Wednesdays With PHRI… An Informational Webinar Series Session 3 April 16, S&I = S TANDARDS AND I NTEROPERABILITY F RAMEWORK PHRI = P UBLIC H EALTH R EPORTING I NITIATIVE

Policy Framework for Standardization An Informational Webinar Series Session 3: o Health IT Standards and Standardization Process o ONC's Strategy on Public Health in the Standards & Interoperability (S&I) Framework

Agenda TopicTime Allotted Welcome/Introductions, Walter Suarez, Moderator 4:00 – 4:05 Policy Framework for Standardization, Health IT Standards and Standardization Process, Anna Orlova ONC's Strategy on Public Health and the Standards & Interoperability (S&I) Framework, John Saindon and Jim Daniel 4:05 – 4:45 Questions and Answers4:45 – 4:59 Adjourn5:00

Anna Orlova Public Health Data Standards Consortium and Johns Hopkins University

Wednesdays With PHRI: Webinar 3 Policy Framework for Standardization, Health IT Standards and Standardization Process

“Today, more than ever, standards are an imperative undertaking. Standards are the building blocks for innovation and competitiveness. Our nation’s ability to compete and lead in a rapidly changing global economy is closely related to our leadership in the development and effective use of standards and standardization processes. Standards provide the common language that keeps domestic and international trade flowing. It is difficult to overestimate their critical value to both the U.S. and global economy. “ — Patrick Gallagher, Director of the National Institute of Standards and Technology, 2010 United States Standards Strategy, United States Standards Strategy Committee. At: edition/USSS% sm.pdf edition/USSS% sm.pdf Standards are the Building Blocks for Innovation and Competitiveness Source: Centers for Disease Control and Prevention (CDC). Presentation by Dr. N. Lipskiy on Public Health Data Standards: Federal Laws and Regulations at the National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Standards. November 12, 2013

A series of statutes, regulations, and administrative orders comprise the legal framework that defines the Federal government’s use of standards, and its participation in the development of standards. Statutes and administrative requirements that contain provisions addressing standardization policies, standards development, use, and related government engagement include: National Technology Transfer and Advancement Act (NTTAA) of Office of Management and Budget (OMB) Circular A-119 of Federal Engagement in Standards Activities to Address National Priorities. Background and Proposed Policy Recommendations. Subcommittee on Standards, National Science and Technology Council of Principles for Federal Engagement in Standards Activities to Address National Priorities. Memorandum from Executive Office of the President for Heads of Executive Departments and Agencies of National Legal Framework and Policies for Standardization Source: Dr. Nikolay Lipskiy, CDC 1. National Technology Transfer and Advancement Act (NTTAA). URL: 2. Office of Management and Budget (OMB). Circular A-119, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities. URL: 3. Executive Office of the President. National Science and Technology Council. Federal Engagement in Standards Activities to Address National Priorities. Background and Proposed Policy Recommendations Subcommittee on Standards. Washington, DC. October 10, URL: Principles for Federal Engagement in Standards Activities to Address National Priorities. Executive Office of the President, Office of Management and Budget, United States Trade Representative, Office of Science and Technology Policy. Memorandum for for Heads of Executive Departments and Agencies, URL:

National Technology Transfer and Advancement Act of 1995 (NTTAA) 1. The NTTAA’s goal is to adopt voluntary consensus standards, wherever possible, in lieu of creating proprietary, non-consensus standards by federal agencies 1 2. NTTAA directs:  federal agencies with respect to their use of and participation in the development of voluntary consensus standards  the National Institute of Standards and Technology (NIST) to coordinate the standards and conformity assessment activities of federal agencies, as well as state and local governments with the private sector in order to reduce unnecessary duplication and complexity of conformity assessment schemes 3. Progress towards accomplishing NTTAA aims is summarized in annual reports prepared by NIST, in collaboration with the Interagency Committee on Standards Policy (ICSP). National Technology Transfer and Advancement Act (NTTAA). URL: Source: Centers for Disease Control and Prevention (CDC). Presentation by Dr. N. Lipskiy on Public Health Data Standards: Federal Laws and Regulations at the National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Standards. November 12, 2013

