EuroRec Services

1. An Inventory of Certification Criteria for EHR Systems

Introduction

The importance of EHRs quality criteria in Europe

The overall objective of the QREC project is to develop methods and to create a mechanism for the quality labelling and certification of Electronic Health Record systems (EHRs) in Europe, in primary and acute hospital care settings. Several EU member states have already proceeded with EHRs quality labelling and/or certification, more often in primary care, but these differ in scope, in legal framework under which they operate, in policies and organisation, and perhaps most importantly in the quality and conformance criteria used for benchmarking. This means that the requirements, functionality and quality of EHR systems is at present a patchwork across Europe, leaving:

purchasers of EHR systems to struggle with a piecemeal market of non-comparable systems;
users and clinical governance organisations to contend with inconsistent functionality on which to attempt to harmonise evidence based care;
vendors with heterogeneous and volatile user requirements against which to build systems and a fragmented European market within which to try to sell products.

EuroRec will act as central repository of validated quality criteria and other relevant materials that can be used to harmonise the European testing, quality labelling and procurement specification of EHR systems. EuroRec will also consolidate best practice in testing and certification procedures, including the business models that have proved successful across Europe and internationally. It will not impose particular certification models or specific criteria on any member country but will foster, via its ProRec Centres, the progressive adoption of consistent and comparable approaches to EHR system quality labelling.

Current standing of criteria selection

EuroRec's short term strategy was to firstly collect high priority criteria from existing certification systems in Europe (and worldwide) and to analyse how they could be used in formal certification procedures. Over 1400 functional and other criteria have been analysed and have resulted in this first limited and very preliminary list of EHRs quality criteria.

This initial list covers:

Clinical: medication management
Clinical: health assessment and diagnose documentation
Clinical: care planning, shared care and care pathways
Clinical: findings and result documentation
Clinical: alerts, notifications and reminders
Patient demographic services
Security: Privacy in general
Security: technical

Next steps

It is EuroRec's intention to further refine the list, to rigorously index the criteria and to submit the list to external reviewers (with the help of a wide range of stake-holders: EHR industry, authorities, users...). The aim is to obtain a quality labelling (filter) system enabling :

potential buyers to identify their needs and requirements (specifying their contexts of use, the type of EHR modules they need etc.) and to find appropriate test plans with scenarios and criteria against which a number of EHRs may be tested;
EHR-system-developers and vendors to check their own systems to get a quality label or certificate or to better plan future development;
EU member states to implement EHRs certification in a comparable way.

Preliminary list of EHR certification criteria
The EuroRec/Q-REC repository of certification criteria (under construction!)
Classification of Indices (.pdf)

2. An Inventory of Standards relevant for EHR Systems

The role of standards

The overall objective of standardisation [ ] is to facilitate the production, handling, or use of products or services in the framework of free trade and free market to the best possible satisfaction of both users and suppliers.

The role of standards has repeatedly been highlighted by European Union official policies. For example in Council Conclusions 1999 [2] the Council emphasised « the role of European standardisation as a means to meet specific needs of the European market, to serve the public interest, in particular in support of European policies, to provide standards in new domains, to implement international standards in a coherent way and, while respecting the independence of national standards bodies, to facilitate mutual understanding between Member States' standards bodies and the preparation of coherent positions in international standardisation. »

Additionally, more recently in a Council Resolution 2002 [ ] the Council reaffirmed « the important role of standardisation for the internal market and its growing contribution to different policies and actions such as governance in the EU, e-Europe, the strategy for sustainable development, and global trade. »

The operational goal of standardisation is to provide sets of consistent specifications --called "standards"-- to be shared by all parties manufacturing the same products, or providing the same services, and to form the basis for further developments. The ISO/IEC and CEN definition of a standard [ ] is « document, established by consensus and approved by a recognised body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context ».

Excellent work regarding eHealth standards --in general--, together with their origin and context, can also be found in the Report of the eHealth Standardisation Focus Group (2004-2005) "Current and future standardization issues in the e-Health domain: achieving interoperability" https://www.centc251.org/ehealthfocusgroup.htm which provides a compilation of many existing eHealth standards. Another such compilation is provided by the WHO eHealth Standardisation Co-ordination Group https://www.who.int/entity/ehscg/resources/en/ehscg_standards_list.pdf

1. Report of the eHealth Standardisation Focus Group (2004-2005) "Current and future standardization sues in the e-Health domain: Achieving interoperability" https://www.centc251.org/ehealthfocusgroup.htm
2. Official Journal of the European Union, OJ 2002/c 66/01
3. ISO/IEC Guide 2:2004

Why does EuroRec publish this inventory of standards relevant for EHR systems?

