Nikolay Lipskiy, MD, DrPH, MBA

1. E10: Working towards Health It Standards for Public Health Reporting: Report From the Public Health Laboratory Results Workgroup of the ONC S&I Framework Riki Merrick, MPH Nikolay Lipskiy, MD, DrPH, MBA Association of Public Health Laboratories/ iConnect Consulting Moderator - CDC Anna Orlova, PhD PHDSC Bill Brand, MPH Public Health Informatics Institute

2. Panel Outline • ONC Standards & Interoperability (S&I) Framework, Laboratory Results Interface (LRI) Initiative : Public Health Laboratory Result Workgroup • S&I Community Led Public Health Reporting Initiative: Charter • Q&A and Discussion on Selecting Use Cases for the S&I Public Health Reporting Initiative

3. American Recovery and Reinvestment Act (ARRA) • Feb 17, 2009 – signed • ARRA includes Health Information Technology for Economic and Clinical Health Act (the HITECH Act) for advancing the meaningful use (MU) of health information technology (HIT) to improve quality of care and establish a foundation for health care reform • ARRA created 2 Federal Advisory Committees: • Health IT Policy Committee • Health IT Standards Committee http://www.recovery.gov/About/Pages/The_Act.aspx

4. American Recovery and Reinvestment Act (ARRA) • Meaningful Use (MU) of HIT and Public Health In 2010 HIT Policy and HIT Standards Committees identified three types of public health reporting that were adopted for Stage 1 of the HITECH-funded CMS Incentive Program: Capability to submit electronic data to public health agencies for •  syndromic surveillance • immunization registries •  reportable (as required by state or local law) lab results http://www.recovery.gov/About/Pages/The_Act.aspx

5. About ONC S&I Framework National Coordinator for Health IT Deputy National Coordinator for Programs & Policy Office of Economic Analysis & Modeling Office of the Chief Privacy Officer Deputy National Coordinator for Operations Office of the Chief Scientist Office of Policy & Planning • The Standards and Interoperability (S&I) Framework is a forum –enabled by integrated functions, processes, and tools – for implementers and experts to achieve harmonized interoperability for healthcare information exchange • It represents one investment and approach adopted by the Office of Standards & Interoperability to fulfill its charge of enabling harmonized interoperability specifications to support national health outcomes and healthcare priorities, including Meaningful Use, the Nationwide Health Information Network, etc. Office of Standards & Interoperability Office of Provider Adoption Support Office of State & Community Programs

6. ONC S&I Framework Source: http://wiki.siframework.org/S%26I+Framework+Functions

7. ONC S&I Framework • An S&I Initiative focuses on a single challenge with a set of value-creating goals and outcomes that will enhance efficiency, quality and effectiveness of the delivery of healthcare, through the development of content, technical specifications and reusable tools and services. • Current Initiatives include: • Transition of Care (TOC) • Lab Results Interface (LRI) • Provider Directory • Query Health http://wiki.siframework.org

8. ONC S&I Lab Results Interface (LRI) Initiative • Mission: • To enable ambulatory primary care physicians to receive and meaningfully use standardized structured electronic lab results • Focus: • Establish the nationwide Implementation Guide for electronic submission of Lab Results to Ambulatory EHRs • Build on existing HL7 2.5.1-based lab reporting guides • Incremental approach: ambulatory use case today, others later • Initiative Objectives: • EHR and LIS vendors agree that they can implement and use the IG while minimizing intermediaries, customization and translation • Providers adopt EHRs that conform to the LRI IG, facilitated by Meaningful Use, State HIEs, RECs, and broad product availability 1Office of National Coordinator for Health IT (ONC). Standards and Interoperability (S&I) Framework..The Lab Results Interface (LRI) Workgroup’s Public Health Laboratory Reporting Sub-Workgroup. http://wiki.siframework.org/Lab+Results+Interfacte+(LRI)+Initiative

9. ONC S&I Lab Results Interface (LRI) Initiative • LRI Initiative Working Groups • Use Case and Requirements • Architecture and Implementation Requirements • Vocabulary • Implementation Guide (IG) Analysis • Public Health Laboratory Results • Pilots • Validation Suite

10. ONC S&I LRI Public Health Laboratory Results Workgroup • Purpose • Outline the path forward that will harmonize the laboratory data exchange between public health and clinical care with the Lab Reporting Interface specification. • Develop roadmap to incorporate the Public Health HL7 implementation guide and define a path forward for harmonization. • Deliverables • Public Health Abbreviated use case2 • Required elements in ELR guide table3 • Guide variance analysis including ELR guide4 1Office of National Coordinator for Health IT (ONC). Standards and Interoperability (S&I) Framework..The Lab Results Interface (LRI) Workgroup’s Public Health Laboratory Reporting Sub-Workgroup. URL: http://wiki.siframework.org/LRI+Public+Health+Lab+Results+WG 2http://wiki.siframework.org/file/view/HHS_ONC_Public%20Health%20Reportable%20Lab%20Results%20_Abbreviated%20Use%20Case_FINAL_v%201%200_061511.docx 3http://wiki.siframework.org/file/view/ONC_PH_RequiredFieldsinELR251_DRAFT_v0.3.xls 4http://wiki.siframework.org/file/view/LRI%20Matrix%20Including%20Public%20Health

