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E-HEALTH, HEALTHY LIVING AND AGEING

(A.) Policy and legislation

(A.1) Policy objectives

One of the major challenges that Europe faces today is to ensure the sustainability and quality of healthcare provision. This is caused mainly by demographic changes20, the associated rising prevalence of chronic diseases and the re-emergence of infectious diseases. The White Paper on the Future of Europe identifies some of the drivers of Europe’s future, noting that by 2030 Europe will be the oldest region in the world. Through Digital technologies, citizens’ health and quality of life can be improved while the challenges of how to provide modern healthcare and healthcare systems are addressed. Moreover, technology can offer effective tools to advance research, support the transition from a hospital-based health care model to a citizen-centric model and contribute to the sustainability and resilience of healthcare provision. New approaches could be enabled in order to support personalised medicine, independent living or integrated health and social care, accelerate scientific progress for early diagnosis, prevention of diseases and proactive re-design of working and living environments as well as more effective treatments.

Thus, there is a clear need to move forward by ensuring Citizens’ access to their own electronic health records anywhere in the EU, developing a secure EU-wide digital infrastructure that allows the pooling of electronic health records and other health data in compliance with data protection legislation and support the aggregation of investment plans across Member States and regions to deploy large scale digital health and care programmes (such as mobile health, telemedicine and connected care).

In 2015, the Digital Single Market (DSM) Strategy highlighted the need to make progress on standardisation and interoperability of eHealth solutions in support to health system reforms. Moving towards this direction, several steps have already been taken and the relevant actions include: (i) the adoption of new guidance on interoperability and standards for digital health and care, (ii) strengthening of the digital infrastructure for cross border exchange of health data through the Connecting Europe Facility (CEF), (iii) new investment commitments in large scale implementation of in digital health and social care programmes from national and regional authorities grouped under the European Innovation Partnership on Active and Healthy Ageing and (iv) Recommendation on the European Electronic Health Record exchange format.

More specifically, on 28 July 2015 the Commission has adopted the Decision on the identification of ‘Integrating the Healthcare Enterprise’ profiles for referencing in public procurement. In 2016 a total of 74 European regions from 18 Member States were awarded the title of ‘Reference Sites of the European Innovation Partnership on Active and Healthy Ageing’ (EIP on AHA). Moreover, under the Framework setup by the CEF programme, Member States have worked together with the Commission to build the eHealth Digital Service Infrastructure (DSI)21 for cross-border exchange of Patient Summaries and ePrescription.(1) Co-funded by CEF, the first Member States started going live in 2019, and since then the number of participants to the exchange has grown. In alignment with these efforts, the Commission has sponsored standardisation initiatives around Patient Summaries and ePrescription, which have led to the publication of the ISO Identification of Medicinal Products (IDMP) standards and the CEN International Patient Summary (IPS) standards.  Also in 2017, the Commission launched 24 European Reference Networks, which will provide an unprecedented capacity for cross-border collaboration to diagnose and treat rare diseases, using online consultation tool built with Connecting Europe Facility co-funding. They will pool knowledge and expertise, and offer an opportunity for clinical and scientific innovation.

Moreover, the digital transformation of health and care is one of the priority areas in the modernisation of public services identified in the midterm Review of the DSM strategy. Towards this direction, the Commission adopted a Communication in April 2018 (COM(2018) 233) on enabling the digital transformation of health and care in the Digital Single Market. This Communication addresses the need and scope for further measures in the area of digital health and care, in line with legislation on the protection of personal data, patient rights and electronic identification and in particular as regards the following three priorities:

  • Citizens´ secure access to electronic health records and the possibility to share it across borders.
  • Supporting data infrastructure, to advance research, disease prevention and personalised health and care in key areas including rare, infectious and complex diseases.
  • Facilitating feedback and interaction between patients and healthcare providers, to support prevention and citizen empowerment as well as quality and patient-centred care, focussing on chronic diseases and on a better understanding of the outcomes of healthcare systems.

