Cross Border EHR Certification: Step towards harmonisation and interoperability

1
Cross Border EHR CertificationStep towards
harmonisation and interoperability

• Dr. Jos Devlies
• Medical Director EuroRec

2
Overview

• Importance of Certification
• Status on Certification in Europe
• EuroRec Repository Tools
• EuroRec Seal
• EHR-QTN project 2009-2012
• EuroRec Community
• Conclusions

3
Importance of Certification

• EHR systems are largely accepted as important
  tools for
• Safe care
• content warning / surveillance systems
• safety reliability / access management
• High Quality care pro-active decision support /
  care pathways
• Effective care management monitoring / outcome
  management
• Clinical Research trials, vigilance, knowledge
  acquisition
• But how do you prove that a given system meets
  the quality and functional requirements in a way
  that their output can be considered as
  trustworthy?
• certification of all applications processing
  patient data!

4
Who wins from certification?

• Patient quite obviously safer/better care
• Health authorities
• Enabling / guaranteeing that better care
• Possible to enforce a strategy how do you
  otherwise get a wish on the market / available
  at the point of care
• Care Professionals as users
• Guarantee that a system fulfils its promises
• Suppliers / industry
• Unambiguous specification of market national
  requirements
• Market clearing possible on quality issues

5
EHR Certification in Europe (1/4)

• Belgium started 1999, first label 2002, a grant
  of 800 for the users as important incentive,
  driven by health authorities, different
  professions, some signs of exhaustion messaging
  and functionality.

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EHR Certification in Europe (2/4)

• Denmark Since 2002 focusing on messaging in
  primary care. Some attempts in secondary care
  promoting a common basic structure (BEHR) mainly
  messaging, not on functionality.
• France Haute Autorité de Santé has a program for
  certification of modules/applications for
  electronically assisted prescribing. Status
  unclear. Difficult to get information on the
  status. Related to one single (main)
  functionality.

7
EHR Certification in Europe (3/4)

• Ireland initiated in 1994, reviewed in 1998 by
  the National GPIT group resulting in a new scheme
  in 2003 and in 2008. Certification on the basis
  of these criteria done in june october 2008. 4
  GP systems certified. Addressing all the complete
  system.
• Netherlands first specification in late 80s,
  first certifications in the 90s (WCIA label for
  GP systems). Incentive included in standard
  annual fee per patient. Criteria 95 not used
  anymore. Important reduction of vendors and no
  more certification actually.

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EHR Certification in Europe (4)

• Norway Started in 2005, focused on messages (now
  25). Managed by KITH. Functionality only
  indirectly addressed.
• United Kingdom First in 1993 GP Requirements
  for Accreditation, issued by NHS for Primary Care
  Systems. No accreditation for other areas. Except
  a procurement based process used by the NHS
  National Programme for IT.
• Other countries no certification nor requirement
  specifications as far as reported.

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Conclusions of the overview

• More (?) differences than commonalities
• In domain / functionality GPs gtlt Hospitals
• In scope messaging/interchange gtlt functions of
  the system as such
• In Legal Framework Organisation (public /
  private)
• Content and formulation of the conformance
  criteria
• Criteria are defined each time, considering
  (main) domain of application, market reality and
  local good or best practice considerations.

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Main steps to harmonisation

• Consolidate the different approaches into a
  comprehensive common set of criteria.
• gt EuroRec Repository and Certification Tools
• Increase awareness of certification throughout
  the Union
• gt EHR-QTN Thematic Network project
• Start small
• gt EuroRec Seal 2008
• gt Repository of available resources for
  interoperability
• gt Create a community

11
EuroRec Certification Instruments
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EuroRec Repository Flow
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Fine Grained Statement

• Granular expression describing a single aspect or
  property of an EHR function or content element
• Purely descriptive statement.
• To be considered as a domain specific linguistic
  expression.
• They become criteria by adding attributes as
  mandatory/optional
• Indexed by means of a multi-axial indexing
  system.
• Nearby 1.400 FGS in the Repository.
• At present partially translated in up to 11
  languages.

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Good Practice Requirements

• Fine Grained Statements are regrouped in Good
  Practice Requirements.
• Homogeneous sets of FGSs.
• Related to Good Practice not necessarily Best
  Practice.
• Some of them are related to existing practice
  rather than to good practice.
• Centrally managed (user rights, authorship,
  national variants, translations, version
  management, indexing).
• Exploitable by means of the EuroRec Tools.
• Used by the EuroRec Tools for retrieval of
  statements.

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EuroRec gtlt National statements

• Decomposed.
• Local aspects removed
• Reworded in a consistent way.
• Does not include regulatory or good practice
  options
• gt Purely descriptive statement.
• gt To be considered as a domain specific
  linguistic expression.
• Attributes as mandatory/optional are defined at
  usage level, within a given certification basket.

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HL7 Criteria Statements
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EuroRec gtlt HL7 Profiles / Criteria

• As expected quite some similarities
• Fine Grained Statements HL7 Conformance
  Criteria
• Good Practice Requirements HL7 Statements
• Main difference
• The normative aspects are NOT included in the
  EuroRec descriptive statements
• Normative issues to be defined considering the
  domain of application when composing baskets for
  certification.
• Why? gt Heterogeneity of the European Market
• Result
• no duplication of profiles nor discussions on
  shall/should
• more flexibility

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A sample of Fine Grained Statements
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Translations
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Conclusion EuroRec Certification

• Use the same instruments to describe and to
  evaluate the EHR systems, available in all the
  languages of the union.
• Use generic statements, defined to be
  universally applicable/ used in different
  contexts.
• Specifications should be linked to identified
  certification sessions (in a given country, for
  identified types of applications and for defined
  session)
• Products meeting an increasing number of similar
  criteria will be at least functionally
  increasingly comparable.

