Second Consortium Meeting

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Second Consortium Meeting

• Sarajevo, Bosnia-Herzegovina
• August 31st, 2009

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Agenda
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What was expected? What has been realised?

• National Workshops
• EHR Market Overview
• EuroRec Certification Criteria (translation)
• EuroRec Seal 2010
• EHR Legal Overview
• Survey Implementation EHR systems
• Dissemination

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Meetings and Workshops
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Overview Meetings 2009-2012
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Content of First Workshop

• E.U. Recommendations
• COM(2004) 356 An action plan for a European
  e-Health area
• COM(2008) 689 on telemedicine for the benefit
  of patients, healthcare systems and society
• COM(2008) 3282 on cross-border interoperability
  of electronic health record systems
• Collecting Market Data (National Report)
• Local legal and regulatory context of
  certification services
• Promotion of the EuroRec approach repository and
  tools.

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Commitments for Workshops 2009
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Reported Workshop

• March 27 Bratislava-SK Effective requirements
  for eHealth implementation.
• June 6 Brussels-BE Semantic Interoperability.
  Co-organised ProRec-BE and EuroRec
• June 9, Bratislava-SK Effective requirements for
  eHealth implementation.

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Announced Workshops

• Austria 2 workshops announced
• September 1st in Vienna
• December in cooperation with IIR
• Czech Republic in the Autumn
• Estonia September / October
• Greece end of November at Annual HL7-Hellas
  Conference
• Hungary in October. To be defined.
• Ireland Q4 either combined with HISI or separate
• Netherlands
• October 8, Amsterveen with NVMA
• November 26 at the MIC2009 conference.
• Romania December 8, Bucharest
• Spain early December with AENOR.

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Status Workshops 2009
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National Workshops

• Announcement on the web site EHR-Q-TN Important
  for the visibility.
• There may be more than one in a country.
• At least one should cover aspects related to
  interoperability of EHR systems and to
  certification.
• Reporting by using appropriate template is
  essential

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EHR Market Overview
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EHR Market Overview

• Important issue, also for the Commission.
• Deliverable D3.1, due M15 (April 2010).
• We need 3 months to compile the different
  contributions. January 2010 should be end date
  for the collection of data.
• Developed a web form
• To enable cooperative work
• To enable gradual completion of the report
• 4 countries started to use that interface.
• Some submitted yet some elements using the
  Template. Obviously acceptable as alternative.

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Market Overview Inclusion Criteria

• Do they (actually) have an active role in quality
  assurance of EHR systems?
• Did they manifest a particular knowledge of the
  domain (certification / quality labelling) in the
  past?
• Is their cooperation or at least approval
  essential in order to introduce successfully
  certification and quality labelling of EHR
  systems?
• Are they representative or an important party in
  the particular EHR market, addressing a specified
  group of users?
• Is there a risk of obstruction not including them
  in the process of certification and quality
  labelling?
• Are they representative or an important party of
  their class of products addressing a specified
  group of users?

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Market Overview content related

• Name of Organisation in original language
• Description in English
• Info intended for people without any knowledge
  about the stakeholder dont simply translate
  promotional talk. Stay concise and relevant.
• Contact information is essential.
• Dont list local or regional branches but
  Federations, Groups, Associations, Umbrella
  Organisations.
• We dont produce a phone book.
• Provide the link(s) to the web site(s).

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Certification Criteria Translations
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Status of Repository TranslationsFebruary 2009
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Actual Status
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Evaluation

• Good progress
• New languages started CZ, EE, GR, HR, HU, PT, SP
• Important progress for SK, SB
• Two languages missing NO, PL
• Some countries no effort during this project.
• Considering the 3 years timeframe on track.

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Certification Criteria Quality Issue
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Quality Issues - General

• Some translators made very accurate remarks on
  some criteria and/or indicated language/typing
  errors. (GR,SK mainly).
• Voting Form Seal 2010 generated interesting and
  valuable remarks
• What happens with them?
• In principle they get an answer
• As a comment added to the statement (translator
  informed)
• As interpretation, if important to anyone all
  translators warned
• As a mail or in the form, as for the Seal Voting
  Form
• Statement adapted.
• If no change in the meaning no new version.
• If yet translated and new version mail to warn
  the authors of the translated versions

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Quality Issue definitions

• Yet addressed in February
• Indeed required.
• We agreed to list the concepts.
• Not possible to add a definition in the
  interpretation folder for each individual
  statement.
• Development ongoing for a tool for maintenance
  and availability of these definitions.
• Definitions are intended to be used in the
  context of certification of EHR systems.

