house keeping rules
TRANSCRIPT
HOUSE KEEPING RULES
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DISCLAIMER
Welcome to the Innovation Day
SPMS Cátia Pinto
X-eHealth intends to contribute to the Digital Single Market Strategy of the European Commission.
The Digital Single Market in Health in Europe is based on three pillars:
Citizens’ secure access to their health data, also across borders
Personalised medicine through shared European
data infrastructure
Citizen empowerment with digital tools
for user feedback and person-centred care
The Digital Single Market strategy seeks to ensure better access for consumers and business to online goods and services across Europe, for example by removing barriers to cross-border e-commerce and access to online content while increasing consumer protection.
PROJECT OBJECTIVES
Personalized MedicinePrivacy & Securty of my Health Data Prevention
Exchange of dataBetween persons | family relatives and Next kin; GP and HCPEU Cross-BorderInternational & Global
Individual Planned Care
Portability of HealthdataAccess and availability of Electronic Health Record and Personal Health Record
Citizens Healthcare Professionals Healthcare Organisations Policy Makers
Secondary use of HealthdataPublic Health; ResearchGenomics; Data QualityArtificial Intelligence
Strategic Focus
AGENDA
10:00 - 10:05 | Welcome
10:05 - 10:20 | Innovation Day 2021: Towards an eHealth Community in Europe
• About EHRxF – European Commission’s Outlook
• About today’s event - SPMS
10:20 - 10:35 | X-eHealth – Exchanging EHR in a common framework
• Standardizing how information should be shared & Roadmap for EHRxF in Europe
10:35 - 10:50 | European EHRxF Communities of Practice
• The vision | a way forward - Communities of Practice, Projects, Products and Services
10:50 – 11:10 | EHRxF Ecosystem in Motion
11:10 - 11:45 | Innovation inside X-eHealth
• The Progress line - from function to technical and architectural specifications
11:45 – 12:00 | Explaining the afternoon session
• From the EHRxF to the new health services/domains
• Q&A - Open questions from the audience
12:00 | Closing
14:00 - 14:05 | Welcome
14:05 - 14:15 | Introduction to the Workshop
• Objective, methods and output
• Participants division into working groups
14:15 - 15:15 | Breakout session
• Problem Statement for:
Medical Image | Laboratory results | Discharge letters |
Rare diseases
• Hands-on experience with the EHRxF
15:15 - 15:20 | Coffee Break
15:20 - 15:45 | Presentations: working groups’ Outcomes
• Working Groups' rapporteurs
• Q&A - Open questions from the audience
15:45 – 16:00 | Wrap-up and Next Step
16:00 | Afternoon Session Closure
Towards an eHealth Community in Europe About EHRxF – European Commission’s Outlook
DG CNECT – Saila RinneDG SANTE – Natalia Zylinska-Puta
X-eHealth Innovation DayIntroduction – European Commission
7 October 2021Saila RINNE, Head of Sector for EU policy
DG CNECT Unit “eHealth, Wellbeing and Ageing”Natalia ZYLINSKA-PUTA, Policy Officer
Digital health - eHDSI business owner representative DG SANTE Unit “Digital Health, European Reference Networks”
Digital transformation of health and care
• Secure access to citizens’ health data across borders (EHRs)
• Citizen empowerment (access to / portability of health data)
• Cybersecurity and trust
• Pooling and linking of data, expertise, computing and storage capacities across EU
Ø Genomic dataØ Cancer Imaging InitiativeØ AI Testing and Experimentation Facility for health
Unlocking health data
• Support Members States in their efforts to build interoperableelectronic health records, ensuring adequate protection and security of health data
• Proposes an EEHRxF – i.e. a common set of technical specifications to be used across the EU for different kinds of health data that do or will form part of the EHR
The European Electronic Health Record Exchange Format (C(2019)800) of 6 February 2019
13
EUROPEAN HEALTH DATA SPACEUse of data for healthcare (primary use of data)
Give citizens better access to their health data, everywhere in EU
From 2019 exchange of:ePrescriptionsPatient SummariesAccess by healthcare professionals in their native language
25 MS joined
From 2022 exchange of:
Original Clinical Documents
From 2024 exchange of:Laboratory reportsMedical images and reportsHospital discharge lettersin healthcare professional language
As in Recommendation on an Electronic Health Record exchange format
in cooperation with DG CNECT
From 2022, MS will pilot PATIENTS DIRECT ACCESS TO THEIR
TRANSLATED DATA through MyHealth@EU
Citizens residing in another Member State
• Additionally to translated Patient Summary, doctors will have an access to lab result and medical images – in universal medical language, which offers a lot of important information;
• This will allow to avoid the cost of unnecessary repeating expensive tests;
• Multilingual doctors will be able to access from abroad the health data of your citizens (recorded in your country);
• Many diaspora patients are likely to go to doctor speaking the same
Whom MyHealth@EU can help?
Doctors would be able to access Lab reports
Hospital discharge letter
Medical images
https://ec.europa.eu/eurostat/statistics-explained/index.php?title=EU_citizens_living_in_another_Member_State_-_statistical_overview#Who_are_the_most_mobile_EU_citizens.3F
What is the scale?
In 01.2019900,159
Spaniards resided in other
MS262,488
28,250
13,375
What it means in terms of numbers?
https://www.ine.es/en/prensa/pere_2019_en.pdf
Thank you
© European Union 2020
Unless otherwise noted the reuse of this presentation is authorised under the CC BY 4.0 license. For any use or reproduction of elements that are not owned by the EU, permission may need to be sought directly from the respective right holders.
