Interoperability Testing and Certification. Lisa Carnahan Computer Scientist Standards Coordination Office

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1 Interoperability Testing and Certification Lisa Carnahan Computer Scientist Standards Coordination Office

2 Discussion Topics US National Institute of Standards & Technology American Recovery & Reinvestment Act US Health & Human Services (HHS) Criteria & Standards US Health & Human Services (HHS) EHR Certification Program Test Method Development 2

3 US DOC/NIST Mission To promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life. DOC: US Dept of Commerce 3

4 The Driver for EHR systems Certification in the US American Reinvestment & Recovery Act (ARRA) 3001(c)(5) of the PHSA requires the [US HHS] National Coordinator in consultation with the Director of NIST to keep or recognize a certification program or programs for the voluntary certification of HIT such program shall include, as appropriate, testing in accordance with 13201(b) of the HITECH Act 13201(b) the Director of NIST shall support the establishment of a conformance testing infrastructure may include a program to accredit independent, non- Federal laboratories to perform testing. 4

5 National Technology Transfer and Advancement Act (NTTAA) Directs US Federal agencies with respect to their use of private sector standards and conformity assessment practices. The objective is for US Federal agencies to adopt private sector standards, wherever possible, in lieu of creating proprietary, non-consensus standards. Directs US NIST to coordinate Federal, State, and local technical standards activities and conformity assessment activities, with private sector technical standards activities and conformity assessment activities, with the goal of eliminating unnecessary duplication and complexity in the development and promulgation of conformity assessment requirements and measures. March

6 What We Do Assist U.S. Federal Government Agencies in developing conformity policies and administrative infrastructure Design and assist in the implementation of related conformity assessment programs Develop test methods and tools for industry use in standards development and implementation Do not operationally test products Do not certify products 6

7 Conformity Assessment demonstration that specified requirements relating to a product, process, system, person or body are fulfilled ISO/IEC

8 Risk and Conformity Assessment-- How Much Confidence is Needed? Certification 3 rd party conformity assessment Perceived Risk Supplier s Declaration 1 st party conformity assessment Independence and Rigor of Conformity Assessment 8

9 Typical Use Certification (3 rd Party CA) Used when the risks associated with non-conformity are moderate to high Includes evaluation, compliance decision, attestation of conformity and some form of surveillance or follow up Always conducted by a third party ISO/IEC Guide 65 9

10 Typical Use Testing (1 st, 2 nd or 3 rd Party CA) Used when the critical characteristics can be evaluated via measurement under specified conditions Type testis a test carried out on samples that represent production for the purpose of determining conformity May be an element of a supplier s declaration or certification system ISO/IEC

11 Typical Use - Accreditation Used to assess and ensure/enhance ongoing conformity assessment body and program for competence, management and technical requirements Used to attain needed confidence in laboratory testing operation and results Used to attain needed confidence in certification system ISO/IEC

12 How Does All This Work? Meaningful User of Certified EHR Technology Meaningful Use Regulations & Objectives Measures Certified Complete EHR = Combination of Certified EHR Modules HIT Certification Programs Regulations ONC-ATCB / ONC-ACB Correlated Certification Complete EHR Criteria HIT Standards & Certification EHRs Criteria Modules Regulations 12 12

13 MU Criteria & Standards 13

14 Approved Test Procedures Versions a Drug-drug, drug allergy, formulary checks b Drug formulary checks c Maintain up-to-date problem list * d Maintain Active Medication List * e Maintain Active Medication Allergy List f.1 Vital Signs * f.2 Body Mass Index f.3 Growth Charts g Smoking Status h Incorporate Lab Test Results * i Generate Patient Lists j Medication Reconciliation k Submission to Immunization Registries * l Public Health Surveillance (v1.2) m Education Resources * n Automate Measure Calculations o Access Control p Emergency Access q Automatic Log-off r Audit Log s Integrity t Authentication *Errata also posted Underlined denotes interoperability requirement u General Encryption v Encryption when exchanging electronic health information * w Accounting of Disclosures a Computerized Provider Order Entry * b Electronic Prescribing * c Record Demographics d Generate Patient Reminder List e Clinical Decision Support f Electronic Copy of Health Information * g Timely Access h Clinical Summaries * i Exchange Clinical Information and Patient Summary Record * j Calculate & Submit Quality Measures a Computerized Provider Order Entry b Record Demographics c Clinical Decision Support d.1 Electronic Copy of Health Information * d.2 Electronic Copy of Health Information e Electronic Copy of Discharge Information f Exchange Clinical Information and Patient Summary Record * g Reportable Lab Results * h Advance Directives i Calculate & Submit Quality Measures 302: All environments 304: Ambulatory 306: In-patient 14

