Statement regarding COM(2009)324
“Modernising ICT standardisation – The Way Forward”
By Siemens AG Healthcare, Dr. Georg Heidenreich, Manager Healthcare IT Standards
This White Paper COM(2009)324 allows to expand and recognize expertise that has been developed over years -not necessarily within ESOs- but also by fora and consortia.
The work done at international level shall have prioritiy in order to minimize fragmentation at national level, and to move towards a more efficient integrated system that can follow the evolution of technologies.
The underlying Commission initiatives regarding IPR and the inclusion of fora and consortia are significant positive steps forward.
As to the attributes (section 2.1) – for standards as well as for the standardisation process- those attributes should be identical to the agreed WTO (“Technical Barriers to Trade”) principles. “Consensus” may include rules for quorum and/or majority voting among key stakeholders such as industry, users, operators, etc.
The required clarification regarding the need to implement standardised interfaces to platforms, frameworks etc. should include an evaluation of the work of relevant SDOs including fora and consortia in the respective field of application.
Since researchers are stakeholders like any other participants in standardisation, they shall as well adhere to the above attributes (see section 2.1 of the White Paper) which would allow them to propose their work via open, transparent, consensus-based processes to relevant SDOs.
Today’s “IPR-in standards” systems of upfront disclosures and FRAND commitment are balanced and work well, and should be implemented by all relevant SDOs. Further improvements could be sought but in our view ex-ante declaration of terms is not a good route.
EU legislation and policies for regulation should avoid referencing fora and consortia work. However, specific fora and consortia work should play a role in non-regulatory ICT standardization provided they include an appropriate number of experts and level of expertise in specific fields, and that they comply with the attributes of section 2.1.
Standards should be produced when there is a need expressed by relevant stakeholders, rather than by discretion of the ESOs. The reason why fora and consortia have been created is that ESOs often did not provide the platform to create market-relevant standards. Fora and Consortia such as DICOM or HL7 have proven successful as several of their documents were published via ISO/CEN. However a more transparent way to recognize this work via ESOs should be established. As a result of such improved cooperation, ESOs may refer to published work of fora and consortia – rather than issuing new standards.