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Towards an eHealth Community in Europe About today’s event
SPMSMiguel Santinhos
X-eHealth Timeline
359 Registrations
Bring Stakeholders into the European EHRxFdevelopment process
Ø 359 registrations from 27 European Countries
[+ Canada, India and USA]
Raising Awareness
Stakeholder roles:
• National Competance Center -
Policy Maker
• National Competance Center –
Developer
• Researcher
• Health Professional
• Standards Developer
• Hospital Manager
• Industry - Business Analyst
• Industry - Developer
X-eHealth Stakeholder Target Groups
67 138 132 22
Exchanging EHR in a common frameworkStandardizing how information should be sharedRoadmap for EHRxF in Europe José Dias – SPMS
Juergen Brandstatter – IHEVincent van Pelt – NICTIZAlexander Berler– MoH-GRMarcello Melgara – ARIAGaby Wildenbos – NICTIZ
X-EHEALTH PROJECT OBJETIVES
Ø Improve the healthcare quality and safety for citizens by allowing them to access and manage their electronic health record from any place in the EU;
Ø Contribute to standardisation and harmonisation of eHealth services in the EU by setting European agreements on diverse levels of interoperability;
Ø Contribute to defragmentation of European services;
Ø Facilitate interaction between patients and healthcare providers, to support prevention and citizen empowerment.
X-EHEALTH SPECIFIC OBJECTIVES Ø Reach a common understanding in the EU on the efforts needed to adopt the commonly defined EEHRxF
specifications at different levels and within their national EHR solutions;
Ø To define, specify and demonstrate the EEHRxF use cases laboratory results, medical imaging and reports, hospital discharge reports and patient summary for those suffering from rare disease and/or comorbidities;
Ø To elaborate the roadmap for the above-mentioned use cases for future uptake on the eHDSI as well as for the additional usage within Member Ststes on national, regional or local level;
Ø To submit the outcomes and recommendations of X-eHealth regarding EEHRxF deployment to the relevant bodies on policy, strategic and operational level (e.g. eHealth Network, National Competence Centres for eHealth, eHDSI operators);
Ø To propose a governance framework for the sustainable maintenance, evolution and distribution of standardisation and interoperability.
Laboratory Results Medical Imaging
Discharge LettersRare Diseases
PROJECT SCOPE
Morning Session: Laboratory Result Report EHRxF LRR
Jürgen Brandstätter, Hynek KružíkOctober 7, 2021, 10:20-10:35
Clinical / Business Need
• Laboratory is an essential domain for diagnostics and clinical decision making
• Main cross boarder laboratory use cases:• Laboratory test order
• Lab test order could be sent to laboratory in another country (e.g., to referential laboratory)
• Sharing laboratory test result report• Lab results could be delivered to ordering party from another country• Lab results from country A could be delivered to a point of care in country B on request
Sharing of lab test results is essential for continuity
of care in X-border situations
To assure flawless interpretation, laboratory results should be recorded in a universal manner by means of standard coding systems and data models for test methods, specimens, and results.
Clinical / Business Need
• Lab functional specifications (T5.3)• Include all interoperability layers according to the ReEIF
• LRR Information Model
• Innovations:• Harmonization of Terminologies
(e.g., Study Types, …)• Concept for Search & Filter
(Metadata)• Cooperation and co-creation
with Standards DevelopmentOrganizations
Example LRR implementation template: Laboratory Report
XeH Laboratory Specialty Section
XeH Laboratory Report Data Processing Entry
Exchanging EHR in a common frameworkStandardizing how information should be sharedRoadmap for EHRxF in Europe
Vincent van Pelt – NICTIZ
Domain: Images and Imaging Reports
§ Image study sharing§ Image report sharing§ Querying, retrieving and viewing of imaging studies and report
3 Priority Use Cases
§ Document level: categorisation of medical documentation § Section level: basic division of the report, standardised family of sections§ Concept level: examples of fully structured reporting as inspiration
Functional and technical specifications
Putting structure to the reports
1. Document
2. Section
3. Concept / value
Green field, blue ocean: start big, end small
• Document level:
• naming of medical documentation
• filter, sort, order, select documents
• basis for content-driven authorisation and consent
• Section level:
• division of a report in paragraphs
• Common structure
• Concept level:
• start with high volume reports
• hybrid structure
Exchanging EHR in a common frameworkStandardizing how information should be sharedRoadmap for EHRxF in Europe
Alexander Berler – MoH-GR
Clinical / Business Need
• MyHealth@EU story – clinical need for standardized hospital discharge report across borders in Europe (EHRxF HDR)
• Mr Horvat, a resident of Dubrovnik, Croatia is admitted to a hospital in Athens, Greece, with Myocardial Infraction. Following discharge from the hospital he has two options: • CASE 1 (Pull): Mr Horvat returns home to Dubrovnik, Croatia. He notifies verbally his GP, who
retrieves the EHRxF HDR from Greece.• CASE 2 (Push): Mr Horvat requests that his EHRxF HDR be available to his GP home in
Dubrovnik, Croatia, at the time of discharge and the system notifies his GP.
• A Croatian Story – clinical need for standardized hospital discharge report within a country (EHRxF HDR)
• Mr Horvat, a resident of Dubrovnik, Croatia is transferred to a rehabilitation center in Zagreb and his discharge letter is made available in the EHRxF format
Information Model of the EHRxFHDR: a modular approach
ENCOUNTER DETAILS
ADMISSIONEVALUATION PATIENT HISTORY HOSPITAL STAY ENCOUNTER
SUMMARY DISCHARGE DETAILS
TYPE OF ENCOUNTER(e.g., emergency, planned care)
ORIGIN OF REFERRAL(e.g., ref. physician, self-referral)
DATE OF ADMISSION
REASON FOR ADMISSION
PATIENT CONDITION ON ADMISSIONAnthropometric results, vital signs, physical exam per organ system, functional status assessment, admission (working) diagnosis…
FAMILY HISTORYParents or ascendants, siblings, descendants, other relatives…
SOCIAL HISTORYEducation level, occupation, marital status, sporting and free-time activities, accommodation type
MEDICAL HISTORYAllergies & intolerances, history of previous health problems, medical devices and implants, history of procedures, medication history, vaccinations…
URGENT INFORMATIONAllergy, adverse effects and developed other risks during the encounter
DIAGNOSTIC RESULTSPhysical examination, (diagnostic observation, functional assessment) Laboratory test results (blood, urine, biochemistry, histopathology)Imaging results (ultrasound, X-ray, CT, MR…)
PROCEDURESProcedure details (reason, code, category, description, outcome, complications, devices used…)
PHARMACOTHERAPYNew, ongoing and withheld medications…
Structured clinical narrative by individual systems/problems
Active problems at discharge, prognosis
Patient clinical condition and functional status at discharge
Main discharge diagnosis
Secondary discharge diagnoses
Discharge mode
Future management plan/discharge instructions
Recommended pharmacotherapy
Other recommended therapies
Regime recommendations (dietary, physical activity, work restrictions…)
DOCUMENT HEADER (ID, date/time of creation etc.)
