Germany: MII Infrastructure and Data Access National Strategies For Making EHR Data Available for Secondary Use in Research - Preparatory EU Workshop Webmeeting - 26-10-2020 Sebastian Claudius Semler, TMF e.V. - on behalf of the MII Coordination Office - Seite 1
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Germany: MII Infrastructure and Data AccessNational Strategies For Making EHR Data Available for Secondary Use in Research - Preparatory EU WorkshopWebmeeting - 26-10-2020
Sebastian Claudius Semler, TMF e.V.
- on behalf of the MII Coordination Office -
Seite 1
Fragmentation of German Health Care System
MII Infrastructure and Data Access | Semler | 26/10/2020 Seite 2
Source: Frankfurter Rundschau 2014
3
Fragmentation of German Health Care System
Physicians` Associations
Financed by social or private healthinsurance funds oremployers` liability insuranceassociations
State Hospital Association
Financed by social or private healthinsurance funds oremployers` liability insuranceassociations
Out-Patient Sector
Acute Care Hospital Sector
Rehabilitation SectorVarious Interest Groups
Financed by social or private healthinsurance funds orsocial pensionfunds
Different
Governance
Funding Schemes
Coding & Documentation(IT-Systems)
Data Repositories & Responsibility
No
Overall Interoperability
Overall Data Access & Integration
Joint Regulated Framework
Data not accessible for research
MII Infrastructure and Data Access | Semler | 26/10/2020
Fragmented landscape of data ownership in Germany
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Source: Schepers J, Semler SC et al., TMF Expertise for theGerman Federal Parliamenton Data Mining in Health Care, 2015
Fragmented legal framework for medical research
Different data protection laws on state level Different hospital laws on state level
(relevant for use of patient care data for medical research)
Page 5
Data procession by order
Source: TMF Legal Expertise on secondary use of patient care data, U.Schneider 2015
Intramural research Consent obligation
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Medical Informatics Initiative
Funded by the Federal Ministry for Education and Research (BMBF) over the next decade: 160 Millions € for the years2018-2021 (funds for 2022-2025 to be defined)
Coordination office: TMF, MFT, VUD – Berlin
Goals: Improve research opportunities and patient care through
innovative IT solutions (initial focus on university hospitals, but including further partners)
Intensify the exchange and sharing of data between the biomedical research community and the health care delivery system (data sharing across institutions and sites)
Position medical informatics as a progressive field in research, teaching and continuing education
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Project Phases
Page 7
Current project phase prolonged for 1 year ( 12/2022)MII Infrastructure and Data Access | Semler | 26/10/2020
Consortia and participantsin the current funding phase
4 consortia
+ coordination office
36 university hospital sites with 29 data integration centres
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Governance
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Page 10
Participation of AG Consent and AG Data Sharing
Participation of Data Sharing working group and Interoperability working group
Task force data protectionwith data protectionworking group (TMF)
Task force Use & Access
Consentworking group
Data Sharing working group
Interoperabilityworking group
Communication working group
Task forceAudit preparation
Task forceCommunication strategy
Task force education Task forcedocument governance
Participation of AG Data Sharing
Task forceProcess models
Governance structure of the MII
MII Infrastructure and Data Access | Semler | 26/10/2020
Task forcedata platform
Communication working group
Communication working group
Communication working group
finished task forces:• Task force demonstration study
MII workstreams and topics (page 1/2)
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WG Consent WG Data Sharing WG Interoperability
Clarifying legal and ethical questions
Formulate consent documents
Define data formats Specify data set Describe information
models and profiles
WS 1: Ballot and implement consent Consent
WS 2: Ballot data protection/privacy measures Approval by theauthorities
Key deliverables(results & products)
WS 3: Design and realize trust centers Trust Center
