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Big data analysis in health care and the General Data Protection Regulation [email protected] @FrRobben https://www.ehealth.fgov.be https://www.ksz.fgov.be https://www.frankrobben.be

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Page 1: ] P v o Ç ] ] v Z o Z v Z ' v o W } ] } v Z P µ o ] } v · , o z o ( } u w ] z ] µ %dvlf 6huylfhv h+hdowk sodwirup 1hwzrun 3dwlhqwv khdowk fduh surylghuv

Big data analysis in health careand the

General Data Protection Regulation

[email protected]

@FrRobben

https://www.ehealth.fgov.behttps://www.ksz.fgov.behttps://www.frankrobben.be

Page 2: ] P v o Ç ] ] v Z o Z v Z ' v o W } ] } v Z P µ o ] } v · , o z o ( } u w ] z ] µ %dvlf 6huylfhv h+hdowk sodwirup 1hwzrun 3dwlhqwv khdowk fduh surylghuv

Outline

• Big data analysis– some characteristics– components– value chain– some areas in health care

• EU General Data Protection Regulation (GDPR)– principles– methodology

• The main challenge– how to use the opportunities of big data analysis in health care– while effectively managing the risks

• Implementation in Belgium: possible support by– the eHealth platform– the HealtData.be platform

17/04/2018 22

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Some characteristics of big data analysis

• Data characteristics– high volume, variety, velocity, veracity– multiple data sources– data collection too large and/or too complex to be treated

by traditional software

• Characteristics of methods/techniques to analyse data– data driven, looking for patterns and correlations– rather than hypothesis driven, looking for causalities

17/04/2018 3

Page 4: ] P v o Ç ] ] v Z o Z v Z ' v o W } ] } v Z P µ o ] } v · , o z o ( } u w ] z ] µ %dvlf 6huylfhv h+hdowk sodwirup 1hwzrun 3dwlhqwv khdowk fduh surylghuv

Big data analysis components

17/04/2018 4

Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4341817/

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Big data analysis value chain

• Iterative, rather than sequential process• Use of data can be

– descriptive– predictive– prescriptive

• Need for appropriate measures to mitigate risks– in all phases– taking into account the type of use

17/04/2018 5

Data collection

Preparation& storage Analysis Use

Page 6: ] P v o Ç ] ] v Z o Z v Z ' v o W } ] } v Z P µ o ] } v · , o z o ( } u w ] z ] µ %dvlf 6huylfhv h+hdowk sodwirup 1hwzrun 3dwlhqwv khdowk fduh surylghuv

Big data analysis areas in health care

• Support of clinical operations– comparative effectiveness research to determine more

clinically relevant and cost-effective ways to diagnose and treat patients

• R&D– predictive modeling to and produce a leaner, faster, more

targeted R&D pipeline in drugs and devices– statistical tools to improve clinical trial design and patient

recruitment– analyzing clinical trials and patient records to identify

follow-on indications and discover adverse effects before products reach the market

17/04/2018 6

Source: McKinsey

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Big data analysis areas in health care

• Public health– analyzing disease patterns and tracking disease outbreaks

and transmission– faster development of more accurately targeted vaccines– turning large amounts of data into actionable information

that can be used to• identify needs• provide services• predict and prevent crises

17/04/2018 7

Source: McKinsey

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Big data analysis areas in health care

• Contribution to– evidence-based medicine– genomic analytics– pre-adjudication fraud analysis– device/remote monitoring– patient profile analytics to identify individuals who would

benefit from preventive care or lifestyle changes

17/04/2018 8

Source: McKinsey

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EU General Data Protection Regulation

• Main principles– purpose limitation– proportionality– accuracy and data quality– security– transparancy– accountability

17/04/2018 9

• Methodology– risk based approach– documentation duty– privacy by design– privacy by default– codes of conduct– certification– additional measures for

sensitive data

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Some risks and how to manage them

• Risk of singling out individuals without necessity– aggregation, anonymisation and pseudonymisation of data– small cells risk analysis– legal obligation to not to attempt to re-identify data

subjects

• Risk of data bias– careful selection of data used– reliable analysis methodologies (interative modelling)– ‘equal opportunity by design’– appropriate training– transparancy

