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
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/Q-REC 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.