OMB Circular No A-119 Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities The OMB Circular No A-119 for Heads of Executive Departments and Agencies: 1. Guides Federal agencies on the NTTAA implementation 2. Establishes policies on Federal use and development of voluntary consensus standards and on conformity assessment activities 3. Establishes reporting requirements, and authorized the National Institute of Standards and Technology (NIST) to coordinate conformity assessment activities of the agencies 4. Issues guidance on responsibilities of Agency Heads and Agency Standard Executives in development and implementation of standards. Office of Management and Budget (OMB). Circular A-119, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities. URL: Source: Centers for Disease Control and Prevention (CDC). Presentation by Dr. N. Lipskiy on Public Health Data Standards: Federal Laws and Regulations at the National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Standards. November 12, 2013

Guidance on National Standardization Policies 1.Federal executive departments and administrative agencies write standardization policies and regulations to implement the authority of laws. They act in a scope that is authorized by Congress. 2. The Office of the President, as authorized by Congress, guides the U.S. government to coordinate agency standards activities and engagement recognizing the integrity of the existing U.S. standards process, guides agencies on their roles as active participant in standards development and as user of the standards for regulation and procurement 1,2 3. Government Leadership in Select Technology Areas. “In a limited number of specific cases, such as cybersecurity, health IT, smart grid and public safety communications, the Federal government has taken on a leadership role in private sector standards development.” 3 Based on the federal regulatory guidance, federal agencies, acting in a scope of their authority, shell coordinate and lead development of data standards that used in health IT area. CDC takes a leadership in health IT standardization in a scope of it’s authority “to protect America from health, safety and security threats, both foreign and in the U.S..” 4 Sources: 1. Executive Office of the President. National Science and Technology Council. Federal Engagement in Standards Activities to Address National Priorities. Background and Proposed Policy Recommendations Subcommittee on Standards. Washington, DC. October 10, URL: Principles for Federal Engagement in Standards Activities to Address National Priorities. Executive Office of the President, Office of Management and Budget, United States Trade Representative, Office of Science and Technology Policy. Memorandum for Heads of Executive Departments and Agencies, URL: Principles for Federal Engagement in Standards Activities to Address National Priorities. Executive Office of the President, Office of Management and Budget, United States Trade Representative, Office of Science and Technology Policy. Memorandum for Heads of Executive Departments and Agencies, p. 6. URL: About CDC. Mission, Role and Pledge. URL: Source: Centers for Disease Control and Prevention (CDC). Presentation by Dr. N. Lipskiy on Public Health Data Standards: Federal Laws and Regulations at the National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Standards. November 12, 2013

Publishing the CDC Report on NTTAA/ OMB Circular A-119 Implementation CDC annual reports on implementation of NTTAA and OMB Circular A-119 are included into the HHS reports to NIST/OMB They are published by NIST at through the agencies’ reporting tool (URL: They include information on implementation of data standards Source: Centers for Disease Control and Prevention (CDC). Presentation by Dr. N. Lipskiy on Public Health Data Standards: Federal Laws and Regulations at the National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Standards. November 12, 2013

Wednesdays With PHRI: Webinar 3 Policy Framework for Standardization, Health IT Standards and Standardization Process

Standards World S&I Framework

Developed in 2009 through the CDC Cooperative Agreement. Standards and Standardization Public Health Data Standards Consortium (PHDSC). Business PHDSC Business Case on the Role of Public Health in HIT Standardization URL:

Health IT Standards Categories 1.Data Standards 2.Information Content Standards 3.Information Exchange Standards 4.Identifiers Standards 5.Privacy and Security Standards 6.Functional Standards 7.Other, e.g., Business Standards This classification of HIT standards types has been developed by the Health Information Technology Standards Panel (HITSP, in 2006www.hitsp.org

Standards for Biosurveillance Use Case Biosurveillance Use Case Charge: "Transmit essential data from electronically enabled healthcare to authorized public health agencies in real-time." Health Information Technology Standards Panel (HITSP). Biosurveillance Interoperability Specification (IS-02). URL:

Standards for Biosurveillance Use Case Health IT Standards Categories: 1.Data Standards 2.Information Content Standards 3.Information Exchange Standards 4.Identifiers Standards 5.Privacy and Security Standards 6.Functional Standards 7.Other, e.g., Business Standards Total Health Information Technology Standards Panel (HITSP). Biosurveillance Interoperability Specification (IS-02). URL:

