germany: mii infrastructure and data access

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


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)

Data procession by order

Source: TMF Legal Expertise on secondary use of patient care data, U.Schneider 2015

Intramural research Consent obligation


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

Page 7MII Infrastructure and Data Access | Semler | 26/10/2020 Seite 6

Project Phases

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


Governance


Participation of AG Consent and AG Data Sharing

Participation of Data Sharing working group and Interoperability working group

National Steering CommitteeDIFUTURE . HiGHmed . MIRACUM . SMITH, Coordination Office

Task forceCore data set

Task forceDIC concepts

Task forceMeta data

Task forceConsent implementation

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


Task forcedata platform




finished task forces:• Task force demonstration study

MII workstreams and topics (page 1/2)


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)


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


Clinical Documentation

Data StructureData Elements

Metadata

Interoperability

Tasks of the Data Integration Centres

Page 10MII Infrastructure and Data Access | Semler | 26/10/2020 Seite 14

Data Extraction

Data Integration

DataProvision

Core Data Set – 17 modules to organise


Strong impulse on use of LOINC


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)


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


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)


Representative Online Survey on Attitudes towards„Data Donation“ for Medical Research in Germany


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

Netherlands and Germany“https://rdcu.be/b7W97

https://rdcu.be/b7W97


Patient communications

Explanatory video Leaflet Microsite www.vernetzen-forschen-heilen.de (launch expected 12/2020)

http://www.vernetzen-forschen-heilen.de/

https://youtu.be/QL8TaahVZ4A

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


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

https://www.medizininformatik-initiative.de/de/covid-19-forschungsuebersicht


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


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


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 €)


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


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


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


Thank youMore information:www.medizininformatik-initiative.de/en

[email protected]

Medical Informatics Initiative Coordination Officec/o TMF e.V.Charlottenstraße 42/Dorotheenstraße10117 Berlin, Germany

+49 (30) 22 00 24 [email protected]

@TMF_eV


http://www.medizininformatik-initiative.de/en

mailto:[email protected]

mailto:[email protected]


www.medizininformatik-initiative.de

germany: mii infrastructure and data access

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