argos global conference @ budapest – may 11th 2011 georges de moor, md, phd the current status of...

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

The Current Status of Certification of Electronic Health Records

in the US and Europe

Georges De Moor, MD, PhDEuroRec President

ARGOS Global Conference @ Budapest – May 11th 2011Georges De Moor, MD, PhD 2

Outline

• Introduction• US• Europe• Summary


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


Short History ofCertification 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


Short History ofCertification 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)


Short History ofCertification 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 17025 and 17011

• 2010 (July): HHS issued a Final Rule on the initial set of standards and certification criteria


Certification in the US: status/evolution(4)

1. Voluntary, but incentivized2. Certification of not only complete EHRs but also of EHR modules3. 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 specific5. Scope is evolving: from EHRs in different settings to …PHRs6. As of May 11: six ONC-ATCBs and +680 products tested and certified7. 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


“Meaningful User of Certified EHR Technology”

Certified Complete EHR

Combination of Certified EHR

Modules=Objectives Measures&

ONC-ATCB / ONC-ACB

Certification Criteria

StandardsEHR

ModulesComplete

EHRs

Correlated

Meaningful UseRegulations

HIT Certification Programs Regulations

HIT Standards & Certification Criteria Regulations

How Does All This Work?

Source: Lisa Carnahan (NIST)


HHS EHR Permanent Certification Program

ONC-Authorized Certification Bodies

NVLAP-Accredited Testing Laboratories

Tests Complete EHRs/

EHR Modules

Certifies Complete EHRs/

EHR ModulesVendors/Self-Developers

AuthorizesApproves

Accredits

Accredits

ONC-AAONC-AA

Publishes

Certified HIT

Products List

Testing: Tools/Data/ Procedures

NIST

NVLAPNVLAPTesting:

Tools/Data/ Procedures

Technical Requirements

National Coordinator

ISO/IEC 17011 & MRA status

ISO/IEC Guide 65ISO/IEC 17025

ISO/IEC 17011



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 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

ATCB Testing of EHRs


http://www.cchit.org/

http://www.cchit.org/

http://www.drummondgroup.com/

http://www.infogard.com/

http://www.infogard.com/

http://www.icsalabs.com/

http://www.sliglobalsolutions.com/

http://www.surescripts.com/

http://www.surescripts.com/


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.


EuroRec Federation of National ProRec Centresin Europe

Members:

AustriaBelgiumBulgariaCzech RepublicDenmarkFranceItalyGermanyIrelandNorwayRomaniaSloveniaSpainSlovakiaSerbiaThe NetherlandsUnited Kingdom

New applicants:

CyprusGreeceHungaryPolandPortugalSweden


The EuroRec Repository


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).


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.


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.


The EuroRec Use Tools


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.


EuroRec’s EU funded research projects (1)

Project acronym FP Timeline Topic

MediRec FP3 1994-1995 Declaration (Recom. 9)

ProRec FP4 1996-1998 Creation of first ProRec centres

Widenet FP5 2000-2003 Creation of EuroRec

Q-Rec FP6 2005-2008 Creation of Repository & Tools

RIDE FP6 2006-2007 Roadmap for Interoperability

EHR-Implement FP6 2007-2010 National Policies for EHR Implementation in the European area: social and organisational issues

Past Projects



Project acronym FP Timeline Topic

EHR-QTN FP7 2009-2012 Thematic Network on Quality Labelling and Certification of EHR Systems

ARGOS FP7 2010-2011 Transatlantic Observatory for Meeting Global Health Policy Challenges through ICT-Enabled Solutions

HITCH FP7 2010-2011 Healthcare Interoperability Testing and Conformance Harmonisation

EHR4CR IMI call 2 2011-2015 Electronic Health Records for Clinical Research

INBIOMEDvision FP7 2011-2013 Promoting and Monitoring Biomedical Informatics in Europe

eHealth Innovation FP7 2011-2013 eHealth Innovation – Scaling up eHealth facilitated personalized health services: Developing a European roadmap for sustained eHealth Innovation

Ongoing Projects



Project acronym FP Topic

EURECA FP7 Enabling information re-use by linking clinical research and care

SALUS FP7 Scalable, standard based interoperability framework for sustainable proactive post market safety studies

SemanticHealthNet FP7 Network of Excellence on semantic interoperability and European health infostructure

Future Projects


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)


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• …


Presentation will be made available via:

http://argos.eurorec.org/Budapest_11May2011/documents.cfm

Thank you!

Certification Policy Brief Contributors:

Georges De MoorPascal CoorevitsDouglas Fridsma

Carol BeanJohn O’BrienJos Devlies

Georges J.E. De Moor, MD, PhD [email protected]

mailto:[email protected]

argos global conference @ budapest – may 11th 2011 georges de moor, md, phd the current status of...

Documents

certification criteria

argos global conference

short history of certification

adoption of health

certification bodies

europe georges

health information technology

meaningful use criteria