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Some risks and how to manage them

• Risk of violation of purpose limitation principle– preliminary transparency about purposes of big data analysis– respecting GDPR, especially in case of big data analysis for

public health or scientific research purposes

• Risk of huge increase of data storage (quantity and duration)– limitation of personal data storage to the extent and during the

time useful for the foreseen legitimate purposes– aggregation, anonymisation or pseudonymisation of personal

data that are only stored for public health or scientific research purposes

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Page 12: ] P v o Ç ] ] v Z o Z v Z ' v o W } ] } v Z P µ o ] } v · , o z o ( } u w ] z ] µ %dvlf 6huylfhv h+hdowk sodwirup 1hwzrun 3dwlhqwv khdowk fduh surylghuv

Mission of the eHealth platform

• How?– through a well-organised, mutual electronic service and

information exchange between all actors in health care– by providing the necessary guarantees with regard to

information security, privacy protection and professional secrecy

• What?– optimisation of health care quality and continuity – optimisation of patient safety– reduction of administrative burden for all actors in health

care– thorough support of health care policy and research

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Page 13: ] P v o Ç ] ] v Z o Z v Z ' v o W } ] } v Z P µ o ] } v · , o z o ( } u w ] z ] µ %dvlf 6huylfhv h+hdowk sodwirup 1hwzrun 3dwlhqwv khdowk fduh surylghuv

10 Tasks of the eHealth platform

• Development of a vision and of a strategy for eHealth

• Organization of the cooperation between all governmental institutions which are charged with the coordination of the electronic service provision

• The motor of the necessary changes for the implementation of the vision and the strategy with regard to eHealth

• Determination of functional and technical norms, standards, specifications and basic architecture with regard to ICT

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Page 14: ] P v o Ç ] ] v Z o Z v Z ' v o W } ] } v Z P µ o ] } v · , o z o ( } u w ] z ] µ %dvlf 6huylfhv h+hdowk sodwirup 1hwzrun 3dwlhqwv khdowk fduh surylghuv

10 Tasks of the eHealth platform

• Registration of software for the management of electronic patient files

• Managing and coordinating the ICT aspects of data exchange within the framework of the electronic patient files and of the electronic medical prescriptions

• Conceptualization, design and management of a cooperation platform for secure electronic data exchange with the relevant basic service

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10 Tasks of the eHealth platform

• Reaching an agreement about division of tasks and about the quality standards and checking that the quality standards are being fulfilled

• Acting as an independent trusted third party (TTP) for the encoding and anonymisation of personal information regarding health for certain institutions summarized in the law for the support of scientific research and the policymaking

• Promoting and coordinating programmes and projects

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Possible support by eHealth platform

• Stakeholder involvement– Board of Directors– Users Committee

• Organisational and technical support– proposals for policies and codes of conduct – trusted third party for anonymisation and

pseudonymisation of data (separation of duties)– organisation of small cells risk analysis

• Independent Information Security Committee designated by Parliament– approval of policies and codes of conduct– authorisation for data exchange => preventive measures

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Page 17: ] P v o Ç ] ] v Z o Z v Z ' v o W } ] } v Z P µ o ] } v · , o z o ( } u w ] z ] µ %dvlf 6huylfhv h+hdowk sodwirup 1hwzrun 3dwlhqwv khdowk fduh surylghuv

Governance of the eHealth platform

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Users Committee Board of Directors

Administration

Information Security

Committee(Parliament)

advice

decisionsupervision

proposal fordecision

authorisation

eHealth platform

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eHealth platform: basic architecture

17/04/2018 18

Basic ServiceseHealth-platform

Network

Patients, health care providersand health care institutions

AS ASAS

Suppliers

Users

portal of the eHealth-platform

Health portal

VASHealth care institutionsoftware

VASMyCareNet

VAS

Health care providersoftware

Site RIZIV

VAS

ASASAS

VAS

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eHealth platform: 10 basic services

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Coordination of electronic sub-processes Portal Integrated user and

access management

Logging management System for end-to-end encryption eHealthBox

Timestamping Encoding and anonymization

Consultation of the National Identification Registers

Reference directory(metahub)

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What the eHealth platform does NOT

