Health Information Technology Standards and Systems Interoperability

In April 2004, President Bush’s Executive Order No.13335 (1) established the Office of National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS) to coordinate health information technology adoption (2). The vision is to develop a Nationwide Health Information Network (NHIN or NwHIN) of regional Health Information Exchanges (HIEs) connecting electronic health record systems (EHR-Ss) deployed in clinical practices with each other and with other systems required to support the healthcare system. The 2008-2012 ONC Coordinated Federal HIT Strategic Plan (3) focused on two goals: Patient-focused Healthcare to enable the transformation to higher quality, more cost-efficient health care through electronic health information access and use by care providers, and by patients and their designees; and Population Health to enable the appropriate, authorized, and timely access and use of electronic health information to benefit Public Health, biomedical research, quality improvement and emergency preparedness. The Plan is based on four objectives: Collaborative Governance; HIT Adoption, Privacy and Security and Interoperability, i.e., the ability of different information systems to communicate (exchange) data accurately, effectively and consistently (4). The Health Information Technology for Economic and Clinical Health (HITECH) Act of the American Recovery and Reinvestment Act of 2009 (ARRA (5)), is aimed at advancing HIT by supporting the adoption and “meaningful use” of certified electronic health record systems through incentive payments to eligible professionals (physicians and hospitals) (6). Recipients of these incentive payments may be required to report clinical, and quality measures to demonstrate accountability for achieving the meaningful use parameters promised. In addition, the EHR-S technology adopted under these provisions must be compatible with State or Federal administrative management systems (7). The updated Federal Health IT Strategic Plan defines national goals for HIT adoption through 2015 (8). Public health data systems are created to support the specific needs of certain program areas i.e., newborn screening, birth defects, immunization, communicable disease surveillance, injury prevention, bioterrorism, etc. Systems maintained by these programs are populated with data reported by health care providers usually using paper-forms. These “silo”-type public health data systems may deploy certain software products that are often custom-made to serve particular programmatic needs and are not interoperable across health departments. Lack of integration and interoperability across public health program systems leads to the inefficient use of resources and frustration among families and providers asked to provide the same information on multiple forms of varying formats to various programs. The current systems do not allow easy aggregation of patient’s information to provide real-time data back to the provider’s office and to conduct research. Because of the automation of clinical data – inpatient and increasingly outpatient – via the EHR systems (EHR-S), public health programs stand at the threshold of change in the way in which they can gather and analyze programmatic data. The EHR is a pivotal instrument in integrating clinical and public health data systems - EHR-PH systems, so public health authorities will have reliable, real-time access to patient data to support health policy decisions for disease prevention interventions. The EHR-based bi-directional data interchange between clinical and public health settings will improve care coordination, healthcare resources allocation and healthcare delivery planning for better and safer care. The integrated EHR-PH systems will become the backbone of a National Health Information Network and regional health information exchanges (RHIEs). To facilitate the development of interoperable EHR-PH systems there is a need for standardization of health information exchanges across the clinical and public health enterprise. The National Health Information Technology Standards Panel (HITSP) (9) identified the following categories of standards for system interoperability:

1. Data content standards, i.e., vocabularies and terminology standards
2. Information content standards, i.e., Reference Information Models (RIMs)
3. Information exchange standards, e.g., messaging standards
4. Identifier standards, e.g., National Provider Identifier (NPI) standard
5. Privacy and security standards
6. Functional standards, i.e., workflow/dataflow standards
7. Other, e.g., information technology infrastructure standards.