Notwithstanding this substantial progress, there are still challenges that need to be addressed in order to reap all the benefits of a fully mature and interoperable eHealth environment in Europe. Also, barriers continue to exist and need to be addressed in order to unlock all the benefits from active and healthy living and ageing environments in Europe. Among the main issues to be tackled are the need for interoperability between the solutions provided in both eHealth and active and healthy living and ageing domains, which shall be addressed on all concerned levels including a strong contribution from standardisation and harmonisation.

(A.2) EC perspective and progress report

In alignment with the Commission Communication (COM(2018) 233) on enabling the digital transformation of health and care in the Digital Single Market, the Commission wants to encourage and facilitate better cross-border access to health data for citizens. To this end, in February 2019, the Commission adopted a Recommendation for a European Electronic Health Record exchange format. In the Recommendation, the Commission recommends (i) a set of principles, (ii) to start work to prepare for the exchange of three new kinds of health information (lab reports, medical images and reports, hospital discharge reports. (iii) A baseline set of technical

specifications for the exchange of this health information, and (iv) a Joint Coordination Process involving the Member States, the Commission and relevant stakeholders, including civil society organisations, to support the further elaboration of the European EHR exchange format and to drive implementation. This Recommendation takes into account the guidelines already adopted by the eHealth Network for the cross-border exchange of Patient Summaries and ePrescriptions/eDispensations by the eHDSI. Following broad support for the approach taken in the Recommendation, the Commission, together with Member States, is putting in place the elements of a Joint Coordination Process (as set out in the Recommendation) to take forward the development of the exchange format, and interoperability. Via the Joint Coordination Process, the Commission seeks to ensure that full opportunities exist to allow stakeholders to contribute their reflections and expertise to the work. The renewed eHealth Stakeholder Group will also play an important part in this work.

Interoperability of ICT-enabled solutions and of data exchange is the precondition for achieving better health of the European citizen and improved delivery of healthcare services, unlocking the EU digital single market in that field and including active and healthy ageing with ICT and the data exchange surrounding it.

The use of European and international standards is a way to ensure the interoperability of ICT solutions in general. In eHealth however, such standards have often not been specific enough. The eHealth network identified more detailed specifications, which could be used for public procurement, in the framework of the new EU standardisation regulation, contributing to the technical and semantic levels of the eHealth Interoperability Framework. One example is the IHE set of specifications identified for use in procurement by Commission Decision (EU) 2015/1302 of 28 July 201522 under Article 14 of the EU Regulation 1025/2012.

The European Interoperability Framework (EIF) was presented in the context of the implementation of the Interoperability Solutions for European Public Administrations (ISA²) programme (2016-2020) and as part of the Communication (COM(2017)134) from the European Commission, adopted on 23 March 2017. The framework gives specific guidance on how to set up interoperable digital public services. It offers public administrations 47 concrete recommendations on how to improve governance of their interoperability activities, establish cross-organisational relationships, streamline processes supporting end-to-end digital services, and ensure that both existing and new legislation do not compromise interoperability efforts.

The new EIF is undertaken in the context of the Commission priority to create a Digital Single Market in Europe. The EIF is accompanied by the Interoperability Action Plan, which outlines priorities that should support the implementation of the EIF from 2016 to 2020. The Interoperability Action Plan is comprised of five focus areas, addressing issues related to the identification of mechanisms to govern interoperability, collaboration between organisations, engagement of stakeholders, and raising awareness of the benefits of interoperability.

A refined eHealth European interoperability framework (ReEIF) was adopted by the eHealth Network in November 2015. It represents a common refined framework for managing interoperability and standardisation challenges in the eHealth domain in Europe, offering a framework of terms and methodologies for reaching a common language, and a common starting point for the analysis of problems and the description of eHealth solutions throughout Europe.

In addition to European and international standards and specifications, interoperability testing, labelling and certification processes are also essential. Several projects are successfully testing and implementing standards, open and secure architecture, clinical workflows and subsets of terminologies and making policy recommendations, to prepare the deployment of eHealth services on a large scale.

