Study on Big Data in Public Health, Telemedicine and Healthcare

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eHealth Network Meeting

Brussels, November 21st

Claudia Habl

Outline of the presentation

I. Overview of the “Study on Big Data in Health, Telemedicine and Public Health”

II. Final Policy recommendations for Big Data in health

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Context of the study – Definition(s) of Big Data

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“data of a very large size, typically to the extent that its manipulation and management present significant logistical challenges” (OECD)

“datasets whose size is beyond the ability of typical database software tools to capture, store, manage, and analyse” (McKinsey)

“describes any voluminous amount of structured, semi-structured and unstructured data that has the potential to be mined for information.” (TechTarget)

“characterized by such a High Volume, Velocity and Variety to require specific Technology and Analytical Methods for its transformation into Value.” (DeMauro et al., 2015)

“analysis of data that’s really messy or where you don’t know the right questions or queries to make analysis that can help you find patterns, anomalies, or new structures amidst otherwise chaotic or complex data points.” (Philip Ashlock, gov.uk)

Our working definition for Big Data in Public Health: • Large routinely or automatically collected datasets • Electronically captured and stored • Reusable and multipurpose data • Fusion and connection of existing databases • Purpose of improving health and health system

performance • Not: data collected for a specific study (clinical trial)

Background of the study

» Commissioned by DG SANTE/CHAFEA

» Project team: Sogeti (LU) and GÖ FP (AT)

» Time line: February 2016 – October 2016

» Objective:

» Identification of applicable examples of use of Big Data in health and development of recommendations for their implementation

» Methods as specified by commissioning bodies:

» Literature review

» SWOT analysis

» Expert consultation

» Public consultation

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Identification of policy recommendations

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Literature search Hand search

12 fields of policy actions

Expert workshop & electronic expert

consultation

9 revised policy recommendations

SWOT analysis

Experts in health policy Experts in health information Stakeholder representatives

Public consultation

10 revised policy recommendations

Final electronic expert feedback

Civil servants Technicians

Industry Health researchers

10 final policy recommendations

Experts in health policy Experts in health information Stakeholder representatives

Policy recommendations - Framework

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Policy recommendations – Scope

» Show Benefits for European citizens and patients – Public Health Perspective strengthening health and improve

performance of MS’s health systems

» General notions:

» Target Group: Decision makers in Member States (MS) and on EU-level

» Big Data is not a goal in itself, but a tool to reach a certain purpose

» Current ethical standards must not be weakened or compromised

» All relevant stakeholders (especially patients represented by their advocacy groups) need to be included in the implementation of the proposed recommendations and in production of future recommendations

» Only issues distinctively important for the use of Big Data in health should be covered

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Recommendation 1: on Awareness Raising I

» Raise awareness of practical use of Big Data in Health and its benefits to make it more tangible and understandable for public and concerned citizens

» Encourage a positive public mind-set by strengthening dialogue between stakeholders and provide fact-based information towards citizens

» Communication and discourse with and within: the society, patients, healthcare providers, technology vendors and other stakeholders

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Develop and implement a communication strategy to increase the awareness of the added value of Big Data in Health and encourage a positive public mind set towards Big Data in Health

Recommendation 1: on Awareness Raising II

» Develop a sound communication strategy

» Map and align all current national and EU-efforts on communication and awareness raising

» Generate scientific evidence of added value of Big Data in Health

» Anchor idea that Big Data in Health leverages, amplifies and generates valuable knowledge

» Take into account all relevant stakeholders

» Involve patient organisations is crucial to (re)establish trust and confidence in the application of Big Data in Health

» Identify target groups within main stakeholder groups and address them purposefully

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Develop and implement a communication strategy to increase the awareness of the added value of Big Data in Health and encourage a positive public mind set towards Big Data in Health

Recommendation 1: on Awareness Raising III

» National communication strategies

» Shall be developed bottom-up by each MS in order to reach citizens and patients in order to account for specific national circumstances

» Involve all relevant national stakeholders in the preparation of national communication strategies

» Support of EC through provision of best practice examples and toolkits and by mapping existing communication activities

Stimulate a continuous, open dialogue with all stakeholders

and patient groups, e.g. by an European platform for Experience exchange

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Develop and implement a communication strategy to increase the awareness of the added value of Big Data in Health and encourage a positive public mind set towards Big Data in Health

Recommendation 2: on Education and Training

» Increase digital health literacy of healthcare professionals and allied health professionals

» Integrate data handling in their curricula

» Increase training resources for

» Data and system management

» Advanced statistical analysis

» Information technologies

» Adapting and augmenting educational system

» to be realised national level

» EC can facilitate by enabling and funding of relevant initiatives

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Strengthen human capital with respect to the increasing need for a workforce that can utilize the potential of Big Data in Health

Recommendation 3: on Data Sources

» Adapt and expand existing Big Data sources

» Assess available data sources and their infrastructure

» Targeted exploration of new data sources, including outpatient and primary care sector and sectors other than health care

» Linkage of various health data sources within / between MS

» Setting standards for quality and reliability to safeguard data quality across EU