There are many reasons for applying standards (formal or informal) to EHR systems, two of them being related to interoperability issues:

the need to communicate between systems in such a way that data originating from any EHR system should be and remain usable by any receiving systems;
the need for durability and long-term availability --possibly lifelong and beyond-- of personal health data, primarily for the sake of continuity of personal health care, secondarily for public health and other similar collective purposes.

The use of standards like interchange formats, among others, is a prerequisite for interoperability of EHR systems. "Functional" interoperability involves the lower tiers of the classical OSI model (levels 6 and below), but the ultimate objective is the semantic interoperability which implies inter-system compatibility at the level of the top tier (level 7).

Additionally, several EHR quality criteria may reference health informatics or technical standards: formal, thus "de jure" or informal or “de facto”, a.o. industry authored.

Many EHR-related standards --formal or informal-- exist, established by various kinds of organisations: CEN/TC 251, ISO/TC 215, HL7, DICOM, IEEE, etc. EHR system developers need guidance to find their way and easily identify the relevant ones through an up-to-date documented inventory of all existing EHR-related standards. Other standards might not underpin EHR systems themselves but other health care software or systems that interact with EHR systems.

The existing list is preliminary and flat and still does not provide enough guidance to the suppliers and/or users. Moreover, their scope is too broad, and the need is increasingly felt of a more restricted and better targeted list, which will be more rigourously indexed. The objective of such inventory will be:

to provide reference pointers to those standards that complement the EHR quality criteria;
to provide a useful overview and critique of other relevant standards that an EHR system vendor, purchaser or adopter might wish to adopt (cf. the recently published ISO Health Informatics Profiling Framework -friendly web interface for searching and browsing).

Important note: the EuroRec/QREC certification will not be restricted to (technical) conformance testing against such existing standards (which only are intermediate instruments to achieve interoperability or to reach higher goals, ultimately the optimal management of health). The certification approach adopted by Eurorec will therefore be pragmatic and primarily focus on ‘functional’ criteria which will be directly related to the quality, safety, security, equity and efficiency of the health(care) services.

List of EHR standards
List of standardisation bodies
An inventory of standards relevant for EHR systems (.pdf)
EHRcom - EN 13606 - Parts 1 and 4 now officially approved as European Standards (.rtf)

3. EHR Archetypes

Background

EHR Archetypes are a formal, rigorous and standardised (interoperable) specification for an agreed consensus or best practice representation of a clinical data structure within an electronic health record.

The strength of the approach taken internationally on the communication (sharing) or electronic health record information has been the development of a rigorous generic representation suitable for all kinds of entries. Provided that the communications architecture is common to both a sending and a receiving information system, any health record extract will contain all of the structure and names required for it to be interpreted faithfully on receipt even if its organisation and the nature of the clinical content have not been “agreed” in advance.

ISO/EN 13606 is a forthcoming EHR Communications standard that defines such a generic information model. A richer EHR model has been published by the openEHR Foundation, which draws on over fifteen years of international research on the EHR.

However the scalable sharing of health records, and their meaningful analysis across distributed sites, also requires that a consistent approach is used for the naming and organisation of EHR hierarchies, so that requesting processes can precisely specify the desired parts of an EHR within a request, and anticipate the kinds of data structures that will be provided in response. EHR Archetypes are a standardised way of specifying these clinical data hierarchies and the kinds of data values that may or must be included.

EHR Archetypes originate from over ten years of research and clinical demonstrators in Europe and Australia; much of this work has in recent years been consolidated within the openEHR Foundation. ISO/EN 13606 Part 2 incorporates the openEHR archetype approach as a standard information model, and an exchange representation, for the communication of EHR Archetypes.

One notable challenge in designing libraries of Archetypes to meet broad areas of clinical practice, for example to cover the complete clinical information needs of a speciality or professional discipline, is to ensure that Archetypes are evidence based or meet de facto established clinical needs. Given that many Archetypes may be needed to cover a given domain, it is also important for them to be mutually consistent and bind to terminology systems in appropriate and consistent ways. This is necessary in order to minimise the diversity of ways in which a given kind of EHR data might be represented. This consistency is needed by clinical applications, decision support and other analytic software that need to retrieve or filter EHR data, or assist users with selective navigation through a large EHR or across populations of EHRs.

