News from the working groups

30 June 2016
When the working group structure of CEN/TC 251 was revised in 2015, the active work items (WIs) of the former four working groups were allocated to the two new ones. This has been the proper moment of time to take a close look at the WIs and check which of them are still relevant and up to date and what new WIs should be taken into the work program.

The WIs of WG II Technology and Applications can be divided into three groups

WIs coming from the ISO/TC215

  • A number of ISO IEEE 11073 Point-of-Care Medical Device Communication standards
  • A number of ISO IEEE 11073 Personal Health Device standards
  • A Number of ISO 21549 Patient Health card data standards
  • EN ISO 12052:2011 Digital imaging and communication in medicine (DICOM) including workflow and data management

Usually CEN/TC 251 has just expressed its support to these work items. May of the 11073 standards have also been recognized by the FDA in USA. Currently the IEEE 11073 is making some corrections to the 11073 nomenclature to some rarely used codes. The codes are freely available in the NIST website in the USA. The 12052 needs a revision (to be done in ISO/TC215) because it points to an outdated version of DICOM which has already published three versions in 2016.

WIs coming from the former CEN/TC251/WG IV

  • EN ISO 18812:2003 Health informatics – Clinical analyser interfaces to laboratory information systems – Use profiles (ISO 18812:2003)
  • EN 1064:2005+A1:2007 Health informatics – Standard communication protocol – Computer-assisted electrocardiography

The 18812 was almost removed from the work program some years ago but the Irish national body requested to keep it as it was still used in Ireland. The EN 1064 is currently being revised by a WG II project team. Its ISO version is also recognized by the FDA.

Legacy WIs from other CEN/TC 251 working groups:

  • CEN/TS 15260:2006 Health informatics – Classification of safety risks from health informatics products
  • ENV 12537-1:1997 Medical informatics – Registration of information objects used for EDI in healthcare – Part 1: The Register
  • CR 13694:1999 Health Informatics – Safety and Security Related Software Quality Standards for Healthcare (SSQS)
  • CEN/TR 15299:2006 Health informatics – Safety procedures for identification of patients and related objects
  • EN 12381:2005 Health informatics – Time standards for healthcare specific problems
  • CEN/TR 15253:2005 Health informatics – Quality of service requirements for health information interchange

These are the work items that need to be discussed in WG II. Input from national member bodies is also welcome when the future of these WIs is planned.
WG II is not only about history, though. The working group members, more than 40 listed in May 2016, are free to propose new work items for development in WG II.

Reform of the European Data Protection Directive
The European Union has revised its Data Protection Directive from 1995. The new directive General Data Protection Regulation (GDPR) shall fully apply from 25 May 2018 to old and new systems alike. The GDPR has an interesting new requirement concerning data portability in Article 20. The data subject has the right to data portability meaning that his/her personal data must be transferrable from one electronic system to another one. This is yet another reason for manufacturers of medical devices and health information systems to look at standards based ways of storing and transmitting information which (partly) have been developed by CEN/TC 251, ISO/TC 215 and IEEE 11073.

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