Certification of EHR systems

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Certification of EHR systems Some experiences (in
Belgium)
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• Is there really a need for certification?
• The increasing role of the healthcare
  authorities.
• Certification as a means to reach what?
• Certification in Belgium was based on a consensus
  model between most stakeholders.
• History of certification of ambulatory care EHR
  systems in Belgium.
• From GP systems to other health professions.
• Certification in other countries. What was the
  model?
• General issues regarding procedures and criteria.
• Dangers and risks of certification.
• Why an European, an EuroRec approach?
• EuroRec certification status.

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Certification a need? Why should someone
invest in certification?

• EHR systems are becoming complex and clinical
• More than simply store and retrieval systems.
• Increasing importance of care management
  affecting the quality of care.
• Increasing importance of being communicative
  supporting continuity of care.
• Expectations are therefore day by day higher and
  higher
• Integrated decision support and workplan
  management requires reliable systems.
• Health care professionals want systems that meet
  their expectations.
• Patients want healthcare professionals using
  thrustworthy and secure systems.
• Product documentation sometimes from confusing
  to misleading
• Some functions are not addressed in the
  documentation.
• Some documentation is not detailed enough.
• Obvious functions are not always present.
• Purchasers / clients / users want to know what
  they buy
• Not always possible, as client, to validate all
  the functions.
• Requirements are frequently misunderstood by the
  suppliers.

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The role of healthcare authorities regarding
clinical systems

• Healthcare authorities are no longer
  spectators, even in countries with a so called
  free or competitive health care.
• Healthcare authorities requires that all the
  systems used
• offers standard practice management, e.g.
  regarding prevention risk management or billing
  or reporting functions.
• are reliable / thrustworthy.
• support cost-effective care and if possible
  better care for the same cost, through
• standardisation of care, implementing clinical
  pathways.
• interoperability and data sharing.
• Interoperability is more than availability of
  patient summaries. Real interoperability of
  systems means being able to provide system
  services by using each others resources.
• replacing legacy systems by new systems from
  scratch is dream ware.
• legacy systems will need to evolve... in a
  controlled way.

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Certification as a means for what?

• Certification can be defined as The process of
  granting to a given product or service, by an
  authorised / accepted body, a compliance
  attestation to a specific set of functional
  and/or quality criteria.
• More than simply a validation of a product.
• Adds a third party level to the validation of a
  function or application.
• Certification as a means to
• harmonise (existing / legacy) systems systems
  doing the same things the same way or at least
  with the same result
• by upgrading systems rather than eliminating
  systems.
• increasing interoperability as a logical result.
• stimulate / favour the use of high(er) quality
  systems
• Certification can be dangerous when used as a
  means to
• interfere in / disrupt the market.
• reduce / eliminate competition, resulting in
• less development and progress.
• less responsiveness of the market to new
  requirements / expectation.
• finally less or extinguishing certification in a
  scanty market.

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Certification in Belgium based on a consensus
model between the different stakeholders

• National health authorities (are also the
  insurers/main payers) finally took the
  responsibility for
• what should be certified (does this happens in a
  consistent way?).
• when certain goals should be reached (in a
  step-by-step approach).
• The same authorities created an incentive,
  promoting the use of certified systems
  (essential!).
• EHR Users (individual users as well as user
  representatives and professional bodies) where
  involved in the what, when and even more how.
• EHR System Providers were involved from the start
  at equal level as the authorities and users,
  influencing priorities and feasibility of the
  certification criteria as well as the
  certification procedure.
• No real certification body involved, mainly based
  on good will one of the main weaknesses of the
  Belgian implementation gt resulting in some
  conflicts in setting-up the certification
  sessions.

