QUALITY ASSESSMENT OF EHR SYSTEMS IN BELGIUM
Quality Labelling and Certification 2 Distinguish authority driven and market driven QL & C Authority driven In principal national. European authority absent Not only state driven Cross border aspects through harmonisation of procedures and test content Result: certificate OR label Market driven Industry driven OR independent organisation EuroRec = independent organisation I.H.E. and Continua Health Alliance = industry driven In principle cross border Result is a label or a quality mark / attestation
EHR-Q TN Functional Diagram 3 Initiator IAF Supplier Authority Accreditation body Certification body Certificate Label CAB Product
Quality Attestations 4 Quality Assessment Procedure Attestation granted Third party assessment by a CAB being a public authority or an organisation granted power by a public authority either by law or by regulation. Certificate Third party assessment by a CAB on requirements issued by an organisation not empowered by law or by regulation. Quality Label Self-assessment with an external audit. Conformity assessment is done by the supplier and documented to a third party, being a public entity, a professional organisation or an industry federation. No attestation but a Quality Mark on the product is allowed Self-assessment by vendor who performed testing on his own products and affirms that they conforming to a given set of requirements. Declaration of quality
Quality Labelling and Certification 5 Important to make a distinction between Authority driven Market driven Authority driven In principle national Not mandatory state driven Cross border aspects through harmonisation of test procedures and test content Result: certificate OR label
Belgian Certification 6 Example of a National Regulatory Driven Certification Not addressing in this presentation the EuroRec Cross Border Seal Focusing on functionality, including data-exchange aspects Interoperability is important but considered as a side-effect of certified application Addressing clinical software for General Practitioners Private Physiotherapists Homecare Nursing Dentist Logopaedists Other domains, e.g. hospital software, limited to reporting and billing > 10 years of experience in quality labelling and certification
When and how did it start? 7 Initial request from the market Use of purely clinical systems since mid 80 s Market Fragmentation in the 90 s: > 50 GP systems: sometimes kitchinette software Data exchange (lab data since late 80 s but still - with different protocols) Discontinuation of providers User expectations are very disparate
When and how did it start? 8 Authorities willing to Protect patient data Protect users (healthcare professionals) Have reliable and trustworthy systems on the market Functional quality of the systems (all of them meeting essential user requirements ) Improve clinical availability of patient data Obtain standardised comparable data for management purposes (longer term objective) Belgrade, Serbia November 22, 2011
When and how did it start? 9 1997 Declaration of Minister of Health defining main functions of an EHR. December 1997 Working Group Consensus Text Functions of the Electronic Medical Record for the General Practitioner 12 specialised physicians / users & academics Main functions of the EHR Expression / symbol of the relation between patient and healthcare professional (GP) Care related functions: memory, continuity, synthesis, prevention and risk management, coordination & communication, quality of care monitoring Evaluation of clinical practice Decision support, research activities, epidemiology, education Medico legal Practice Management Belgrade, Serbia November 22, 2011
When and how did it start? 10 1998 1999: ProRec-BE project Mission: translating the document of the Ministry in concrete Technical Implementation Requirements Joint working party of main vendors and user representation. Result: 333 criteria listed with indication: optional / mandatory. ProRec-BE project 1999.jpg One of the main sources for the EuroRec fine grained statements
Kings Decree 78, 1999-01-25 11 KB/DR78 (10.11.1967) about health professions Law adding EHR principles to the decree in 1999 (art. 45bis) 1 His Majesty may define minimal criteria to be met by software applications managing the electronic medical and electronic nursing records in order to be homologated by the Minister of Health. 2 The criteria to be met may address the following not limited aspects: January 26,2012
12 The functional processes The medical and nursing datasets used internally and their exchangeability Structure of the record Codes and coding systems Clinical decision support (help in diagnosis and prescription) The patient data to be sharable The patient identification The billing and reporting for health insurance
King s Decree 78, 1999-01-25 13 3 The criteria will be issued by His Majesty after decision by the Government and based on an advice of a multidisciplinary group nominated by Royal Decree 4 The workgroup sub 3 has at least one representative of the Ministries of Health, of Social Affairs, of Justice and of Economic Affairs as well as representatives of the different professions. 5 The Minister is entitled to homologate Electronic Medical and Nursing Records based on the advise of the multidisciplinary workgroup.