The HIT standardization process consists of the following six phases:

1. Identify HIT Interoperability Needs and Priorities
2. Develop and Maintain Standards
3. Select and Harmonize Standards
4. Test Standards Interoperability (Trial Implementations)
5. Certify Interoperable HIT Products
6. Deploy Interoperable HIT Products

Various public and private entities have been created to carry out these phases as follows:

HIT Standardization Phase	HIT Standardization Entity Examples
Identify HIT Interoperability Needs and Priorities	HIT Policy Committee (10) and HIT Standards Committee (11) (formerly AHIC, American Health Information Community (12))
Develop and Maintain Standards	Health Level Seven (HL7) (13), SNOMED (14), LOINC (15), ASC X12 (16)
Select and Harmonize Standardize	Integrating the Healthcare Enterprise (IHE) (17) (formerly Health Information Technology Standards Panel (HITSP) (18)
Test Standards Interoperability	Integrating the Healthcare Enterprise (IHE)
Certify Interoperable HIT Products	Certification Entities (19): Certification Commission for HIT (CCHIT), Drummond Group, InfoGard Laboratories, SLI Global Solutions, ICSA Labs, Surecripts LLC
Deploy Interoperable HIT Products	Users: Clinical and Public Health Community at Large, NHIN

Each of these entities has been working to produce standards-related documents (e.g., use cases, profiles, interoperability specifications, HIT product certification criteria) to ensure systems interoperability. Table 1, below, presents HIT standardization phases, examples of standardization entities and their products (20). Table 1. Health Information Technology Standardization Phases, Products and Entities

HIT Standardization Phases	Needs & Priorities	Development & Maintenance	Selection & Harmonization	Trial Implementation	Certification	Deployment
Goals	What should be accomplished?	What are the standards?	What standards to use?	Show what can be accomplished	Certify standards-based products	Deploy standards-base products
HIT Standardization Entities	HIT Policy Committee HIT Standards Committee (Formerly AHIC, to be superseded pending ONC decisions)	SDOs (e.g., HL7, SNOMED [IHTSDO], LOINC, ASC X12)	IHE (Formerly HITSIP, to be superseded pending ONC decision	NHIN IHE	Certification Entities	Proposed IHE & PHDSC Deployment Workshops
Standards Documents	Uses Cases (Description of the health information exchanges)	Standards	Interoperability Specifications Technical Frameworks Integration Profiles	Implementation Reports	Certification Criteria	Deployment Reports

The Health Information Technology Standards and Systems Interoperability course is designed to provide health professionals with an understanding of the existing health information technology (HIT) standards and HIT standardization processes. The goal of this course is to provide students with methods and tools for participation as users in the HIT standardization activities for the design and evaluation of integrated health data systems at the local, state, regional, national or international levels. The intended audience is comprised of public health and medical professionals responsible, or advocating, for information systems used in (1) providing services; (2) developing; implementing and evaluating policies; and (3) performing research. References

