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Digital health, healthy living and ageing (RP2024)

(A.) Policy and legislation

(A.1)   Policy objectives

The creation of the European Health Data Space (EHDS), which will enable secure and trustworthy accessibility to health data across the EU, is one of the priority areas of the current Commission 2019-2024. In this context, the Commission adopted its proposal for a Regulation on the European Health Data Space on 3 May 2022. The European Health Data Space is a key pillar of a strong European Health Union and the first sector-specific European data space emerging from the 2020 European Strategy for Data. The proposed regulation provides for rules, common standards and practices, infrastructures and a governance framework for the primary and secondary use of electronic health data.

The aims of this proposed regulation are to:

  1. ensure that individuals have access to and control over their health data in the context of healthcare (primary use);
  2. establish a genuine single market for digital health through the certification of Electronic Health Record systems (EHR systems) and the labelling of wellness applications;
  3. allow researchers, innovators, policymakers and regulators to make the most of the available health data in the context of their activities for the benefit of society, while preserving trust and security (secondary use).

It builds on the priorities set in the Commission Communication (COM(2018) 233) on enabling the digital transformation of health and care in the Digital Single Market and the Commission Recommendation for a European Electronic Health Record exchange format (EEHRxF) of 2019 (C(2019)800). Both part of the Commission Priority "A Europe fit for the digital age".

(A.2) EC perspective and progress report

Recent, ongoing and future EU initiatives will contribute to foster the implementation of the European Health Data Space.

On the primary use of health data, the Commission aims to continue developing the cross-border infrastructure MyHealth@EU further and to promote the use of the European electronic health record exchange format (EEHRxF). As of January 2024, there are 12 countries operational in MyHealth@EU, which allows the cross-border exchange of health data, and its translation to the language of the country of destination. The services currently available under MyHealth@EU are: ePrescription and Patient Summary. Nevertheless, the extension to new categories of health data (laboratory results, medical images and hospital discharge reports) is already foreseen for the coming years. In February 2019, to facilitate the interoperability of health data in the EU, the Commission adopted a Recommendation for a European electronic health record exchange format (EEHRxF). The EEHRxF Recommendation outlines technical specifications for patient summaries, ePrescriptions and eDispensations, laboratory results, medical imaging studies and reports as well as hospital discharge reports. The eHealth Network has also adopted further guidelines on all the listed data categories, to facilitate their implementation in MyHealth@EU and in other contexts. The proposal for the EHDS Regulation aims to promote the adoption of the EEHRxF allowing citizens to receive and share medical data in this format.

The proposed EHDS Regulation includes harmonised rules on interoperability and security for electronic health record systems (EHR systems) and devices feeding data into EHR systems and proposes a voluntary label for wellness applications. Joint Action Xt-EHR funded under the 2022 EU4Health work programme is conducting further work on technical specifications for the primary use of health data (for healthcare) in the context of the preparatory actions for the European Health Data Space. This includes technical specifications on the interoperability of specific categories of health data, telehealth services and the use of electronic identification but also in relation to the certification of electronic health record systems and the quality of mobile wellness applications.

To prepare such technical specifications, the joint action will build upon previous initiatives, such as the X-eHealth project which ended in 2022. It is also in part supported by the ongoing XpanDHand xShare projects that support experimentation with the EEHRxF.

Furthermore, the PaTHED project, launched in January 2023, aims at piloting patient access to translated health data in the context of MyHealth@EU infrastructure. This pilot project, which is expected to last 18 months, will develop a reference implementation of such solutions, for example in the form of a patient-facing mobile app. Patients' access to their health data will also be targeted in the context of the large scale pilots (LSPs) supporting implementation of the EU Digital Identity Framework. These pilots are expected to deploy the first set of EU Digital Identity Wallet functionalities for different use cases, including one on ePrescription ("POTENTIAL" project).  

The "POTENTIAL" consortium selected by the EC is the Large Scale Pilot project with the eHealth use case, e-Prescription. This use case is based on eHealth Network approved Vision document on how to integrate EUDI Wallet functions with the cross-border ePrescription workflow supported by the MyHealth@EU (European Health Digital Service Infrastructure). In total 148 participants from 19 EU member states and Ukraine gather in the "POTENTIAL" Consortium to pilot new coming EU Digital Identity Wallet (EUDIW) prototypes in six Use Cases: e-Presciption alongside Electronic Government services, Account opening, SIM registration, Mobile Driving Licence, Remote Qualified Electronic Signature, and Electronic Prescription.

Finally, the Horizon Europe project 'Label2Enable' started in June 2022. This two year project will promote the CEN-ISO/TS 82304-2 health app assessment framework and label in Europe. The objective of Label2Enable is threefold: to achieve trust, use and adoption. In 2021, CEN-ISO/TS 82304-2- health and wellness apps - quality and reliability' was published.

