0A4F4F9BD490A749D5437F821CF06DF1
Health Research: CNIL Adopts New Simplification Measures (2018)
https://www.cnil.fr/fr/recherches-dans-le-domaine-de-la-sante-la-cnil-adopte-de-nouvelles-mesures-de-simplification
http://leaux.net/URLS/ConvertAPI Text Files/F65B0B6AE826F84103FA6F2EEC7E2061.en.txt
Examining the file media/Synopses/F65B0B6AE826F84103FA6F2EEC7E2061.html:
This file was generated: 2020-07-14 08:33:12
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Social / Access to Social Goods
Searching for indicator access:
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p.(None): Individual Professional
p.(None): MY STEPS
p.(None): THEMES
p.(None): TECHNOLOGIES
p.(None): OFFICIAL TEXTS
p.(None): THE CNIL
p.(None): MY COMPLIANCE WITH THE GDPR
p.(None): THEMES
p.(None): TECHNOLOGIES
p.(None): OFFICIAL TEXTS
p.(None): THE CNIL
p.(None): NEED HELP ?
p.(None): FR | EN
p.(None): > Research in the health sector: the CNIL adopts new simplification measures
p.(None): Health research: the CNIL adopts
p.(None): new simplification measures
p.(None): July 16, 2018
p.(None): To ease the formalities related to data processing carried out in research
p.(None): in the health sector, the CNIL has adopted five new benchmark methodologies
p.(None): adapted to the legal framework for health data.
p.(None): The CNIL has adopted five new reference methodologies (MR-001, MR-003, MR-004, MR-005 and MR-006) which
p.(None): offer a secure framework for the implementation of research treatments in the health field. She comes
p.(None): also to approve a simplification procedure to access the "EGB" (Generalist Sample of
p.(None): Beneficiaries) from the medico-administrative base of SNIIRAM). These new frameworks reflect the will of the
p.(None): Commission to continue its process of simplifying formalities in the field of health research.
p.(None): An update required
p.(None): The creation and updating of reference methodologies were made necessary by the evolution of the texts
p.(None): national laws, by the entry into force of the General Data Protection Regulation (GDPR) as well as by
p.(None): feedback from the field actors on existing frameworks (see below for the main
p.(None): news).
p.(None): As required by law, prior consultation with representative public and private bodies took place in
p.(None): 2018.
p.(None): Advantages of reference methodologies
p.(None): The adoption by the CNIL of these methodologies aims to create a favorable protective framework for the persons concerned
p.(None): research, innovation and competitiveness.
p.(None): When the data controller performs research in accordance with a reference methodology, the
p.(None): authorization request to the CNIL is not necessary. So :
p.(None): . In the context of research involving the human person, only the opinion of a personal protection committee, provided for by the
p.(None): public health code, must be obtained;
p.(None): . In the context of research that does not involve the human person, the opinion of CEREES is not necessary. However, the
p.(None): data controller must register his treatment in the public directory maintained by the INDS.
p.(None): Who is concerned ?
p.(None): Research promoters who process data as part of research, study or evaluation in the
p.(None): field of health.
p.(None): The scope of the reference methodologies is clarified:
p.(None): . From now on, MR-001 & MR-003 concern research involving the human person, as defined by the code of
p.(None): public health ;
p.(None): . The new MR-004, relates to research not involving the human person, studies or evaluations in the field of
p.(None): health;
p.(None): . Finally, the MR-005 & MR-006 are the first reference methodologies for one of the components of the SNDS: the
p.(None): PMSI (Information Systems Medicalization Program). They allow access to PMSI data by
p.(None): health establishments, federations and manufacturers in the health sector for the purpose of carrying out studies under conditions
p.(None): strict confidentiality and security.
p.(None): New reference methodologies may be adopted, depending on the needs identified.
p.(None): What are the formalities to be carried out?
p.(None): The data controller who wishes to implement one or more treatments in accordance with one of
p.(None): these reference methodologies send the CNIL a declaration attesting to this compliance for each
p.(None): reference methodology applicable to its projects.
p.(None): This declaration applies to all the processing operations implemented, which must be documented in the
p.(None): within the register of processing activities provided for by the GDPR.