With the purpose of implementing Patient Summary and ePrescriptions data exchange among Member States, the eHN adopted three guidelines on cross-border exchange of health data: the guidelines on a minimum/non exhaustive patient summary dataset for electronic exchange (2013, revised in 2016), on an ePrescription dataset for electronic exchange (2014, revised in 2016); and on an Organisational Framework for eHealth National Contact Points (2015). In addition, a recommendation to promote the use of patients’ registries has been adopted in 2015, and a guideline on the electronic exchange of health data under Cross-border directive 2011/24/EU was adopted in 2016.

The Commission is working on the setting up of European reference networks (ERN) on rare diseases pursuant to Article 12 of Directive 2011/24 on patients’ rights in cross-border healthcare. The main aim is to provide health care in a networking environment.  Such cooperative work requires an IT setup that allows healthcare providers to discuss and share knowledge and clinical information on concrete and real-time patient cases (a virtual consultation system) including the use of the use of EHR PACS systems.

The eHealth Interoperability Framework Study23 identifies a representative set of the most relevant use-cases within the eHealth environment and initiating the specification of requests to foster ICT products and services. Further citizen-centred work is needed to cover different forms of actor/user involvement. The use of European and international standards is a way to ensure the interoperability of ICT solutions in general. In the area of ICT for an active and healthy ageing, however, such standards are often not specific enough. In addition, standards in response to identified needs could apply across different environments, e.g. smart homes, smart workplaces, smart cities and synergies should be further enhanced.,

Several projects are successfully testing and implementing standards, open and secure architecture and subsets of terminologies and making policy recommendations, to prepare the deployment of ICT services for an active and healthy ageing on a large scale. It is proposed to boost interoperability by further developing and validating specifications and components, partly through the launch of standardisation mandates, projects or direct grants, the definition of interoperability profiles and certification, if deemed necessary. Coordination with the JIC and other SDOs will be pursued. The availability of new infrastructure for the Internet of Things (IoT), such as Lora and Zigbee provides promising new opportunities for the development of ICT applications for monitoring care of people living at home.

On 5 April 2017, two new Regulations on medical devices were adopted. These replace the existing Directives.

  • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC,
  • Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

The new rules will apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

Moreover, several H2020 projects on eHealth standardisation, harmonisation and interoperability were finalised, providing concepts and proposed approaches for standards and standardisation roadmap development:

  • OpenMedicine, supporting a common EU, standards-based, database of medicinal products;
  • eStandards to support the optimisation of standardisation processes and development of roadmaps;
  • AssessCT to assess SNOMED CT24 terminology;
  • VALUeHEALTH addresses how interoperability of health information can consistently create, capture and deliver value for all stakeholders;
  • EURO-CAS, contributed to a European eHealth Interoperability Conformity Assessment Scheme aiming at maintaining and developing the adoption and take-up of testing the interoperability of ICT solutions;
  • PROGRESSIVE contributed to a framework for standards and standardisation on ICT related to active and healthy ageing;
  • Trillium-II, advanced further the global Electronic Health Record (EHR) interoperability with activities surrounding the International Patient Summary (IPS) standards.
  • CEN IPS project International Patient Summary for the creation of an IPS specification at global level.

More EU funded projects on eHealth standardisation and harmonisation are ongoing:

  • InteropEHRate, complementing and integrating the current interoperability infrastructures with new technologies for health data exchange centred on the citizen;
  • Smart4Health, enabling the citizen-centred EU-EHR exchange for personalised health;
(A.3) References 

(B.) Requested actions

Addressing key aspects of identification (citizens, workforce actors, hospitals, clinics, doctors, diseases, medicinal products, etc.) and required interoperability should be considered at European level as a priority for work on eHealth, since many other areas depending on these. In particular, agreement should be reached on the categories of workforce actors in order to enable access management of citizens’ health information. This includes the needs related to secure authentication of these professionals and their authorisations. The eIDAS Regulation (EU) No 910/2014 may solve parts of the issues on identification and authentication processes. Work is ongoing in the Member states to finalise the transposition of the eIDAS Regulation.

Action 1 For the further development of the citizens’ electronic health records, evaluate and address standardisation needs of high relevance for the citizen in technical reports and beyond regarding terminological and technological profiles for the cross-border digital single European market.