King s Decree 78, 1999-01-25 14 Article 45ter about incentives 1 Health professionals recording patient data and transferring anonymous data to the Ministry and the National Health Institute may be granted a subvention. 2 His Majesty issues, after decision by the Government, the requirements to be met by the healthcare professionals (also regarding the data) in order to obtain that subvention. Belgrade, Serbia November 22, 2011
EMDMI 15 Not for profit organisation, created Jan. 2000, with Representatives of Ministry of Health and of Social Security Domain experts and Academics Role Validation of the technical implementation criteria Prioritisation & Classifying the criteria Mandatory within 1 year Mandatory over 2 3 years Optional but will become mandatory (soon) Optional but important on longer term Optional / Commercial differentiation of the products Nominating members of a multi-disciplinary group Prioritised Criteria.jpg December 26, 2012
Sessions GP Software 16 Session 2002 (18 April) Limited set of 37 criteria to be tested Double test procedure: Functional test by a user Technical test (database, versioning ) Administrative compliance validation (maintenance contracts, ) 21 applications (from >50), 17 succeeded Session 2003 (October) 135 criteria mandatory Important focus on Coding and the use of a standard national drug database + ATC Structuring the EHR
Sessions GP Software 17 Session 2004 (November) => 2005 Sumehr (Summary EHR) Export only Structuring the EHR Postponed to March 2005 Session 2006 (September) Sumehr Import (non structured) Coding Session 2007 => stucked Change of responsible authority in 2008
Test session 2010-2011 18 ehealth platform Created by law of 21 august 2008 Mission : healthcare backbone and IT services to the health community Also responsible for quality assessment of healthcare software Preliminary activities Updating existing functional and interoperability criteria (03-04/2009) Selection of new and updated criteria to be effectively tested in 2010-2011 (04-09/2009) Meeting with suppliers => 587 questions Focus Sumehr export and import as document (= patient summary) Prevention management (breast ca, colon ca, cervix ca) Access management, encryption and versioning of data GP Software Migration (export and recuperation of complete practice databases)
Test Session 2010-2011 19 Tender for CAB (Conformity Assessment Body) Two lots: scenario development and effective testing of the applications Redaction of a tender (09-11/2009) Launching tender and selection (12-05/2010) Setting up context for quality assessment Redaction of scenarios and documentation (04-06/2010) Definition of test population and test patients (05-07/2010) Validation of documentation, scenarios and use cases (07-08/2010) Distribution of documentation, Q&A (08-09/2010) Analysis of maintenance contracts (01-02/2011) First session Test period (10/2010 01/2011): 17 applications Analysis of the results (02/2011) Presenting results to National Commission (03/2011) Documenting decisions & feedback suppliers (03-04/2011)
Session 2010-2011 - Final 20 Second Session 2 applications only two criteria to be tested 11 applications: full retest 5 still failed for a limited number of criteria (=> 3 rd test) GP Migration Format Test Purpose: recuperation of the complete practice database when changing application by decision of user or because of failure of supplier Goal: Reconstruct the patient files as recorded, rebuilding history of data entry New data should be a trustworthy copy (in juridical sense) 17 tested, 6 failed Retest successful for all Certificates were granted to 17 end 2011
Session 2010-211 Budget 21 Directly related to quality labelling and certification Budget spent by health authorities 313.000 Total cost for involved suppliers related to the tests 73.500 First session per supplier: 3.000 Second session per supplier: 2.500 Other costs for suppliers Total budget (product development) : 879.750 Budget per supplier between 40.500 and 63.000 Data entry test population Upgrading of the application Pretesting Attending meetings Test session(s) Incentives 800 per user Estimated users (some are refusing subvention) 10.000 Total incentives budget: 8.000.000
22 Why are the parties doing these efforts? The authorities want: Quality Reliable and trustworthy systems Comparable and more and more interoperable systems Their projects to be implemented and available to the users The users want: Good functionality and practice management support Reliable and trustworthy systems A health added value (prevention, decision support ) Sharable patient data The suppliers want: A fair competition, cooperating with authorities and not competing with authorities Market fragmentation reduction is NOT a goal, but may be an effect Validated application, not having to prove all the time compliance Systems evolving in the same direction Happy users Belgrade, Serbia November 22, 2011
Conclusions 23 Involvement of ALL stakeholders is essential (= also the industry). Health authorities should take the lead. Testers and Certifiers should be different organisations. Quality has a cost. Take profit from existing experience. Take your time there is no rule that applications need to be certified every year. Belgrade, Serbia November 22, 2011