Special Interest Session II Electronic Health Records and Interoperability Measures for implementing quality labelling and certification Gerard Hurl ProrecIreland
Rationale for Certification Critical component in ensuring the quality of EHR systems is the introducing of a Quality Labelling and Certification process Certification of EHRs can be defined as the procedure and action by which a body duly authorised and recognised as a legitimate provider of this service evaluates and certifies an Electronic Health Record system as meeting predetermined quality standards
How Certification Works Based on the existing certification processes in Europe and the USA outlined in the Q-REC State of the Art report, the following is an outline of the various stages of the certification procedure Initial contect by supplier/developer/purchaser Formal application Statement of criteria for Certification Following formal application: Documentation to be supplied by vendor Testing Schedule Certification Register: Certificate/Seal Publication
The Certification Process Initial contact Manual/Handbook providing instruction /information /guidelines for the Certification process. Details include: Benefits and rationale for certification Overview of certification process How to apply Documentation required Criteria to attain certification Overview of range of functional, operational, implementation, standards and user criteria used for tests Overview of tests and testing methodologies Approval process Retest and appeal process Fees Formal application: Application /Test Pack containing: Detailed description of certification process Detailed description of test process/methodology Documentation to be completed Supporting documentation required Detailed set of criteria to be utilised for testing Statement of Criteria Requirements for Certification regarding Functionality Interoperability Security Data Structures, Codes and Standards Test Scripts/Scenarios to test each of the criteria
Following formal application: The Certification Process Contract to be completed between Certification Authority and Applicant: Contract to cover the certification process, specifying Certification Authority and Vendors rights, accountability, responsibilities, limitations, confidentiality, freedom of information and waivers. Documentation to be supplied by vendor Software/Hardware Maintenance. Agreement(s) Employment contracts and agreements Procedures document System documentation (including operating systems and database) Hardware/communications specifications User Manual Conformance statement Training manual and arrangements Software/Product Licence Escrow agreement Licences from relevant Third party suppliers. Testing Schedule 2 levels: Pre-test self-assessment External evaluation Certification Register: Details certification status of each product Schedule of dates for retesting/recertification Certificate/Seal issued on successful completion of test Publication of certified products
Certification in Europe - The EuroRec Institute Eurorec has the overall objective to improve the standards by which Electronic Health Record software is developed and implemented for the ultimate aim of improving care provided to citizens/patients across the European Community. In the fulfilment of this objective Eurorec sees its mission as one of overseeing and providing for the development, introduction and support of a European wide Quality Labelling methodology, Certification system and service that will be applied and operated through locally based Prorec Centres in each of the EC countries for Electronic Health Record software.
Measures for implementing quality labelling and certification Developing the methodologies and processes Developing the business case Promoting and developing political support, supplier and user awareness Managing the process Key success factors
The Q-Rec Project To develop formal methods and to create a mechanism for the quality labeling and certification of EHR systems in Europe, in primary- and in acute hospital-care settings Q-REC will compare and harmonise existing certification processes and procedures at a European level. The main objective of Q-REC is to create an efficient, credible and sustainable mechanism for the certification of EHR systems in Europe. Q-REC will produce: A Labelling Terminology and Functional Profiles for classification of EHRs to be certified; Model Certification Guidelines and Procedures; A Benchmarking Services Manual for EHRs Quality Labelling and Certification; An Inventory of Resources for EHR Interoperability including: A register of Conformance Criteria and Guidance Documents for obtaining EHR Certification; an inventory and guidelines for EHR Archetypes; a register of Coding Schemes in Europe (as mandated by CEN/TC 251); an inventory of relevant EHR related standards; a register of XML Schemas and Open Source components for EHRs
Q-Rec Business Plan For the Eurorec Institute to be successful in business terms, in its offering of Europe wide quality labelling and certification services through the benchmarking of EHR systems, a clear and realistic Business Plan is required setting out how the conclusions of the Q-REC project can be taken forward to create the new Quality Labelling and Certification services.