p.(None): It is not necessary for data controllers who have already made a commitment to comply with
p.(None): old versions of a reference methodology send a new declaration of conformity to this text. The
p.(None): processing operations must, however, comply with the new text.
p.(None): > Make a declaration attesting to compliance with a reference methodology
p.(None): If the treatment does not comply with one of the RMs:
p.(None): . For research involving the human person, a CNIL authorization request must be made online:
p.(None): . For research not involving the human person, a file must be submitted to the INDS.
p.(None): Main new features of the reference methodologies (MR-001.003, MR-
p.(None): 004)
p.(None): The main new products from RM:
p.(None): . the obligation for the controller to designate a data protection officer (DPO);
p.(None): . informing people whose content must now comply with the provisions of article 13 or 14 of the GDPR;
p.(None): . the possibility of processing directly identifying data by subcontractors of the data controller under
p.(None): certain conditions and for specific missions (reimbursement of costs, allowances, follow-up of people (sending a message
p.(None): text, link to an online questionnaire etc.), product delivery); attention, data processing directly
p.(None): identifiers and health data by the same subcontractor remains excluded from the reference methodology. The treatment of
p.(None): name of the body responsible for treatment, even if it can reveal an area of health (cancer, AIDS etc.) is admitted
p.(None): MR;
p.(None): . the possibility of processing the department of residence (the commune of residence being excluded as well as the data of
p.(None): geocoding);
p.(None): . the possibility of communicating data to independent experts or researchers responsible for re-analyzing the data,
p.(None): especially at the request of publishers of scientific journals.
p.(None): In this specific case, the data controllers must use a technical solution allowing only the consultation
p.(None): data, without the possibility of extracting personal data.
p.(None): . An arrangement of the individual information of people in the event of data reuse (MR-004): or
p.(None): the information delivered during the collection of data and / or biological samples refers to a specific information device,
p.(None): to which the persons concerned may refer before the implementation of each future treatment (for example: a site
p.(None): Internet).
p.(None): The new features of the reference methodologies are detailed in the articles below:
p.(None): > Research in the health field: what changes with the new reference methodologies
p.(None): > Access to the Information Systems Medicalization Program (PMSI) for research purposes
p.(None): Generalist Sample of Beneficiaries
p.(None): Finally, in April 2018, the CNIL approved conditions for the provision of the Generalist Sample of
p.(None): Beneficiaries (EGB) from the National Inter-Regime Health Insurance Information System (SNIIRAM),
p.(None): allowing, for certain treatments and subject to specific conditions, a single examination by the INDS (therefore without
p.(None): CEREES opinion and without authorization from the CNIL).
p.(None): See Deliberation n ° 2018-134 of April 12, 2018 approving the conditions of provision of the sample
p.(None): generalist of beneficiaries (EGB) and thematic databases called "datamarts" of the National System
p.(None): Information System for Health Insurance (SNIIRAM)
p.(None): Learn more about benchmark methodologies
p.(None): > MR-005 Studies requiring access to PMSI and / or SPS data by health establishments and federations
p.(None): hospitable
p.(None): > MR-006 Studies requiring access to PMSI data by healthcare industry
p.(None): > MR-004 Research not involving the human person, studies and evaluations in the health field
p.(None): > MR-003 Research in the health field without obtaining consent
p.(None): > MR-001 Research in the health field with consent
p.(None): Keywords associated with this article
p.(None): #Medical research
p.(None): This may also interest you ...
p.(None): HEALTH RESEARCH: WHAT CHANGES WITH NEW REFERENCE METHODOLOGIES
p.(None): Since 2006, the CNIL has undertaken a simplification of the procedures for the processing of personal data implemented
p.(None): works within the framework of research in the field ...
p.(None): July 16, 2018
p.(None): ACCESS TO THE INFORMATION SYSTEMS MEDICALIZATION (PMSI) PROGRAM FOR RESEARCH PURPOSES
p.(None): The MR-005 & MR-006 reference methodologies simplify access to hospital data (PMSI - Program de
p.(None): medicalization of information systems), in ...
