EHR Systems Certification in Belgium Belgrade, November 22, 2011 Dr. Jos Devlies ProRec-Belgium

Belgian Certification Example of a National Regulatory Driven Certification Not addressing here the EuroRec Cross Border Seal Focusing on functionality, including data-exchange aspects Interoperability is considered as a side-effect of certified quality of the appl. Addressing “clinical” software for General Practitioners Private Physiotherapists Homecare Nursing Dentist Logopaedists 10 years of experience in quality labelling and certification Other domains, e.g. hospital software, limited to reporting and billing November 22, 2011Belgrade, Serbia2

When and how did it start? Initial request from the market Use of purely clinical systems since mid 80’s Market Fragmentation in the 90’s: > 50 GP systems: “kitchinette software” sometimes Data exchange (lab data since late 80’s but with different protocols) Discontinuation of providers User expectations are very disparate November 22, 2011Belgrade, Serbia3

When and how did it start? 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…) Improve clinical availability of patient data Obtain “standardised” comparable data for management purposes (longer term objective) November 22, 2011Belgrade, Serbia4

When and how did it start? 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 November 22, 2011Belgrade, Serbia5

When and how did it start? 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.jpgProRec-BE project 1999.jpg One of the main sources for the EuroRec “fine grained statements” November 22, 2011Belgrade, Serbia6

Kings Decree 78, KB/DR78 ( ) 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: November 22, 20117Belgrade, Serbia

The functional processes The medical and nursing datasets used internally and their exchangeability Structure of the recordCodes and coding systemsClinical decision support (help in diagnosis and prescription)The patient data to be sharableThe patient identificationThe billing and reporting for health insurance November 22, 2011Belgrade, Serbia8

King’s Decree 78, ◦§3 The criteria will be issued by His Majesty after decision by the Government and based on an advice of a multi-disciplinary 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 multi-disciplinary workgroup. November 22, 2011Belgrade, Serbia9

King’s Decree 78, 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. November 22, 2011Belgrade, Serbia10

EMDMI 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 Optional but important on longer term Optional / Commercial differentiation of the products Nominating members of a “multi-disciplinary group” Prioritised Criteria.jpg November 22, 2011Belgrade, Serbia11

Sessions GP Software Session 2002 (18 April) Limited set of 37 criteria to be tested Functional test by a user Technical test (database, versioning…) Administrative test (maintenance contracts,…) 21 applications (from >50), 17 succeeded Session 2003 (October) 135 criteria mandatory Important focus on Coding and drug database Structuring the EHR November 22, 2011Belgrade, Serbia12

Sessions GP Software 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 => stuckedChange of responsible authority in 2008 November 22, 2011Belgrade, Serbia13

Session eHealth platform Created by law of 21 august 2008 Also responsible for quality assessment of healthcare software Preliminary activities Updating existing functional and interoperability criteria (03-04/2009) Selection of updated criteria to be effectively tested in (04- 09/2009) Meeting with suppliers => 587 questions Focus Sumehr export and import as document 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) November 22, 2011Belgrade, Serbia14

Session Tender for CAB (Conformity Assessment Body) Two lots: scenarios and effective testing 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) November 22, 2011Belgrade, Serbia15

Session Final Second Session 2 applications only two criteria to be tested 11 applications: full retest 5 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 (retesting ongoing) Certificates will be granted before end 2011 November 22, 2011Belgrade, Serbia16

Session Budget Directly related to quality labelling and certification Budget spent by health authorities € Total cost for involved suppliers related to the tests € First session per supplier:3.000€ Second session per supplier:2.500€ Other costs for suppliers Total budget (product development) : € Budget per supplier: € € Data entry test population Upgrading of the application Pretesting Attending meetings and test session(s) Incentives 800€ per user Estimated users (some are refusing subvention) Total incentives budget: € November 22, 2011Belgrade, Serbia17

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 November 22, 2011Belgrade, Serbia18

Conclusions 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. November 22, 2011Belgrade, Serbia19