Action 2 Evaluate the needs, produce a report on necessary key types of identifiers and identification processes needed as components in a European eHealth digital single market. In this context, a special emphasis on the items listed below, which go beyond the key types of identifiers and identification processes, should be provided.

  • Standardised medicinal products identifiers to support national and international interoperability of health services (online or other), while complying with the legislation protecting patients, and including specific rules of enforcement of delivery on medical prescriptions[2]. Agreements on standards in this field should take into account the needs of cross-border exchange of electronic health records since their medication part faces similar terminological challenges.
  • Agreements 1. on a terminological profile for minimum sets of fields included in the patient summary, and 2. on technical profiles for the cross-border exchange of electronic health record information with identified socioeconomic importance. The consent of patient and the citizen shall be considered in the development of the standard.
  • The needs for standards supporting the ICT services provided through the European reference networks (ERNs) for rare diseases regarding communication and data sharing addressing areas such as fast and easy sharing of digital medical images through picture archive and communication systems (PACS) in the context of the eStandards project and its focus area description for ERN, as well as the ValueHealth project with its use case for Chronic Diseases;
  • Agreements on a terminological profiles for Telemedicine application, allowing healthcare providers to share real-time knowledge and decisions; sharing of best practices and clinical decision-making tools (i.e. guidelines); solutions to support collaborative research between healthcare providers, through the development of clinical trials and/or epidemiological studies; and establishment of shared databases and registries.
  • The move towards personalised medicine requires standardisation of data related to the field of biology and biomarkers.  In particular, clinical laboratories are subject to a process of accreditation according to ISO 15 189 that should be supplemented by standardisation processes in ICT.

CEN proposes to build on this work in 2020-2023, in collaboration with ISO and IEC, to develop a new Technical Specification: “Digital Representation of Requirements for Quality and Reliability of Health and Wellness Apps”. The Digital Representation of the set of questions used for collecting information on and evidence of conformity to the requirements (Quality Requirements Conformity Assessment) would be developed with end users and: 

  • allow profiles and extensions to be authored, maintained, distributed, filtered, sorted, compared and checked more easily;
  • enable issuing and having both manufacturers and distributors publish a digital easily administrable up-to-date Standardised Label, to increase transparency and enable consumers to make informed decisions. Its contents would be derived from the answers and evidence provided by the manufacturers in the Quality Requirements Conformity Assessment. The label could include an acknowledgement that the information provided is checked or certified by a specified app checker. 

The development of the Digital Representation would be supported by stakeholder engagement and research, in particular exploring uptake of the Technical Specification for Quality and Reliability Requirements for Health and Wellness Apps by citizens, healthcare providers, authorities, payers, app checkers and app developers, including SME’s, to identify success factors that further secure transparency, uptake and conformity.

Action 3 Evaluate and report on the opportunities and needs for standardisation supporting active living and ageing with special emphasis on:

  • Open service platforms APIs taking into account progress made under H2020 on the top smart homes and smart cities
  • Service robotics for assisted working, and independent living including regulatory acceptance:
  • Identify standardisation needs to support specific issues, e.g. occupational health and safety, memory deficiency, mental health issues.
  • Ensuring interoperability of devices to enable plug-and-play connectivity of the different devices and services for personal management and delivery of the actual services for an active and healthy ageing.

Whereas:

  • it is necessary to facilitate the involvement of societal stakeholders in the development of standards in the field of active and healthy ageing; ensure user participation from the beginning to avoid purely technical-driven innovation, e.g. by involving specific user groups in SDOs. 
  • given the challenge of the aging population, the standardisation work must also take into account aspects of personal services dedicated to the autonomy including ICT solutions in order to promote secure and harmonised solutions at the European level;
  • it is important to consider the synergies between standardisation and active and healthy ageing with similar standards in the areas of ambient assisted living and eHealth as proposed by the H2020 PROGRESSIVE project and referenced in the eStandards project and activities undertaken by the Task Force ‘Ageing in community’ in ISO/TC 215;
  • all the standardisation work on active and healthy ageing should ensure a high-level of privacy protection and of security.