ADMIN DETAILS
SPECIFIC MODULES: GYNAECOLOGY/OBSTETRICS…
PATIENT INFOIdentification (name, date of birth…)Contact information (email, telephone…)
Example HDR implementation template: Discharge Details
• Discharge Diagnosis
• Discharge Medications
• Plan of Care
• Discharge Summary
Exchanging EHR in a common frameworkStandardizing how information should be sharedRoadmap for EHRxF in Europe
Marcello Melgara – ARIA
Use case unplanned care• French 15 year-old boy presenting to an Italian emergency
department with respiratory distress after banal bronchitis lasting
for a couple of days. In addition, he complains of disabling
abdominal pain. He reports having been diagnosed with Steinert
disease.
• Worst scenario:
• Doctor does not know much about Steinert disease, but wants to
rule out a surgical abdomen. Patient suffers respiratory arrest when
lying down for examination. Intubation is diffcult and a tracheotomy
should be performed
• Better scenario:
• Doctor does not know much about Steinert disease, but consults
ePatient Summary for information. He can access emergency
guidelines and avoid further complications. He can also call the
patient’s doctor at the expert centre
ORPHA:273https://www.orpha.net/consor/cgi-bin/OC_Exp.php?lng=EN&Expert=273
Rare Diseases (including Rare Cancers)
Unplanned care (incl. emergency/surgery)
RD diagnosis X
Disease name X
ORPHAcode X
Diagnosis assertion status X
Treatments X
Treatment specific for the RD: yes/no X
Name and posology of the ongoing treatment(s) (RD specific; others) X
Care pathway X
Name of the physician in charge of the patient: X
Rare disease centre following the patient: name of the centre/hospital/location/phonenumber (incl. emergency phone number)
X
Is the RD center part of an ERN (yes/no) XERN name XUseful information Xurl leading to information on the disease, including CPGs, emergency and anesthesiaguidelines
X
Main alert messages X
Partially included in eHN Guidelines on Patient Summary
Release 3
Rare Diseases (including Rare Cancers)
Possible use cases for Planned healthcare¾Multidisciplinary team (MDT) consultations
¾Concise summary for attending clinicians; for GP involvement; for external
consultations
¾Second opinions/multidisciplinary consultations (ERN consultation)
¾Concise summary for consultations concerning availability of ongoing clinical
studies/eligibility check
¾Concise summary for patients
Rare Diseases (including Rare Cancers)
Clinical models and expertise required
Innovation in eHealth
READ
INES
S -E
FFEC
TIVE
NES
S
1) PS; eP/eD 2) Patient Access; Health Care Encounter Report (HCER); Medication Related Overview, Emergency 112, EHIC
PS; eP/eD; Patient Access; Health Care Encounter Report
(EU)PS; eP/eD; Original Clinical Document
CEF eHDSI
(I)PS; eP/eD; OrCD, Lab Report; Patient Access
+ Lab Results, Hospital Discharge Letters(HCER), Images and reports, Rare Diseases+ new technologies & Use Cases/scenarios
Exchanging EHR in a common frameworkStandardizing how information should be sharedRoadmap for EHRxF in Europe
Gaby Wildenbos – NICTIZ
Roadmap for new domains & use cases
Now
Next - List of mentioned desired new domains and use cases throughout X-eHealth period
- Criteria for identification of new domains and use cases
- Process regarding applying for new use cases, i.r.t. sustainable governance model
Sustainable governance model - Description of status quo on management
of European eHealth digital exchange activities
- Needs analysis on governance of eHealth EEHRxF
- Conceptual governance model based on needs and preferences
- Requirements for operationalization - Roadmap for operationalization
à 29 & 30 November 2021: online workshop on roadmap and governance model [email protected] | [email protected]
European EHRxF Communities of PracticeThe vision | a way forward
Launch EHRxF CoP, EHRxF Projects & Initiatives, EHRxF Products & Services Registries
Catherine Chronaki – HL7 EuropeAsimina Boumpaki – MoH-GRDiogo Canudo – SPMSVanessa Viana – SPMS
On the road to EHRxF innovation
• Communities of Practice build on • a domain of knowledge, and • people that practice this knowledge
sharing and learning from each other developing skills and capacity
• to advance consistent implementation of the European EHRxF
• for sharing of high quality health data in a reliable and trustworthy manner.
Today as we mark the middle of x-eHealth we launch three registries:1) CoPs: about people2) Projects and Initiatives: about innovating with EHRxF3) Products and services: about delivering value
x-eHealth innovation management framework
Vision:• Make EEHRxF an integral part of the digital health innovation process that
turns ideas into interoperable high-quality services.