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EuroRec Seal vs. standards Torbjørn
Nystadnes, KITH EHR-Q TN meeting Sarajevo 31.
August 2009
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EuroRec Seal

• A considerable number of the statements has
  parallels in standards, technical specifications
  etc. from ISO, CEN, HL7 (and others)
• And in national standards
• The terminology used in the statement doesn't
  seem to be consistent with the terminology used
  in health informatics standards
• This leads to ambiguous statements
• A comprehensive list of "Terms and definitions"
  is needed

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Statements should

• Refer to clauses in standards whenever relevant
• Not be in conflict with any standard
• Unless the reason for this conflict is given
• Have the same wording as statements in standards
  when the purpose is the same
• Use terms as they are defined in standards

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Some relevant standards

• prEN ISO 10781 Electronic Health Record-System
  Functional Model
• HL7 EHR System Functional Model
• ISO/DIS 18308. Health informatics - requirements
  for an electronic health record architecture
• EN 13940 System of concepts to support
  continuity of care (CONTSYS)

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prEN ISO 10781 Electronic Health Record-System
Functional Model
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ISO/DIS 18308. Health informatics - requirements
for an electronic health record architecture

• 4.3.3 Identification and authentication
• The EHR shall ensure that users who author or
  authorise entries in a health record are uniquely
  and reliably identified
• The EHR shall represent the date and time at
  which each health record entry was originally
  committed to a health record
• 4.2.1 Kinds of health record entries
• The EHR shall be able to represent reported,
  assessed and measured observations.
• The EHR shall be able to represent opinions,
  suggestions and hypotheses.
• The EHR shall be able to represent intentions,
  goals, care plans and actions performed.
• The EHR shall be able to represent concerns,
  risks, alerts, precautions or warnings about
  situations to be avoided or activities not in
  future to be performed

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EN 13940 CONTSYS
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Health issue
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Terms and definitions
3.2 clinical data recorded facts regarding the
health of a subject of care (3.14) 3.3 clinical
information set of clinical data (3.2) processed
for use in a specific context 3.6 episode
time situation considered to occupy a time
interval EN 123812005 3.7 health
care activities, services, or supplies related to
the health of an individual ISO/TR 183072001,
modified 3.8 health record repository of
information regarding the health of a subject of
care ISO/TR 205142005 3.10 organisation unique
framework of authority within which a person or
persons act, or are designated to act towards
some purpose ISO 6523-11998 NOTE 1 Groupings
or subdivisions of organisations may also be
considered as organisations where there is need
to identify them in this way for purposes of
information interchange. NOTE 2 In this European
Standard, this definition applies to any kind of
organisations, whatever their legal status. 3.12
party enterprise object modelling a natural
person or any other entity considered to have
some of the rights, powers and duties of a
natural person ISO/IEC 154142002 3.13
role specific function expected to be assumed by
a person or an organisation (3.10)
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EuroRec Seal 2010
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EuroRec Seal 2010

• To be announced tomorrow.
• A common basic set of various criteria selected
  by experts to be committed in order to obtain
  the Seal.
• Not defining the best EHR system
• Not the ambition to be complete
• Addressing several issues as reliability,
  trustworthiness and version management,
  confidentiality, access control, display
• Complete certification needs to be done locally
  considering use context and local requirements
• Important for our visibility.

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Countries yet voted for the Seal
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First Results lowest scores

• Only 2 statements less than 2,5 average ( less
  than 50)

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First Results highest scores

• All of them statements yet required for Seal
  2008.
• All of them related to consistency of the system.

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EuroRec Seal 2010

• Not a boys game
• Best/only way to come to cross-border
• EHR quality convergence
• EHR interoperability
• Best way to promote your self as ProRec centre or
  Associated centre
• Certification of candidate applications not an
  easy thing but we can help.
• Best way in cooperation with a certification
  body (if you dont want to do it by yourself)

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EHR Legal Overview
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EHR Legal Overview

• Not a contractual obligation
• Somewhat overlooked
• No so tremendous as effort. Purpose describe
  in general terms the legal and regulatory
  framework in place and related to the use of
  e-Health applications in general and more
  precisely Electronic Health Record systems,
  focusing more especially on quality assessment
  and certification of those applications
• Template available
• We consider to offer a web form for data entry.
• Interesting dont we need it if we want to
  understand the local context for certification?

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EHR Implement Survey
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EHR Implement Survey

• Not a contractual obligation
• EuroRec is responsible for conducting such a
  survey
• and cant realise this without help nationally
• Either to complete the survey
• Or at least to give hints that identify the
  appropriate national contact person
• Web form available
• Template available

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EHR-Implement Survey Completed
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Dissemination
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Dissemination

• EHR-QTN is essentially a dissemination project.
• EHR-QTN will be compared to other Thematic
  Network projects Calliope
• Presence on the field is important.
• Presence on the web is as important.

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EHR-QTN link on national web
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Dissemination strategy

• Announce all the workshops on your own website,
  with reference to EHR-QTN
• All activities should be announced on the central
  web site.
• Make as much as possible documents available.
• Link the Repository (public access) to your web
  site in your language.

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Report per partner
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Next Meeting(s) - Dublin
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Dublin Schedule

• HISI Congress
• Pre-Conference Workshops November 18
• Conference November 19
• EuroRec General Assembly
• November 17, 1300 1600
• Amendment to / New Articles of Association
• Elections
• EHR-QTN Consortium Meeting
• November 17, 1630 1900 part I
• November 18, 0930 1630 part II
• November 18, 1700 Academic Session HISI
• November 18, 2000 Conference Dinner

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Other meetings to be scheduled