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EHR Certification in Europe:
steps towards harmonisation and
interoperability
Dr. Jos Devlies
Medical Director EuroRec
Overview
1. Importance of Certification
2. Status on Certification in Europe
3. EuroRec Repository & Tools
4. EuroRec Seal
5. EHR-QTN project 2009-2012
6. Conclusions
19 November 2008 HISI - Dublin 2
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!
19 November 2008 HISI - Dublin 3
Who wins from certification?
Patient: quite obviously: safer/better care
Health authorities:
Enabling / guaranteeing that better care
Possible to influence the product development: how to get
otherwise a “wish” on the market / at the point of care?
Care Professionals as users:
Guarantee that a system fulfils it’s “promises”
Suppliers / industry:
Unambiguous specification of market – national requirements
Market competition based on “quality issues”
19 November 2008 HISI - Dublin 4
EHR Certification in Europe (1/4)
Belgium: started 1999, first label 2002, a grant of
810€ for the users as important incentive, driven by
health authorities, different professions, some signs
of exhaustion: messaging and functionality.
19 November 2008 HISI - Dublin 5
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.
19 November 2008 HISI - Dublin 6
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 the full application. By far the most
advanced.
Netherlands: first specification in late 80’s, first
certifications in the 90’s (WCIA label for GP systems).
Incentive included in standard annual fee per patient.
Criteria ‘95 never implemented. Important reduction of
vendors and absence of new incentives => stand still.
19 November 2008 HISI - Dublin 7
EHR Certification in Europe (4)
Norway: Started in 2005, focused on messages (now
25). Managed by KITH. Functionality only indirectly
addressed, through the ability to produce messages.
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.
19 November 2008 HISI - Dublin 8
EHR Certification outside Europe
USA – CCHIT: functional testing started in 2006,
addresses ambulatory and in-patient care, not-for-profit
but initially heavily sponsored, only 29% of ambulatory
practices are using an EHR,now also “incentive” approach:
700 M$
Canada: provincial initiatives, more practice management
related – Canadian Infoway, Nov. 12, 2008: Richard
Alvarez, president and CEO, Canada Health Infoway: "The
launch of our new certification service will help the vendor
community to develop new products accordingly, and
provide buyers and users of those systems with some
assurances the solutions are of high quality."
Japan: no certification initiative identified
Australia: no certification initiatives identified.
19 November 2008 HISI - Dublin 9
Other quality assurance initiatives
IHE – Integrating the Healthcare Enterprise:
focus on sharing care related data, on
communication and security standards, not on
functionality of the EHR systems at the point of care.
Based on “profiles” or “protocols” and using DICOM &
HL7.
Industrial Certification, e.g.
Welch Allyn EHR Certification program
19 November 2008 HISI - Dublin 10
Conclusions of the overview
More (?) differences than commonalities:
In domain / functionality: GP’s >< Hospitals
In scope: messaging/interchange >< 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.
Need for harmonisation… and for Cross Border
Certification (long term!)
19 November 2008 HISI - Dublin 11
Main steps to harmonisation
Consolidate the different approaches into a
comprehensive common set of criteria.
=> EuroRec Repository and Certification Tools
Increase awareness of certification throughout
the Union
=> EHR-QTN – Thematic Network project
Cooperation between authorities and
certification bodies
Start small …
=> EuroRec Seal 2008 => 2009 => 2010
=> Repository of available resources for interoperability
19 November 2008 HISI - Dublin 12
EuroRec Certification
Instruments
EuroRec Repository Flow
19 November 2008 HISI - Dublin 14
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.
19 November 2008 HISI - Dublin 15
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.
19 November 2008 HISI - Dublin 16
EuroRec >< National statements
Decomposed.
Local aspects removed
Reworded in a consistent way.
Does not include “regulatory” or “good practice”
options
=> Purely “descriptive” statement.
=> To be considered as a domain specific “linguistic
expression”.
Attributes as mandatory/optional are defined at
usage level, within a given certification basket.
19 November 2008 HISI - Dublin 17
HL7 Criteria & Statements
19 November 2008 HISI - Dublin 18
EuroRec >< 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? => Heterogeneity of the European Market
Result:
no duplication of profiles nor discussions on shall/should
more flexibility
19 November 2008 HISI - Dublin 19
A sample of Fine Grained Statements
19 November 2008 HISI - Dublin 20
Translations
19 November 2008 HISI - Dublin 21
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.
