1. August 2006 Health Information Technology Standards Panel HITSP Technical Committee and Approval of its Interoperability Specifications Charles Parisot, GE Healthcare

2. 1 HITSP- Standards Harmonization Process for HIT The Community is the hub that drives opportunities for increasing nation wide health information interoperability Health Information Technology Standards Panel (HITSP) National Health Information Network (NHIN) Architecture Projects The Health Information Security and Privacy Collaboration (HISPC) The Certification Commission for Health Information Technology (CCHIT) American Health Information Community CCHIT focuses on developing a mechanism for certification of health care IT products HITSP brings together all relevant stakeholders to identify appropriate IT standards HISPC addresses variations in business policy and state law that affect privacy and security NHIN is focused on interoperability pilots

3. 2 HITSP- Standards Harmonization Process for HIT HITSP was formed to prototype a process used to harmonize industry-wide HIT standards... HITSP formed under the sponsorship of the American National Standards Institute (ANSI), coordinator of the U.S. voluntary standardization system Brings together a wide range of stakeholders into a formal panel to identify, select, and harmonize standards for communicating data throughout the healthcare spectrum Formation of the Panel was endorsed by a number of industry groups and has the oversight and backing ONCHIT John D. Halamka, MD, MS, CIO of the Harvard School of Medicine chairs the Panel A total of 200 organizations participate in HITSP representing consumer, SDO, non- SDOs, and government interests Non SDO make up 67% of the panel and include clinicians, providers, safety net providers, vendors, purchasers, payers, public health professionals, and researchers

4. 3 HITSP- Standards Harmonization Process for HIT... The process is repeatable and fully integrated with CCHIT and AHIC 1.For each AHIC Use Case, HITSP Technical Committees identify candidate standards which are harmonized into a final list of standards They also identify overlaps and highlight gaps. Gaps are forwarded to Standards Development Organizations for their guidance as to emerging candidate standards or new standards requirements. 2.The final standards chosen by the Technical Committees are discussed and ratified by the HITSP panel. 3.These standards are available for public comment and feedback. 4.Technical Committees work with SDOs and other groups to produce detailed specifications, an unambiguous cookbook, for the implementation of chosen standards. HITSP provides a convening and facilitation function for this activity. 5.HITSP work products are delivered to AHIC for their endorsement. 6.CCHIT will include functional criteria for interoperability based on HITSP specifications in its certification work

5. 4 HITSP- Standards Harmonization Process for HIT The HITSP process results in creation of an Interoperability Specification used to promote nationwide interoperable health information exchange I Harmonization Request Harmonization Process Steps II Requirements Analysis III Identification of Candidate Standards IV Gaps, Duplications and Overlaps Resolution V Standards Selection VI Construction of Interoperability Specification VII Inspection Test VIII Interoperability Specification Release and Dissemination IX Program Management Begin Support Receive Request

6. 5 HITSP- Standards Harmonization Process for HIT The three HITSP Technical Committees are working toward a September deadline to publish Interoperability Specifications Biosurveillance 63 members Transmit essential ambulatory care and emergency department visit, utilization, and lab result data from electronically enabled health care delivery and public health systems in standardized and anonymized format to authorized Public Health Agencies with less than one day lag time. Floyd P. Eisenberg, MD MPH, SIEMENS Medical Solutions Health Services - Presenter Peter L. Elkin MD FACP, Mayo Clinic College of Medicine Shaun Grannis, MD, The Regenstrief Institute, Indiana University School of Medicine Consumer Empowerment 61 members Allow consumers to establish and manage permissions access rights and informed consent for authorized and secure exchange, viewing, and querying of their linked patient registration summaries and medication histories between designated caregivers and other health professionals. Charles Parisot, EHR Vendor Association Elaine A. Blechman PhD, Professor, Univ. of Colorado-Boulder Electronic Health Record 77 members Allow ordering clinicians to electronically access laboratory results, and allow non- ordering authorized clinicians to electronically access historical and other laboratory results for clinical care. Jamie Ferguson, Kaiser- Permanente - Presenter John Madden, MD, PhD, SNOMED Intl Steve Wagner, Department of Veterans Affairs