Health IT Standardization Phases & Entities Priority Setting Standard Development and Maintenance Standards Harmonization Standards Testing Standards Certification Standards Adoption

Health IT Standardization Phases & Entities Priority Setting Standard Development and Maintenance Standards Harmonization Testing Standards Certification Standards Adoption Standards Development Organizations (HL7, INTSDO, LOINC, DICOM, CDISC,X12, etc.) Past: Health Information Technology Standards Panel (HITSP) Now: Integrating Healthcare Enterprise (IHE) ONC Standards and Interoperability (S&I) Framework ONC Authorized Certification Bodies Past: American Health Informatics Community (AHIC) Now: HIT Policy Committee & HIT Standards Committee US

PHDSC Business Case: HIT Standardization Phases, Products and Entities HIT Standardization Phases Needs & Priorities Development & Maintenance Selection & Harmonization Testing/Trial Implementation CertificationDeployment Goals What should be accomplished ? What are the standards? What standards to use? Show what can be accomplished Certify standards- based products Deploy standards- based products HIT Standards and Interoperability Framework Development Entities HIT Policy Committee HIT Standards Committee (Formerly AHIC, to be superseded pending ONC decisions) SDOs (e.g., HL7, SNOMED (IHTSDO), LOINC, ASC X12, NUBC, ISO TC215) IHE ONC S&I Framework, e.g., Public Health Reporting Initiative (PHRI) IHE Connectathon ONC Authorized Certification Entities (e.g., Drummond Group, Inc) ONC S&I Pilot Projects PHDSC- CDC Pilot Projects Standards Documents Use Cases (Description of the health information exchanges) Standards Interoperability Specifications Technical Frameworks Integration Profiles Test Reports Certification Criteria Certified Products List Deployment Reports Public Health Data Standards Consortium (PHDSC). Business PHDSC Business Case on the Role of Public Health in HIT Standardization URL:

PHDSC Business Case: HIT Standardization Phases, Products and Entities HIT Standardization Phases Needs & Priorities Development & Maintenance Selection & Harmonization Testing/Trial Implementation CertificationDeployment Goals What should be accomplished ? What are the standards? What standards to use? Show what can be accomplished Certify standards- based products Deploy standards- based products HIT Standards and Interoperability Framework Development Entities HIT Policy Committee HIT Standards Committee (Formerly AHIC, to be superseded pending ONC decisions) SDOs (e.g., HL7, SNOMED (IHTSDO), LOINC, ASC X12, NUBC, ISO TC215) IHE ONC S&I Framework IHE Connectathon ONC Authorized Certification Entities (e.g., Drummond Group, Inc) ONC S&I Pilot Projects PHDSC- CDC Pilot Projects Standards Documents Use Cases (Description of the health information exchanges) Standards Interoperability Specifications Technical Frameworks Integration Profiles Test Reports Functional Profiles Certification Criteria Certified Products List Deployment Reports Based on the standards-readiness assessment, the Community-led Public Health Reporting Initiative, ONC S&I Framework identified 7 domains (in purple ovals) that had been working on standardization of public health reporting. HAI Adverse Event Reporting Admin Data Reporting Early Hearing Detection and Intervention (EHDI) Infectious Diseases: Initial Case and Lab Reporting Cancer Vital Records Immunization Obesity Occupational Health

