{"id":4066,"date":"2017-01-20T15:16:34","date_gmt":"2017-01-20T15:16:34","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Ploug-WMA-The-Danish-Debate-on-Health-Data-2015.pdf"},"modified":"2017-01-20T15:16:34","modified_gmt":"2017-01-20T15:16:34","slug":"ploug-wma-the-danish-debate-on-health-data-2015-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/ploug-wma-the-danish-debate-on-health-data-2015-2\/","title":{"rendered":"Ploug-WMA—The-Danish-Debate-on-Health-Data—2015"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Ploug-WMA---The-Danish-Debate-on-Health-Data---2015<\/a><\/p>\n

Thomas Ploug<\/p>\n

5 oktober 2015<\/p>\n

The Danish Debate on Research using Health
\nData and Biological Material<\/p>\n

Key values, challenges and ways forward as seen by the
\nDanish Council of Ethics<\/p>\n

1<\/p>\n

Thomas Ploug<\/p>\n

5 oktober 2015<\/p>\n

Danish Research Infrastructure <\/p>\n

Databases:<\/p>\n

\u2022\u202f Medical records <\/p>\n

\u2022\u202f The National Health Databases <\/p>\n

\u2022\u202f Research databases <\/p>\n

\u2022\u202f Secondary data from previous and ongoing studies <\/p>\n

\u2022\u202f Databases with data from clinical trials <\/p>\n

Biobanks:<\/p>\n

\u2022\u202f PKU Biobank <\/p>\n

\u2022\u202f The Patobank (pathology data bank) <\/p>\n

\u2022\u202f Capital Region Biobank <\/p>\n

\u2022\u202f SSI\u2019s diagnostic samples <\/p>\n

\u2022\u202f Danish Cancer Biobank <\/p>\n

Note:<\/p>\n

\u2022\u202f All Danes have a SSN allowing for linkage across databases and biobanks <\/p>\n

2<\/p>\n

Thomas Ploug<\/p>\n

5 oktober 2015<\/p>\n

Legal regulation <\/p>\n

Legal de\ufb01nitions and requirements:<\/p>\n

\u2022\u202f Anonymous data, i.e. a person cannot be identi\ufb01ed, is not protected by law. <\/p>\n

\u2022\u202f Non-sensitive personal information such as name, age, gender, SSN etc. can be used for
\nscienti\ufb01c research if necessary and if the use is in the interest of society. <\/p>\n

\u2022\u202f Sensitive personal information such as health information can be used for scienti\ufb01c
\nresearch if consent is provided or if the data is necessary and of signi\ufb01cant value to society.<\/p>\n

\u2022\u202f A biobank is considered a manual database with personal and sensitive information.<\/p>\n

Protective \u2018bodies\u2019:<\/p>\n

\u2022\u202f Handling of personal and sensitive information in relation to research \u2013 public or private \u2013
\nmust be approved by the Danish Data Protection Agency. <\/p>\n

\u2022\u202f Acces to medical records must be approved the National Board of Health (Ministry).<\/p>\n

\u2022\u202f Research on biological material must be approved by a Research Ethics Committee. <\/p>\n

3<\/p>\n

Thomas Ploug<\/p>\n

5 oktober 2015<\/p>\n

Utility and Solidarity <\/p>\n

Protects\/speaks for:<\/p>\n

\u2022\u202f Extensive collection of data with the purpose of improving therapy.<\/p>\n

\u2022\u202f Citizens making their health data available for research purposes.<\/p>\n

Challenges:<\/p>\n

\u2022\u202f In general there are limits to the violations of principles of privacy and autonomy we will
\naccept in order to postpone death and generate better health\/quality of life.<\/p>\n

\u2022\u202f Individual or organizational failure to embody solidarity in the exchange of health data. <\/p>\n

\u2022\u202f Commercialization of data generated in a public (private?) health care system. <\/p>\n

Recommendations:<\/p>\n

\u2022\u202f Promoting a research culture with deeply rooted respect for privacy and autonomy.<\/p>\n

\u2022\u202f Require open sharing of data and results of research on data between citizens,
\nresearchers, institutions and companies.<\/p>\n

