Ploug-WMA—The-Danish-Debate-on-Health-Data—2015
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Thomas Ploug
5 oktober 2015
The Danish Debate on Research using Health
Data and Biological Material
Key values, challenges and ways forward as seen by the
Danish Council of Ethics
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Thomas Ploug
5 oktober 2015
Danish Research Infrastructure
Databases:
• Medical records
• The National Health Databases
• Research databases
• Secondary data from previous and ongoing studies
• Databases with data from clinical trials
Biobanks:
• PKU Biobank
• The Patobank (pathology data bank)
• Capital Region Biobank
• SSI’s diagnostic samples
• Danish Cancer Biobank
Note:
• All Danes have a SSN allowing for linkage across databases and biobanks
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Thomas Ploug
5 oktober 2015
Legal regulation
Legal definitions and requirements:
• Anonymous data, i.e. a person cannot be identified, is not protected by law.
• Non-sensitive personal information such as name, age, gender, SSN etc. can be used for
scientific research if necessary and if the use is in the interest of society.
• Sensitive personal information such as health information can be used for scientific
research if consent is provided or if the data is necessary and of significant value to society.
• A biobank is considered a manual database with personal and sensitive information.
Protective ‘bodies’:
• Handling of personal and sensitive information in relation to research – public or private –
must be approved by the Danish Data Protection Agency.
• Acces to medical records must be approved the National Board of Health (Ministry).
• Research on biological material must be approved by a Research Ethics Committee.
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Thomas Ploug
5 oktober 2015
Utility and Solidarity
Protects/speaks for:
• Extensive collection of data with the purpose of improving therapy.
• Citizens making their health data available for research purposes.
Challenges:
• In general there are limits to the violations of principles of privacy and autonomy we will
accept in order to postpone death and generate better health/quality of life.
• Individual or organizational failure to embody solidarity in the exchange of health data.
• Commercialization of data generated in a public (private?) health care system.
Recommendations:
• Promoting a research culture with deeply rooted respect for privacy and autonomy.
• Require open sharing of data and results of research on data between citizens,
researchers, institutions and companies.
• Avoid commercialization of data (not commercial exploitation of data).
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Thomas Ploug
5 oktober 2015
Privacy and Confidentiality
Protects:
• Against negative emotional reactions (fear), stigmatization and discrimination.
• Against social pressure from groups/State to conform to others’ norms of healthy living.
• Confidentiality promotes trust in health care professionals.
Challenges:
• More data is collected, stored and exchanged between systems. Very little is destroyed.
• More health professionals get access to data, and the data is used for more purposes.
• Anonymisation is increasingly difficult and IT-security turns out to be flawed.
Recommendations:
• Right to correct/withdraw data. Anonymisation > Pseudonomisation. Encryption of data.
• Restricting number of people with access. Data only used for purpose. Proportionality.
• Continous monitoring of data protection by authorities. Harder sanctions?
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Thomas Ploug
5 oktober 2015
Trust
Protects:
• Trust is a quality of human relations that we value in itself.
• Trust is a precondition of sharing information, and therefore in turn for adequate therapy.
Challenges:
• Disappointment of expectations concerning quality of therapy and patient protection:
- Scandals of all sorts in the health care system, and in particular scandals involving loss or illegal
collection of sensitive health data.
• Lack of transparency concerning use of personal and sensitive health information.
Recommendations:
• Transparency concerning …:
- Who has access to data (which groups of health care professionals?)
- For what purposes (therapy, research, quality-assurance?)
- Under what conditions (anonymised, time-span, level of security?)
- Unauthorised access, loss or misuse of data (who, for what, when?)
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Thomas Ploug
5 oktober 2015
Autonomy and Informed Consent
Protects:
• An individual against suffering physical harm.
• An individual’s ability to form and pursue his or her own goals and plans.
• An individual’s ability to define a sphere of privacy.
Challenges:
• Routinisation of consent.
• Practical problems associated with obtaining informed consent.
• Consent bias.
Recommendations:
• Development and use of IT-platforms for obtaining consent.
• New models of consent: Specific, broad, open, presumed and meta consent.
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Thomas Ploug
5 oktober 2015
Thank you!
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Thomas Ploug
5 oktober 2015
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Meta consent