Past, present and future (H2020) projects focused on eHealth standardisation, harmonisation and interoperability include:

  • Unicom, working on the implementation of the ISO IDMP (IDentification of Medicinal Products) standards and on their piloting in national and cross-border digital health services, particularly in ePrescription.
  • 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;
  • X-eHealth 
  • label2enable
  • XpanDH 
  • xShare

More specifically, InteropEHRate and Smart4Health provided interoperability protocols and technologies for health data exchange centred on the citizen.

On secondary uses of health data, the Commission will be supporting the establishment of health data access bodies across Member States, and it aims to enable them to handle multi-country access requests through HealthData@EU, an infrastructure connecting health data access bodies, health data research infrastructures and EU bodies of the health domain. A project was launched in autumn 2022 to pilot this infrastructure. Member States will also be supported in the establishment of health data access bodies through direct grants. The Commission will also launch a specific project to support building capacity at Member States for secondary uses of health data.

The Joint Action “Towards a European Health Data Space” (TEHDaS) has contributed to the design and development of the EHDS and will be followed up by a new joint action between Member States. Given the challenges in the re-use of health data, standardisation may be helpful in relation to health datasets metadata, health data minimisation (anonymisation, pseudonymisation, linkage and synthetic data), data quality and utility assessment (e.g. through a label), health data secure processing environments and data access request applications format and procedures. 

To ease the transition from primary use of health data to secondary use, the alignment of data standards for secondary use with the EEHRxF standards and terminologies, as employed in primary use of health data under the EHDS, should be explored.

(A.3) References 

*Note: The Rolling Plan 2024 also includes chapter 3.2.6 Pandemic Preparedness

(B.) Requested actions

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

Identify and address possible standardisation needs to ensure smooth implementation of the EHDS, including patients' access to priority categories of health data, support to the development of the EEHRxF and its wide implementation and integration in EHR systems as well as support to the implementation of identification management and telemedicine services. 

Areas of specific relevance and interest for EHDS implementation are:

  • Technical specifications (datasets, data fields, data groups, coding systems and values, content representation and transmission, base standards and profiles, etc) to be implemented as part of the European electronic health record exchange format (EEHRxF) for the priority categories of health data (ePrescription, patient summary, laboratory results, medical images and reports, discharge reports);
  • Functional and technical specifications applicable to all Electronic Health Record systems for the registration, interoperability and security of health data;
  • Technical specifications for the interoperable, cross-border identification and authentication mechanism for patients and health professionals.  
  • Technical specifications for cross-border identification and authentication mechanism for patients, healthcare professionals, and healthcare provider organizations

Action 2: Evaluate and report on the opportunities and needs for standardisation supporting active and healthy living and ageing with special emphasis on:

  1. Open service platforms APIs taking into account progress made under H2020 on the top smart homes and smart cities
  2. Service robotics for assisted working, and independent living including regulatory acceptance:
  3. Identify standardisation needs to support specific issues, e.g. occupational health and safety, memory deficiency, mental health issues.
  4. 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 living and 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 ageing 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 living and ageing should ensure a high-level of privacy protection, security and adhere to principles of good ethical practice.

Action 3: '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, particularly in the context of the EHDS and the measures regarding EHR systems, devices connecting to EHR systems and wellness applications.

Action 4: Evaluate the needs and options on standardisation of health datasets metadata, techniques for health data minimisation and confidentiality (anonymisation, pseudonymisation, linkage and synthetic data), data quality and utility assessment (e.g. through a label), health data secure processing environments, measures necessary to preserve the confidentiality of IP rights and trade secrets when processing health data for secondary uses, and data access request applications format and procedures, in the context of the proposed European Health Data Space Regulation.

(C.) Activities and additional information 

(C.1) Related standardisation activities
BSI

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

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 an International Patient Summary standard (EN ISO 27269) and a European implementation guide (TS 17288). The technical committee is also responsible for the development, publication and maintenance of the EN ISO IDMP series  of standards (Health informatics - Identification of medicinal products), accompanying implementation guides and related standard requirements documents and logical data models. These will be used for the medication section of the patient summary and the ePrescribing/eDispensation. For medical imaging and image reports, CEN/TC 251 publishes the “DICOM” standards (EN ISO 12052) and is in the process of adopting an ISO reference standards portfolio for clinical imaging (ISO 21860). CEN/TC 251 experts are actively participating in EU (HORIZON) projects supporting the adoption and use of standards and specifications in conjunction, contributing to maturing the European Electronic Health Record Exchange Format. 

