ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD The Current Status of Certification of Electronic Health Records in the US and Europe Georges De Moor, MD, PhD EuroRec President

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 2 Outline Introduction US Europe Summary

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 3 Introduction: rationale Care Providers: assurance and trust in quality and functionality of EHRs and other eHealth solutions Vendors: de-fragment market and improve market access Health care authorities: promote use of high quality systems and make sure that the anticipated benefits are realised (e.g. inter- operability) Patients: quality of care, safety, privacy

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 4 Short History of Certification in the US (Pre-Obama) (1) 2004: Creation of the Office of the National Coordinator for Health IT (ONC) …start of a process around standards and certification. 2004: CCHIT founded with support from AHIMA, HIMSS and the Alliance. 2005: CCHIT develops Certification Criteria and starts testing and certifying EHR Technology … AHIC (determining as Federal Advisory Committee the priorities for Health IT standards and charged in 2005 with making recommendations to HHS on strategies to increase the rate of IT adoption) … HITSP (created in 2005 by ANSI and tasked by ONC to harmonize the standards in a given AHIC use case) 2008: AHIC becomes the National eHealth Collaborative

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 5 Short History of Certification in the US (2) 2010: Health Information Technology for Economic and Clinical Health (HITECH) Act within the American Reinvestment & Recovery Act (ARRA), committing +19 billion dollars to a variety of initiatives aimed at increasing the adoption of health IT. ONC and HHS chose to define the initial set of criteria in the context of the HITECH Medicare and Medicaid Incentives Programs providing incentive payments for adoption, implementation and demonstration of “meaningful use of certified EHR technology” 2010 (January): ONC released its initial set of HHS-adopted Certification Criteria as an Interim Final Rule (IFR) entitled: “HIT: Initial Set of Standards, Implementation Specifications and Certification Criteria for EHR Technology”… (these criteria being mapped to Stage 1 Meaningful Use Criteria)

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 6 Short History of Certification in the US (3) 2010 (March): ONC released a Notice of Proposed Rulemaking in which the process is proposed by which organizations would be authorized to perform testing and certification and the processes these organizations would use to test and certify EHR technology… a time-limited, temporary program was created and a future permanent program (with more robust approach) proposed 2010 (June): HHS issued a Final Rule to establish the Temporary Program outlining how organizations can become ONC Authorized Testing and Certification Bodies (ONC-ATCBs) which have to comply with ISO/IEC Guide 65, ISO/IEC and (July): HHS issued a Final Rule on the initial set of standards and certification criteria

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 7 Certification in the US: status/evolution(4) 1.Voluntary, but incentivized 2.Certification of not only complete EHRs but also of EHR modules 3.Because of the linkage of the Certification criteria to the Meaningful Use criteria, the criteria will be updated as each new stage of Meaningful Use comes into existence… 4.Incremental: criteria becoming more stringent and specific 5.Scope is evolving: from EHRs in different settings to …PHRs 6.As of May 11: six ONC-ATCBs and +680 products tested and certified 7.Plans for the permanent certification program are currently under regulatory development …NVLAP of NIST will accredit the competency of testing faciilities and in the future only one ONC Approved Accreditor (ONC-AA) will be responsible for accrediting the ONC- Authorized Certification Bodies (ONC-ACBs) further certifying products

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 8 “Meaningful User of Certified EHR Technology” Certified Complete EHR Combination of Certified EHR Modules = ObjectivesMeasures & ONC-ATCB / ONC-ACB Certification Criteria Standards EHR Modules Complete EHRs Correlated Meaningful Use Regulations Meaningful Use Regulations HIT Certification Programs Regulations HIT Standards & Certification Criteria Regulations How Does All This Work? Source: Lisa Carnahan (NIST)

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 9 HHS EHR Permanent Certification Program Source: Lisa Carnahan (NIST)

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 10 From Recommendation to Certified Products MU Recommendations from ARRA HIT Policy and Standards Committees CMS Final Rule – Meaningful Use Objectives and Measures ONC Final Rule – Certification Criteria and Standards Approved Test Procedures ATCB Test Scripts Accredited Testing and Certification Bodies (ATCBs) ONC Certified Products List 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 Certification Commission for Health Information TechnologyCertification Commission for Health Information Technology Complete EHR and EHR Modules. Drummond Group, Inc.Drummond Group, Inc. Complete EHR and EHR Modules. InfoGard Laboratories, Inc.InfoGard Laboratories, Inc. –Complete EHR and EHR Modules. ICSA LabsICSA Labs - Complete EHR and EHR Modules. SLI Global SolutionsSLI Global Solutions Complete EHR and EHR Modules. Surescripts LLCSurescripts LLC - EHR Modules: E-Prescribing, Privacy and Security. ATCB Testing of EHRs Source: Lisa Carnahan (NIST)