EHR Archetypes themselves therefore need to be quality assured, since they will direct the ways in which clinical data is captured, processed and communicated. EuroRec is partnering the openEHR Foundation in developing governance practices for archetype development and the quality criteria and editorial policies by which certified libraries of EHR Archetypes can be recognised. In the future EuroRec will reference the organisations and EHR Archetype repositories whose governance and editorial policies have met EuroRec standards, and whose Archetypes are therefore considered to be of good quality.

Further information on EHR Archetypes may be found on the openEHR web site, at: https://www.openehr.org/FAQs/t_archetypes_FAQ.htm

White paper: Archetype paradigm: an ICT revolution is needed (.pdf)

4. Open Source Components and XML Schemata

Background

EuroRec's EHR Quality Labelling service will also incorporate an inventory of “trustworthy” open source EHR-related software and tools i.e. that Q-REC is satisfied meets suitable quality criteria (e.g. open source components, implementable technical specifications such as XML Schemata and other EHR-related specifications).

It is not the intention of EuroRec to promote open source products in competition with vendor products.

XML Schemas, other Implementation Technology Specifications and open source components can all play a role in supporting interoperability and quality of EHR systems. A number of tools, small-scale components and engineering artefacts are considered useful to many EHR system implementers but cannot always be quality assured.

EuroRec will provide an inventory and quality labelling for such artefacts, with links to the actual objects and information about their provenance and evidence base (including any live use). The role that each of these might contribute to EHR quality and interoperability will be outlined. Relationships will be established with the developers of each resource to ensure that the inventory is regularly updated.

5. EHR Tutorials

About the Q-REC EHR tutorials

The EHR Tutorials will aim to reach 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.

Such interest groups or stakeholders will include:

industry/vendors;
purchasers and policy makers (healthcare providers and authorities, hospitals);
end users (physicians and other health professionals, patients/citizens).

The central messsage of the Tutorials will be about the quality labelling and certification of EHR systems products as meeting a set of prescribed criteria for functionality, interoperability and security or other standards based criteria. The aim will be 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.

The Tutorials are structured on the basis of 4 Modules.

The Development and Rationale for EHR Certification
Is aimed at all stakeholders.

About Electronic Health Records (EHRs)
Is expected to have different levels of learning interest amongst the various stakeholders.

Certification of EHRs
Is also likely to have different levels of learning interest depending on who is the stakeholder.
This module contains information on key learning points for different stakeholder groups about what quality labelling and certification of EHRs could mean for them.

European EHR Certification Initiative - The QREC project
Contains a range of learning information about the work of QREC, its objectives and expected outcomes. The material can be ’tailored’ for presentation to different levels of learning interest.

The tutorials

6. Register of Health Coding Systems in use in Europe

Background

The growing use of Information and Communication Technology results in more interchange of data and information in machine processable formats.
The representation of data and information in coded form facilitates their processing by computers, just as it enables them to be expressed with a precision and independence from language that otherwise prove difficult to achieve. Coded representation is therefore frequently used in information interchange e.g. in eHealth applications.

Motivation

There are many coding systems in use in health, and it will most probably remain so for a long time since international adoption of a single coding system for each different type of health information is impossible (coding systems often serve different goals).
Therefore, when interchanging data, information or knowledge, it is necessary to unambiguously identify the coding systems used for their representation. This register will provide a first level of response to such need.

The registration procedure is also intended to discourage the unnecessary proliferation of coding systems used for the interchange of health information. Whenever a recognised coding system is in use, it could be recommendable to try and use it for a similar topic, instead of inventing a new one from scratch.

A European standard for the registration of coding systems

The European standard EN 1068:2005 "Health Informatics - Registration of Coding systems" published by CEN, the European Standardisation Body, specifies a procedure for the registration of coding systems used for defined health purposes, and it provides a mechanism to assign a unique Health Coding System Designator (HCD) to each one of them.

EN 1068:2005 is implemented in a context where, to date, there has been no other successful implementation of any International Standard addressing the same needs and this while there is an urgent need to facilitate information interchange in health within Europe.
It is nevertheless recognised that the subject is a matter for world-wide co-operation. Within the framework defined by ISO/IEC 11179-6, this register is to be considered as sectoral --for health--, and regional --at least for Europe--.

The European Institute for Health Records has been designated by CEN as the Registration Authority for EN 1068:2005, with the task of implementing that comprehensive register of health coding systems used in Europe, and making it available to all those parties who may benefit from the information it contains.

Disclaimer

At this early stage, this European register does not provide the full list of code values and code meanings within each coding system that it references.
Nor does this European register of health coding systems specify any mandated use of coding systems in a defined context or describe methods for storing or conveying information in coded form in messages or Electronic Health Records.

Another register, the one of Archetypes will also be provided as a EuroRec service.

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