• How ?• Capacity building with communities of practice• Synergies with collaboration agreements• Innovation management – as a x-eHealth activity
within and without• Plan-Do-Act-Check specifications (WP4-5-6-7)• Communication and Dissemination (WP2)• Roadmapping and evaluation (WP1, WP3)• Case studies (WP8)
CEN Standards on innovation management
• CEN/TS 16555-1 Innovation Management - Part 1: Innovation Management System• CEN/TS 16555-2, Innovation management — Part 2: Strategic intelligence management• CEN/TS 16555-3, Innovation management — Part 3: Innovation thinking• CEN/TS 16555-4, Innovation management — Part 4: Intellectual property management• CEN/TS 16555-5, Innovation management — Part 5: Collaboration management• CEN/TS 16555-6, Innovation management — Part 6: Creativity management• CEN/TS 16555-7, Innovation management — Part 7: Innovation management assessment• EN ISO 9001, Quality management systems - Requirements (ISO 9001)• Oslo Manual: Guidelines for Collecting and Interpreting Innovation Data. OECD, Third
Edition, 2005
Innovation Funnel
Innovation management assessment
• Source: cen-ts16555-7
WP1: Survey "Solutions for exchange" | X-eHealth & eHN Technical Subgroup
WP2: Dissemination planWP8: Communities of PracticeWP3: Evaluation
WP4-5-6-7 (iterative)WP8: Synergies
WP2: Innovation Days
WP1:roadmapsWP2: CommunicationWP8: Innovation infrastructure
Level of innovation management
X-eHealthambition
Innovation assessment
Wp1,2,3Project execution Wp8.5
X-eHealth as catalyst in EHRxF innovation
EHRxF CoP terms of reference (Feb 2021)
Draft EHRxFSpecs (9.21)
CoP registry (10.21)
EHRxF Projects Registry and EHRxF Products Registry (10.21)
EHRxF Proof of Concept (6/22)
Defining a Community of Practice
DOMAIN Area of shared
interest and key issues
COMMUNITY Relationship built
through discussion,
activities and learning
PRACTICE Body of
knowledge, methods, stories, tools developed
Communities of practice “are groups of people who share a concern or a passion for something they do and learn how to do it better as they interact regularly”.
(Introduction to communities of practice - A brief overview of the concept and its uses, Etienne and Beverly Wenger-Trayner)
Structural characteristics of a CoP:• Domain of knowledge: WHAT WE CARE ABOUT
• Practice: WHAT WE DO TOGETHER ABOUT IT
• Community: WHO CARES ABOUT IT
Communities of Practice
Graphic illustration by Nitya Wakhlu, produced at the Experience Engagement conference in October 2015
EEHRxF Communities of Practice: from Proof of Concept to large scale adoption and Infrastructure for Innovation• EEHRxF in rare diseases proof of concept Case Study
This task uses the EEHRxF domains to construct the patient case of a rare disease and interface rare disease registries. The project would seek to collaborate with a rare disease network for this proof of concept concentrating on meaningful data.
• EEHRxF in chronic diseases management and prevention proof of concept case studyThis task will provide at least one proof of concept EEHRxF demonstrator for chronic disease patients or patients suffering from comorbidity (e.g. in cancer, diabetes, chronic pain, hypertension, cardiovascular/stroke, or other chronic conditions).
• EEHRxF to decision aids and citizen driven health-science: Exploratory Proof of concept studyThis exploratory task links EEHRxF to parallel initiatives that are in the process of assessing and integrating new concepts and tools such as for example AI, outcomes-based research, clinical research, clinical trial integration, business analytics, decision aids for patients, and citizen-driven health-science, etc.
• Taking a patient-centric approach, this work will contribute towards addressing local, national, cross-border/international aspects along with professional collaboration with patients, multilingualism, differences in terminology, and other well-known organizational barriers.
• If you have other suggestions, please bear with us!
EHRxF Case Studies
Join us: We need you!
Registry of CoPswith connection to X-eHealth
X-eHealth Collaborative Partners, including projects, organisations and initiatives that are organised in CoPs to advance their strategic goals and that wish to explore the implications of using EEHRxF in there area of work
Registry of EU funded projects and national initiatives
Projects and initiatives that are aware of the European EHRxF and would like to be informed and contribute
Registry of digital health products and services
Products, services and tools that commit to implementing and showcasing the European EHRxF
The way forward – 3 Registries
• To help the project connect with the Communities of Practice, thefollowing elements were created:
Communities ofPractice Page
List of Productsand Services
Supporting theEuropean EHRxF
Page
National Initiatives& European
Commission co-Funded Projectssupporting the
European EHRxFPage
Products andServices Form
Initiatives andProjects Form
Share your CoP
Submit your products and
services
Let your project sign the x-
eHealth pledge
How can you contribute?
• All the contents are online in the EHRxF Innovation menu found in thetop menu of the X-eHealth website:
https://www.x-ehealth.eu/
EHRxF innovation online!
• Communities of Practice Page
https://www.x-ehealth.eu/communities-of-practice/
Here you can have a more comprehensive view of this initiative and see which are thecurrent Engaged collaborative partners and Communities of Practice.
EHRxF innovation online!
List of Products and Services Supporting theEuropean EHRxF Page
https://www.x-ehealth.eu/list-of-products-and-services-supporting-the-european-ehrxf/This page represents a registry of products and services that intentto support the European EHRxF. In the end of the page, you can finda button to submit the product or service that you want to beinvolved in the innovation program of X-eHealth.
EHRxF innovative products online!
Join us... Enter your innovative product here...
https://mkt.egoi.page/5Be6BePFS/productsandservices
EHRxF innovation online!Share your EHRxF products
EHRxF innovation projects and initiatives online!
• National Initiatives & European Commission co-Funded Projectssupporting the European EHRxF Page
https://www.x-ehealth.eu/national-initiatives-european-commission-co-funded-projects-supporting-the-european-ehrxf/
This page represents a registry the list of national initiatives & European Comission co-Funded Projectssupporting the European EHRxF. If your project is not list on that page, you can fill the form for to be added.
• Click on the QR code to share your innovative project or initiative!
https://mkt.egoi.page/5Ce6CePFS/initiativesandprojects
EHRxF innovation online!
Products and ServicesForm:
corresponds to theproducts and servicesthat intend to supportthe European EHRxF.
Initiatives and ProjectsForm:
corresponds to NationalInitiatives & European
Commission co-Fundedthat intend to supportthe European EHRxF
EHRxF innovation online!
Industry and Innovators
National/Regional authorities
Consortia
Why join us?