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 11 The EuroRec Institute and the EuroRec Repository (1) The EuroRec Institute (EuroRec) is a European independent not-for-profit organisation, whose main purpose is promoting the use of high quality Electronic Health Record systems (EHRs) in Europe. EuroRec is overarching a permanent network of National ProRec centres and provides services to industry (developers and vendors), healthcare systems and providers (buyers), policy makers and patients. EuroRec produced and maintains a substantial resource with ±1700 functional quality criteria for EHR-systems, each categorised and translated in several European languages. The EuroRec Use Tools help users to handle this resource.

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 12 EuroRec Federation of National ProRec Centres in Europe Members: Austria Belgium Bulgaria Czech Republic Denmark France Italy Germany Ireland Norway Romania Slovenia Spain Slovakia Serbia The Netherlands United Kingdom New applicants: Cyprus Greece Hungary Poland Portugal Sweden

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 13 The EuroRec Repository

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 14 The EuroRec Repository (2) At present, the EuroRec Repository contains 1697 Fine Grained Statements with index links. The majority of the Fine Grained Statements are referencing one or more Source Statements (at the moment 3816 links exist) and can be grouped into Good Practice Requirements. The current database contains 179 of these Good Practice Requirements. A large number of these Fine Grained Statements have been translated into 18 European languages (Bulgarian, Croatian, Czech, Danish, Dutch, Estonian, French, German, Greek, Hungarian, Italian, Polish, Portuguese, Romanian, Serbian, Slovakian, Slovenian and Spanish).

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 15 The EuroRec Seals Seal Level 1 The EuroRec EHR Quality Seal Level 1 has been unveiled during the High Level Interministerial eHealth 2008 Conference in Portoroz, Slovenia. Seal Level 2 The EuroRec Seal Level 2 has been published during the Health Informatics Society Ireland Annual Conference in Dublin, November, 2009.

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 16 The EuroRec Profile for EHRs Compliant to Clinical Trial Requirements In December 2009 EuroRec has released a profile identifying the functionalities required of an EHR system in order to be considered as a reliable source of data for regulated clinical trials. Details of the profile, including information designed to support use, are accessible from the EuroRec website. A sister profile has been endorsed by Health Level Seven® (HL7®). As both the EuroRec and HL7 profiles draw upon the same standard requirements for clinical trials, conforming to one will mean, in principle conformance to both.

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 17 The EuroRec Use Tools

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 18 Validation activities The EuroRec functional Descriptive Statements, the EuroRec Use Tools and the EuroRec Seals have undergone several types of validation over the last years through a.o. the EHR-Q TN project. The EuroRec Seals have been validated during Validation Workshops and by testing the conformance of commercial products against Seal Levels 1 and 2 criteria.

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 19

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 20 EuroRec’s EU funded research projects (1) Past Projects

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 21 EuroRec’s EU funded research projects (2) Ongoing Projects

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 22 EuroRec’s EU funded research projects (3) Future Projects

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 23 Impact of past, ongoing and future EU efforts Deployment of certification at Pan-European level (EHR Q TN) Strenghtening collaboration with IHE (HITCH) and others Continued cooperation with the US (ARGOS) Further development of the certification criteria for the re-use of EHR data for clinical research (EHR4CR) More focus on semantics, clinicians’ involvement and more EHR-content- related criteria (SemanticHealthNet) Personalised Medicine issues: integration of biomedical data and PHRs issues (INBIOMEDvision and eHealth Innovation)

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 24 Recommendations As a result of the fledgling stage of both the ONC (temporary) Certification Program and the EU/ EuroRec Certification Activities and changing requirements, the cooperation through ARGOS was (so far) mainly concentrated on information exchange related to the variety of certification approaches. A number of recommendations on further EU-US cooperation on EHR certification (for the short- and mid-term) will follow from the discussions to be held this afternoon; issues to be discussed: Perceived strengths and weaknesses of each of the existing schemes Areas of commonality and difference Exploration of areas of potential for joint endeavour or for convergence Areas for joint pursuance of industry/procurer/user views on value and contribution of certification schemes …

ARGOS Global Budapest – May 11th 2011 Georges De Moor, MD, PhD 25 Presentation will be made available via: Thank you! Certification Policy Brief Contributors: Georges De Moor Pascal Coorevits Douglas Fridsma Carol Bean John O’Brien Jos Devlies Georges J.E. De Moor, MD, PhD