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The Current Status of Certification of Electronic Health Records in the US and Europe Georges De Moor, MD, PhD EuroRec

The Current Status of Certification of Electronic Health Records in the US and Europe Georges De Moor, MD, PhD EuroRec President. Outline. Introduction US Europe Summary. Introduction: rationale.

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The Current Status of Certification of Electronic Health Records in the US and Europe Georges De Moor, MD, PhD EuroRec

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  1. The Current Status of Certification of Electronic Health Records in the US and EuropeGeorges De Moor, MD, PhDEuroRec President

  2. Outline • Introduction • US • Europe • Summary

  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

  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: CCHITfoundedwith support from AHIMA, HIMSS and the Alliance. • 2005: CCHITdevelops 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

  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)

  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 outlininghoworganizationscanbecome ONC AuthorizedTestingandCertificationBodies (ONC-ATCBs) which have tocomplywithISO/IEC Guide 65, ISO/IEC 17025 and 17011 • 2010 (July): HHS issued a FinalRule on the initial set of standardsandcertification criteria

  7. Certification in the US: status/evolution(4) • Voluntary, but incentivized • Certification of notonly complete EHRs but also of EHR modules • 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… • Incremental: criteria becoming more stringent and specific • Scope is evolving: from EHRs in different settings to …PHRs • As of May 11: six ONC-ATCBs and +680 products tested and certified • Plans for the permanent certification program are currentlyunderregulatorydevelopment …NVLAP of NISTwillaccredit the competency of testingfaciilitiesand in the futureonlyone ONC ApprovedAccreditor (ONC-AA) willberesponsibleforaccrediting the ONC- AuthorizedCertificationBodies (ONC-ACBs) furthercertifying products

  8. How Does All This Work? “Meaningful User of Certified EHR Technology” HIT Certification Programs Regulations Meaningful Use Regulations Objectives Measures & = Certified Complete EHR Combination of Certified EHR Modules ONC-ATCB / ONC-ACB Correlated HIT Standards & Certification Criteria Regulations Certification Criteria Standards Complete EHRs EHR Modules Source: Lisa Carnahan (NIST)

  9. HHS EHR Permanent Certification Program NIST National Coordinator Technical Requirements Certified HIT Products List Approves Testing: Tools/Data/ Procedures Testing: Tools/Data/ Procedures Publishes NVLAP Authorizes ISO/IEC 17011 & MRA status ONC-AA Accredits Accredits ISO/IEC 17011 NVLAP-Accredited Testing Laboratories ONC-Authorized Certification Bodies Tests Complete EHRs/ EHR Modules Certifies Complete EHRs/ EHR Modules ISO/IEC Guide 65 ISO/IEC 17025 Vendors/ Self-Developers Source: Lisa Carnahan (NIST)

  10. From Recommendation to Certified Products MU Recommendations from ARRA HIT Policy and Standards Committees 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 Accredited Testing and Certification Bodies (ATCBs) CMS Final Rule – Meaningful Use Objectives and Measures 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. http://onc-chpl.force.com/ehrcert ONC Final Rule – Certification Criteria and Standards Approved Test Procedures ATCB Test Scripts ATCB Testing of EHRs ONC Certified Products List Source: Lisa Carnahan (NIST)

  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.

  12. EuroRec Federation of National ProRecCentres in Europe Members: Austria Belgium Bulgaria CzechRepublic Denmark France Italy Germany Ireland Norway Romania Slovenia Spain Slovakia Serbia The Netherlands United Kingdom New applicants: Cyprus Greece Hungary Poland Portugal Sweden

  13. The EuroRec Repository

  14. The EuroRec Repository (2) • At present, the EuroRec Repository contains 1697 Fine Grained Statements with 14339 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).

  15. The EuroRec Seals • Seal Level 1 • The EuroRec EHR Quality Seal Level 1 has been unveiled during the High Level InterministerialeHealth 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.

  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.

  17. The EuroRec Use Tools

  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-QTN 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.

  19. EuroRec’s EU funded research projects (1) Past Projects

  20. EuroRec’s EU funded research projects (2) Ongoing Projects

  21. EuroRec’s EU funded research projects (3) Future Projects

  22. Impact of past, ongoing and future EU efforts • Deployment of certification at Pan-European level (EHR Q TN) • Strenghteningcollaborationwith IHE (HITCH) andothers • Continued cooperation with the US (ARGOS) • Furtherdevelopment of the certification criteria for the re-use of EHR data forclinical research (EHR4CR) • More focus on semantics, clinicians’ involvementand more EHR-content-related criteria (SemanticHealthNet) • PersonalisedMedicine issues: integration of biomedical data andPHRs issues (INBIOMEDvisionandeHealthInnovation)

  23. 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: • Perceivedstrengths and weaknesses of each of the existingschemes • Areas of commonality and difference • Exploration of areas of potentialfor joint endeavour or forconvergence • Areasfor joint pursuance of industry/procurer/user views on value and contribution of certificationschemes • …

  24. Thankyou! Presentation will be made available via: • http://argos.eurorec.org/Budapest_11May2011/documents.cfm • CertificationPolicy Brief Contributors: • Georges De Moor • PascalCoorevits • Douglas Fridsma • Carol Bean • John O’Brien • Jos Devlies Georges J.E. De Moor, MD, PhD georges.demoor@ugent.be

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