• Benefits to projects that pledge support the European EHRxF
understand the EEHRxF functional requirements and
specifications across and within
national EHR solutions
demonstrate EEHRxF use cases laboratory results, medical imaging
and reports, hospital discharge
reports and patient summary for rare diseases
Help elaborate roadmap for use cases for future uptake on the
eHDSI as well as for the additional usage within MS
on national, regional or local
level
Showcase your outcomes within
X-eHealth recommendations
on EEHRxF deployment to the relevant bodies on
policy, strategic and operational
level
Contribute to a governance and
operational framework for the
sustainable maintenance, evolution and distribution of
standardisation and
interoperability
Understand EHRxF
demonstrate EHRxF
Propose new EHRxF use cases
demonstrate EHRxF
Showcase your project
Innovate with EHRxF
https://mkt.egoi.page/5Be6BePFS/productsandservices
• Click on the QR code to share your innovative product or service!
• Click on the QR code to share your innovative project or initiative!
https://mkt.egoi.page/5Ce6CePFS/initiativesandprojects
Be the first to join in!
EHRxF Ecosystem in MotionMedTech | COCIR | CPME |ECHAlliance | EHTEL | EFMI
Michael StrubinDanny van RoijenSara RodaAndy BleadenMarc LangeLars Lindskold
The EEHRxF Community and the medical technology industry
X-eHealth Innovation Day7 October 2021Michael Strübin, Digital Health Director
73
About medical technologyMedical technology is any technology used to save and improve lives of individuals suffering from a wide range of conditions.
There are more than 500,000 products, services and solutions currently available
74
The MedTech Industry in Europe
€ 140billionmarket
33,000+Companies of which 95% are SMEs
760,000+employees
#1In filing patent applications 9% more than computer technology industries and 66% more than the pharmaceutical industry
75
The industry’s views on interoperability
• The digital transformation of healthcare requires better data exchange and overcoming barriers, including lack of interoperability.
• We see increasingly national and regional healthcare systems requiring developers of medical technology solutions to deliver data along certain specifications.
• There is a risk of fragmentation. We welcome European coordination.
à The medtech industry welcomes and supports the European EHR Exchange Format and the X-eHealth mission to build a EHRxF community.
à We would welcome further development of the EHRxF to cover specifications for data from medical/IVD devices and services.
76
Our contributionThe joint COCIR/MedTech Europe White Paper “Interoperability standards in digital health”• Published on 6 October 2021 • To promote shared understanding about the relevant
standards in digital health• Available at the MedTech Europe website.
Launch webinaron Monday, 18 October 2021, 16.00-17.00 CEST• Presentation by Paul Coebergh van den Braak, Philips• Panel with Ceri Thompson (EC), Ron Roozendaal
(Dutch MoH/eHealth Network), Amit Trivedi (HIMSS)…• For more information and to register click here.
EHRxF Ecosystem in MotionCOCIR
Danny van Roijen
COCIR views• Interoperability is an enabler• Interoperability is possible
X-eHealth is essential• Cross-border and intra-border exchange are interlinked• Building a community is key
Road to implementation• More governance is needed• Keep the dialogue going
www.cocir.org
Shaping the Healthcare Sector Interoperability Policy
Sara RodaSenior Policy Adviser
Standing Committee of European Doctors
Introducing CPME
• CPME represents national medical associations across Europe,covering 1.6 million European Doctors.• CPME promotes highest level of medical training & practice; provision
of evidence-based, ethical and equitable healthcare services.• 5 priority areas: professional practice & patients’ rights,
pharmaceuticals & healthcare products, public health & diseaseprevention, eHealth.
Some major challenges• Lack of common technical specifications to exchange electronic health
records • Dependency of software industry – ‘last mile’; public procurement• Lack of trust for secure access and exchange of health data – protected
infrastructures needed (e.g. wearables, health apps, EHR, digital solutions)Caution:• Interoperability between healthcare sector and other sectors of the public
administration – risk of repurposing without patient’s consent
Fundamental principles• Security by design, privacy by design, medical confidentiality and ethical
principles – WMA Declarations of Helsinki and Taipei• Healthcare system, patients and healthcare professional needs to drive
forward the design of technical systems and interoperable processes• Interoperability YES, BUT not at all costs – do not reduce financial
resources for clinical care• Do not increase digital inequalities – prevent digital divide Recommendation: • Directive on minimum interoperability requirements
Andy BleadenC ommunities D irector
ECHAll iance
www.echalliance.com
@andybleaden
@ECHAlliance
Community of 20,000+
digital health experts
WHO
WHAT
About ECHAlliance
Not for Profit Organisation
Connecting the dots
Comms & networking
Global Events
Funding/Tenders
Network of Geographical & Thematic Health
Ecosystems
Member Organisation (850+ organisations)
Companies, policy-makers, research orgs, health & social care providers, patient groups,
insurance, procurers, government ministries
Registered in Ireland and in the UK
WHERE Global reach across 78 Countries and4.6 billion people
International Network of 70+ Digital Health Ecosystems(200+ ecosystem gatherings a year)
Supporting our members
Promote your organisation Discount on Events Speaking Slots Opportunities
Join Working Groups Make Direct Connections
Collaboration in Funded Projects Access our Ecosystems
Boost your network
Become a member of ECHAlliance
Funding and TenderAlerts
...bring together a permanent community of all stakeholdersto develop a joint health agenda, aimingto address and find common solutions to regional health challenges
Match need and solution
The m ain benefit o f w orking together in an Ecosystem is the m ultip lie r e ffect o f col laborat ing in our International Network of Ecosystem s of over 70 Ecosystem s.
Ecosystems:• break downsilos,• transformhealthcaredelivery,• create economic growth
Ecosystems – What are they and what do they do?