The Business Plan will: Q-Rec Business Plan Identify the possible risks and hurdles and specify preliminary measures to minimise their impact; Suggest appropriate alliances (authority, software industry, Prorec centres) for the deployment of the Q-REC services Develop possible pricing strategies, including available sources of financing (Health authorities, industry, health insurance companies & organisations ) Specify alternative implementation strategies
Q-Rec Business Plan The main components of the plan include: - A statement of the mission The rationale for the adoption of a Certification service within each country and throughout Europe An assessment of all the stakeholders involved A full description of the services being offered An analysis of the market potential and a marketing plan A financial analysis and a financial plan A strategy to achieve the mission objectives The organisation structure to support achievement of the objectives
Q-Rec Business Plan Deliverables (1) The plan will address how the Certification services can be established by drawing together the conclusions from all the relevant work packages within Q-REC programme to provide: - The rationale for the adoption of a Certification service within each country and European wide The goals and milestones for setting up a certification service The rationale, objectives, milestones and timetable for setting up one or more pilot schemes to fully evaluate the methodologies and practice inherent in a certification service The pro s and con s of creating a Q-REC model that should act as a standard certification service on which each country bases their scheme. The financial, information and market benefits to be expected from the adoption of such a service to the health community, the health funding agencies, the IT industry and the patient community
Q-Rec Business Plan Deliverables (2) The resourcing implications in the setting up of such a service for all stakeholders including some appreciation of the financial consequences upon the industry and the health community An assessment of the competitive advantages to the health IT industry of such a service and how this can be applied against non-european competitors and to advantage in markets outside the European countries An assessment of all the stakeholders involved whose interest and support is essential to bring a service into full use at a country level. This will include a review of how each might contribute, their interest level, the priorities involved in their participation and the impact of failing to gain less than unanimous support A risk assessment both of setting up a certification service and the potential impact of not doing so on all the stakeholders A summary of the way forward including the key steps, decision points and further action.
Promoting and developing political support, supplier and user awareness If Quality Labelling and Certification for EHR software is to become a reality in the near future then the business case for it, and for the organisation to make it happen, needs endorsement at the highest levels within the EC, Governments, Ministries of Health, healthcare provider organisations and the supplier industry. Without full EC and Political commitment to make QL mandatory neither the ICT industry nor the healthcare providers will endorse the programme.
Promoting and developing political support, supplier and user awareness A key aspect of EuroRec s work is the promoting the use and need of high quality Electronic Health Record systems. To help achieve endorsement and commitment from all stakeholders, there is major focus on disseminating the current and potential outcome of it s activities through : Publications, and presentations The EuroRec web site (www.eurorec.org) Tutorials
Q-Rec Project -Tutorial Structure The tutorials are aimed at all those who should be made aware of the benefits of European quality labelling and certification services for Electronic Health Record (EHR) system products and who can or are likely to influence the uptake of such new services. The tutorials are developed around a core theme and are essential to the marketing and business plan for the new benchmarked quality labelling and certification services for EHR systems to be offered by the EuroRec Institute. The central message of the tutorials is the quality labelling and certification of EHR systems products to meet a set of prescribed criteria for functionality, interoperability and security or other standards based criteria. The aim is to communicate to the different stakeholders an appreciation of what this process involves and enable them to learn of the potential impact of this and of the potential benefits to them.
Q-Rec Project -Tutorial Structure The tutorials will be made available on an individual country basis across Europe and the associated states through the network of national ProRec centres and by the EuroRec Institute through its website and liaison activities. The target group for tutorials will be those who should be made aware of the potential benefits relative to costs, of the new quality labelling and certification services and who can or are likely to influence acceptance and uptake of the new services. This group will include: policymakers, managers, procurement specialists, IT professionals, health professionals and end users, industry/vendors, patients /citizens groups and academics/researchers.
How Certification will be Managed The role of Eurorec - initially through the Q-Rec project Build and develop the QL & Certification process centrally Distribute the QL & Certification process to Prorec Centres Assist and support Prorec Centres in introduction and adoption Providing guidance and education to all stakeholders in the market Auditors of the process Establish and Maintain Registers Maintaining the standards The role of the Prorec Centres Taking the QL & Certification process and adapting for local needs Be the centre of QL accreditation for each country Establish and Maintain Registers Maintaining the standards
Key Success factors In achieving the objectives the focus on ensuring the success of the following is essential: The Prorec centres must have national standing and be recognised within their countries as the sole institution for quality labelling (QL) and certification of EHR software Eurorec, through the Q-Rec project, defines the initial version of the EHR quality labelling standard for Europe which is then piloted in at least two key countries Eurorec provides the essential expertise and support to Prorec centres so they in turn can adapt the standard to local conditions Eurorec together with the Prorec centres engages with the Purchaser and Supplier communities to promote the QL standard and secure support for its introduction Support from the EC at political level across Europe is mandatory to winning support for QL and Certification