p.(None): July 16, 2018
p.(None): Subscribe to the newsletter
p.(None): nom@example.fr SUBSCRIBE TO THE NEWSLETTER
p.(None): Your email address is only used to send you CNIL newsletters. You can use the link at any time
p.(None): unsubscribe integrated into the newsletter. Learn more about managing your data and your rights
p.(None): Follow us
p.(None): MEDIA
p.(None): GLOSSARY
p.(None): FR-EN LEXICON
p.(None): NEED HELP
p.(None): HURRY
p.(None): FR | EN
p.(None): COOKIES MANAGEMENT
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.(None): identifiers and health data by the same subcontractor remains excluded from the reference methodology. The treatment of
p.(None): name of the body responsible for treatment, even if it can reveal an area of health (cancer, AIDS etc.) is admitted
p.(None): MR;
p.(None): . the possibility of processing the department of residence (the commune of residence being excluded as well as the data of
p.(None): geocoding);
p.(None): . the possibility of communicating data to independent experts or researchers responsible for re-analyzing the data,
p.(None): especially at the request of publishers of scientific journals.
p.(None): In this specific case, the data controllers must use a technical solution allowing only the consultation
p.(None): data, without the possibility of extracting personal data.
p.(None): . An arrangement of the individual information of people in the event of data reuse (MR-004): or
p.(None): the information delivered during the collection of data and / or biological samples refers to a specific information device,
p.(None): to which the persons concerned may refer before the implementation of each future treatment (for example: a site
p.(None): Internet).
p.(None): The new features of the reference methodologies are detailed in the articles below:
p.(None): > Research in the health field: what changes with the new reference methodologies
p.(None): > Access to the Information Systems Medicalization Program (PMSI) for research purposes
p.(None): Generalist Sample of Beneficiaries
p.(None): Finally, in April 2018, the CNIL approved conditions for the provision of the Generalist Sample of
p.(None): Beneficiaries (EGB) from the National Inter-Regime Health Insurance Information System (SNIIRAM),
p.(None): allowing, for certain treatments and subject to specific conditions, a single examination by the INDS (therefore without
p.(None): CEREES opinion and without authorization from the CNIL).
p.(None): See Deliberation n ° 2018-134 of April 12, 2018 approving the conditions of provision of the sample
p.(None): generalist of beneficiaries (EGB) and thematic databases called "datamarts" of the National System
p.(None): Information System for Health Insurance (SNIIRAM)
p.(None): Learn more about benchmark methodologies
p.(None): > MR-005 Studies requiring access to PMSI and / or SPS data by health establishments and federations
p.(None): hospitable
p.(None): > MR-006 Studies requiring access to PMSI data by healthcare industry
p.(None): > MR-004 Research not involving the human person, studies and evaluations in the health field
p.(None): > MR-003 Research in the health field without obtaining consent
p.(None): > MR-001 Research in the health field with consent
p.(None): Keywords associated with this article
p.(None): #Medical research
p.(None): This may also interest you ...
p.(None): HEALTH RESEARCH: WHAT CHANGES WITH NEW REFERENCE METHODOLOGIES
p.(None): Since 2006, the CNIL has undertaken a simplification of the procedures for the processing of personal data implemented
p.(None): works within the framework of research in the field ...
p.(None): July 16, 2018
p.(None): ACCESS TO THE INFORMATION SYSTEMS MEDICALIZATION (PMSI) PROGRAM FOR RESEARCH PURPOSES
p.(None): The MR-005 & MR-006 reference methodologies simplify access to hospital data (PMSI - Program de
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.(None): PMSI (Information Systems Medicalization Program). They allow access to PMSI data by
p.(None): health establishments, federations and manufacturers in the health sector for the purpose of carrying out studies under conditions
p.(None): strict confidentiality and security.
p.(None): New reference methodologies may be adopted, depending on the needs identified.
p.(None): What are the formalities to be carried out?
p.(None): The data controller who wishes to implement one or more treatments in accordance with one of
p.(None): these reference methodologies send the CNIL a declaration attesting to this compliance for each
p.(None): reference methodology applicable to its projects.
p.(None): This declaration applies to all the processing operations implemented, which must be documented in the
p.(None): within the register of processing activities provided for by the GDPR.