7. 6 HITSP- Standards Harmonization Process for HIT Progress to date has positioned each committee to provide NCVHS with relevant insights into NHIN requirements In June of 2006, HITSP reduced 570 candidate standards to 90 appropriate standards for secure exchange of medication, lab, allergy and demographic data By September 29, 2006, HITSP will deliver unambiguous interoperability specifications which will enable vendors, hospitals and government to create software components for clinical data exchange Beyond 2006, HITSP will develop harmonized standards and unambiguous implementation guides which provide precise instructions for data sharing for all future requests for harmonization Also, it will standardize the interoperability specifications for technology products, while permitting differentiation and competitive advantage in the marketplace. HITSP hopes to empower patients and care providers with Electronic Health Records (EHR) that facilitate easy access to critical health data that is accurate, private and secure. HITSP is a key component of the Health and Human Services vision to create an interoperable healthcare system, and we look forward to our work products empowering patients, providers and government stakeholders in 2006 and beyond

8. 7 HITSP- Standards Harmonization Process for HIT DICOM I Harmonization Request Harmonization Process Steps II Requirements Analysis III Identification of Candidate Standards IV Gaps, Duplications and Overlaps Resolution V Standards Selection VI Construction of Interoperability Specification VII Inspection Test VIII Interoperability Specification Release and Dissemination IX Program Management Begin Support Receive Request The actual harmonization process is a series of steps taken by industry stakeholders within the context of a standards panel -- HITSP March-August 2006 HL7 X12 NCPDP SNOMED ASTMCORE LOINC IHE Fed. Medications RXNorm

9. 8 HITSP- Standards Harmonization Process for HIT AHIC-ONC CE Consolidated Use Case Consumer Empowerment Registration & Meds History - Interoperability Specification Component Registration & Med History Doc Content Base Std HL7 V2.5 Consumer Empowerment Registration and Medication History Documents Overview Transaction Package Consumer/Patient Id X-ref IHE PIX PDQ IHE XDS Base Std NCPDP 8.1 Base Std X12 270/271, ASTM CCR 2369 Base Std HL7 CDA r2 IHE XPHR Base Std ISO 15000 ebRS 2.1/3.0 Transaction Package Manage Sharing of Docs Map X12 Reg. to Reg/Med Doc Map CCR Reg/Med to Reg/Med Doc. Base Std LOINC Base Std NDC RxNorm SPL Map NCPDP Med. to Reg/Med Doc CAQH Core Transaction Patient Demographics Query Base Std ASTM/HL7 CCD Other Base Standards Federal Medication Terminologies HITSP

10. 9 HITSP- Standards Harmonization Process for HIT AHIC-ONC EHR Consolidated Use Case EHR – Laboratory Results Reports - Interoperability Specification Component Lab Report Document Base Std HL7 V2.5 EHR Sharing Lab Results Documents Overview Transaction Package Consumer/Patient Id X-ref IHE PIX PDQ IHE XDS Base Std HL7 V3 Lab Base Std HL7 CDA r2 IHE XDS-LAB Base Std ISO 15000 ebRS 2.1/3.0 Transaction Package Manage Sharing of Docs Transaction Patient Demographics Query Other Base Standards Transaction Notif of Doc Availability Transaction Package View Lab From Web Transaction Package Send Lab Result Msg to Ordering Clinician IHE NAV Component Lab Report Message Component Lab Terminology Base Std LOINC Base Std HL7V2.5 HITSP

