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Lect. Mircea Focsa, MD, PhD University of Medicine and Pharmacy Timisoara
Prorec Romania Association
Certification of Electronic Health Record Systems - EHRQTN POLAND 2012
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
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
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
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 Health
for 2008-2010
[2] Law no 677 on the Protection of individuals with regard to Processing
of Personal Data and onthe Free movement of such Data, November 2001
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 (www.prorec.ro, www.paginamedicala.ro, Google map)
Romanian Medical Science Academy –session dedicated to EHR certification ( Apr. 2012)
Romanian eHealth strategy - amendment regarding the necessity of a quality certification mechanism
Prorec.ro 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
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
General information
Eurorec Seal criteria
Evaluation request form
Focused on validation of the repository ◦ Content wise:
EuroRec Seal Level 2
◦ Translations:
Terminology – Definitions
Consistency - sometimes an issue
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
http://www.prorec.ro/sondaj
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
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 patient's administrative data.
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
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
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
Don't 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
Questions?