data sharing for a learning health system across a german …€¦ · •bioinformatics / medical...

#IoT4health

Data Sharing for a learning health system across a

German University Hospital Network Prof. Dr. Hans-Ulrich Prokosch

Prof. of Medical Informatics, FAU Erlangen-Nürnberg

CIO, Erlangen University Hospital

Miracum Coordinator

#IoT4health

Motivation

NEW RETINA MD. FALL 2013, 9-12. http://vestrumhealth.com/files/news/articles/New_Retina_MD.pdf

#IoT4health

Motivation

NEW RETINA MD. FALL 2013, 9-12. http://vestrumhealth.com/files/news/articles/New_Retina_MD.pdf

#IoT4health

We need

• coordinated

• secure

• data protected

• governed

access to data

based on a trustworthy framework of technologies and policies

Motivation

#IoT4health

• Findability

• Accessibility

• Interoperability

• Reusability

Motivation

#IoT4health

The German Medical Informatics Funding Scheme

15. November 2015

Conceptual Phase: 8/2016 – 4/2017

7 funded consortia

Define a trustworthy concept for

• coordinated

• secure

• data protected

• governed

access to data

based on a framework of technologies and policies

#IoT4health

The German Medical Informatics Funding Scheme

15. November 2015

Conceptual Phase: 8/2016 – 4/2017

7 funded consortia

10. Juli 2017 Development and Networking Phase

1/2018 – 12/2021

4 consortia: ~ 120 Mio. Euro

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The German Medical Informatics Funding Scheme http://www.medizininformatik-initiative.de/

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The German Medical Informatics Funding Scheme • Networking Data – Improving Healthcare

• Combining disciplines – for individualized medicine

• Using the wealth of data – for improved patient care

• establish technical and non-technical conditions for multi-site synergetic use of data from research and health care at university hospitals

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The German Medical Informatics Funding Scheme

• As a key element data integration centres (DIC) are to be set up and interlinked by the university hospitals and their partners

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The German Medical Informatics Funding Scheme

• As a second key element the development of IT solutions for specific applications (use cases) which will be aided by the multi-site exchange of research and patient care data

#IoT4health

The German Medical Informatics Funding Scheme

today

2018 - 2021

#IoT4health

The German Medical Informatics Funding Scheme • 1 Federal Government

• 16 States • 16 financial resonsibilities

• 16 infrastructure budgets

• 16 different laws on state level

• 16 State Data Protection Acts (vs. Federal DP Law, vs. EU DP Directive)

• > 90% of German University Hospitals

• > 10% of all German Inpatient Cases

Conceptual Phase

adapted from “Medical Informatics Initiative | Central Office| July 5th 2017”

#IoT4health

The German Medical Informatics Funding Scheme

adapted from “Medical Informatics Initiative | Central Office| July 5th 2017”

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The German Medical Informatics Funding Scheme

• WG Interoperability

• WG Data Sharing

• WG Consent

adapted from “Medical Informatics Initiative | Central Office| July 5th 2017”

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The German Medical Informatics Funding Scheme

• WG Interoperability

• Joint Interoperability Key Issues Paper

• Core Data Set

adapted from “Medical Informatics Initiative | Central Office| July 5th 2017”

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The German Medical Informatics Funding Scheme

• WG Data Sharing

• Analysis of Chances/Obstacles for Data Sharing

• Uniform Use and Access Policy Key Issues Paper

• Draft Audit Concept for the DIC

adapted from “Medical Informatics Initiative | Central Office| July 5th 2017”

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The German Medical Informatics Funding Scheme

• WG Consent

• Patient Consent Form Template

• Cooperation with

• German WG of Ethics Committees

• WG of State Data Protection Officers

adapted from “Medical Informatics Initiative | Central Office| July 5th 2017”

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The German Medical Informatics Funding Scheme

• monthly meetings

• Dialogue Forum with healthcare organisations & industry

• yearly general assembly meeting

https://www.uniklinika.de/media/file/13041.17-04-21_Mission_Paper_Vernetzungs-Inititative_Deutsche_Hochschulmedizin.pdf

Mission Paper

Roadmap 2018 - 2021

adapted from “Medical Informatics Initiative | Central Office| July 5th 2017”

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The German Medical Informatics Funding Scheme

today

Supplementary Funding Module 1 young researcher groups

Supplementary Funding Module 2 adding university hospitals to the

funded consortia

2018 - 2021

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The German Medical Informatics Funding Scheme

Medical Informatics in Research and Care in

University Medicine

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MIRACUM . . .

is the largest consortium

• eight University Hospitals and Medical Faculties

• two Universities of Applied Science

• one industrial partner

• across five German States

• associated with four German Health Research Networks (Lung, Cardiovascular and Infectious Diseases, Oncology)

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MIRACUM . . .

is the largest consortium

• eight University Hospitals and Medical Faculties

• comprising ¼ of all German University Hospitals

• handling clinical and research data of more than 10 Mio patients

#IoT4health

MIRACUM . . .

is the largest consortium

• eight University Hospitals and Medical Faculties

• comprising ¼ of all German University Hospitals

• handling clinical and research data of more than 10 Mio patients

• covering a large inpatient catchment area

Map was generated based on in-patient data loaded into the eight MIRACUM DIC

#IoT4health

MIRACUM . . .

brings disciplines together

Bioinformatics

Biostatistics

Translational Research

Clinical Medicine

Medical Informatics

#IoT4health

MIRACUM architecture is based on . . .

