Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD


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Validating the methodology and the functional criteria of EuroRec Seal - an example of Romania - Mirea Focsa, MD, PhD

  1. 1. Lect. Mircea Focsa, MD, PhDUniversity of Medicine and Pharmacy Timisoara Prorec Romania Association Certification of Electronic Health Record Systems - EHRQTN POLAND 2012
  2. 2.  Romanian Health IT market Legislative and organizational framework Steps to certification of EHR systems Tools and Methodology supporting the Eurorec Seal The assessment of the functional criteria The lesson learned
  3. 3.  Basic facts about ROMANIA ◦ Population: 21,504,442 (2002) ) – 19,042,936 (preliminary results 2011) ◦ Life expectancy at birth: 73.4 y (WHO 2009) Basic facts about the romanian health care system ◦ HC expenditure: 5.5% of GDP (WHO 2008) ◦ Public sector hc expenditure as % of total hc expenditure: 81.7% (OECD 2007) ◦ Organization: central / district auth./ local units  Ministry of Health (MoH) / 41 District Health Authorities  National Health Insurance House (NHIH) / 41 District HIH
  4. 4.  Simplified version (SIUI) = 100% (mandatory) in both primary care and hospitals Extended version: ◦ primary care ~ 50% (from small companies) ◦ hospitals ~90% large hospitals, ~30% small hospitals Number of applications on the market ◦ Primary care: ~20, but only ~10 have acceptable quality ◦ Hospitals: 5 better known applications ◦ Pharmacies: ~10 ◦ Dentistry: 8-10 Empirica 2010
  5. 5. Any legislation / regulation: Yes [1] ◦ about the use of EHR systems? - Not explicit ◦ about functionalities of the systems  related to functional system requirements? No  related to data-exchange and/or interoperability? No (*)(*) Note: it does exist only related to protection of personal data [2][1] Ministry of Health: Strategic Plan of the Ministry of Public Healthfor 2008-2010[2] Law no 677 on the Protection of individuals with regard to Processingof Personal Data and onthe Free movement of such Data, November 2001
  6. 6. Dissemination and promotion of EHR certification: EFMI – Special Topic Conference 2006 - Timisoara Workshops: ◦ Present and Future of EHR in Romania Bucuresti 2007 ◦ The quality of EHR systems – developers perspectives Bucuresti 2009 ◦ First step validation of the Eurorec Seal criteria Timisoara 2010 ◦ Validation of the Eurorec Seal tools and methodology Timisoara 2011 Letter for authorities and decision bodies Emails to the major EHR systems developers Online announcements (,, Google map)
  7. 7.  Romanian Medical Science Academy –session dedicated to EHR certification ( Apr. 2012) Romanian eHealth strategy - amendment regarding the necessity of a quality certification mechanism website – online resources for evaluating the quality of EHR systems: ◦ Full documentation ◦ Registration for applicants ◦ Online tools for self-assessment ◦ Online assistance during the whole process
  8. 8. Procedure of granting the Eurorec Seal: The session opening announcement followed by the online registration Access to the informative resources Request for evaluation and payment Personalized calendar of assessments Self-evaluation and online documenting the requirement’s accomplishment Testing session by the Prorec Romania experts and collecting the documentation [Re-testing during the same session] Final resolution
  9. 9.  General information Eurorec Seal criteria Evaluation request form
  10. 10.  Focused on validation of the repository ◦ Content wise:  EuroRec Seal Level 2 ◦ Translations:  Terminology – Definitions  Consistency - sometimes an issue
  11. 11.  Issues quality related: ◦ Formulation: correct and understandable ◦ Content acceptable (not normative!) ◦ Completeness (of the set) ◦ Technically correct (doubles, not granular…) Issues usage related ◦ Importance ◦ Feasibility
  12. 12.
  13. 13.  Requirements included in Eurorec Seal Level 2 covers basic functionality Some criteria are derived from the very model of a DBMS - ease accepted by the developers Other criteria - too specific or too vague The necessity of ◦ Clear definition of terms ◦ Explanations to be included with the criteria ◦ Headings for grouping the criteria
  14. 14.  GS001611.01: The system is able to present all the documentation associated to a contact for that patient. ◦ SS000595. 01 - CCHIT-06 - 55 - The system shall display documentation GS002243.1 Security service issues and operation of the system are well documented. GS002625.1 The system enables the user to modify patients administrative data.
  15. 15.  GS001550.6 The system presents a current medication list associated with a patient. GS001559.2 The system presents a medication history associated with a patient. GS002638.1 The system distinguishes actual or active medication items from past medication items when including and displaying medication items in lists or in a journal
  16. 16.  Workshop: Validation of the Eurorec Seal tools and methodology - Timisoara, April 2011 Medins ◦ EMR for GPs, patient oriented ◦ Data grouping by SOAP and by episodes ◦ Coding system: ICPC-2 and ICD-10 Assessment data collected on a framework build based on Danish and Slovenian templates
  17. 17.  Present state regarding the certification: ◦ lack of “motivation” for the developers ◦ Lack of awareness for the clinicians Implementing the certification mechanism took time and need a proper preparation Need of “pressure” for accepting the necessity of EHR certification Create incentives for the use of EHR certified systems
  18. 18.  Dont reinvent the wheel – use existing methodology Share expertise and resources Work in small groups and try to involve various stakeholders Always display the English version of the statement near the translated one. Reference statements could bring clarity Identify unclear situations about the criteria accomplishment and consult as many opinions
  19. 19. Questions?