WG Communication political communication , publications, press releases, conferences
WS 4a/b: Update and implement core data set Data provision
WS 5: Define and implement interoperability services TerminologyMetadata
permission touse data from
the patient
WS 6a: Organize data use & access
WS 6b: Define and implement application management and registry
Process organisationLegal framework
Application officeregistry
Strategic Aim
provision of usable dataprovision of useful data
provision of requested data
efficient dataprovision
Formulate contract, usage regulations, application form
Define processes
Record Linkage
There is a responsible person in the coordination office for every working group, taskforce and Workstream
MII workstreams and topics (page 2/2)
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WG Consent WG Data Sharing WG Interoperability
Clarifying legal and ethical questions
Formulate consent documents
Define data formats Specify data set Describe information
models and profiles
WS 7a: Use case CORD
WS 7b: Use case POLAR
WS 8: Prepare Audit
WG Communication political communication , publications, press releases, conferences
WS 9: Design and implement patient communication
WS 10: Stakeholder management
Testingoverarching
infrastructure
WS 11 Strengthening teaching and education
Strategic Aim
Information, acceptanceStakeholder
supportPromotion of
junior staff
Formulate contract, usage regulations, application form
Define processes
Data on rare deseasis
Data on pharmaz. interactions
proof of goal achievement
patient participation
Communication
Adapted curricula
Key deliverables(results & products)
usable dataand processes
There is a responsible person in the coordination office for every working group, taskforce and Workstream
Central portal for data exchange and data use across consortia
Seite 13
ConsortiumA
ConsortiumD
DIZ1
DIZ8
DIZ2
DIZ3
DIZ4
DIZ5
DIZ6
DIZ7
DIZ3
ConsortiumB
DIZ6 DIZ
4DIZ5
DIZ1 DIZ
2
DIZ7
DIZ1
DIZ2
DIZ3
DIZ4
DIZ1
DIZ8
DIZ10
DIZ9
DIZ7 DIZ
6
DIZ3
DIZ5
DIZ2
DIZ4
ConsortiumC
Central Portal
Scientist
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Clinical Documentation
Data StructureData Elements
Metadata
Interoperability
Tasks of the Data Integration Centres
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Data Extraction
Data Integration
DataProvision
Core Data Set – 17 modules to organise
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Strong impulse on use of LOINC
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Ongoing Survey on Status of Implementation – Preliminary Results
mapping is already
completed50%
mapping will be completed until
end of 202040%
mapping will be completed
2021 or later10%
MAPPING TO MII LOINC SUBSET
0
1
2
3
4
5
6
7
8
L A B O R A T O R Y C L I N I C I A N S
L A B O R A T O R Y T E C H N I C I A N S
( B I O ) M E D I C A L I T S P E C I A L I S T S
O T H E R
QUALIFICATION OF PEOPLE WORKING ON LOINC MAPPING(multiple answers possible)
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A major achievement of the MII: SNOMED CT finally available in Germany
15 years forerun to the introduction of SNOMED CT in Germany …
National Release Center
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TMF supporting SNOMED CT introduction and use
License management and support
Communication with SNOMED Intl. and contact person for users
Organisation of training measures („ teach the teacher“)
discounted price conditions for online courses
Expert communication on SNOMED CT use in Germany
Delegates = experts from the WG IOP MII
German Translation Group: German cooperation with representatives from DACHL
Patient involvement
08/2019: Kick-off workshop “Patient participation” under the patronage of the Federal Commissioner for Patients Prof. Schmidtke
09/2020-12/2020: Online dialogue event series with patient organisations, patient advocates and patient support groups Topics:
participation; acceptance of broad consent; requirements for framework conditions, transparency and communication of medical research projects; expectations of patient organisations regarding the implementation of the broad consent; user test of transparency portal website; data donation (future directions of patient autonomy)
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Representative Online Survey on Attitudes towards„Data Donation“ for Medical Research in Germany
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Conducted by forsa Politik- und Sozialforschung GmbH on behalf of TMF e.V.
