Projects

TC 251 projects


 

Health and wellness apps
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:

  • App developers are a disruptive community, with many members who are entering the Health and Wellness IT market without prior experience in a Health Informatics context. These developers will not have experienced a transfer of health informatics knowledge and good practice from co-workers and broader corporate memory. The specification will compensate for this by providing a set of requirements that have been through a rigorous standards development process.
  • This community does not expect to have to read multiple documents, and map generic standards into their context of use. Apps are typically developed to deliver a small piece of functionality, building on an existing platform – often with a small team doing the work. The specification will directly address the needs and concerns of app developers.
  • Apps run on platforms, and are made available through distinct channels such as app stores and libraries. These platforms and channels provide potential points of control where quality and reliability of apps can be influenced, and this will be taken into account during the development of the specification.
  • There is a need for a specification to establish a consistent set of criteria for among the controlled channels being maintained as trustworthy sources of health and wellness apps in the many national health initiatives within the EU.

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.”

Those interested in participating on this project should contact their national standards organisation via ISO and/or CEN-CENELEC.

For more information on European standardization activities in relation to Health, please see this CEN website.

International Patient Summary (IPS)
Participation in the creation of an International Patient Summary specification

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:

  • European Standard for the International Patient Summary (ref. EN 17269:2019);
  • CEN Technical Specification for the implementation guideline for European use of the International Patient Summary (ref. CEN/TS 17288:2020).

The project team (PT) comprises the following experts:

  1. Stephen Kay, project leader
  2. Shirin Golyardi, PT-administrator
  3. Karima Bourquard, PT-member
  4. Giorgio Cangioli, PT-member
  5. Vincent van Pelt, PT-member

Context

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.

IPS Dissemination
Understanding IPS

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.

To view the Preziy, click here. Once the Prezi is launched, please click the ‘readme’ section to get the most from the presentation.

Trillium II
Placing IPS standards at the core of a global community for digital health innovation

This multi-stakeholder project ran 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.

Go to the website of Trillium II  for more information.

UNICOM
Improving patient safety and better healthcare for all

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:

  • regulatory purposes of national medicinal product authorities in Member States of the European Union and the European Medicines Agency (EMA);
  • global pharmacovigilance with all stakeholders involved;
  • advancing cross-border digital health services, particularly ePrescription and eDispensation;
  • better healthcare for all, including public health services, clinical research, data analytics and artificial intelligence.

The 4-year project has objectives focusing on a number of areas in support of the implementation of IDMP for the above purposes:

  • Adaptation and implementation of IDMP-related standards and terminologies at the EU and NCA (National Competent Authority) level
  • Incorporation into Member State’s cross-border digital health services (in particular ePrescription, eDispensation and Patient Summary services)
  • Exploration and implementation of IDMP-related standards and terminologies for pharmacovigilance reporting, medicinal products dictionaries, digital health support services and patient empowerment.

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.

Visit the website of UNICOM.

X-eHealth
A project of strategic relevance for tomorrow’s European eHealth Union

ssembling a shared commitment of 47 health actors, the underlying idea of this project is to develop the basis for a workable, interoperable, secure and cross border Electronic Health Record exchange Format in order to lay the foundation for the advance of eHealth sector while using the 3 pillars put forward by the EC as reference.

Aimed at promoting a faster and sustainable EU digital transformation, this Cooperative and Support Action is made up of 8 Work Package in which 4 exclusively focus on technical-functional activities (WP4 to WP7). From Generic Aspects to System Architecture and Integration, passing by Functional and Technical Specifications, X-eHealth objective is to move towards a uniform interoperable data-sharing format framework. In addition, to enhance EU’s public health state of play, WP1 and WP8 are responsible for implementation studies, practicality and continuity of eHealth interoperability development.

On this basis and building upon the already in place Patient Summary, X-eHealth purpose is to develop the foundations for a common framework for medical imaging, discharge letters, laboratory results and rare diseases to flow both alongside citizens care pathway and across health entities between EU Member States and Neighbour Countries.
Focus on cross-border services, this consortium aims to advance an interoperable Common European Health Data Space for citizens and health providers engagement in accordance with privacy and cybersecurity regulations.

To achieve this end, X-eHealth gathers 36 consortium partners plus 5 collaborative partners and 6 eHealth skilled experts, eager to develop the above mentioned 4 domains, and distinguished by policy and political actors mixed with national competent authorities to indeed concretely plan, implement and maintain national eHealth infrastructures.

This TC is involved in:

  • WP4: Generic Aspects of EEHRxF recommendation
  • WP5: Definition of EEHRxF functional specifications
  • WP6: Definition of EEHRxF technical specifications
  • WP8: EHRxF Communities of Practice: from Proof of Concept to large

More information about this project can be found here.