15 HHS EHR Certification Program: A Temporary to Permanent Transition Temporary Program Necessary response to regulatory timeline Private sector testing & certification activities Public sector accreditation Requires Federal FTE use in accreditation & operations Permanent Program Market provided resources Private sector testing & certification activities Private sector certification accreditation body NVLAP (NIST) testing laboratory accreditation body (fee based) Federal FTE use focused on policy & oversight (reduced from temporary) 15

16 HHS EHR Temporary Certification Program Publishes NIST Testing: Tools/Data/ Procedures Technical Requirements Authorizes ONC-Authorized Testing & Certification Bodies National Coordinator 4 Reports Certified Product Info 5 Certified HIT Products List Complete EHR/ EHR Module Submitted 1 Test 2 3 Report Certification Application and Agreement Vendors/ Self-Developers 16 16

17 HHS EHR Permanent Certification Program NIST NVLAP ISO/IEC & MRA status Accredits Testing: Tools/Data/ Procedures Technical Requirements Testing: Tools/Data/ Procedures ONC-AA ISO/IEC National Coordinator Approves Accredits Publishes Authorizes Certified HIT Products List ISO/IEC NVLAP-Accredited Testing Laboratories Tests Complete EHRs/ EHR Modules Vendors/ Self-Developers ONC-Authorized Certification Bodies Certifies Complete EHRs/ EHR Modules ISO/IEC Guide

18 The (NIST) National Voluntary Laboratory Accreditation Program (NVLAP) A process for accreditation of testing and calibration laboratories Established in 1976 Procedures set out in the U.S.Code of Federal Regulations (Part 285, Title 15) Linked to NIST measurement research Based on ISO/IEC standards Available to any qualifying laboratory 18

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20 Meaningful Use Criteria, Test Method and Testers Criteria and Standards Stage 1 - HHS/Office of the National Coordinator (ONC) Interim Final Rule (IFR) published in the Federal Register on January 13, 2010 Stage 1 - HHS/ONC Final Rule (FR) published in the Federal Register on July 28, 2010 Stage 2 Q1, 2012 Stage ? Test Method 42 Test procedures covering 40 criteria developed Incrementally published with feedback during IFR and FR release Test method, procedures and tool Approved by HHS/ONC Testing and Certification Organizations (current) Products tested & certified by 6 Authorized Testing & Certification Bodies (ATCBs) Authorized by HHS/ONC 20

21 Approved Test Procedures Versions a Drug-drug, drug allergy, formulary checks b Drug formulary checks c Maintain up-to-date problem list * d Maintain Active Medication List * e Maintain Active Medication Allergy List f.1 Vital Signs * f.2 Body Mass Index f.3 Growth Charts g Smoking Status h Incorporate Lab Test Results * i Generate Patient Lists j Medication Reconciliation k Submission to Immunization Registries * l Public Health Surveillance (v1.2) m Education Resources * n Automate Measure Calculations o Access Control p Emergency Access q Automatic Log-off r Audit Log s Integrity t Authentication *Errata also posted Underlined denotes interoperability requirement u General Encryption v Encryption when exchanging electronic health information * w Accounting of Disclosures a Computerized Provider Order Entry * b Electronic Prescribing * c Record Demographics d Generate Patient Reminder List e Clinical Decision Support f Electronic Copy of Health Information * g Timely Access h Clinical Summaries * i Exchange Clinical Information and Patient Summary Record * j Calculate & Submit Quality Measures a Computerized Provider Order Entry b Record Demographics c Clinical Decision Support d.1 Electronic Copy of Health Information * d.2 Electronic Copy of Health Information e Electronic Copy of Discharge Information f Exchange Clinical Information and Patient Summary Record * g Reportable Lab Results * h Advance Directives i Calculate & Submit Quality Measures 302: All environments 304: Ambulatory 306: In-patient 21