Thematic Ecosystems
Smart Care and Ageing at Home
Webinars/Networkingand Events
Networking, policy exchange, funding and collaboration
across borders
Permanent Dedicated Platform/Repository +
Social Media Communities
Health Procurement
Integrated Care
Digital Health & Wellbeing
Mental Health
Housing and Health
Skills for Health
Share
The Digital Health SocietyAmulti-stakeholder initiative
The Digital Health Society (DHS)is the data arm of ECHAlliance
contact: [email protected] www.thedigitalhealthsociety.com
Share Insights on Harnessing the Potential of Data
Reflect
Reflect on Health data Governance
Mobilize the European Health Data Space
Mobilize
Needs assessment & specif ications
D is sem inat ion Leader
• Support in scouting funding opportunities fitting local and regional needs• Support in building international partnerships and consortia• Support in partner search• Lead consortia applying to strategic calls relevant to our community• Carrying out different tasks in R&I projects:
Ex p lo ita t ion Leader
Project m an agem ent
Eventmanagement
Social mediamanagement
Deployment plans &p ilo t c oord inat ion
S c a lab ility &transferability plans
Funding Services What we can do for and with you
Andy BleadenDirector Ecosystems &
Membership at EC HAlliance
www.echalliance.com
@andybleaden
@ECHAlliance
Thank you!
Towards citizen-centric data sharing
Marc Lange - EHTEL
EHTEL’s vision of EHDS priorities
“The ability for European citizens to access, and control access to, their electronic health records (EHR) across the EU should be greatly improved by 2030”
(2030 Digital Compass: the European way for the Digital Decade)
► More than giving consent to access own health dataThis would mean:
► Enabling citizens to become a data-sharing actorCitizen-Centric Data Sharing Approach
Citizen-Centric Data Sharing ApproachCitizens need to be equipped with easy-to-use and secure technological solutions to exchange their data with other healthcare providers or researchers in a controlled and secured way
Healthcare Organizations
Research Centres
Citizens
Healthcare Organizations
Technical specifications, interoperability profiles, secure infrastructure and public acceptability
EHDS1, EHDS2 and digital health services and products will all benefit from this approach
Public acceptability
Digital solutions need to be:► Totally under citizens’ control
► Part of a health data ecosystem developed along the line of Fair Data Economy principles sets by the IHAN® project
How can we action citizen-centric data sharing?► InteropEHRate has developed
protocols to allow citizens to access their own data from healthcare providers and share it with others.
► InteropEHRate has also developed solutions to facilitate data sharing for research purposes.
Have your say!
Further exploring all
this?
EHRxF Ecosystem in Motion
EFMI
Lars Lindskold
InteroperabilityThe Things in between
Cross-disciplinary collaboration and sharing of research data will be a requirement to accelerate new discoveries.
To improve care and reduce costs with this new science, we must focus on what drives 80% of of outcomes, the non-clinical factors which include social, economic and psychological determinants of health.
Health and healthcare will reach its full potential with new incentives and the democratization of health data
This new science will arrive at an evidence-based understanding of what works through a great wealth of shared longitudinal health data captured through mobile devices, sensors and health records. It must be mindful of the concept of transforming Data to Information, Knowledge and Wisdom.
Verifiable but de-identified, health data will become part of a unified view of healthcare for research and risk assessment ). Individuals will have the choice to contribute / donate.
Individuals have a right to health data privacy. Rights to sharing must be established with the individual it originates from, or their legal agent, in advance of sharing. GDPR
providers/patients
The most relevant providers/ patients will learn and will be conversant in data analytics and tools. They will be experts in care delivery/usage, not just diagnostics and traditional medical science.
“Patient engagement” is valuable, but backwards. Individuals need the health system to be engaged with them regularly, and not just during visits. ( Prevention)
Healthcare organizations that aggressively promote health literacy will build community capacity in addressing health issues. This may mean enabling and curating others in the community to reach all facets of the community.
Summary : The Future of Health-Stakeholder perspectiveCONNECTING HEALTH DATA ACROSS EUROPE
( World)
Advancing Europe as a leader in health data and data-driven
solutions.
PERSONALISED CARE
Ensuring individuals and the system as a whole can get the most out of new technologies.
PERSON AND PATIENT EMPOWERMENT
Allowing each person to take full control of their own
wellness and care
DATA SHARING AND GOVERNANCE
Understanding as much as possible about each
person’s circumstances and needs
TECH AND AI
Enabling technologies and health interventions to
work together
GENOMICS
Ethical use of genome-based diagnosis and treatment solutions
PREVENTION AND EARLY DETECTION
Getting care as early as possible or avoiding the need for care altogether
Source: Nordic Health 2030 Vision www.CIFS.dk
• Livet som gåva – våga ge och våga ta emot
Inne i dig öppnar sig valv bakom valv oändligt.
Du blir aldrig färdig, och det är som det skall.”Tomas Tranströmer
Innovation inside (X-)eHealthThe Progress line - from function to technical and architectural specifications Marcello Melgara [moderator] - ARIA
Vincent van Pelt – NICTIZEspen Borde - SEHAGiorgio Cangioli – HL7Vanja Pajić – Kraj VysočinaKarima Bourquard – IHEKlara Jirakova – Kraj Vysočina
Innovation in eHealth
From clinical requirements to implementation
• Clinical need for information exchange is the starting point
• Many use cases, in different health and care domains
• Standardisation: reusability, understandability, quality
• Whole system in the room
Interoperability - alignment between all stakeholders
Process
Policy
IT Infrastructure
Legal and regulatory
Information
Applications
Policy makers, CMIOs
Information analysts, terminologists
Software engineers
Healthcare-Managers
System architects
Regulators and advisors
System engineers
Business- and information architects
Healthcare directors
Healthcare professionals
Patients
Strategic Tactical Operational
System managers
Lawyers
Secu
rity,
Priv
acy,
Gov
erna
nce
Stan
dard
s an
d Pr
ofile
s, C
ertif
icat
ion
Interoperability development cycle
Logical specification
Implementation
Testing and qualification
Technical specification
Business need
Use case
Deployment and use
Evaluation, change proposalsStan
dard
s an
d Pr
ofile
s, C
ertif
icat
ion
Secu
rity,
Priv
acy,
Gov
erna
nce
• Use case• process flow, process steps• exchange of information
• Logical specification• breakdown of the information into reusable
information building blocks• understandable by end users• stable basis for technical specification
• Technical specification• based on the logical model• future proof - new versions of standards can be
implemented from the logical model.