1. National Archives and Records Administration. Federal Register. Executive Order 13335 – Incentives for the use of Health Information Technology and Establishing the Position of the National Health Information Technology Coordinator. URL’s: http://edocket.access.gpo.gov/2004/pdf/04-10024.pdf. and URL: http://waysandmeans.house.gov/media/pdf/110/hit2.pdf  Last accessed March 05, 2009
2. Thompson TG and Brailer DJ. The Decade of Heath Information Technology to Deliver Consumer-centric and Information-rich Health Care. Framework for Strategic Action. US DHHS, July 21, 2004. URL: http://www.hhs.gov/healthit/strategicfrmwk.html
3. Department of Health and Human Services. The ONC Coordinated Federal Health Information technology Strategic Plan. June 3, 2008. URL: http://www.hhs.gov/healthit/resources/HITStrategicPlanSummary.pdf
4. Department of Health and Human Services. Office of National Coordinator for Health Information Technology.  Consensus Conventions for the Use of Key HIT Terms Project. 2008
5. The American Recovery and Reinvestment Act. 2009. URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf.
6. Health Information Technology for Economic and Clinical Health (HITECH) Act. Federal Register/ Vol. 74, No. 101/ Thursday, May 28, 2009/ Notices: p.25550-25552.
7. Health Information Technology Policy Committee (a Federal Advisory Committee). URL: http://healthit.hhs.gov/portal/server.pt?open=512&objID=1269&parentname=CommunityPage&parentid=8&mode=2&in_hi_userid=10741&cached=true
8. HHS Office of National Coordinator of Health Information Technology (ONC). Federal Health Information Technology Strategic Plan: 2011-2015. URL: http://healthit.hhs.gov/portal/server.pt?open=512&mode=2&cached=true&objID=1211&PageID=15583
9. Health Information Technology Standards Panel (HITSP). American National Standards Institute (ANSI). URL: http://www.hitsp.org
10. Health Information Technology Policy Committee. URL: http://healthit.hhs.gov/portal/server.pt?open=512&objID=1269&parentname=CommunityPage&parentid=0&mode=2&in_hi_userid=10741&cached=true
11. Health Information Technology Standards Committee. URL: http://healthit.hhs.gov/portal/server.pt?open=512&objID=1271&parentname=CommunityPage&parentid=4&mode=2&in_hi_userid=10741&cached=true
12. American Health Information Community (AHIC). URL: http://www.phdsc.org/health_info/american-health-info.asp
13. Health Level Seven (HL7). URL: www.hl7.org
14. International Health Terminology Standards Development Organization (IHTSDO). URL: http://www.ihtsdo.org/ former Systematized Nomenclature of Medicine – Clinical Terms (SNOMED). URL: http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt{actionForm.contentReference}=snomed%2Fsnomed_ct.html&_state=maximized&_pageLabel=cntvwr
15. Logical Observation Identifiers Names and Codes (LOINC). URL: http://loinc.org/
16. The Accredited Standards Committee (ASC) X12. URL: http://www.x12.org/
17. Integrating the Healthcare Enterprise (IHE). URL: http://www.ihe.net
18. Health Information Technology Standards Panel (HITSP). URL: http://www.hitsp.org
19. The Office of the National Coordinator for Health Information Technology (ONC). URL: http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__onc-authorized_testing_and_certification_bodies/3120
20. Public Health Data Standards Consortium (PHDSC). Web Resource Center. Health Information Technology Standards. Online Module. URL: http://phdsc.org/standards/health-information-tech-standards.asp

Course Objectives

• To understand health information exchanges (HIEs) between clinical and public health/population health data systems
• To understand the main categories of HIT standards
• To understand the HIT standardization process
• To know HIT standardization entities
• To understand the role of users in HIT standardization
• To be able to participate in the design of information systems in public health

At the end of the course, the students shall be able to:

1. Understand HIT standardization processes and entities
2. Participate as users in the HIT standardization activities
3. Develop a functional requirements specification document (functional standards) for the information system for a specific public health problem/domain

Discussion Questions Students will be asked to respond to discussion questions following each lecture. Most of the lectures have at least one discussion question. Although students are encouraged to respond to others answers, please be aware that each student is required to answer the question. Please note that the 1st discussion - Getting to Know You - will not be graded. Information that students provided in this discussion regarding their area of work / interest will be used by the Instructor to compose the list of public health problems / domains for the Group Projects (student presentation and final assignment) as described below. Due date for responding to the Discussions is 1 week after correspondent lecture. Student Presentation (Lecture 14) The student presentation is a Group Project to present the status of the development of the Functional Requirements Specification. The presentation is entitled "Design of the Information System for a Selected Public Health Problem." The presentation will be developed using MS PowerPoint. It is limited to up to 14 slides including the title slide. The names of group members must appear on the title slides as co-authors of the presentation indicating the role each member played in the design process.  Please see the presentation outline below. Student presentations will be posted for viewing during Lecture 14. Final Assignment The final assignment for this course is a Group Project to develop Functional Requirements Specification for a Selected Public Health Problem (10 pages excluding title page; New Times Roman Font; Size 12; single space). The document is limited to 10 pages maximum excluding the title page. Only the first 10 pages of the document will be graded. The names of group members must appear on the title page as co-authors of the document indicating the role each member played in the design process. Reference list should be included in the 10 page limit. Please see the Specification's outline below. Functional Requirements Specification (or Requirements Analysis Document (RAD) describes a problem (domain) (e.g., taking care of patient, conducting public health case investigation, disease surveillance, health education) for which public health practitioners and/or clinicians need to exchange information using information technology (database, information system). This document describes your (user) needs for the information system (functional requirements) in your own words and in the format of the Requirements Analysis Document that will help IT vendors to better design an information system that will meet your (user) needs. The Presentation is aimed to view the group work progress on the Specification document and to facilitate your Group Project review by your classmates from other Groups. The Presentation outline follows the outline of the Specification document (please see below). For both assignments (Student Presentation and Final Assignment – Functional Requirements Specification), students will work in groups of 4-6representing the following participants in the design of the information system for a selected public health problem:

• Two-Four (2-4) End Users / Domain Experts (e.g., physician, laboratory personnel, public health official, researcher, funder, etc.) – responsible for describing a public health or clinical problem, identifying the need for information system in solving the problem, and developing an evaluation plan for the information system development.
• One (1) System Designer – responsible for developing diagrams
• One (1) Project Manager – Group Leader – responsible for coordinating Group activities on the presentation and final assignment development, and creating a timeline for the information system development.

The Group will decide on how to assign these roles to its members. The Instructor will compose the list of public health (or clinical) problems (domains) for the Group Projects based on students work areas/interests described in the Getting To Know You Discussion that follows Lecture 1, e.g., Environmental Health, Chronic Care, Child Health, Women Health, etc.. Students will be given a one-week period to sign-up for a particular problem/domain of his/her interest to form the groups to work on the Presentation and the Specification. The broadcast e-mail message will be sent by the Instructor to announce the group sign-up period. Please note that Group Projects are commonly used in the information systems design and development when users and developers are working together towards an operational IT product that will support user needs. Group Projects are the format of all standards development activities that operate through conference calls, e-mail communication and shared working environment. Thus, the Group Project in this course is aimed to familiarize students with the remote group working practices.

Functional Requirements Specification Document Outline

1. Introduction

1.1 Description of a Public Health (or Clinical) Problem (Domain) 1.2 Purpose of the Proposed Information System 1.3 Actors and Scope of the Proposed System 1.4 Objectives and Success Criteria of the Project

2. System Requirements

2.1 Functional Requirements 2.2 Non-functional Requirements

3. System Models

3.1 Use Case(s) Description 3.2 Use Case Models

3.2.1 Use Case Diagram(s) 3.2.2 Data Flow and Workflow Diagram (Activity Diagram)

3.3 High-Level System Architecture

4. Selected Standards Table 5. Hardware and Software Requirements 6. Testing / Evaluation Plan 7. Project Development Timeline The assignment will be graded on two criteria: (1) the extent to which the document is internally consistent; and (2) the extent to which informatics concepts from lectures and readings are utilized. Student Presentation Outline Each group will develop a PowerPoint Presentation describing the development of the Functional Requirements Specification for the Design of the Information System for a Selected Public Health (or Clinical) Problem (Domain). The Presentation will describe the Specification selected for the Final Assignment. The Presentation follows the Specification’s outline.

Slide 1 – Title, List of Group Members with Roles in the Project Slide 2 – Public Health (Clinical) Problem Overview Slide 3 – Information Systems Overview and Scope Slide 4 – Information Systems Goals (WHAT) Slide 5 – Actors (Perspectives) (WHO) Slide 6 – Functions that System will Support (HOW) Slide 7 – Non-functional Requirements Slides 8 & 9 – Use Case(s); Use Case Diagram(s); Work Flow and Data Flow Diagram(s) Slide 10 – Proposed System Architecture Slide 11 – Selected Standards Table Slide 12 – Hardware and Software Requirements Slide 13 – Evaluation Plan Slide 14 – System Development Timeline and Deliverables

Student Evaluation

Student evaluation and grading will be based on:

• Completion of the weekly assignments and participation in bulletin board discussions (33%)
• Presentation-Group Project (33%)
• Final assignment-Group Project (34%).

Extra credit of 7 points will be available for listening to the recording and completing bulletin board discussions under Lecture 15. Grades will be assigned based on demonstrated ability to utilize concepts from lectures and readings. Please note, that the Student Presentation and Final Assignment are the Group Projects. The grade given to the group for these assignments will apply to each group member unless the group will decide to grade members based on each member's contribution to the group work. It is critical for the success of the Group Project that each group member contributes to the best of his/her ability to the group work.