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EHR-QTN

• Thematic Network on Quality Labeling and
  Certification of EHR Systems.

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EHR-QTN project - Objectives

• Main objective prepare the health community
  across Europe for more systematic, comparable and
  large scale quality assurance and certification
  of e-Health products (with special emphasis on
  Electronic Health Record systems).
• By building a Network of interested and involved
  stakeholders around that theme!
• By improving the instruments developed in the
• Q-REC project.

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EHR-QTN Beneficiaries
28 Partners 24 Countries
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EHR-QTN Main Tasks

• Validate and Customise the EuroRec criteria in 24
  countries, focused on
• Prescription and Medication Management
• Patient Summary services
• Inventory of legal issues.
• National coordination educational meetings.
• Workshops to validate
• The EuroRec Repository.
• The tools for certification, product
  documentation and procurement.
• The procedures for EHR Quality Labelling and
  Certification.
• Annual EuroRec Conference.

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EHR-QTN expected results

• EHR Q TN will result in 82 meetings resulting in
  increase of awareness for Certification in Europe
• Interesting deliverables
• Legal issues- report on certification and quality
  assessment of e-Health services
• EHR market - report
• Validation Report of the EuroRec Descriptive
  Statements and the EuroRec Use Tools
• Validation Report of the EuroRec Certification
  Procedures and Quality Assessment Scenarios
• Roadmap to Pan-European Certification of EHR
  systems
• Profit report for the different stakeholders
  involved in the Certification of EHR systems
• Procedures and Quality Assessment Scenarios
• A robust foundation for further e-Health quality
  labelling in Europe!

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EuroRec Seal

• Seal granted across national borders to
  applications meeting a base level set of
  requirements.
• Certification can be done
• by any national authorised body, based on an
  agreement with EuroRec.
• by EuroRec at request of the industry
• Will favour progressive harmonisation of products
  across the union.
• Will enforce product quality all over the union.

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EuroRec Seal Content

• 20 criteria
• Generic ones (not related to specific or
  specialised functions)
• Independent from specific national regulatory
  aspects as e.g. funding
• Mainly focusing on the trustworthiness of the
  content of an EHR.
• Accessible on the web
• http//www.eurorec.org/services/repository/seal.c
  fm?actiefservices

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EuroRec Seal 2008 Criteria (1/2)
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EuroRec Seal 2008 Criteria (2/2)
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EuroRec Seal Announcement

• Certification done by the GPIT group (National
  General Practice Information Technology Group) in
  Ireland has been recognised as compliant with the
  EuroRec Seal 2008 requirements.
• Four Irish GP Information Systems are the first
  to obtain the EuroRec Seal certificate.
• The certificates will be officially handed over
  during HISI (Health Information System Ireland)
  Conference, November 19th in Dublin.

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EuroRec Seal Evolution

• Content of the Seal will be extended in 2009
• From 20 to 40 criteria.
• Still mainly generic criteria.
• Some domain specific EHR content related topics.
• Direct certification of EHR systems
• on demand of the supplier
• Still limited to the EuroRec Seal criteria
• Increase cooperation with national certification
  centres.
• EuroRec Seal Cross Border Certification
• EuroRec Seal Gradual Harmonisation of
  applications

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Repositories for Interoperability

• Arch-Q
• Repository of Quality Assessed Archetypes

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Arch-Q

• Archetypes can be considered as the most
  promising evolution towards interoperability
  since years.
• Arch-Q intends to address the issue of
  Governance of these artefacts
• Nice tools available to build archetypes
• But a Lack of rules / agreements on content
• A lack of availability
• EuroRec has the ambition to centralise quality
  assessed archetypes.
• Actually still at project level obviously in
  cooperation with third parties.
• Support (also financial) is welcome.

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EuroRec Community
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EuroRec Community

• Launching dual membership individual and
  industrial membership.
• Individual membership also Membership of a
  national ProRec centre. Profit mainly when
  attending EuroRec supported conference.
• Industrial membership three levels (Gold Member
  Silver Member Sponsor Member) (10, 5 and 2
  thousand ) with advantages.
• More info on the web site of EuroRec
  www.eurorec.org
• Visit our booth at the Centre Hall.

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Conclusions

• Harmonisation is phase 1 of interoperability.
  Interoperability will be the result of
  harmonisation not the other way around
• Certification is a powerful weapon to increase
  that harmonisation as you believe in, use it!
• Take advantage of the growing EuroRec repository
  and of the broadening certification scope (e.g.
  EHRs in other settings and other software
  applications) resulting from European investments

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Conclusions

• Build a long term, incremental and consistent
  certification roadmap which is in harmony with
  your overall healthcare strategy and which aligns
  on European and International ones (cf.
  standards, coding systems ...)
• Prepare the harmonisation at content levelthe
  archetypes.
• Professionalise the certification procedures
• ...EuroRec is your partner and is at your service
  !