11. 10 HITSP- Standards Harmonization Process for HIT AHIC-ONC BIO Consolidated Use Case BIO – Ambulatory, Emergent Encounter, Utilisation, Lab - Interoperability Specification Component Lab Report Document Base Std HL7 V2.5 Biosurveillance Ambulatory, Emergent Encounter, Utilization, Lab data to Public Health Transaction Package Consumer/Patient Id X-ref IHE PIX PDQ IHE XDS Base Std HL7 CDA r2 IHE XDS-LAB Base Std ISO 15000 ebRS 2.1/3.0 Transaction Package Manage Sharing of Docs Transaction Patient Demographics Query Other Base Standards Transaction Notif of Doc Availability Transaction Package Send Lab Result Msg to Ordering Clinician IHE NAV Component Lab Report Message Component Lab Terminology Base Std LOINC Base Std HL7V2.5 HITSP Component Anonymize Transaction Pseudonimize Component Encounter Msg Component Radiology Msg Component Utilization Msg Base Std HL7V2.5

12. 11 HITSP- Standards Harmonization Process for HIT I Harmonization Request Harmonization Process Steps II Requirements Analysis III Identification of Candidate Standards IV Gaps, Duplications and Overlaps Resolution V Standards Selection VI Construction of Interoperability Specification VII Inspection Test VIII Interoperability Specification Release and Dissemination IX Program Management Begin Support Receive Request The actual harmonization process is a series of steps taken by industry stakeholders within the context of a standards panel -- HITSP You are here

13. 12 HITSP- Standards Harmonization Process for HIT The testing process will occur over a two-weeks period with updates scheduled throughout Activities August 182122232425262728293031 Phase 2 Receive Testing Package Testing Period Testing Period Kick-off Mid-Point Telecon EHR IS Walkthrough Telecon BIO IS Walkthrough Telecon CE IS Walkthrough Telecon End-Point Telecon Key Deliverable Key Meeting

14. 13 HITSP- Standards Harmonization Process for HIT The Inspection Test is just one in a series of tests that will be performed to validate the utility of the specification The HITSP harmonization process results in an interoperability specification that will be widely disseminated A series of tests is required to validate the quality and usability of the specification The first test in the series of test is the Inspection Test The objective of the Inspection Test is to ensure that the IS meets the requirements of the Use Case and can be used to implement the requirements TitleDue to HHSStakeholders Inspection TestSept 29, 06HITSP, EHRVA, IHE, Govt, others Plan for testing the capability Testing the Capability (self test) Sept 29, 09 Nov 2006 HITSP, NIST, NLM, others Third party testing2007HITSP, NIST, CCHIT Orchestration and implementation test 2007HITSP, IHE, FHA, EHRVA, NHIN

15. 14 HITSP- Standards Harmonization Process for HIT Interoperability Specifications will be inspected to meet the following objectives Conforms to Style and Editorial Guidelines Ensure the integrity of document pieces – that all the cascading documents are present Validate grammar, spelling, and consistency of terminology Validate that it follows the style guide for text and graphics Contains Accurate References and Data Validate the references to other documents and data sources are valid and that data in tables is accurate. Meets Use Case RequirementsValidate that the IS when implemented will meet the specific requirements as defined in the use case Is Technically ValidCheck the specification to determine the existence of the following: a.Ambiguities/ lack of specificity b.Inconsistencies c.Gaps and overlaps d.Testability e.Completeness f.Internal consistency g.Ability to implement Presents a Reasonable Solution To the extent possible in the limited time frame, accessibility to standards documentation, and using the high level requirement, testers will determine the extent to which the selected standards are reasonable within this context

16. 15 HITSP- Standards Harmonization Process for HIT The inspection testing process steps... 1.Identify and engage key volunteer test resources – assign testers to IS documents 2.Develop the tools and procedures for gathering and responding to test findings 3.Instruct testers about the general process and schedule 4.Distribute Interoperability Specifications to the assigned testers – conduct a test kick-off conference call ~ Aug 21 5.Post IS at HITSP.org and send message to list serve to invite informal review- Aug 18 6.Collect interim test results on conference call ~ Aug 25 7.Collect final results and conduct conference call ~ August 31 8.Analyze test results and disposition them through the formal Change Control Board 9.Provide approved change requests to the IS writers 10.Implement IS changes 11.Validate IS changes