19 November 2008 HISI - Dublin 22
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 for individual EHR
products.
Will favour progressive harmonisation of products
across the union.
Will enforce product quality all over the union.
19 November 2008 HISI - Dublin 23
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.cfm?actief=ser
vices
19 November 2008 HISI - Dublin 24
EuroRec Seal 2008 Criteria (1/2)
Deletion of a health item results in a new version of that health item with as
GS001593.01 status “deleted”.
Each health item is uniquely and persistently associated with an identified
GS002265.01 patient.
GS002281.01 All patient data can be accessed directly from the patient record.
Each patient and his/her EHR are uniquely and persistently identified within
GS002307.01 the system.
GS003952.01 The system does not display deleted health items, audit logs excepted.
The system does not include deleted health items in clinical documentation or
GS003953.01 export, for audit purposes excepted.
Each version of a health item has a status of activity, e.g. active or current,
GS001579.02 inactive, history or past, completed, discontinued, archived.
GS002268.01 Each user is uniquely and persistently identified.
Each version of a health item has a person responsible for the content of that
version. The person responsible for the content can be a user or a third
GS001594.02 party.
The system enables the user to designate individual health items as
19 November 2008
GS001945.01 confidential. HISI - Dublin 25
EuroRec Seal 2008 Criteria (2/2)
The systems enables to assign different access rights to a health item (read,
GS002269.01 write,...) considering the degree of confidentiality.
The system takes the access rights into account when granting access to
health items, considering the role of the care provider regarding the
GS002415.01 patient.
GS001537.01 Each version of a health item has a date and time of registration.
Each version of a health item has a user responsible for the effective data
GS001538.01 entry identified.
GS001539.01 Each update of a health item results in a new version of that health item.
GS001901.01 Each version of a health item has a date of validity.
GS002266.01 Each version of a health item is uniquely and persistently identified.
GS001598.01 A complete history of the versions of a health item can be presented.
The systems offers to all the users nationally approved coding lists to assist
GS002437.03 the structured and coded registration of health items.
The pick lists and reference tables offered by the system are the same for all
GS002672.03
19 November 2008 users of the same HISI - Dublin
the application. 26
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:
Complete GP, version 2.1, Complete GP, Mallow
Health One, version 6, Health Ireland Partners, Arklow
Helix Practice Manager, version 1, Helix Health, Dublin
Socrates, version 1.5, Technical Ideas, Ballinoe Stigo
19 November 2008 HISI - Dublin 27
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
19 November 2008 HISI - Dublin 28
EHR-QTN
Thematic Network on Quality Labeling and
Certification of EHR Systems.
2009-2011
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.
By promoting cooperation with third parties.
Resulting in real certification on as much European
Countries as possible.
19 November 2008 HISI - Dublin 30
EHR-QTN Beneficiaries
United Kingdom Austria
Belgium
Spain
Bulgaria
28 Partners
Slovenia
Croatia
24 Countries
Slovakia Cyprus
Serbia
Denm ark
Rom ania Estonia
Portugal France
Poland Germ any
Norw ay Greece
Netherlands Hungary
Luxembourg Ireland
Italy
19 November 2008 HISI - Dublin 31
EHR-QTN Main Tasks
1. Validate and Customise the EuroRec criteria
in 24 countries, focused on:
• Prescription and Medication
Management
• Patient Summary services
2. Inventory of legal issues.
3. National coordination & educational meetings.
4. Workshops to validate
• The EuroRec Repository.
• The tools for certification, product
documentation and procurement.
• The procedures for EHR Quality
Labelling and Certification.
5. Annual EuroRec Conference.
19 November 2008 HISI - Dublin 32
Conclusions (1/2)
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
19 November 2008 HISI - Dublin 33
Conclusions (2/2)
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 ...).
Professionalise the certification procedures.
Do not forget to incentivise the use of certified
EHR systems
...EuroRec is there to promote certification and to
harmonise the approaches within Europe!
19 November 2008 HISI - Dublin 34