With respect to the proposed Artificial Intelligence Act and the related draft standardization request, CEN/TC 251 is actively participating in the preparatory work on the application of AI in healthcare. 

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

CEN-CLC/JTC 11 has just ended the works related to the standardisation of the built environment, which is a key issue regarding older people:

  • EN 17210:2021 Accessibility and usability of the built environment - Functional requirements
  • CEN/TR 17621:2021 Accessibility and usability of the built environment - Technical performance criteria and specifications
  • CEN/TR 17622:2021  Accessibility and usability of the built environment - Conformity assessment 
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. Work under the Web-Accessibility Directive and under EN 301 549 has impact on life of older people. Please see the chapter on Accessibility for details.

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.

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.

The following standards are published 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 TC eHealth: In addition to the activity jointly with CEN and CENELEC noted above ETSI through the efforts of the eHEALTH group, acting within ETSI as a "Hub for Health", have prepared a number of documents to bring the efforts across ETSI into focus for responding to the actions of the plan listed above. Of particular note with respect to Actions 1 and 2 the eHealth group has published a short series of white papers, a Special Report into the role of ICT on recovery from COVID, and is maintaining and extending its work programme developing use cases and data models. This is closely aligned to the work in ETSI CYBER on further development of the "secure by design", "privacy by default" paradigms (particularly with respect to IoT in EN 303 645), and with integration to the semantic identification frameworks developed in SmartM2M for SAREF. Thus as a "hub for health" ETSI is actively promoting the implementation of the driver that "Very little of ICT is eHealth specific, all of eHealth depends on ICT" with a view to ensuring that all of ETSI's output is societally and eHealth relevant for enabling Health crisis management and recovery as well as for the core operation of all health operations.  https://www.etsi.org/technologies/ehealth

Published (with links) and in further development: 

  • TR 103 477: eHEALTH; Standardization use cases for eHealth
  • TR 103 817: eHEALTH; Presence preserving proximity function trigger (3PFT)
  • ES 203 668: eHEALTH Data recording requirements for eHealth
  • SR 003 809: eHEALTH; The role of ICT to enable Health crisis management and recovery; Responding to the 2019 SARS-CoV-2 Pandemic
  • White paper 29: The argument in favour of eHealth standardization in ETSI
  • White paper 33: The role of SDOs in developing standards for ICT to mitigate the impact of a pandemic

ETSI TC DECT: 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.

ETSI TC smartBAN: is working on smart body area networks. Standards for a dedicated radio technology for these networks are being developed.

ETSI SC USER: In the series of documents “User-centric approach in digital ecosystem”, SC USER has worked on use cases including e-health and is currently working on the “Smart Identity” (STF 626) as the first step of the project “Smart Interface” and focused on the use case “Health”. ETSI is one of the SDOs listening the voice of users, their expectations, behaviors and requests through the User Group.

ETSI ISG F5G: The Use Cases identified as drivers for the F5G work include several aspects of digital health. The architecture defined (second Release under development) provides the essential characteristics required to support those use cases. Specific studies will in future allow a detailed discussion of the features of the network needed to serve healthcare specific applications.

ETSI TC smartM2M: The SAREF ontology, which makes use of oneM2M as communication framework (ETSI TS 103 264 (Reference Ontology and oneM2M Mapping), was enhanced with a specific extension i.e. SAREF4EHAW: extension for the eHealth/Ageing-well domain.
Sources: https://saref.etsi.org/sources/saref4ehaw/. ETSI Technical Specification: ETSI TS 103 410-8 V1.1.1 (2020-07): "SmartM2M; Extension to SAREF; Part 8: eHealth/Ageing-well Domain"

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

IEEE 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. There is an increasing focus on addressing challenges utilizing devices and services in the form of remote patient monitoring and care. Inclusive in these programs are solutions for addressing the portability, interoperability, verification and validation for data to be utilized for clinical research, healthcare delivery and monitoring and precision medicine. 

IEEE 442, IEEE Guide for Thermal Resistivity Measurements of Soils and Backfill Materials.

IEEE 1708, Standard for Wearable Cuffless Blood Pressure Measuring Devices.

IEEE 1752 is a Standards Series for mobile health data for different measures (sleep activity, Cardiovascular, Respiratory, and Metabolic Measures).

IEEE 2621, Standard for Wireless Diabetes Device Security Assurance is a standards series providing frameworks and guidance for product and profile security of wireless devices designed for diabetes measurement.

IEEE 2621.2/UL 2621-2, IEEE/UL Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions.

IEEE 2791, Standard for Bioinformatics Computations and Analyses Generated by High-Throughput Sequencing (HTS) to Facilitate Communication.

The IEEE 11073 Standards Series enables service-oriented (medical) device connectivity including semantic interoperability.