Action 4 ‘Data protection by design’ (GDPR, Article 25) in eHealth products and services

It is recommended to check whether a standardisation request might be needed pursuant to Regulation 1025/2012 for one or more European standardisation deliverable(s) concerning data protection by design for the development of eHealth products and services.

(C.) Activities and additional information  

(C.1) Related standardisation activities
CEN

CEN/TC 251 provides a focal point for the development of standards in the Health Informatics domain, in close collaboration with ISO/TC 215. CEN/TC 251 is taking forward the eHN guidelines, contributing to international standardisation solutions, while providing Europe with a Patient Summary standard and an implementation guide. The technical committee is also responsible for the development, publication and maintenance of the ISO-EN IDMP series (Health informatics - Identification of medicinal products): EN-ISO 11238, 11239, 11240, 11615 and 11616 (and their accompanying implementation guides, as CEN ISO/TS 20440, 20443, 20451, 19844), which also refer to the openMedicine results: http://www.open-medicine.eu/downloads.html CEN/TC 251 maintains the “DICOM” standards (and notably EN ISO 12052: Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management).

In the frame of the standardisation request M/530 on privacy and personal data protection management, CEN/TC 251 will liaise with CEN-CLC/TC 8 (Privacy in products and services) and CEN-CLC/TC 13 (Cybersecurity and data protection) to address the particular requirements of eHealth

CENELEC

CENELEC has adopted as European Standards IEC 62304 (Medical device software -- Software life cycle processes) and IEC 82304-1 (Health software – Part 1: General requirements for product safety)

CEN, CENELEC, ETSI        

CEN-CENELEC-ETSI are starting to work on the revision of EN 301 509, which deals with the accessibility of ICT products and services (CEN-CENELEC-ETSI Joint Working Group on eAccessibility). The purpose of this revision is to meet the essential requirements included in the Directive on the accessibility of the websites and mobile application of public sector bodies. This work will have an impact on the life of older people, easing the use of ICT products and services

BSI

PAS 277:2015 Health and wellness apps — Quality criteria across the life cycle — Code of practice

ISO

The European Medicines Agency is part of a project to finalise the implementation guides to support the adoption of the ISO standards for the identification of medicinal products (IDMP).

This set of standards and implementation guides are being developed jointly by ISO/TC 215 and CEN/TC 251, where this work started originally.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000645.jsp&mid=WC0b01ac058078fbe2

There is a newly-formed ISO/TC 215 subcommittee in the area of Genomic Informatics (https://www.iso.org/committee/7546903.html).  This is collaborating with other SDOs

ISO/IEC JTC 1     

A framework for personalization and adaptation of user interfaces at runtime, based on the context of use (consisting of a user’s needs and preferences, their envisioned tasks, their equipment and environmental parameters of interaction). The framework is based on the well-known REST protocol, and JSON and XML formats. A registry-based approach is employed for the definition of terms describing a user’s personal preferences and needs.

Currently, the following standards are being developed as part of this framework:

ISO/IEC CD 24571-1 Information Technology – Individualised adaptability and accessibility in e-learning, education and training – Part 1: Framework and reference model

ISO/IEC DIS 24752-8 Information technology -- User interfaces -- Universal remote console -- Part 8: User interface resource framework

ISO/IEC

The standard 62304 Health software - Software life cycle processes is being updated, by ISO and IEC. One of the issues to be addressed is about the improvement of the security aspects that relate to health software. This has also led to the onset of the development of a new standard ISO/IEC 80001-5-1 Safety, Security and Effectiveness in the implementation and use of connected medical devices or connected health software - Part 5: Security -Sub-Part 5-1: Activities in the Product Lifecycle in ISO/TC215/JWG 7

ETSI

ETSI is developing digital enhanced cordless telecommunications (DECT) ultra-low energy (ULE), a low-power wireless technology providing optimal radio coverage in indoor scenarios for reliable audio and data services suitable for many eHealth applications, e.g. health monitoring, emergency alarms for vulnerable people and remote medical monitoring.