Representative online survey panel, 1.006 respondents aged 18 and over in Germany
Survey period 13 - 18 August 2019, error tolerance +/- 3 percentage points
Forthcoming publication:European Journal of Human
Genetics: "Secondary researchuse of personal medical data:
Attitudes from patient and population surveys in The
MII has prepared 9 covid-19 research proposals since April – some are going to be implemented within the National COVID-19 research network (NUM1)
1. Overview of data collection and analysis at MII university hospital sites
2. Short-term data collection with I2B2
3. Further development and completion of the core data set
4. Deep documentation of COVID cases and integration with national and international register activities
5. Overarching use case COVID-19 infection control
6. Modelling of epidemic dynamics in the population including prediction of clinical resource needs
7. Pharmacoepidemiological studies on Covid-19
8. NLP-based text mining for COVID items from PUBMED and Archive Servers
9. Provision of an FHIR-based data repository and an associated FHIR-based query and analysis platform, including information on available biomaterial on COVID-19 cases
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1) Netzwerk Universitätsmedizin – network university medicine2) German Corona Consensus - Covid-19 Research-Dataset3) Nationales Pandemie Kohorten Netz4) FoDaPl = National Research Data Platform COVID-19 – to be built
by MII (all partners/= consortia + coordination office) until 03/2021
GECCO2)
Cooperation with
NUM (NAPKON3))
NUM(FoDaPl covid-19)
Proposals
PREDIC-AIDpotential usecase project in preparation
MII has prepared 9 covid-19 research proposals since April – some are going to be implemented within the National COVID-19 research network (NUM1)
1. Overview of data collection and analysis at MII university clinics sites
2. Short-term data collection with I2B2
3. Further development and completion of the core data set
4. Deep documentation of COVID cases and integration with national and international register activities
5. Overarching use case COVID-19 infection control
6. Modelling of epidemic dynamics in the population including prediction of clinical resource needs
7. Pharmacoepidemiological studies on Covid-19
8. NLP-based text mining for COVID items from PUBMED and Archive Servers
9. Provision of an FHIR-based data repository and an associated FHIR-based query and analysis platform, including information on available biomaterial on COVID-19 cases
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1) Netzwerk Universitätsmedizin – network university medicine2) German Corona Consensus - Covid-19 Research-Dataset3) Nationales Pandemie Kohorten Netz
GECCO2)
Cooperation with
NUM (NAPKON3))
NUM(FoDaPl covid-19)
Proposals
PREDIC-AIDpotential usecase project in preparation
MII builds up a data platform for NUM and covers already 70 % of the data required
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perspectively
NUM FoDaPlcovid-19
(MII)
70%
30%
Basic Modules
Advanced Modules GECCO data items
projects
Core Data Set at university hospital sites
(perspectively regular hospitals)
Overview: Medical Informatics Initiative Germany is driving the e-health landscape
BMBF funding programme with a volume of more than 160 million euros Nationwide establishment of a federated data infrastructure with local
data integration centres, but a one-stop shop for researchers Definition of a Germany-wide core data set consisting of 7 basic and 14
extension modules as an interoperability leap. Interconnected with COVID-19 research data set (GECCO)
Introduction of SNOMED CT to Germany and licensing for the contents of the electronic patient file brings international connectivity
GDPR-based broad consent accepted for the first time by all data protection agencies: important, among other things, to be able to adopt flexibly to changing knowledge about emerging diseases (see Covid-19)
proof of concept use cases: e.g. Collaboration on Rare Diseases (CORD-MI) or Polypharmacy (POLAR-MI). Use Case Infection Control COVID-19 in preparation (incl. modelling / AI)
MII starts on a national COVID-19 data NFN platform (25 Mio €)
Page 25MII Infrastructure and Data Access | Semler | 26/10/2020
Outlook: medical research within the ongoing digitization in the German healthcare sector ...
Seite 26MII Infrastructure and Data Access | Semler | 26/10/2020
Shaping the secondary data use landscape
New Legislation: Early arrival of structured, research-compatible national EHR (rel. 3.0) as of 1.1.2023
Specifications to be developed by Gematik in agreement with MII/TMF experts
(MII) broad consent anchored in § 363 para. 8 SGB V Opening clause for consent based research projects
(MII blueprint)
MIOs as structured content of EHR 2.x ff based on MII core data set ( cooperation MII & KBV)
Seite 27MII Infrastructure and Data Access | Semler | 26/10/2020
Seite 28
EHR 3.0 – ready for research applications
Cross-sector coverage
Uniform governance,
modularConsent
& Privacy Policy
Modular,structured &semantically
annotated data,Metadata & Interfaces
ComprehensiveID Management & Authentication
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MII proposal for Future EHR 3.0 -Research Data export and reporting
Seite 29
Extract
Prozess
Maps
Routes
Transform Load
DATAWAREHOUSE
Health care
Research
Network hospital / university hospital
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Challenges and perspectives
Bringing different stakeholders and initiatives together Patient care & medical research governance (national & EU level) Different funding bodies (national & EU level) Different strategy EU projects in research and strategy level (e.g. EHN)
Interoperability across EU (targeted e.g. in X-e-Health, EHDS Joint Action)
Establishing harmonized & reliable legal framework across Europe forsecondary use of health care data for medical research
Fostering patient participation in date use for research
Winning public acceptance !!! Special issue: rules & organization of data access to medical research industry
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