Medical Informatics ReusAble eCo-system

of Open source

Linkable and Interoperable software tools – X

MIRACOLIX

#IoT4health

MIRACUM architecture is based on . . .

Medical Informatics ReusAble eCo-system

of Open source Linkable and Interoperable software tools – X

MIRACOLIX

Unfortunately its not

MIRACULIX

it´s not magic

and we are not finished yet

#IoT4health

Translational Research Toolkit

developed at Harvard Medical School

From whom we can learn . . .

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From whom we can learn . . .

11

18

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From whom we can learn . . .

The OHDSI – OMOP Common Data Model

#IoT4health

From whom we can learn . . .

#IoT4health

MIRACUM architecture is based on . . .

Medical Informatics ReusAble eCo-system

of Open source Linkable and Interoperable software tools – X

and applies amongst many others

MIRACOLIX

#IoT4health

MIRACOLIX is . . .

• pragmatic

• modular

• reusable

• open source

• interoperable

• federated

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MIRACUM DIC data flow

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MIRACUM DIC data flow and governance

UAP

DIC Governance Structures

UAC

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MIRACUM Federation

Federated data integration centers based on MIRACOLIX 0.9

Bring the analysis to the data

R-Script SQL-

Statement

Erlangen

Magdeburg

Frankfurt Gießen Freiburg

Mainz Marburg Mannheim

#IoT4health

MIRACUM Federation

Federated data integration centers based on MIRACOLIX 0.9

Bring the analysis to the data

Erlangen

Magdeburg

Frankfurt Gießen Freiburg

Mainz Marburg Mannheim

aggregated results

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

Two clinical research questions:

• Stroke / Thrombectomy Analysis of Guideline Adherence

• Colorectal Cancer Analysis of Treatment Patterns

#IoT4health

MIRACUM Federation

Federated data integration centers based on MIRACOLIX 0.9

Bring the analysis to the data

Erlangen

Magdeburg

Frankfurt Gießen Freiburg

Mainz Marburg Mannheim

aggregated results

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

Two clinical research questions:

• Stroke / Thrombectomy Analysis of Guideline Adherence

• Colorectal Cancer Analysis of Treatment Patterns

submitted to:

#IoT4health

MIRACUM Federation

Federated data integration centers based on MIRACOLIX 0.9

Bring the analysis to the data

Erlangen

Magdeburg

Frankfurt Gießen Freiburg

Mainz Marburg Mannheim

aggregated results

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

Two clinical research questions:

• Stroke / Thrombectomy Analysis of Guideline Adherence

• Colorectal Cancer Analysis of Treatment Patterns

#IoT4health

MIRACUM Cross Consortia Cooperation

Federated data integration centers based on MIRACOLIX 0.9

Bring the analysis to the data

Erlangen

Magdeburg

Frankfurt Gießen Freiburg

Mainz Marburg Mannheim

aggregated results

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

SQL / R

Charité

Vivantes

Ulm

#IoT4health

• IT Support for Patient Recruitment

• Medical Informatics / Clinical Trials

Alerting in Care

• Clinico-molecular Predictive Knowledge Tool

• Biostatistics / Prediction Models / Med. Inf.

From Data to

Knowledge

• Support for Molecular Tumor Boards

• Bioinformatics / Medical Informatics / Precision Medicine

From Knowledge to Action

Use Cases

#IoT4health

• Support for Molecular Tumor Boards • Bioinformatics / Medical Informatics / Precision Medicine

From Knowledge to Action

• Integrating clinical decision support systems for pharmacogenomic testing into clinical routine

Systematic Literature Review

• Review amongst clinicians abut their knowledge about, experience with and attitutudes towards molecular-guided clinical decision making tools

• Analysis of local processes and IT applied to support moleculare tumor boards

Local Status Analysis (eight university hospitals)

Example: Use Case 3

#IoT4health

• Hinderer M, Boeker M, Wagner SA, Lablans M, Newe S, Hülsemann JL, Neumaier M, Binder H, Renz H, Acker T, Prokosch HU, Sedlmayr M. Integrating clinical decision support systems for pharmacogenomic testing into clinical routine - a scoping review of designs of user-system interactions in recent system development. BMC Med Inform Decis Mak. 2017 Jun 6;17(1):81.

From Knowledge to Action

• Hinderer M, Boeker M, Wagner SA, Binder H, Ückert F, Newe S, Hülsemann JL, Neumaier M, Schade-Brittinger C, Acker T, Prokosch HU, Sedlmayr B. The experience of physicians in pharmacogenomic clinical decision support within eight German University Hospitals. Pharmacogenomics. 2017; Jun 8. (Epub ahead of print). doi: 10.2217/pgs-2017-0027.

Systematic Literature Review

• Hinderer M, Boerries M, Haller F, Wagner S, Sollfrank S, Acker T, Prokosch HU, Christoph J. Supporting Molecular Tumor Boards in Molecular-guided Decision Making - the Current Status of Five German University Hospitals. Stud Health Technol Inform. 2017;236:48-54.

Local Status Analysis (eight university hospitals)

Example: Use Case 3

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MIRACUM Team Erlangen and MIRACUM Steering Board

Förderkennzeichen: 01ZZ1801A

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MIRACUM International Scientific Advisory Board

George Hripcsak

Richard Frackowiak

Kai Uwe Heitmann

Stefan Schulz

Charles Sawyers

Lisa McShane

Zak Kohane

Thank you very much for your attention

Förderkennzeichen: 01ZZ1801A