(A.) Policy and legislation
(A.1) Policy objectives
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 inApril 2018 (COM(2018) 233) on enabling the digital transformation of health and care in the Digital Single Market. This Communicationaddresses 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.
(A.2) EC perspectiveand progress report
The Commission announced the creation of a European Health Data Space in 2019 that will enable secure and trustworthy accessibility to health data across EU borders. To this end, the Commission plans to make legislative proposals by the end of 2021.To facilitate the interoperability of health data in the EU, the Commission adopted a Recommendation for a European Electronic Health Record exchange format (EEHRxF) in February 2019.
The EEHRxF Recommendation sets out the current consensus with regard to technical specifications for patient summary reports, and e-prescriptions. The eHealth Network adopted these specifications in guidelines in June 2019.
The X-eHealth project will provide draft interoperability specifications for new health domains (lab tests, hospital discharge letters, medical images and image reports) by September 2022.
InteropEHRate and Smart4Health will devise interoperability protocols and technologies for health data exchange centred on the citizen.
The new Commission proposal for a trusted and secure Digital Identity for all Europeans will provide a framework for all EU citizens, residents, and businesses in the EU to prove their identity and share electronic documents from their European Digital Identity wallets with the click of a button on their phone.
H2020 projects on eHealth standardisation, harmonisation and interoperability 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
- COM/2018/233 final on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society
- Commission Recommendation on a European Electronic Health Record exchange format (C(2019)800)
- eHealth Network Guidelines
- https://www.x-ehealth.eu/
- https://www.interopehrate.eu/
- https://smart4health.eu/en/
(B.) Requested actions
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. 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 ISO15189that should be supplemented by standardisation processes in ICT.
CEN proposes to build on this work in 2020-2023, incollaboration with ISO and IEC, to develop a new Technical Specification: “DigitalRepresentationof 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 manufacturersand 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 QualityRequirements Conformity Assessment.The labelcould 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-playconnectivity of the different devices and services for personal managementand 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
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 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
CEN-CENELEC/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.
Currently, the following standards have been 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 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 eHealthspecific, 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 and in further development:
TR 103 477: eHEALTH; Standardisation 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 standardisation 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. ETSI is one of the SDOs listening the voice of users, their expectations, behaviors and requests through the User Group.
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 P1752 is a draft Standards Series for mobile health data for different measures (sleep activity, Cardiovascular, Respiratory, and Metabolic Measures)
- 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 P2933 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 series defines criteria for 3D medical applications and printing
- The IEEE 11073 standards series enables service-oriented (medical) device connectivity including semantic interoperability.
- IEEE P2791 Optimized Drug Discovery for Precision Therapeutics–Moving Towards the Reality of Precision Medicine for All
- 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 P2968 Standards Series for Decentralized Clinical Trials, on Patient Safety, as well as Thread Modeling, Cybersecurity, and Data Privacy
Pre-standards activities
- Technology and Data Harmonization for Enabling Decentralized Clinical Trials Industry Connections Program
- Transforming the Telehealth Paradigm: Connectivity, Accessibility, Privacy and Security for ALL pre-standards activity
- 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.
Further information is at: https://ieeesa.io/rp-ehealth
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), ajoint 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”. ITU-T 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/tsg20
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
TheOASIS Security TCand theOASIS Web Security Services TCdeveloped and maintain foundational Web Services security standards such as SAML (also ITU-T Recommendation X.1141) and WS-Security, which are used in theIntegrating the Healthcare Enterprise (IHE)technical framework used in theeHealth Digital Service Infrastructure, the initial deployment and operation of services for cross-border health data exchange under the Connecting Europe Facility (CEF).
TheOASIS Emergency Management TCdeveloped, 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 relatedETSI 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
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.
JAseHN
Joint Action to Support the eHealth Network (Member States), followed by eHAction, the third Joint Action, as of July 2018
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 projecthelps 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…
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.
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.3) additional information
Guidelines, code of conduct
The following links provide additional information of ongoing work.
Guidelines on:
- On the electronic exchange of health data under Cross Border Directive 2011/24/EU revised in 2016
- On an Organisational Framework for eHealth National Contact Points (2015)
http://ec.europa.eu/health/ehealth/key_documents/index_en.htm
- Report of the Working Group on mHealth assessment guidelines
- Code of Conduct on privacy for mobile health apps,
- Consultation on safety of apps