\u2022\u202f Avoid commercialization of data (not commercial exploitation of data).<\/p>\n

4<\/p>\n

Thomas Ploug<\/p>\n

5 oktober 2015<\/p>\n

Privacy and Con\ufb01dentiality <\/p>\n

Protects:<\/p>\n

\u2022\u202f Against negative emotional reactions (fear), stigmatization and discrimination. <\/p>\n

\u2022\u202f Against social pressure from groups\/State to conform to others\u2019 norms of healthy living.<\/p>\n

\u2022\u202f Con\ufb01dentiality promotes trust in health care professionals.<\/p>\n

Challenges:<\/p>\n

\u2022\u202f More data is collected, stored and exchanged between systems. Very little is destroyed.<\/p>\n

\u2022\u202f More health professionals get access to data, and the data is used for more purposes. <\/p>\n

\u2022\u202f Anonymisation is increasingly dif\ufb01cult and IT-security turns out to be \ufb02awed.<\/p>\n

Recommendations:<\/p>\n

\u2022\u202f Right to correct\/withdraw data. Anonymisation > Pseudonomisation. Encryption of data.<\/p>\n

\u2022\u202f Restricting number of people with access. Data only used for purpose. Proportionality.<\/p>\n

\u2022\u202f Continous monitoring of data protection by authorities. Harder sanctions?<\/p>\n

5<\/p>\n

Thomas Ploug<\/p>\n

5 oktober 2015<\/p>\n

Trust<\/p>\n

Protects:<\/p>\n

\u2022\u202f Trust is a quality of human relations that we value in itself.<\/p>\n

\u2022\u202f Trust is a precondition of sharing information, and therefore in turn for adequate therapy. <\/p>\n

Challenges:<\/p>\n

\u2022\u202f Disappointment of expectations concerning quality of therapy and patient protection:<\/p>\n

-\u202f Scandals of all sorts in the health care system, and in particular scandals involving loss or illegal
\ncollection of sensitive health data.<\/p>\n

\u2022\u202f Lack of transparency concerning use of personal and sensitive health information.<\/p>\n

Recommendations:<\/p>\n

\u2022\u202f Transparency concerning \u2026:<\/p>\n

-\u202f Who has access to data (which groups of health care professionals?)<\/p>\n

-\u202f For what purposes (therapy, research, quality-assurance?)<\/p>\n

-\u202f Under what conditions (anonymised, time-span, level of security?)<\/p>\n

-\u202f Unauthorised access, loss or misuse of data (who, for what, when?)<\/p>\n

6<\/p>\n

Thomas Ploug<\/p>\n

5 oktober 2015<\/p>\n

Autonomy and Informed Consent<\/p>\n

Protects:<\/p>\n

\u2022\u202f An individual against suffering physical harm.<\/p>\n

\u2022\u202f An individual\u2019s ability to form and pursue his or her own goals and plans. <\/p>\n

\u2022\u202f An individual\u2019s ability to de\ufb01ne a sphere of privacy.<\/p>\n

Challenges:<\/p>\n

\u2022\u202f Routinisation of consent.<\/p>\n

\u2022\u202f Practical problems associated with obtaining informed consent.<\/p>\n

\u2022\u202f Consent bias.<\/p>\n

Recommendations:<\/p>\n

\u2022\u202f Development and use of IT-platforms for obtaining consent.<\/p>\n

\u2022\u202f New models of consent: Speci\ufb01c, broad, open, presumed and meta consent.<\/p>\n

7<\/p>\n

Thomas Ploug<\/p>\n

5 oktober 2015<\/p>\n

Thank you!<\/p>\n

8<\/p>\n

Thomas Ploug<\/p>\n

5 oktober 2015
\n 9<\/p>\n

Meta consent <\/p>\n"},"caption":{"rendered":"

Ploug-WMA—The-Danish-Debate-on-Health-Data—2015 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 1 Thomas Ploug 5 oktober 2015 Danish Research Infrastructure Databases: \u2022\u202f Medical records \u2022\u202f The National Health Databases \u2022\u202f Research databases \u2022\u202f Secondary data […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Ploug-WMA-The-Danish-Debate-on-Health-Data-2015.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/4066"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=4066"}]}}