p.(None): It is not necessary for data controllers who have already made a commitment to comply with
p.(None): old versions of a reference methodology send a new declaration of conformity to this text. The
p.(None): processing operations must, however, comply with the new text.
p.(None): > Make a declaration attesting to compliance with a reference methodology
p.(None): If the treatment does not comply with one of the RMs:
p.(None): . For research involving the human person, a CNIL authorization request must be made online:
p.(None): . For research not involving the human person, a file must be submitted to the INDS.
p.(None): Main new features of the reference methodologies (MR-001.003, MR-
p.(None): 004)
p.(None): The main new products from RM:
p.(None): . the obligation for the controller to designate a data protection officer (DPO);
p.(None): . informing people whose content must now comply with the provisions of article 13 or 14 of the GDPR;
p.(None): . the possibility of processing directly identifying data by subcontractors of the data controller under
p.(None): certain conditions and for specific missions (reimbursement of costs, allowances, follow-up of people (sending a message
p.(None): text, link to an online questionnaire etc.), product delivery); attention, data processing directly
p.(None): identifiers and health data by the same subcontractor remains excluded from the reference methodology. The treatment of
p.(None): name of the body responsible for treatment, even if it can reveal an area of health (cancer, AIDS etc.) is admitted
p.(None): MR;
p.(None): . the possibility of processing the department of residence (the commune of residence being excluded as well as the data of
p.(None): geocoding);
p.(None): . the possibility of communicating data to independent experts or researchers responsible for re-analyzing the data,
p.(None): especially at the request of publishers of scientific journals.
p.(None): In this specific case, the data controllers must use a technical solution allowing only the consultation
p.(None): data, without the possibility of extracting personal data.
p.(None): . An arrangement of the individual information of people in the event of data reuse (MR-004): or
p.(None): the information delivered during the collection of data and / or biological samples refers to a specific information device,
p.(None): to which the persons concerned may refer before the implementation of each future treatment (for example: a site
p.(None): Internet).
p.(None): The new features of the reference methodologies are detailed in the articles below:
p.(None): > Research in the health field: what changes with the new reference methodologies
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): July 16, 2018
p.(None): To ease the formalities related to data processing carried out in research
p.(None): in the health sector, the CNIL has adopted five new benchmark methodologies
p.(None): adapted to the legal framework for health data.
p.(None): The CNIL has adopted five new reference methodologies (MR-001, MR-003, MR-004, MR-005 and MR-006) which
p.(None): offer a secure framework for the implementation of research treatments in the health field. She comes
p.(None): also to approve a simplification procedure to access the "EGB" (Generalist Sample of
p.(None): Beneficiaries) from the medico-administrative base of SNIIRAM). These new frameworks reflect the will of the
p.(None): Commission to continue its process of simplifying formalities in the field of health research.
p.(None): An update required
p.(None): The creation and updating of reference methodologies were made necessary by the evolution of the texts
p.(None): national laws, by the entry into force of the General Data Protection Regulation (GDPR) as well as by
p.(None): feedback from the field actors on existing frameworks (see below for the main
p.(None): news).
p.(None): As required by law, prior consultation with representative public and private bodies took place in
p.(None): 2018.
p.(None): Advantages of reference methodologies
p.(None): The adoption by the CNIL of these methodologies aims to create a favorable protective framework for the persons concerned
p.(None): research, innovation and competitiveness.
p.(None): When the data controller performs research in accordance with a reference methodology, the
p.(None): authorization request to the CNIL is not necessary. So :
p.(None): . In the context of research involving the human person, only the opinion of a personal protection committee, provided for by the
p.(None): public health code, must be obtained;
p.(None): . In the context of research that does not involve the human person, the opinion of CEREES is not necessary. However, the
p.(None): data controller must register his treatment in the public directory maintained by the INDS.
p.(None): Who is concerned ?
p.(None): Research promoters who process data as part of research, study or evaluation in the
p.(None): field of health.