11. S&I Framework Lab Results Interfaces (LRI) Initiative: Outcomes and Next Steps Outcomes: • Consensus on new HL7 2.5.1-based IG, with some elements of HL7 2.6/2.7 pre-adopted (balloting expected in September) • IG approach enables flexibility for future harmonization with ELR Guide, while using “profiles” to enable constrained guidance today • Consensus on use of SNOMED CT & LOINC as vocabularies • Use of UCUM vocabulary for Units of Measure and SNOMED for specimen information is subject to pilots • Presented findings to HIT Standards Committee for consideration as a recommended standard for Meaningful Use Stage 2 Next Steps: • Limited Production Implementations (“pilots”) planning underway • Community-driven PH effort has formed, and is focused on creating a charter that will be presented to ONC in September.

12. S&I LRI Initiative Wiki Screenshot http://wiki.siframework.org/Lab+Results+Interface+%28LRI%29+Initiative

13. ONC S&I LRI Public Health Laboratory Results Workgroup Identifies the Need for an New Initiative • During the June S&I Face-to-Face meeting the LRI Public Health Laboratory Results Workgroup recognized the need for harmonization of Health IT standards for data exchanges for public health programs beyond three public health domains in MU Stage 1 warranting the creation of a new community led initiative on Public Health Reporting Office of National Coordinator for Health IT (ONC). Standards and Interoperability (S&I) Framework..The Lab Results Interface (LRI) Workgroup’s Public Health Laboratory Reporting Sub-Workgroup. URL: http://wiki.siframework.org/LRI+Public+Health+Lab+Results+WG

14. S&I Community Led Public Health Reporting Initiative • Purpose: The purpose of the community led initiative is to gather Public Health Reporting experts to determine the scope for a potential Public Health Initiative, based on the needs of the Public Health Community. Once the scope and charter have been determined, it will be presented as a potential S&I initiative to stakeholder agencies (e.g., ONC, CDC, and possibly others) in an effort to obtain agency support for addressing initiative objectives. • Charge: The S&I community led Public Health Reporting Initiative will develop and implement a standardized approach to electronic public health reporting from electronic health record (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. http://wiki.siframework.org/Public+Health+Reporting+Initiative

15. Proposed S&I Public Health Reporting Initiative • Addressing Interoperability Challenges: • Lack of harmonized activities to enable electronic data exchange between clinical and population care and across public health agencies • No consistent unified practice on reporting public health cases/events and patient safety, product safety/ effectiveness events http://wiki.siframework.org/Public+Health+Reporting+Initiative

16. Proposed S&I Public Health Reporting Initiative • Addressing Interoperability Challenges (Continued): • Actions are needed for: • A Unified Approach for harmonization of public health business processes and functional requirements for public health information systems; and • Inclusion of Public Health in the full array of activities under the S&I Framework (standards harmonization and testing; standards-based product certification and deployment ) http://wiki.siframework.org/Public+Health+Reporting+Initiative

17. Proposed S&I Public Health Reporting Initiative • Goal: The goal of the community led S&I Public Health Reporting Initiative is to harmonize HIT standards and implementation guides for bi-directional communication between clinical care and public health entities for selected use cases.   http://wiki.siframework.org/Public+Health+Reporting+Initiative

18. Proposed S&I Public Health Reporting InitiativePublic Health Domains (Programs) The public health domains that will be considered may include but are not limited to: • Maternal and child health (e.g., early hearing detection and intervention (EHDI); vital records) • Communicable diseases • Chronic disease (e.g., cancer, diabetes) • Immunization • Injury • Occupational safety and health • Adverse event reporting (drugs, biologics, devices, tobacco, foods) • Medical countermeasures and emergencies • Surveillance (e.g., syndromic surveillance, biosurveillance, surveillance administered by FDA)

19. Proposed S&I Public Health Reporting Initiative • Timeframe: The S&I Public Health Reporting Initiative will operate starting October 2011 through December 2013 and will strive to deliver deliverables for timely consideration of the HIT Standards Committee during FY 2013 for MU Stage 3 http://wiki.siframework.org/Public+Health+Reporting+Initiative

20. Proposed S&I Public Health Reporting Initiative • Scope: At first, the Initiative will focus on individual-patient reporting from EHR systems and patients/consumers to public health agencies (local, state and federal) for the Initial Case reports. Initial Case Report Local/State/ Federal PH Provider EHR http://wiki.siframework.org/Public+Health+Reporting+Initiative

