1. MEDIQ EuroRec Seal Preparing a certification session Morten Bruun-Rasmussen mbr@mediq.dk √ Vilnius, Lithuania. 26 th January, 2012

2. Guideline for running a test  Introduce a uniform and transparent methodology for the certification of Electronic Health Record systems in Denmark (and Europe)  It is mandatory to follow the guideline by the certification of a system: Result and documentation of specific certifications can be compared Can be repeated – with the same results – by more authorised certifiers MEDIQ

3. Compliance and conformance  The certification, documents to what extend the software product is compliant with the conformance criteria being tested  The certification, does not ensure: Stress testing: system performs with expected volumes Execution testing: system achieves desired level of proficiency Recovery testing: system can be returned to an operational status after a failure Operations testing: system can be executed in a normal operational status Security testing: system is protected in accordance with importance to organisation MEDIQ

4. Certification methodology EHR system EuroRec Seal Guideline Procedure Certification documents Delivery document. # of tests performed Approved Not approved Self evaluation Test-log Validation Test-log Test data set Test criteria

5. EuroRec Seal Statements MEDIQ

6. Test scenarios  The objective is to test and ensure that the business process flows are tested from end to end  Scenarios are simple and based on a number of steps, where each step gives precise instruction on what to do  In average a test of a EuroRec Seal statement will include 3-4 steps. MEDIQ

7. Test data  Data which have been specifically identified for use by testing the EHR against the EuroRec Seal  Some data may be used in a confirmatory way, typically to verify that a given set of input to a given function produces some expected result  It is mandatory to use the specified test data in the scenarios, unless it is clearly stated the test data only serve as examples MEDIQ

8. Conformance criteria  The aim is to test and gain confidence in the correct functioning of the implementation with respect to a specific EuroRec statement  Based on a functional testing (black- box testing) with the emphasis on testing the externally observed functionality against the EuroRec Seal. MEDIQ

9. EuroRec Seal #1,GS001537.1 MEDIQ Each version of a health item has a date and time of registration. Quoted Statement 1.Search for patient 2.Add a health item, eq. a diagnose 3.Add a health item, eq. an intervention 4.Add a health item, eq. a consultation note Test scenario 1.Patient #1 2.Diagnose: Chronic Heart Failure 3.Intervention: Electrocardiogram 4.Consultation note: Congestive heart failure with severe LV systolic dysfunction Test data Check that the date and time for the diagnose, the intervention and the consultation note are the same as the date and time for the registration. The registration is the date and time, when the decision or process happened (not always the date and time for entering the data). Criteria

10. EuroRec Seal #4: GS001579.2 Each version of a health item has a status of activity, e.g. active or current, inactive, history or past, completed, discontinued, archived. Quoted Statement 1.Search for patient 2.Search for a health item, eq. diagnose, intervention or consultation note 3.Display the current status of activity 4.Update the status of activity 5.Repeat step 2-4 minimum 3 times and update status of activity Test scenario 1.Patient #1 2.Diagnose: Chronic Heart Failure 3.N/A 4.Status of activity: State 1, state 2, state 3… 5.N/A Test data Check that the status of activity for a health item (eq. diagnose, intervention, consultation note) can have different status of activity. Conformance criteria

11. Test environment  The vendor will provide minimum two networked computers with printers etc. All necessary components and resources for running the test shall be available (PCs, laptops, printers, servers etc.)  The system shall be preloaded with necessary test data before the test Number of patients and data descriptions are specified in the guideline  The EHR system shall be configured as a “live” system running in daily operation MEDIQ

12. Start Vendor Self-evaluation Week 1Week 2Week 3Week 4Week 5 Valida tion Week 6 Vendor fix errors if not approved Valida tion Test log Test log Delivery document Test log Delivery document

13. Test log  A template which is used to document the actions and results of the test of the EHR system against the EuroRec Seal  It is mandatory to use the test log at both phase I – self evaluation and phase II – validation  If an error during the test is detected it shall be documented exhaustive MEDIQ

14. Delivery document  The objective is to document if the EHR system has passed or not passed the test.  After the end of phase II – validation, the certifier will fill out a delivery document  The delivery document is to be signed by the representative from the vendor and the representative from the certification organization. MEDIQ

15. EuroRec certificate MEDIQ  CSC announces the achievement of the EuroRec certificate world- wide

16. Thank you MEDIQ