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History of Certification of EHR systems in Belgium

• 1996-97 ProRec, E.U. funded project 1997
  foundation of ProRec-BE
• main goal promotion of the use of high quality
  EHR systems
• creation of a forum for suppliers of those
  systems, investing in common syntax definition
  for data exchange
• creation of a forum for users
• certification as an idea
• 1997 Declaration Vandervloed by the Ministry
  of Health Basic principles for the EHRs.
• 1997 Consensus text on Functions of an EHR for
  General Practitioners by a working group, funded
  by Ministry of Health and based on the
  Declaration.
• 1998-1999 Mandate to ProRec-BE
• Translation by the suppliers of the functional
  requirements into Technical Specifications for
  EHR systems in Primary Care 333 different
  technical requirements without mentioning
  mandatory or not.
• Redaction of functional specifications by the
  ProRec-BE user forum

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History of Certification of EHR systems in
Belgium (2)

• 2000 Ministerial decision
• EHR Quality Labelling will be started asap.
• Users of labelled EHR systems will be granted a
  subvention.
• A working group will select the mandatory
  criteria for the first session.
• 2001 Selection of the criteria and definition of
  the procedures
• The option is NOT to eliminate applications but
  to upgrade them progressively
• 35 essential criteria are defined as mandatory
  and accepted as feasible by the suppliers
• Budget of 5 M (740 per user) for 2002.
• 2002-04-18 First labelling
• 20 vendors applies (less than half of the ones in
  use) 17 succeeded
• 2 more applications succeeded in second session
• 2003-11-17 Second labelling
• Up to 135 mandatory criteria
• Use of coding schemes becomes mandatory (ICPC2
  and ICD10). Availability of a national
  Thesaurus.
• Use of a national drug database mandatory.
  Availability for free of a drug database.

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History of Certification of EHR systems in
Belgium (3)

• 2004 no labelling
• consensus model disappeared due to
  interferences of third parties interested in
  other things than the EHR as a professional tool
  for health care practitioners.
• ministry could not finalise unilaterally the
  process.
• 2 new applicants accepted on the basis of the
  2003 criteria total applications 20
• 2005-03-18 third labelling, with a second
  session in september, focused on
• structuring the EHR (health issue, services,
  goal, episode,..).
• SumEHR or Summary EHR possibility to produce and
  to export a patient summary.
• code mapping integrated in the Kmehr (Kind
  Messages for EHR) messages.
• 2006-06-09 fourth labelling
• focused on export and re-import of patient
  summaries.
• most (gt80 of the market failed) due to bad
  communication between certifier and suppliers and
  immaturity of some requirements.
• criteria adapted and interpreted for september
  all applications passed.
• 2007 no labelling, not ready in time

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From GP EHR systems to...

• EHR systems for physiotherapists
• Started in 2003.
• Incentive for the users, similar to the incentive
  for GPs.
• Progressive reduction of number of certified
  applications 23 in 2005, 18 in 2006.
• EHR systems for dentists
• Started in 2005 with 14 applications certified.
• No incentive for the users.
• Last certification december 2006 10
  applications certified (8 providers).
• Electronic Nursing Record for homecare
• Workgroup initiated in 2005.
• 2007 first certification of 29 products (6 used
  by one organisation).
• Incentive decided in 2007, similar to the
  incentive for GPs.
• Patient Records for logopedists
• First certification of mainly administrative
  issues 28 sept. 2007
• 4 applications certified.
• Hospital EHR
• Several attempts failed strong opposition... IT
  staff, providers, directions...

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Certification in other countries

• Clinical Certification is or has been initiated
  in an increasing number of countries
• Denmark, since 2000, in primary care limited to
  message standards and data sharing.
• The Netherlands, already in the late 80s, early
  90s but stopped.
• Ireland, on voluntary basis in late 90s, in
  general practice, starting again with new
  criteria in 2007.
• USA (CCHIT), first certification in 2006.
  Important funding from health institutes.
  Certification for primary care as well as
  (starting) for secundary care.
• Canada (Alberta, Ontario and British Colombia).
• United Kingdom, an accreditation process for GP
  stystems to meet NHS criteria between 1989 and
  2001. Unclear how it evolves now.
• France for the Logiciels daide à la
  prescription to start in 2008..
• Clinical Certification requires an ongoing
  professional effort and sufficient resources.
  Some countries sputtered after a couple of
  years, e.g. The Netherlands, Denmark and
  Ireland... Restarting sometimes after a while.