Selected domains
• Patient Summary / ePrescription is an excellent start, but it is not enough• X-eHealth focus:
• Laboratory - already many highly standardised implementations • Images - DICOM, Scheduled Workflow already fully implemented• Imaging reports - almost a green field, mostly flat text. Work is necessary• Hospital Discharge letters - reusable specialistic information elements• Rare diseases - addition to PS specifications
Standardisation approach: from generic to specific
1. Healthcare, generic2. Domain / specialism3. Problem / disease
115
Are we talking about the same things?
Do I understand what I received?
Are these data useful for me?
Semantics? Giorgio Cangioli
ConceptualLogical
Implementable
Legal Legal and regulatory
Organisational
Policy
Care Process
Semantic Information
Technical
Application
IT Infrastructure
Implementation Independent Implementable Specification
Terminologies
Use Cases
Use Case independent Building Blocks
Legal enablers / showstoppers? Klára Jiráková and Vanja Pajić
ID Legal challenges (from D4.2.1)LC1 Lack of clarity regarding data protection vs consumer protection provisions in the healthcare domain.
LC2 Different legal bases for personal data exchange in healthcare (e.g., informed patient consent in country of treatment vs. other legal basis in country of affiliation).
LC3 Lack of clarity regarding the Member States’ roles in data protection with regards to the GDPR. LC4 Lack of clarity regarding the meaning of “personal data” in the light of the GDPR.
LC5 The implementation of technical processes in the cross-border exchange of data that create gaps in our understanding of personal data processing.
LC6 Lack of clarity regarding the identification means of data subjects within the current infrastructure and the rights of data subjects.
LC7 Lack of clarity in the separation of Member States' and the European Commission's respective roles in cross-board data processing.
LC8 Lack of alignment among Member States regarding legal representation in the context of cross-border healthcare data exchange.
LC9 Lack of alignment among Member States regarding healthcare professional authorizations to access personal data
LC10 Lack of clarity regarding informed consent in specific cross-border data exchange scenarios
Focus on legal and ethical challenges for cross-border sharing of personal data
Legal enablers / showstoppers? Klára Jiráková and Vanja Pajić
Focus on legal and ethical challenges for cross-border sharing of personal data
ID Ethical challenges (from D4.2.1)
EC1 The presence of especially sensitive data may prevent cross-border EHR data sharing.
EC2Cross-border exchange of patient’s will about medical treatment or to appoint medical power of attorney may be
challenging due to the nature of the information.
EC3 Patients may deny their consent to share especially sensitive data depending on their health condition.
EC4 Patients may not be able to share data depending on their health condition or on their digital literacy.
Legal enablers / showstoppers? Klára Jiráková and Vanja Pajić
ID Legal challenges (from D4.2.1)LC1 Lack of clarity regarding data protection vs consumer protection provisions in the healthcare domain.
LC2 Different legal bases for personal data exchange in healthcare (e.g., informed patient consent in country of treatment vs.
other legal basis in country of affiliation).
LC3 Lack of clarity regarding the Member States’ roles in data protection with regards to the GDPR.
LC4 Lack of clarity regarding the meaning of “personal data” in the light of the GDPR.
LC5 The implementation of technical processes in the cross-border exchange of data that create gaps in our understanding
of personal data processing.
LC6 Lack of clarity regarding the identification means of data subjects within the current infrastructure and the rights of data
subjects.
LC7 Lack of clarity in the separation of Member States' and the European Commission's respective roles in cross-board data
processing.
LC8 Lack of alignment among Member States regarding legal representation in the context of cross-border healthcare data
exchange.
LC9 Lack of alignment among Member States regarding healthcare professional authorizations to access personal data
LC10 Lack of clarity regarding informed consent in specific cross-border data exchange scenarios
Focus on legal and ethical challenges for cross-border sharing of personal data
ID Ethical challenges (from D4.2.1)
EC1The presence of especially sensitive data may prevent cross-border EHR
data sharing.
EC2Cross-border exchange of patient’s will about medical treatment or to
appoint medical power of attorney may be challenging due to the nature of
the information.
EC3Patients may deny their consent to share especially sensitive data
depending on their health condition.
EC4Patients may not be able to share data depending on their health condition
or on their digital literacy.
Why do we need to test conformity for interoperability?
For Vendors: • It helps to reduce interoperability issues• It helps to improve Softwares quality• It ensures appropriate methods to have a correct integration between actors• It helps to reduce efforts when integrating systems by using common testing tools or conformity assessment schemes
For the health community:• Data quality and trust to the clinical data coming from other healthcare providers• Conform to the regulation• Usability of the solutions
Accelerate the adoption of the clinical reports over Europe
Validate to trust? Karima Bourquard
Validate to trust?
How to test and validate the medical reports?
Testing framework:• Testing process, test methods and test plan for
testing and assessing the implementation (vendor’ssoftware or NCPeH) of the clinical reports and services
Tool-stacks:• ART DECOR • FHIR tools• Gazelle testing tools as a common platform for all conformity assessments
Exchanging clinical report with trust
Conformity Assessment Scheme:• Provide a framework for testing interoperability
and assess the conformity of products or services to specifications
• It defines the processes, procedures and criteriafor success based on the testing framework
LABEL CERTIFICATE
Validate to trust?
What’s next?
