1.001 What happens if the system does not fulfill one or more of these requirements because they are “not applicable” for the domain of application? What if an application does not have these roles?

Answer: The application should meet all the applicable criteria included in the Seal. The non applicability of a criterion, considering the domain(s) of application and intended user group(s) listed, has to be documented and accepted by EuroRec, being – for the Seal – the responsible certification authority.

1.002 What happens if a system fulfills only 49/50 criteria? Could we get the seal if no “severe problems” occur? What happens if the system does not fulfill these requirements?

Answer: The application should meet all the applicable criteria included in the Seal. This statement does not preclude that a criterion can be met in different ways, even in a different way than originally intended.

1.003 How is compliance evaluated?

Answer: Compliance to a criterion is evaluated by running a test scenario. Self evaluation by the supplier is not sufficient, at least for the Seal. A full documentation should be produced documenting how the application met each of the criteria, before running a test scenario.

1.004 Is it possible to tailor functional statements for use in a specific context without breaking the linkage to the EuroRec Seal?

Answer: The actual Seal and more especially the Level 1 Seal addresses mainly generic requirements that should be met by all the EHR systems, independently the domain of application. We are aware that a number of statements, part of the EuroRec Seal Level 2, aren’t applicable in some environments. This should be documented in the assessment report as “not applicable”. Quality Labelling of “modules” of “separate functions” will be required, as e.g. yet in Germany for the disease management modules, linked to mainly / purely administrative and billing oriented systems. EuroRec decided on the other hand to extend functionality of the Repository in such a way that “national variants” may be added to the Repository.

2.001 It is important to have results of seal certification published. It would allow for comparison on semantics.

Answer: EuroRec Seal evaluation is done on request of the suppliers. They are free to decide on the availability of the evaluation reports as these reports contain confidential information regarding their application. The EuroRec Seal only guarantees that an application has listed and described functionality available. The report reveals how a given application meets those requirements. There is for EuroRec no need to make that public. This does not preclude that an authority deciding to make use of the EuroRec statements for a quality labeling and certification of a given class of systems for use in a given environment may decide – as an authority – to make that documentation publically available. The evaluation reports are kept by EuroRec and/or his National partner organisation. They can be used and consulted in case of contestation of a Seal granted to a particular EHR system.

2.002 What happens if the patient does not want some health item displayed?

Answer: The issue of getting access to patient data in order to validate an EHR system is an issue to be solved by the supplier before submitting the application to quality assessment in order to obtain the Seal or any other Certificate. Quality Assessment can be done on “fictive” patient data. They should of course be representative for a real patient population in quantity and complexity.

2.003 Success of quality labelling and certification will depend on the legal and/or regulatory context and the decisions taken by the healthcare authorities.

Answer: This is completely true. There will not be a large scale quality labelling and certification without the political will and the appropriate regulatory framework installed.

2.004 The EuroRec Seal does not deal with the “content” of the record. Will the Seal contribute to “interoperability” of the systems.

Answer: The EuroRec Repository addressed the content of an EHR application in “generic way”: what “kind of content” can be, should we possibly expect within an EHR system. EuroRec offers to the authorities or authorised organisations the means to define that kind of content for a given domain of application or even the standards to be used. The EuroRec Seal is a subset of 20 or 50 statements out of 1700 statements, addressing, as explained, mainly generic attributes of health items and basic functionalities, favouring reliability and subsequently interoperability of systems, without being sufficient to guarantee yet such an interoperability. The new functionality enabling to define “national variants” offers the health authorities the possibility to be even more precise / more restrictive, regarding possible implementation options.

3.001 We think that Health item should really be health data item.

Answer: EHR systems do not contain something else than “data”. Each element of an EHR is a data element.

3.002 What if the system is not problem oriented?

Answer: A system has not to be problem oriented if this means that every entry needs to be organised around a problem, has to be linked to a problem. A requirement to be problem oriented means that the system should be able to define a problem list and to link ‘services’ or ‘actions’ as e.g. issuing a medicinal product prescription to a problem.

3.003 Some of the criteria contain the concept “Appropriate”. “appropriate” may e.g. be related to the opinion of the person responsible for the validation. It would be useful to define “appropriate”.

Answer: The specification “when appropriate” is mostly used for functions, for attributes that aren’t always applicable. Examples are the statements 1666 “The system stores when appropriate for each medicinal product prescribed the number of renewals permitted” or statement 1667 “The system stores when appropriate for each medicinal product prescribed the number of refills done”. Renewals or refills of a medicinal product are not mandatory. We should nevertheless consider reformulating some of these statements in order to be more explicit.

3.004 What does it mean ‘new version’, how to interpret and how to evaluate it? (WS27)

Answer: Each update or modification of a health item or each change of any attribute of a health itemresult in a changed health item. We name that changed item a “new version of that item”.

3.005 Overall evaluation of section A09 Generic Data Properties (WS26)

Evaluation:

• Content “All the statements have a descriptive approach of the different functions in an EHR.”
• Completeness “The audience assessed statement enough complete”
• Technical correctness “The audience found some statements very closed, it is sometimes necessary to look two times to see the difference. A new representation of some functions, in the form of tree, could perhaps provide a better understanding of all functionalities."

Answer: Indeed some statements are very similar to each other. We nevertheless need to maintain the different statements because they address a different function or a different variant of a function with differences in applicability.

• Importance: Most of the statements were considered as “important” with an average score of 3,8 on a scale from 0 to 5.
• Feasibility : most statements are considered as “feasible with a reasonable time”, being in average 1,27 for over 90 criteria. 37 statements can be realized within one year or less, 39 other statements between one and two years.

Seal Level 1

Apply as EHR vendor for this seal.

Seal Level 2

Apply as EHR vendor for this seal.

Rates for granting a EuroRec Seal Level 2
Form to be completed by the testing organisation.