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Differences and issues related to test criteria
at European level

• Actual sets of labelling criteria / functions to
  be validated are defined nationally
• Considering local (legal / regulatory)
  requirements e.g. regarding demographics,
  mandatory attributes to e.g. bllable acts,
  reporting.
• Considering preferences or favourite
  functions of the / some users.
• Considering local feasability and development
  efforts required
• mostly in the definition of the criteria.
• sometimes only when defining mandatory / optional
  issues.
• Intended user group.
• Previous certification sessions.
• Using sometimes local terminology.
• Similar criteria are exceptionally formulate in
  the same way.
• Most certification criteria are formulated as a
  SHALL or SHOULD...but the shall of one country or
  environment can be a should in another
  environment.
• Procedures are similar definition of criteria,
  test scenarios, testing, evaluation, appeal
  and/or second session.

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Lessons learned...

• Certification without an incentive to the market
  has no sense.
• Negative incentives is one way only certified
  applications are accepted / can be used... or can
  be sponsored.
• Positive incentives seems better gratifying
  users of certified systems.
• Dont use certification for elimination of
  systems
• Improving quality and upgrading systems should be
  progressive.
• Reduction of suppliers will come anyway, natural
  wash-out.
• No bigger danger for innovation and progress than
  a lack of competition.
• Limit your ambition, accordingly to your
  resources
• Most countries sputtered after a couple of years.
• Yearly certification is exhausting, surely when
  new requirements are not limited.
• Consider different certification levels and/or
  certification of specific functions.
• Certification is not only very resource consuming
  for the suppliers, it may avoid them to assign
  sufficient resources to (new) functions not yet
  defined as to be certified but required by the
  users.
• Be aware that users does not always understand
  why an application isnt certified. Therefore
  always foresee a recover procedure and be
  discrete on systems that did not pass a session.
• It is not at all because an application enables
  the user to do something, e.g. problem oriented
  registration, that this functionnality will be
  used.

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Reasons for an European approach

• Health authorities should be enabled, considering
  the subsidiarity, to define their own set of
  criteria for certification...but these criteria
  should be comparable between the countries.
• Industry requires understandable and consistent
  criteria to facilitate their access to several
  national markets with the same products.
• Purchasers and users want to be sure that they
  speak the same language than the suppliers
  describing their offers.
• European criteria should additionally be coded
  and multi-lingual in order to be used in several
  countries. EuroRec statements are yet available
  in
• English (original language)
• French, Dutch and Slovenian (mainly the generic
  and the medication related criteria)
• Bulgarian, Danish, German, Romanian, Serbian and
  Slovakian (more limited set of translated
  statements)

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EuroRec approach and goals

• EuroRec composes a generic and comprehensive
  repository of statements describing use functions
  (entry, display, export, decision support,
  access,...), structuring and data elements of
  Electronic Health Record systems, enabling
  cross-border multi-lingual description and
  validation or certification of those systems and
  use functions.
• EuroRec develops complementary tools
• To build user-defined certification sets of test
  criteria and to perform these system
  certification sessions. EuroRec Composer,
  EuroRec Certifier and EuroRec Scripter.
• To document unambiguously and in a standardised
  way existing EHR products or functions. EuroRec
  Composer and EuroRec Documenter.
• To produce in a standardised comparable way
  procurement documentation regarding EHR products
  or some of their functions. EuroRec Composer and
  EuroRec Procurer.

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EuroRec Quality Criteria Repository
The central repository of validated quality
criteria to be used to harmonise European quality
labelling, procurement specification and
documentation of EHR systems.
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Statistics
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Thank you ! Questions ?
More information available on www.eurorec.org