It is also working on smart body area networks. Standards for a dedicated radio technology for these networks are being developed.

EP eHealth provides a focus point in ETSI on issues such as mHealth and telemedicine. Currently, there is the development of standards to facilitate telemedicine and the “Internet Clinic”.

http://www.etsi.org/technologies-clusters/technologies/medical

In the series of documents “User-centric approach in digital ecosystem”, SC USER has worked on use cases including e-health.

IEC          

IEC SC 62B is developing standard IEC 61910-1, which describes a high-level data exchange language between systems making medical imagery. IEC Systems Committee on Active Assisted Living (SyC AAL) fosters standardisation which enables usability, accessibility and cross-vendor interoperability of AAL systems and services. The work has started with the collection use cases, definition of the terminology and the design of an architecture model for AAL systems

IEEE

The boundaries between healthy living, healthy ageing, preventive medicine, and healthcare are increasingly blurred. IEEE has diverse standards programmes covering many relevant areas within these disciplines. These standards address a wide range of technology components and applications, related to different aspects of the healthcare and related domains, including standards for software, management, guidance and recommended practices.

Below are some examples of the standards in different areas, drawn up by IEEE working Groups.  Further information is at: https://ieeesa.io/rp-ehealthIEEE P1752 is a draft Standard for mobile health data:

IEEE P2727 (two standards) covers medical devices with measurement functions, including cardiac defibrillators

IEEE P2731 is a draft standard for a unified terminology for brain-computer interfaces, based on input from IEEE P2794 “Reporting Standards for in Vivo Neural Interface Research”

IEEE P2733 is a draft standard for clinical IoT data and device interoperability with TIPPSS (Trust, Identity, Privacy, Protection, Safety, Security)

IEEE P2801 is a draft recommended practice for the quality management of datasets for medical AI for datasets

IEEE P2802 is a draft standard for the performance and safety evaluation of AI based medical devices including terminology

IEEE P3333 standards define criteria for 3D medical applications and printing

The IEEE 11073 family of standards enables service-oriented (medical) device connectivity including semantic interoperability.

ITU

World Telecommunication Standardisation Assembly (WTSA) Resolution 78 “Information and communication technology applications and standards for improved access to e-health services” drives ITU-T’s work in this domain.

The ITU published the Continua Design Guidelines in the ITU-T H.810 series (2019), Interoperability design guidelines for personal health systems (which is complemented by 46 conformity testing specifications); ITU-T H.860 (4/2014), Multimedia e-health data exchange services; Y.4110/Y.2065, Service and capability requirements for e-health monitoring services; Y.4408/Y.2075, Capability framework for e-health monitoring services; technical papers HSTP-H810 (7/2014) and HSTP-H810-XCHF (2017) with an introduction to the H.810 series and data exchange within it. Updated editions of the ITU-T H.810 series architecture are produced regularly (annually or so).

More info: https://itu.int/en/ITU-T/e-Health

SG13 is developing a new Recommendation on “QoS requirements for smart healthcare supported by IMT-2020” (Y.IMT2020-qos-req-sh). In addition, SG13 published Supplement 66 to Y.3000-series “Network 2030 Services: Capabilities, performance and design of new communications services for the Network 2030 applications” that depicts the requirements for the telesurgery and robotics surgery for future around year 2020+. Supplement 67 to Y.3000-series of ITU-T Recommendations “Representative use cases and key network requirements for Network 2030” describes the use case with remote robotic surgery

ITU-T SG16 (Multimedia) and ITU-T SG20 (IoT, smart cities and communities) are developing further standards addressing e-health services and systems.

Some of the standards approved under SG16 include:

  • Framework for telemedicine systems using ultra-high definition imaging (Recommendation ITU-T F.780.1)
  • Guidelines for safe listening devices/systems (Recommendation ITU-T H.870), a joint standard with WHO.

More standards on this topic within SG16 are developed under Q28/16 on “Accessibility to multimedia systems and services”: https://itu.int/itu-t/workprog/wp_search.aspx?Q=28/16

The ITU Product Conformity Database contains information on health devices that passed conformance tests against the corresponding ITU-T Recommendations.