22 From Recommendation to Certified Products Accredited Testing and Certification Bodies (ATCBs) MU Recommendations from ARRA HIT Policy and Standards Committees Certification Commission for Health Information Technology Complete EHR and EHR Modules. Drummond Group, Inc. Complete EHR and EHR Modules. InfoGard Laboratories, Inc. Complete EHR and EHR Modules. ICSA Labs - Complete EHR and EHR Modules. SLI Global Solutions Complete EHR and EHR Modules. Surescripts LLC - EHR Modules: E-Prescribing, Privacy and Security. CMS Final Rule Meaningful Use Objectives and Measures ONC Final Rule Certification Criteria and Standards Approved Test Procedures ATCB Test Scripts Based on the requirements in the ONC Final Rule, NIST published 42 test procedures which are in use by the authorized testing & certification bodies to test and certify EHR products for the Meaningful Use Program ATCB Testing of EHRs ONC Certified Products List 22

23 Methodology used in development of test method Conducted an analysis of the HHS/ONC Interim and Final Rules including: the functional and interoperable requirements the referenced standards the derived test requirements based on the functional and interoperable requirements and referenced standards the test methods and test procedures which could be used to validate conformance with the derived test requirements the assumptions which may influence the selection of a specific test method or the scope of testing 23

24 Each test procedure is organized into different sections with traceability to the criteria within the IFR Informative section describing Certification criteria as published in 45 CFR Part 170 Subpart C of the Final Rule in the Federal Register on July 13, 2010 Informative description of how the test procedure is organized and conducted Standards referenced in the certification criteria Normative Test Procedure describes the required vendor information and test procedures for validating conformance to the criteria and standards Example Test Data provides examples of the test data to be used during the test procedure. The test data sets will be expanded for the final version of the test procedures. Conformance Test Tools provides a description and links to the associated conformance test tools, if applicable, to evaluate conformance to the referenced standards. 24

25 NIST Collaboration with Industry for MU Tooling Standards Development Organizations (HL7, NCPDP) Refine understanding of ONCspecified standards and implementation guides Validate our approach through workshops & discussions Partner with industry standards groups Consultant to federal agencies with healthcare missions Development of conformance tests, tools and prototypes Based on industry priorities Prototypes fill in industry gaps Leadership in test/tool development Public Inquiry/Response Process comments to date Immunizations Conformance Tool HL7 Implementation Guide for Immunization Data Transactions (2010) Conformance assessment reports Educational guides Labs to Public Health Conformance Tool HL7 Implementation Guide Electronic Laboratory Reporting to Public Health (2010) Conformance assessment reports Educational guides Patient Summary Record Conformance Tool HL7 CCD + HITSP C32 Conformance assessment reports Educational guides eprescribing Inspection Test NCPDP SCRIPT new prescription Inspection test guide 25

26 Certified Health IT Product List (CHPL) Summary Data 4/5/ Certified EHR Products Ambulatory Inpatient Total Total First group of ATCBs authorized on Sept 3,

27 Summary The HHS/EHR Certification Program makes use of ISO/IEC standards for conformity assessment, accreditation, testing and certification The Approved Test Method addresses the functional requirements and the interoperability requirements defined in the Final Rule criteria and standards To date, there are six Authorized Testing & Certification Bodies (ATCBs), having tested and certified 543 products The HHS Stage 2 criteria & standards will add additional interoperability requirements and further refine the current interoperability requirements The HHS/EHR Certification Program (Permanent in early 2012) will use the National Voluntary Laboratory Accreditation Program (NVLAP) for accrediting testing laboratories. NVLAP is an MRA signatory. The HHS/EHR Certification Program (Permanent in early 2012) will use a privatesector accreditation body for accrediting certification bodies. 27