UNICOM is an Innovative Action project supported by European Commission, focusing on implementing the standards for Identification of Medicinal and pharmaceutical Products (IDMP) as developed, published and maintained by the International Organization for Standardization (ISO). We understand that a full and coordinated set of IDMP-related standards and terminologies will be needed to make it work in real life. Our work will therefore involve further development, testing and implementation to support:
The 4-year project has objectives focusing on a number of areas in support of the implementation of IDMP for the above purposes:
Next to CEN/TC 251, SNOMED International, GS1, IHE, HL7 and others are all part of the project consortium and committed to ensuring their relevant standards can work together in support of project requirements whilst also considering long term sustainability beyond and outside the project.
European development of a quality standard for evaluating health apps
In cooperation with the international standardisation experts in ISO/TC 215/JWG7, a specific expert team in CEN/TC 251/WGII is working on delivering CEN/TS 82304-2 ‘Health software – Part 2: Health and wellness apps – Quality and reliability’.
This project has been started at the request and with the support of the European Commission. It is due to be completed end of 2020. It will help to establish a common framework across Europe for the evaluation of these apps, giving users and health professionals confidence that the apps are fit for purpose, and providing app developers easier access to European markets.
Europe is experiencing a fast growing market for Health and Wellness Apps. At the same time, concerns about the quality and reliability of apps have risen. Many Health and Wellness Apps are being published without clarity on the level of quality and reliability.
This specification addresses the specific needs of the developers of Health and Wellness Apps:
The project team includes members from the following CEN member countries: France (AFNOR), United Kingdom (BSI), Germany (DIN), Netherlands (NEN), Sweden (SIS), Finland (SFS) and Italy (UNI). Quoting the project leader Charles McCay: “Initial work for this standard has already been done in the United Kingdom with the publication by BSI of the publicly available specification PAS 277. This project will expand that work to meet the wider European requirements and ensure compatibility with the world health informatics standards from ISO and IEC.”
Further details about the project can be found here
For more information on European standardization activities in relation to eHealth, please see the CEN website: https://www.cencenelec.eu/standards/Sectors/healthcare/eHealth/Pages/default.aspx
For more information about CEN/TC 251 ‘Health informatics’: https://standards.cen.eu/dyn/www/f?p=204:7:0::::FSP_ORG_ID:6232&cs=18CA078392807EDD402B798AAEF1644E1
International Patient Summary (IPS) project
The aim of the project was to participate in the creation of an International Patient Summary specification, at a global level, and turn this European knowledge and interests into a European Standard, in line with the Guidelines adopted by the European eHealth Network (eHN).
Formal Deliverables have resulted in:
The project team (PT) comprises the following experts:
This proposal addressed the 2015 Rolling Plan on ICT standardization and in particular the work of the Joint Action Supporting the eHN.
This proposal builded upon and formalised the revised Patient Summary (PS) dataset that was initially proposed by the eHN in 2013; its second revision was then officially adopted by the eHN in November 2016.
The Multi-annual Work Plan (2015-2018) of the eHealth Network identified both the work on the cross-border exchange of PS data and the alignment of standardization activities in eHealth as key priority areas. The European eHealth Digital Services Infrastructure (eHDSI) has also been tasked with a deployment project across member states using the eHN PS guidelines as part of their work. With this in mind, the CEN proposal looked to national, regional and international work in PS to produce consistent, implementable Patient Summary standards.
The wider international context, the EU-US collaboration in particular, was taken into account by this proposal. In parallel, HL7 produced its IPS standard and, concurrently, the Joint Initiative Council on Global Health Informatics Standardization (JIC) produced an informative guideline, cataloguing a set of implementable standards for the exchange of a Patient Summary (published in 2017).
For this project, CEN/TC 251 worked together with the Horizon 2020 PHC34 CSA projects, particularly Trillium Bridge and eStandards, and these provided support for the Internationalisation of Patient Summary standards. The Trillium II project, also promoted the IPS work, was instrumental in bringing together two of its participating SDOs, HL7 International and CEN/TC251, to agree a common mission and scope for an International Patient Summary in April 2017.
This very successful collaboration became known as the IPS Project, and the two partners known as CEN IPS and HL7 IPS respectively. A new European eHAction roadmap (2018-2020) seeked to leverage the work of the IPS Project going forward so as to support the eHDSI initiative.
Dissemination has been an on-going part of the IPS Project from its inception, where the CEN and HL7 teams have presented, written and explained what the IPS is, what it can do, and why it is so important.
For IPS to have the intended impact, its story as well as the standards must address multiple audiences, as only a relative few will actually read the specifications.
One attempt to capture the story-line, and thereby ensure the compelling arguments and rationale are not lost, is the CEN IPS Prezi, a presentation which is intended to complement rather than duplicate the IPS standards. Once the Prezi is launched, please click the ‘readme’ section to get the most from the presentation. The URL is: http://bit.ly/IPS-Story
This multi-stakeholder project run between January 1, 2017 and September 2019, in which NEN (representing CEN/TC 251) was one of the 25 partners from Europe and US.
TRILLIUM II was a EU/US Cooperation for Global Interoperability in Digital Health and has advanced an International Patient Summary standard to enable people to access and share their health information for emergency or unplanned care anywhere and as needed starting with immunizations, allergies, medications, clinical problems, past operations and implants.
CEN/TC 251 has lead WP5 ‘EU/US eHealth Interoperability Roadmap, Open innovation and International Patient Summary Standards Governance’ which resulted in two specific deliverables.
For more information, see https://trillium2.eu/