More info: https://itu.int/go/tcdb

ITU-T Focus Group on Artificial Intelligence (FG-AI4H), established in partnership with ITU and WHO, is working towards to establishing a standardized assessment framework for the evaluation of AI-based methods for health, diagnosis, triage or treatment decisions. https://www.itu.int/en/ITU-T/focusgroups/ai4h/

More info: https://www.itu.int/go/fgai4h.

ITU-T SG20 is developing a draft Recommendation ITU-T Y.4908 on “Performance evaluation frameworks of e-health systems in the IoT” (ex Y.IoT-EH-PFE). This is being developed under Q7/20: https://itu.int/itu-t/workprog/wp_search.aspx?Q=7/20. SG20 is also developing a draft Recommendation on “Framework to support semantic mediation of eHealth services” (Y.eHealth-Semantic) under Q4/20: https://itu.int/itu-t/workprog/wp_search.aspx?Q=4/20.

More info: https://itu.int/go/sg20

JIC

Joint Initiative Council for Global Health Informatics Standardisation in which CEN/TC 251, ISO/TC 215, HL7 International, GS1, SNOMED International, CDISC, IHE, DICOM, and PCHA participate as members

OASIS   

The OASIS Security TC and the OASIS Web Security Services TC developed and maintain foundational Web Services security standards such as SAML (also ITU-T Recommendation X.1141) and WS-Security, which are used in the Integrating the Healthcare Enterprise (IHE) technical framework used in the eHealth Digital Service Infrastructure, the initial deployment and operation of services for cross-border health data exchange under the Connecting Europe Facility (CEF).

The OASIS Emergency Management TC developed, in cooperation with ITU-T, the World Meterological Organisation, Health Level Seven (HL7) and emergency agencies, standards for data exchange across emergency-related systems. Emergency Data Exchange Language (EDXL) specifications include EDXL-HAVE, an XML messaging standard primarily for exchange of health facility availability information. EDXL-Situation Reporting (SitRep) supports data sharing of information on situations, incidents, events and responses. EDXL Tracking Emergency Patients (TEP) supports sharing of emergency patient and tracking information from the point of patient encounter through definitive care admission or field release.

OneM2M           

Data Structures like the Electronic Health Records EHR can by exchanged safely, reliable and securely over wide area data networks, between ICT components (oneM2M CSE’s), on site (e.g. in Hospitals) and Data centers.

oneM2M standard based technology enables a multivendor interoperable data exchange framework between clinics, doctors, medicinal products and health care providers and hence enables an eHealth Interoperability Framework.

Other activities related to standardisation
ACT PROJECT (PHILIPS / London Hospital)

Advancing Care Coordination and Telehealth Deployment

http://www2.med.auth.gr/act/news.php

ASSESS CT

Investigating the fitness of the clinical terminology SNOMED CT as a potential standard for EU-wide eHealth deployments, scrutinising clinical, technical, financial, and organisational aspects.

http://assess-ct.eu/

JAseHN

Joint Action to Support the eHealth Network (Member States), followed by eHAction, the third Joint Action, as of July 2018

http://jasehn.eu/

EESSI

Electronic exchange of social security information (EESSI). EESSI is an IT system that will help social security bodies across the EU to exchange information more rapidly and securely, as required by EU regulations on social security coordination.

http://ec.europa.eu/social/main.jsp?catId=869&langId=en

ENGAGED

European innovation partnership on active and healthy ageing; thematic network on innovative and sustainable active and healthy ageing services that make best use of new technologies.

http://www.engaged-innovation.eu/

EIP on Active and Healthy Ageing

Action plan B3 (integrated care)

http://ec.europa.eu/research/innovation-union/pdf/active-healthy-ageing/b3_action_plan.pdf

Action plan C2 (independent living)

http://ec.europa.eu/research/innovation-union/pdf/active-healthy-ageing/c2_action_plan.pdf