IEEE P2673, Standard for Patient Digital Biomedical Data Files with 3D Topological Mapping of Macroanatomy and Microanatomy for Use in Big Data and Augmented Intelligence Systems.

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 P2796, Standard for Framework for the Internet of Food (IoF)

IEEE P2796.1, Standard for Data Requirements for IoF Systems

IEEE P2796.2, Standard for Data Exchange Architecture and Interface Requirements for IoF) Systems

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 P2933 is a draft standard for clinical IoT data and device interoperability with TIPPSS (Trust, Identity, Privacy, Protection, Safety, Security).

IEEE P2968 Standards Series for Decentralized Clinical Trials, on  Patient Safety, as well as Thread Modeling, Cybersecurity, and Data Privacy.

IEEE P2992, Recommended Practice for Data Expression, Exchange, and Processing in Smart Agriculture Food SecurityIEEE P3333 standards series defines criteria for 3D medical applications and printing.

IEEE P3386, Standard for Defining and Inferring User Accessibility Needs for Applications including Augmented Reality and Artificial Intelligence Systems

IEEE P4005, Standard Protocol and Scheme for Measuring Soil Spectroscopy

Pre-standards activities:

  • Technology and Data Harmonization for Enabling Decentralized Clinical Trials pre-standards program
  • Transforming the Telehealth Paradigm: Connectivity, Accessibility, Privacy and Security for ALL pre-standards program
  • Ethical Assurance of Data-Driven Technologies for Mental Healthcare pre-standards activity
  • Zero Trust Cybersecurity for Health Technology Tools, Services, and Devices pre-standards activity
  • Enabling A Smart and Equitable Agriculture Ecosystem pre-standards activity
  • Data Quality Standards of Electronic Health Records Workgroup
  • WAMIII (Wearables & Medical IoT Interoperability & Intelligence) Program which seeks to incubate potential standards that will enable trust in the seamless, secure personal patient area network and bioinformatics highway for connected medical devices in, on or around the human body.

Conformity Assessment Program (Certification):

Medical Devices Cybersecurity—IEEE 2621 Series Of Standards
The certification program is being developed by the IEEE 2621 Conformity Assessment Committee (CAC), comprised of stakeholders, that will benefit users, manufacturers, clinicians, regulators, payers, and other potential beneficiaries.

For more information, see: https://ieee-sa.imeetcentral.com/eurollingplan/.

ITU

World Telecommunication Standardization 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 approved Recommendation ITU-T Y.4908 on “Performance evaluation frameworks of e-health systems in the IoT” and Recommendation ITU-T Y.4484 on “Framework to support Web of Objects ontology based semantic data interoperability of eHealth services”. ITU-T SG20 is also developing draft Recommendation on “Framework for smart public health emergency management in smart and sustainable cities” (Y.FSPH), and draft Recommendation on “Requirements and reference architecture of smart service for public health emergency” (Y.RA-PHE).

More info: https://itu.int/go/tsg20

ITU also coordinates the United for Smart Sustainable Cities (U4SSC) Initiative, which is a UN initiative that develops action plans, technical specifications, case studies, guidelines and offer policy guidance for cities to become smarter and more sustainable. U4SSC developed the U4SSC deliverable on “Smart public health emergency management and ICT implementations”. U4SSC through its Thematic Group on Digital Wellbeing aims to research and benchmark existing digital wellbeing frameworks, approaches, and interventions. More info: https://u4ssc.itu.int/

ITU-T SG5 approved Recommendation ITU-T L.1016 on Method for Evaluation of the Environmental, Health and Safety Performance of True Wireless Stereo Headphones.

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.

The SAREF ontology makes use of oneM2M as communication framework (ETSI TS 103 264 (Reference Ontology and oneM2M Mapping) and a specific extension of SAREF i.e. SAREF4EHAW: extension for the eHealth/Ageing-well domain is available. Sources: https://saref.etsi.org/sources/saref4ehaw/ . The related ETSI Technical Specification is : ETSI TS 103 410-8 V1.1.1 (2020-07): "SmartM2M; Extension to SAREF; Part 8: eHealth/Ageing-well Domain"

All oneM2M specifications are publicly available at: Specifications (onem2m.org)

(C.2) Other activities related to standardisation
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/

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/

UNICOM project

The Horizon 2020 UNICOM project helps to ensure that any medicine and what it contains can be accurately identified anywhere in the world. 

https://unicom-project.eu/

European Innovation Partnership 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

eHR4CR project

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

http://www.ehr4cr.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

(C.3) additional information

Guidelines, code of conduct

The following links provide additional information of ongoing work.

Guidelines on:

https://ec.europa.eu/digital-single-market/en/news/public-consultation-safety-apps-and-other-non-embedded-software

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