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Expand existing and explore new sources of Big Data in Health and secure their quality and safety

Recommendation 4: on Open Data and Data Sharing

» Support and promote secure open use and sharing of government data, non-proprietary private data, data of different health care providers for research in public interest

» Establish common framework including guidelines, operative processes and a secure platform for data sharing on EU level » Inclusion of all relevant elements of Big Data usage (access, data safety,

data quality, reliability and completeness, format, standards, etc. …

» Addresses: stakeholders’ interests, different cultures of data protection

» Data security, data stewardship and data ownership should be addressed

» Safe data sharing need to be ensured

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Promote open use and sharing of Big Data without compromising patients’ rights to privacy and confidentiality

Recommendation 5: on Applications and Purposes

» Identify the stakeholders that could benefit from Big Data in health and consider their needs

» Expand and open up new fields of application accord to varying stakeholders’ interests

» Areas of Big Data applications to be developed in accordance with stakeholders’ needs and expert advice at EU level, e.g. by a platform for open dialogue / experience exchange

» Particular emphasis on patient benefits subject to ethical considerations

» Implementation at MS level facilitated by reserving subsidies especially for Big Data application in health

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Target-oriented application of Big Data analysis in health based on the needs and interests of stakeholders including patients

Recommendation 6: on Data Analysis

» Constantly improve/adapt existing analytical methods and tools

» Facilitate their development and use while keeping in mind the practical use of Big Data

» Take into account ethical considerations for new methods and establish government structures to oversee research process

» Development of new analytical tools and methods: » By experts of (Big) Data analysis at MS level

» Potential demonstrated in pilot studies

» Facilitated by nationally appointed data officers (cf. Recommendation 7 on Governance) and the EC by increasing awareness about necessity of up-to-data analytical approaches and by financial resources for methodological research

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Identify the potentials of Big Data analysis, improve analytical methods and facilitate the use of new and innovative analytical methods

Recommendation 7: on Governance of Data Access and Use I

» Define roles and responsibilities for access and processing of Big Data in health and develop core definitions for Big Data governance (e.g. secondary use, data donor cards) in form of a glossary to encourage common language

» Appoint national health data officers in each MS

» oversee and coordinate national activities and collaborate with data protection authorities and ethics committees

» Established within existing national frameworks

» Establish platform for regular dialogue between national health data officers on European level

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Implement governance mechanisms to ensure secure and fair access and use of Big Data for research in health

Recommendation 7: on Governance of Data Access and Use II

» Guarantee fair and transparent governance mechanisms » independent reviewers should approve processing and linkage of data

sources and access and secondary use

» Facilitated by appointed national health data officers should coordinate governance process and foster cooperation between different database owners

» Establish platform for securely linking and accessing data from different sources on national level

» EU level support by » giving guidance on the process of data access approval and technical

implementation of data platforms

» Facilitate continues exchange of experiences and knowledge between national health data officers, inform MSs about potential security risks

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Implement governance mechanisms to ensure secure and fair access and use of Big Data for research in health

Recommendation 8: on Standards

» Adopt or - where non-existent - develop standards with global scope addressing issue of interoperability

» Introduction of standards can improve interoperability of » different data formats, data sets and data warehouses (cf. ELIXIR and

eTRIKS)

» Patient consent forms - standardise and harmonise core content and structure of patient consent forms

» Development of standards should build on existing work (IHE.net initiative, EXPAND network).

» Existing standards need to be aligned before being adopted by MS national legislation

» Involvement of experts and stakeholders in the formulation of EU level standards and regular updates of outdated standards

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Develop standards for Big Data in Health to enhance and simplify its application and improve interoperability

Recommendation 9: on Funding and Financial Resources

» Spread initial financial burden and the risk of the investment by multi-source financing » public-private or public-public partnerships

» Investment on EU level: Big Data system development, Shared data handling infrastructure, Communication strategy (cf. recommendation 1).

» Investment on national level: Enhanced infrastructure for processing health data, Continuous partnerships between various stakeholders

» EU support by

» informing about existing national initiatives and by issuing guidelines or best practice examples

» Establishment of a coordinating body to steer and monitor these activities

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Ensure purposeful investment steered by the European Commission to warrant cost-effectiveness and sustainability

Recommendation 10: on Legal Aspects and Privacy Regulations

» Align the existing legal frameworks and internal policies » Data-ownership - Secondary use of health data

» Confidentiality of data - Storage and processing of data

» Patient consent - Re-use and cross-border flow of data

» EC Services should provide support for coherent practical application of new EU level Regulations and Directives on privacy and data protection to ensure legal interoperability across MSs

» General Data Protection Regulation (Regulation 2016/679)

» Directive on Security of Network and Information Systems (NIS Directive)

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Clarify and align existing legal and privacy regulation of Big Data in Health

Contact

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Claudia Habl (claudia.habl@goeg.at)

Julia Bobek (julia.bobek@goeg.at)

Stubenring 6

1010 Vienna

T: +43 1 515 61- 161 / 311

F: +43 1 513 84 72

www.goeg.at