Action plan D4 (innovation for age-friendly buildings, cities & environments)

http://ec.europa.eu/research/innovation-union/pdf/active-healthy-ageing/d4_action_plan.pdf#view=fit&pagemode=non

eHealth Governance Initiative — SEHGOVIA

Supporting the   European eHealth Governance Initiative and Action

http://ec.europa.eu/information_society/apps/projects/factsheet/index.cfm?project_ref=270941 

eHR4CR project

IMI project with a focus on the use of electronic Health Records for Clinical Research

http://www.ehr4cr.eu/

eStandards        

Support the optimisation of standardisation processes and development of roadmaps http://www.estandards-project.eu/

Eureca  

Enabling information re-Use by linking clinical REsearch and Care http://eurecaproject.eu/about/

EU-US eHealth Work      

The collection of eHealth related competencies and the provision of educational material, (including eHealth standards) for the health care work force in the EU and USA

EXPAND

Aims to exploit a number of selected eHealth assets developed in various initiatives http://www.expandproject.eu/

NB: The EXPAND project is also a continuation of esSOS which created a pilot (www.epsos.eu)

HAIVISIO

European project which aims to identify and enhance awareness of the results generated by eHealth, active ageing and independent living European projects.

 http://haivisio.eu/

Linked2Safety

A next-generation, secure linked data medical information space for semantically-interconnecting electronic health records and clinical trials systems advancing patients safety in clinical research

http://www.linked2safety-project.eu/node/23

Momentum

Momentum is a platform where key players in telemedicine share their knowledge and experience in deploying telemedicine services in routine care.

http://telemedicine-momentum.eu/

OpenMedicine 

Supporting a common EU, standards-based, database of medicinal products

http://www.open-medicine.eu/home.html

PHS Foresight (Personal Health Systems Foresight Project)

This ongoing project has been researching indicators and milestones for key areas of transformation required by the implementation of eHealth systems

http://www.phsforesight.eu/

PONTE project

Efficient Patient Recruitment for Innovative Clinical Trials of Existing Drugs to other Indications

http://www.ponte-project.eu/

RENEWING HEALTH

REgioNs of Europe WorkINg toGether for health (Renewing health): a European project which aims at implementing large-scale real-life test beds for the validation and subsequent evaluation of innovative telemedicine services using a patient-centred approach and a common rigorous assessment methodology.

http://www.renewinghealth.eu

Salus project

Scalable, standard-based interoperability framework for sustainable pro-active post market safety studies

https://www.i-hd.eu/index.cfm/resources/ec-projects-results/salus/

SemanticHealthNet

Network of excellence in semantic interoperability

www.semantichealthnet.eu

Transform project

Translational research and patient safety in Europe

http://www.transformproject.eu/ 

Trillium Bridge

The Trillium Bridge support action extends the European patient summaries used in epSOS and Meaningful Use II, Transitions of Care in the United States, to establish an interoperability bridge between the EU and the US systems.

http://www.trilliumbridge.eu/

United4Health

European project which aims to adapt and tailor telehealth services from regions and institutions in Europe to large scale deployment within other regions and institutions and maximise the transferability of services and knowledge among European healthcare providers at large scales and in collaboration.

http://ec.europa.eu/information_society/apps/projects/factsheet/index.cfm?project_ref=325215

VALUeHEALTH 

To address how interoperability of health information can consistently create, capture and deliver value for all stakeholders.

http://www.valuehealth.eu/

(C.2) additional information

Guidelines, code of conduct

The following links provide additional information of ongoing work.

Guidelines on:

20 People aged 50+ account for 37% of the population, i.e. 190 million European citizens. Eurostat population projections foresee that the number of people aged over 60 will increase by about two million a year in the coming decades, while the working-age population, as a result of lower fertility rates among post-baby-boom generations, will start to shrink. The number of very old persons, 80 years and older, who are most likely to be in need of care, will increase. At the same time fewer young people will be available to provide informal and formal support and care.

21 DSI: https://ec.europa.eu/cefdigital/wiki/display/EHOPERATIONS/eHealth+DSI+Operations+Home

22 http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOL_2015_199_R_0011

23 http://ec.europa.eu/digital-agenda/en/news/ehealth-interoperability-framework-study

24 http://www.snomed.org/snomed-ct

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