CEN/tc251 EN EHRcom European and National EHR standard has been published on 28 February 2007

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1 CEN/tc251 EN EHRcom European and National EHR standard has been published on 28 February 2007 Gerard Freriks, MD v

2 EN EHRcom CEN/tc251 has published the EN norm for the Electronic Health Record (EHR) National Standardisation Organisations in all European Member States have accepted this new European standard CEN= European acknowledged Normalisation Organisation CEN/tc251= technical committee of CEN 2

3 EN EHRcom European standards become automatically National Standards in all European Member States. CEN= European acknowledged Normalisation Organisation CEN/tc251= technical committee of CEN 3

4 Role of European Standards European standards are produced by officially acknowledged standardisation organisations and play a specific role in: - - European and National legislation European and National procurement 4

5 EN EHRCOM It is an important milestone because: - for the first time plug-and-play semantic interoperability becomes reality - ICT firms implement once one specification in their system software - Communities of healthcare providers decide using archetypes and templates what they need to store, retrieve, present and exchange without any reprogramming of their ICT system 5

6 EN EHRCOM It is an important milestone because: - it provides a solution for several problems national programs experience - like those in England - and the Netherlands 6

7 EN EHRCOM It is an important milestone because: the standard can be applied in: - primary care: GP s, physiotherapists, etc - secondary care: specialists, hosptitals - home care - mental health - clinical pathways - etc, etc 7

8 CEN/tc251 family of EHR related standards ContSys: System of Concepts for Continuity of Care A system of defined concepts healthcare providers need when they co-operate EHRcom: EPD norm Co-operating healthcare providers can document in ICTsystems the treatment of patients and exchange it plug-and-play HISA: Health Information Services Architecture ICT systems and their components are able to co-operate 8

9 Possibilities offered by CEN/tc251 standards Co-operation by healthcare providers and ICT systems ICT systems exchange plug-and-play without any need for reprogramming systems Uniform general clinical decision support becomes a reality 9

10 Possibilities offered by CEN/tc251 standards Data, information, documents, files can be shared for the purpose of: informing colleagues optimisation of business and clinical processes clinical research pharma research obligatory reporting 10

11 EN EHRcom Is the result of more than 15 years of European R&D projects Is the only standard that is based on a requirements for the EHR document by ISO (18308) Has been produced in co-operation with OpenEHR, an open source organisation that produced specifications and software ( 11

12 EN EHRcom Is the result of co-operation with Standards Australia Is on its way to become an International ISO standard - remark: the Netherlands is one of the few countries that voted against - There is a thread that those countries will become isolated in Europe 12

13 EN Five parts: EHRcom Part 1: Reference Model (of any record) part 2: Archetype Reference Model part 3: Term Lists part 4: Security Requirements and Distribution rules part 5: Implementation guides 13

14 EN EHRcom Scope of CEN/tc251 EN EHRcom This standard specifies the information architecture required for interoperable communications between systems and services that request or provide EHR data. This standard is not intended to specify the internal architecture or database design of such systems. This standard is to be used in situations where part or all of an EHR is being accessed or transferred by a requesting process that is considered to be external to the EHR system that holds the data: i.e. this standard will be implemented as an external interface to the EHR system. In cases where the request is internal to the EHR system, or in the form of a query, this standard may possibly also be used but this is outside the scope of the standard. In the case of federation architectures, this standard may be used as the federation schema by which the various feeder systems are combined, and/or used at the external interface from the federation to other systems. The subject of the record extract to be communicated is an individual person, and the scope of the communication is predominantly with respect to that person's care. Uses of healthcare records for other purposes such as administration, management, research and epidemiology, which require aggregations of individual people's records, are not the focus of this standard but such secondary uses could also find the standard useful. This Part 1 of the multipart standard is an Information Viewpoint specification as defined by the Open Distributed Processing - Reference model (ISO/IEC 10746). In practice this standard may be implemented as a message or as an object interface (for example, using CORBA). Conformance to this standard may therefore be met through a message or interface specification that maps directly to this Reference Model. Examples of such interface or message models are given in part 5 of this standard. 14

15 EN EHRcom Five parts: part 1: Reference Model The specification vendors implement once in their system part 2: Archetype Reference Model Specification for the tools healthcare providers use (archetype editor) to define what they have to store, retrieve, present and exchange inn their (local) community part 3: Term Lists Code list that are a part of the standard part 4: Security Requirements and Distribution rules The patient mandate that regulates who has access to what part 5: Implementation guides Implementation advice for vendors and implementers 15

16 EN EHRcom Part 1 has been published Parts 2 and 4 follow this year Parts 3 and 5 later 16

17 EN EHRcom Why is this European standard making possible: plug-and-play exchange? It is based on a new paradigm: The Archetype Paradigma also known as the Two Level Model Paradigm 17

18 HL7 v2 and V3 Messages Each system of each vendor has to implement the message specifications uniformly therefor the message paradigm scales badly organisations like Integrating the Healthcare Enterprise (IHE) are necessary it never is or will be come plug-and-play 18

19 Message Paradigm Berichten Message Paradigma Healthcare providers and ICTvendors get together for long periods of time. Health They produce an implementable message specification. All message specifications must be uniformly implemented by all ICT-vendors in many health domains for all systems. ICT Only then healthcare providers are able to exchange medical information in communities. 19

20 Archetype Paradigm One general Berichten Message health record specification Paradigma has to be implemented once. Each Archetype and Health Template is produced by communities of healthcare providers. Without any reprogramming by ICTvendors healthcare ICT providers can exchange all Templates and associated data. Archetype Paradigm Archtype- Template- Editor Health ICT 20

21 Consequences for present ICT-systems The exiting advantages only can be exploited fully using new EPD-systems The European standard can be applied to connect to present legacy ICT-systems but without the full functionality 21

22 The present situation ICT-systems based on the Message Paradigm ICT-Systems contain clinical domain knowledge programmed in software ICT-Systems when implementing new messages have to reprogram and/or convert data bases ICT-Systems need a lot of resources to implement messages ICT-Systems using messages can not adopt easily to local or ad-hoc requirements ICT-Systems can not easily be integrated ICT-Systems can not deal easily with protocols and clinical pathways, let alone on a small ad-hoc scale Healthcare providers do not have one system of concepts for continuity of care IC T-Systems are not based on ISO 18308: Requirements for EHR-Systems 22

23 Future situation ICT-Systems based on the CEN/tc251 EHR related standards ICT-Systems use clinical domain knowledge defined in healthcare provider defined archetypes ICT-Systems never have to reprogram and/or convert data bases ICT-Systems need no resources to implement new archetypes and templates ICT-Systems using messages can adopt easily to local or ad-hoc requirements ICT-Systems can easily be integrated ICT-Systems can deal easily with protocols and clinical pathways, let alone on a small ad-hoc scale Healthcare providers are provided with one system of concepts for continuity of care IC T-Systems are based on ISO 18308: Requirements for EHR-Systems 23

24 Information Gerard Freriks Past chairman of CEN/tc251 wg1 Involved in: EuroRec (European Institute for Health records) EU project Q-Rec (Quality Labelling and Certification of EHR-systems) Tutorial about new CEN EHR norm March