p.(None): The scope of the reference methodologies is clarified:
p.(None): . From now on, MR-001 & MR-003 concern research involving the human person, as defined by the code of
p.(None): public health ;
p.(None): . The new MR-004, relates to research not involving the human person, studies or evaluations in the field of
p.(None): health;
p.(None): . Finally, the MR-005 & MR-006 are the first reference methodologies for one of the components of the SNDS: the
p.(None): PMSI (Information Systems Medicalization Program). They allow access to PMSI data by
p.(None): health establishments, federations and manufacturers in the health sector for the purpose of carrying out studies under conditions
p.(None): strict confidentiality and security.
p.(None): New reference methodologies may be adopted, depending on the needs identified.
p.(None): What are the formalities to be carried out?
p.(None): The data controller who wishes to implement one or more treatments in accordance with one of
p.(None): these reference methodologies send the CNIL a declaration attesting to this compliance for each
p.(None): reference methodology applicable to its projects.
p.(None): This declaration applies to all the processing operations implemented, which must be documented in the
p.(None): within the register of processing activities provided for by the GDPR.
p.(None): It is not necessary for data controllers who have already made a commitment to comply with
p.(None): old versions of a reference methodology send a new declaration of conformity to this text. The
...
p.(None): name of the body responsible for treatment, even if it can reveal an area of health (cancer, AIDS etc.) is admitted
p.(None): MR;
p.(None): . the possibility of processing the department of residence (the commune of residence being excluded as well as the data of
p.(None): geocoding);
p.(None): . the possibility of communicating data to independent experts or researchers responsible for re-analyzing the data,
p.(None): especially at the request of publishers of scientific journals.
p.(None): In this specific case, the data controllers must use a technical solution allowing only the consultation
p.(None): data, without the possibility of extracting personal data.
p.(None): . An arrangement of the individual information of people in the event of data reuse (MR-004): or
p.(None): the information delivered during the collection of data and / or biological samples refers to a specific information device,
p.(None): to which the persons concerned may refer before the implementation of each future treatment (for example: a site
p.(None): Internet).
p.(None): The new features of the reference methodologies are detailed in the articles below:
p.(None): > Research in the health field: what changes with the new reference methodologies
p.(None): > Access to the Information Systems Medicalization Program (PMSI) for research purposes
p.(None): Generalist Sample of Beneficiaries
p.(None): Finally, in April 2018, the CNIL approved conditions for the provision of the Generalist Sample of
p.(None): Beneficiaries (EGB) from the National Inter-Regime Health Insurance Information System (SNIIRAM),
p.(None): allowing, for certain treatments and subject to specific conditions, a single examination by the INDS (therefore without
p.(None): CEREES opinion and without authorization from the CNIL).
p.(None): See Deliberation n ° 2018-134 of April 12, 2018 approving the conditions of provision of the sample
p.(None): generalist of beneficiaries (EGB) and thematic databases called "datamarts" of the National System
p.(None): Information System for Health Insurance (SNIIRAM)
p.(None): Learn more about benchmark methodologies
p.(None): > MR-005 Studies requiring access to PMSI and / or SPS data by health establishments and federations
p.(None): hospitable
p.(None): > MR-006 Studies requiring access to PMSI data by healthcare industry
p.(None): > MR-004 Research not involving the human person, studies and evaluations in the health field
p.(None): > MR-003 Research in the health field without obtaining consent
p.(None): > MR-001 Research in the health field with consent
p.(None): Keywords associated with this article
p.(None): #Medical research
p.(None): This may also interest you ...
p.(None): HEALTH RESEARCH: WHAT CHANGES WITH NEW REFERENCE METHODOLOGIES
p.(None): Since 2006, the CNIL has undertaken a simplification of the procedures for the processing of personal data implemented
p.(None): works within the framework of research in the field ...
p.(None): July 16, 2018
p.(None): ACCESS TO THE INFORMATION SYSTEMS MEDICALIZATION (PMSI) PROGRAM FOR RESEARCH PURPOSES
p.(None): The MR-005 & MR-006 reference methodologies simplify access to hospital data (PMSI - Program de
p.(None): medicalization of information systems), in ...
p.(None): July 16, 2018
p.(None): Subscribe to the newsletter
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| single | Marital Status |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
protection
Applicable Type / Vulnerability / Indicator Overlay for this Input