be Discussed at the Call on 8-10-11-jodden.doc|Comments to Be Discussed at the Call on 8-10-11-jodden.doc]] || John Odden || 8/10/2011 || Comments on Compiled Comments Document ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_Draft_072711 - Erin.docx|PH_Reporting_Initiative_Charter_Draft_072711 - Erin.docx]] || Erin Fitzsimmons || 8/15/2011 || Comments on Draft Charter ||
 * **Comments Received after August 10, 2011** ||  ||   ||   ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_Draft_slf v2-AOCombined-bb.docx|PH_Reporting_Initiative_Charter_Draft_slf v2-AOCombined-bb.docx]] || Bill Brand || 8/16/2011 || Comments on Draft Charter ||
 * [[file:siframework/PH_Reporting_Initiative_Charter_Draft_slf v2.docx|PH_Reporting_Initiative_Charter_Draft_slf v2.docx]] || Seth Foldy || 8/16/2011 || Comments on Draft Charter ||