21. Proposed S&I Public Health Reporting Initiative • Milestones: The S&I Public Health Reporting Initiative will • examine several reporting use cases that share similar business processes, information exchange requirements and data requirements • Select and harmonize standards, develop harmonized implementation guide(s), reference implementation(s) (testing) and certification criteria and processes for these use cases to be considered for MU Stage 3 • 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 • develop a Roadmap for HIT Standardization for public health reporting http://wiki.siframework.org/Public+Health+Reporting+Initiative

22. Proposed S&I Public Health Reporting Initiative • Milestones (Continued): In the first three months (Fall 2011) the Initiative will focus on: • Building a Consensus on Public Health Reporting Definitions • Building a Consensus on Public Health Reporting HIT Standardization Framework • Assessing Various S&I Initiatives in which public health has to be involved and designate representatives to these initiatives • Selecting Priorities & Establishing Timeline for short-term (ready by December 2013) and longer-term harmonization and testing of standards and specifications for public health reporting, and • Developing a Detailed Workplan for the Initiative activities in 2012-2013. http://wiki.siframework.org/Public+Health+Reporting+Initiative

23. Proposed S&I Public Health Reporting Initiative • Examples of Standards: • Data Standards (Vocabularies & Terminologies, e.g. LOINC, HL7, SNOMED, UCUM, X12) • Information Content Standards (HL7 Reference Information Model (RIM)/Federal Health Information Model (FHIM)) • Information Exchange Standards (e.g. HL7 V2.x; HL7 CDA, ICSR V3.0) • Privacy & Security Standards • Identifier Standards (e.g. NPI) • Functional Standards (IHE, HL7) • Business Process Standards (e.g. BPMN, BPEL, UML) • Interoperability Specifications (ONC S&I guides, HITSP, IHE Profiles) http://wiki.siframework.org/file/view/Charter%20Template_PH_Reporting_080911.pptx – template http://wiki.siframework.org/file/view/PH_Reporting_Initiative_Charter_Draft_072711.docx - word document

24. Proposed S&I Public Health Reporting InitiativeProposed Stakeholders • Centers for Disease Control and Prevention (CDC), DHHS • US Food and Drug Administration (US-FDA), DHHS • Agency for Healthcare Quality and Research (AHRQ), DHHS • Health Resources and Services Administration (HRSA), DHHS • ONC Initiatives including Federal Health Interoperability Modeling and Standards Initiative /FHA/FHIMS, S&I Framework Initiatives (TOC, LRI and others) • State Public Health Departments and Laboratories • Public Health Data Standards Consortium (PHDSC) • Public Health Informatics Institute (PHII) • Joint Public Health Informatics Task Force (JPHIT) • Association of Public Health Laboratories (APHL) • Association of State and Territorial Health Officials (ASTHO) • Council of State and Territorial Epidemiologists (CSTE) • International Society for Disease Surveillance (ISDS) • National Association of City and County Health Officials (NACCHO)

25. Proposed S&I Public Health Reporting InitiativeProposed Stakeholders (Continued) • American Immunization Registry Association (AIRA) • American Clinical Laboratory Association (ACLA) • North-American Association of Central Cancer Registries (NAACCR) • American Health Information Management Association (AHIMA) • National Association of Health Data Organizations (NAHDO) • Health Information and Management Systems Society (HIMSS) • Standards Development Organizations and Standardization Entities, e.g., Health Level Seven (HL7), Integrating the Healthcare Enterprise (IHE), Clinical Data Interchange Standards Consortium (CDISC) and other • EHR Vendors Association • Laboratory Information Systems Vendors Association • Others http://wiki.siframework.org/file/view/Charter%20Template_PH_Reporting_080911.pptx – template http://wiki.siframework.org/file/view/PH_Reporting_Initiative_Charter_Draft_072711.docx - word document

26. Proposed S&I Public Health Reporting Initiative • Charter Developed by the S&I Initiative Group (Sprint Team) during July-August, the Charter describes the Initiative http://wiki.siframework.org/Public+Health+Reporting+Initiative

27. Proposed S&I Public Health Reporting Initiative • PARTICIPATE in the Public Review August 19 – September 5 http://wiki.siframework.org/Public+Health+Reporting+Initiative

28. Proposed S&I Public Health Reporting Initiative PARTICIPATE in the Public Review

29. Proposed S&I Public Health Reporting Initiative Timeline to Launch the Initiative

30. Potential Use /Business Cases

31. Proposed S&I Public Health Reporting Initiative Wiki http://wiki.siframework.org/Lab+Results+Interface+%28LRI%29+Initiative

32. Proposed S&I Public Health Reporting Initiative Participate in Public Review and Join the S&I Initiative Group to Finalize the Charter E-mail to Wendy Scharber at wendy@phdsc.org http://wiki.siframework.org/Public+Health+Reporting+Initiative