• Collecting personal health data

• Storing personal health data

• Storing anonymized or pseudonomized health data

• Analysing health data

• Carrying out studies

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Possible support by Healthdata.be platform

• Public service by Sciensano (formerly known as WIV-ISP)

• Objective: re-use of digitalized information from clinical workflow (real world), and ,preferably, from authentic sources or other validated databases (linked data) for research

• Approach– one technical architecture (free & open)– one information architecture (independent from technical

implementation)– one set of business processes

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The healthdata.be platform

• Ambition: no administrative burden, higher efficiency, should result in– more time for patient and thus higher quality of care– more time for research and thus higher quality of research– lower overall costs

• Guiding scientific principles of the Healthdata.be platform: the FAIR principles (cf Wilkinson et al. 2016): data and metadata should be– Findable– Accessible– Interoperable– Re-usable

2217/04/2018

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Healthdata.be architecture

• One generic technical architecture for collection and management of real world data is in production in all Belgian hospitals and most laboratories

17/04/2018 23

HEALTHSTATHD4RES DATAWAREHOUSE (SAS)

Secure Data

Transfer& Encoding

of ID’s

Data Validation

Annotation & Correction Request

Data Storage

BI-ReportingRegistration in Primary

System

HD4DP

Analysis Data

CollectionData

Monitoring

HealthData.be

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The healthdata.be platform

• Architecture of healthdata.be was thoroughly evaluated:– positive advice from Working Group Architecture of Users

Committee– authorisation from Information Security Committee– approval from eHealth platform

• 25 scientific projects are in production; more then 100 projects on to do list

• Healthdata.be– collects very diverse clinical data: vital signs, diagnoses,

procedures, but also complex “Next Generation Sequence data”, and will also collect Patient Reported Outcomes and Patient Reported Experiences

– collaborates with other data warehouses: e.g. Crossroads Bank for Social Security for research on social impact of diseases and therapies

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Page 25: ] P v o Ç ] ] v Z o Z v Z ' v o W } ] } v Z P µ o ] } v · , o z o ( } u w ] z ] µ %dvlf 6huylfhv h+hdowk sodwirup 1hwzrun 3dwlhqwv khdowk fduh surylghuv

Key determinant : multidimensional interoperability

17/04/2018 25

Being “technically” able to exchange data is not enough !

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Key determinant: trust

• All scientific projects are - before entering into production - subject to :– internal evaluation by responsible physician and Data

Protection Officer (DPO)– external evaluation by Steering Committee and

Information Security Committee

• Collected data becomes available for researchers only after small cell risk analysis by independent specialists, appointed by Information Security Committee

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Key determinant: trust

• Privacy by design: use of trusted third party (eHealthPlatform) for encryption, pseudonymisation, authentication, …

• Applications and datacenter are under supervision by key stakeholders (care providers, patients, governments, …) represented in Management Board eHealth platform

• Monitoring and auditing: use of software that monitors all activity on infrastructure

• Foreseen migration (2019) towards and thus benefit of security measures and services of VAS G-Cloud were other applications with highly sensitive data function

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Page 28: ] P v o Ç ] ] v Z o Z v Z ' v o W } ] } v Z P µ o ] } v · , o z o ( } u w ] z ] µ %dvlf 6huylfhv h+hdowk sodwirup 1hwzrun 3dwlhqwv khdowk fduh surylghuv

Governance of Healthdata.be platform

Users Committee eHealth Platform

Steering Committee

Administration

Information Security

Committee(Parliament)

advice

decisionsupervision

proposal fordecision

authorisation

Healthdata.be platform

Sciensano (WIV-ISP )

Management Board eHealth Platform

technologicalsupervision

Belgian Consultative Committee Bioethics

ad hoc advice

17/04/2018 28

Page 29: ] P v o Ç ] ] v Z o Z v Z ' v o W } ] } v Z P µ o ] } v · , o z o ( } u w ] z ] µ %dvlf 6huylfhv h+hdowk sodwirup 1hwzrun 3dwlhqwv khdowk fduh surylghuv

Thank you ! Any questions ?

[email protected]

@FrRobben

https://www.ehealth.fgov.behttp://www.frankrobben.be

17/04/2018 29


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