Klára Jiráková
Innovation in eHealth
READ
INES
S -E
FFEC
TIVE
NES
S
1) PS; eP/eD 2) Patient Access; Health Care Encounter Report (HCER); Medication Related Overview, Emergency 112, EHIC
PS; eP/eD; Patient Access; Health Care Encounter Report
(EU)PS; eP/eD; Original Clinical Document
CEF eHDSI
(I)PS; eP/eD; OrCD, Lab Report; Patient Access
+ Lab Results, Hospital Discharge Letters(HCER), Images and reports, Rare Diseases+ new technologies & Use Cases/scenarios
Explaining the afternoon sessionFrom the EHRxF to the new health services/domainsQ&A - Open questions from the audience
José Dias – SPMS Catherine Chronaki – HL7
Workshop Agenda
14:00 - 14:05 | Welcome
14:05 - 14:15 | Introduction to the Workshop
• Objective, methods and output
• Participants division into working groups
14:15 - 15:15 | Breakout session
• Problem Statement for:
Medical Image | Laboratory results | Discharge letters | Rare diseases
• Hands-on experience with the EHRxF
15:15 - 15:20 | Coffee Break
15:20 - 15:45 | Presentations: working groups’ outcomes
• Working Groups' rapporteurs
• Q&A - Open questions from the audience
15:45 – 16:00 | Wrap-up and Next Step
16:00 | Afternoon Session Closure
X-eHealth Events for 2022
ØProfessional Training Sessions
• May-June (tbd)
Ø2nd X-eHealth Innovation Day
• Aug-Sep (tbd)
Ø Interoperability Award • Sep (tbd)
X-eHealth Deliverables
Ø July 2022Ø Functional Specification and Guidelines for IMG, LAB, DISCH, Patient Summary
Ø August 2022Ø Services Specifications, Testing Tools and Implementation Guide
Ø March, June and August 2022ØArchitecture Specifications, Testability Strategies, Guidelines to implement EEHRxF in National
Services
Ø June and July 2021ØWP8 – EEHRxF Communities of Practice, EEHRxF Proof-of-Concept and EEHRxF as infrastructure
for innovation
NEXT STEPS
Ø Video Recording Available
Ø Website and Documents
Ø Workshop Presentation and Summary
https://www.x-ehealth.eu/
Takeaway Messages
Q&AOpen questions from the audience
HOUSE KEEPING RULES
Add your Participant name (e.g., ICátiaPinto_SPMS_PT)
Please,
Mute your microphone when you are not speaking
When speaking - state your name and be aware of background noise- you can turn your camera on
You can share your questions on the chat chat or even verbally.
Should any issue arise, you may approach Miguel Santinhos or Diogo Canudo in the chat
• The Innovation Day will be recorded.
• This means the following features will be recorded:
• your name and the registration details you provide
• your image if you choose to turn on your camera at any time
• your voice if you choose to ask a question or make a comment orally, as well as any text you may choose to write in the Zoom platform.
• If you do not consent to your data being recorded, you can either participate as an observer without sound-image-text or not take part in the meeting.
DISCLAIMER
AGENDA
14:00 - 14:05 | Welcome
14:05 - 14:15 | Introduction to the Workshop
• Objective, methods and output
• Participants division into working groups
14:15 - 15:15 | Breakout session
• Problem Statement for:
Medical Image | Laboratory results | Discharge letters | Rare diseases
• Hands-on experience with the EHRxF
15:15 - 15:20 | Coffee Break
15:20 - 15:45 | Presentations: working groups’ outcomes
• Working Groups' rapporteurs
• Q&A - Open questions from the audience
15:45 – 16:00 | Wrap-up and Next Step
16:00 | Afternoon Session Closure
Introduction to the WorkshopObjective, methods and outputParticipants division into working groups
Catherine Chronaki – HL7Vincent van Pelt – NICTIZ
• Familiarize stakeholders with EHRxF
• Sharing (current work) & Receiving Feedback
• Draft Specification as starting point
• Assess implementation challenges
• Define the clinical level and the technical level
Objective
• Hand-on experience on draft specifications
• Explain the different levels X-eHealth is working with (IPL levels)
• Information Model
• Toolkit – ART-DECOR
Example:
clinical needs, use case, template, information model, art decor, CDA
Methods
• Thinking outside the box (per domain)
• Receive use cases
• Clinical diagnostic report designed RN/AOENR is represented on Art
Decor: send it, use it, feedback
Output
1. Medical Image
• Procedure and findings
2. Laboratory Results
• Observation
3. Discharge Letters
• Conditions and vaccinations
4. Rare Diseases
• Alerts
BREAKOUT ROOMS
BREAKOUT SESSIONS
1. Medical Image
Vincent| Karima | Esther | Sofia | Jiri Keller
2. Laboratory Results
Hynek | Jurgen | Gunnar | Daniel
3. Discharge Letters
Catherine | Vanja | Alexandre
4. Rare Diseases
Giorgio | Annalisa | Ana
svava.appEnter code:
Coffee Break5 min’
Presentations: working groups’ outcomesWorking Groups' rapporteursQ&A - Open questions from the audience
Breakout Room Rapporteurs
Medical Image• Procedure and findings
Breakout Room Rapporteurs
Laboratory Results• Observation
Breakout Room Rapporteurs
Discharge Letters• Conditions and Vaccinations
Breakout Room Rapporteurs
Rare Diseases• Alerts
Q&AOpen questions from the audience
Next Steps & Wrap Up
José Dias – SPMS
X-eHealth Deliverables
Ø July 2022Ø Functional Specification and Guidelines for IMG, LAB, DISCH, Patient Summary
Ø August 2022Ø Services Specifications, Testing Tools and Implementation Guide
Ø March, June and August 2022ØArchitecture Specifications, Testability Strategies, Guidelines to implement EEHRxF in National
Services
Ø June and July 2021ØWP8 – EEHRxF Communities of Practice, EEHRxF Proof-of-Concept and EEHRxF as infrastructure
for innovation
NEXT STEPS
X-eHealth Events for 2022
ØProfessional Training Sessions
• May-June (tbd)
Ø2nd X-eHealth Innovation Day
• Aug-Sep (tbd)
Ø Interoperability Award • Sep (tbd)
Ø Video Recording Available
Ø Website and Documents
Ø Workshop Presentation and Summary
https://www.x-ehealth.eu/
Takeaway Messages
Wrap Up & Event Closure
Cátia PintoInternational Relations and Projects Coordinator
SPMS – Shared Services of the Ministry of Health