Public Health Reporting Initiative (PHRI) Standards and Interoperability (S&I) Framework, Office of the National Coordinator for Health IT: URL: Charter/Scope Summary The PHRI develops and implements a standardized approach to electronic public health reporting from EHR systems to local, state and federal public health programs that addresses the needs of various 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. This is a Community-Lead Initiative Leadership Team Co-leads: Dina Dickerson, Riki Merrick, Anna Orlova, and Walter Suarez Current Status Artifacts completed by the PHRI Phase I (September 2011-June 2013) to date include: –Public Health Reporting Initiative Reference Implementation Framework – Reference document on interoperability standards for several public health programs –PHRI CDA Guide - Specifies CDA structure for public health report for Communicable Diseases and Adverse Events –PHRI Standards Testing and Pilots Demonstration – A PHRI web page with documentation on testing or pilot projects demonstrating the use of interoperability standards referenced in the PHRI Reference Implementation Framework In June-September 2013, PHRI continued coordinating its work with the Structured Data Capture Public Health Tiger Team (SDC PH Tiger Team) to plan SDC pilot projects for three domains/programs included in the PHRI Reference Implementation Framework: Early Hearing Detection and Intervention (EHDI), Cancer Surveillance, and Communicable Disease Reporting. EHDI (a collaboration between PHRI and CDC EHDI Program) was selected as the top program by the SDC PH Tiger Team to move forward piloting. On September 25, 2013 PHRI started Phase II (September 2013 – August 2014) that will focus on –the analysis of new user stories for public health reporting and bi-directional data exchange between clinicians and public health –harmonization of data sets across these stories –analysis and harmonization of standards to support data exchanges under these stories and –educational campaign Wednesdays with PHRI to raise awareness of the use of interoperability standards in the different areas of Public Health and the intersection with other areas of healthcare PHRI will continue collaborative support for the SDC PH Tiger Team and will also reach out to other S&I Initiatives in support of their work related to public health.

Resources on Health IT Standards and Standardization URL:

Resources on Health IT Standards and Standardization URL:

Standards and Interoperability Public Health Tiger Team (PHTT) Jim Daniel, MPH John Saindon, DrHSc, MT Public Health Lead Health Scientist ONC CDC 25

S&I: Public Health Tiger Team (PHTT) 26 Standards and Interoperability: Public Health Tiger Team Data Access Framework (DAF) Structured Data Capture (SDC) Clinical Quality Framework (CQF)

Why consolidate into PHTT? Best use of resources and time Assurance that these initiatives will have Public Health Representation Strengthened partnership between community and vendor based partners SDC/DAF/HeD work in parallel with each other 27

S&I Framework Overview Specific health interoperability initiatives guide the design and development of a fully integrated and connected health information system. An S&I Initiative focuses on a single challenge with a set of value-creating goals and outcomes, and the development of content, technical specifications and reusable tools and services. Call for Participation: The overall success of the S&I Framework is dependent upon volunteer experts from the healthcare industry and we welcome any interested party to get involved in S&I Framework Initiatives, participate in discussions and provide comments and feedback by joining the Wiki: 28

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Structured Data Capture Data Architecture Infrastructure will consist of four new standards that will enable EHRs to capture and store structured data: 1.Standard for the CDEs that will be used to fill the specified forms or templates 2.Standard for the structure or design of the form or template (container) 3.Standard for how EHRs interact with the form or template 4.Standard to auto-populate form or template 30 Standards will facilitate the collection of data so that any researcher, clinical trial sponsor, reporting and/or oversight entity can access and interpret the data in electronic format Will leverage existing standards such as XML and CDISC Retrieve Form for Data Capture (RFD) Standards will facilitate the collection of data so that any researcher, clinical trial sponsor, reporting and/or oversight entity can access and interpret the data in electronic format Will leverage existing standards such as XML and CDISC Retrieve Form for Data Capture (RFD) 30

EHR PH Form Sample Types of Reporting Quality Resear ch Public Health Case Reporting (Pilot CDA) EHR and SDC Model ELR Immunization Cancer CDA Forms Repository Request Form (CDISC RFDC) Deliver Form Deliver data from form {Format Type, TBD} Example Types of Reporting CDEs Meta Data Business Logic Define Forms 31

HeD - Use Case 1

Where can you support? PHTT: Participate in weekly collaborative meetings SDC-PH: –mapping of CDEs into SDC format –Pilot site for proposed use case (FUNDING Recommendations) DAF-PH: Pilots/PH Use Cases CQF-PH: Pilots/PH Use Cases 35

PH TT Contact Information ONC Public Health Lead: Jim (James) Daniel CDC Public Health Lead: John M. Saindon PHTT Wiki Page: SDC Wiki Page: DAF Wiki Page: HeD Wiki Page: CQF Wiki Page Weekly PHTT Meeting Info (Tuesdays): Time: 2:00pm - 3:00pm Eastern URL: Dial-In Number: Access Code:

Thank you for your support. Q/A? 37 Standards and Interoperability: Public Health Tiger Team Data Access Framework Structured Data Capture Health eDecisions/CQF

Questions?