REGULATION – not a directive. Directly applicable in all EU Member States.
Still not clear what the scope is of anonymous information including for statistical or research purposes. Identifiable? Taking into account costs and amout of time required for identification, the available technology and the technology at the time of the processing.
http://www.privacy-analytics.com/de-id-university/webinars/anonymization-ema-policy-0070/ Anonymous datasets can be enriched or combined
Potential future health status: any information where there is a scientifically proven or commonly perceived risk of disease in the future, such as obesity, blood pressure, personal habits involving tobacco, alcohol or drugs
Past, current and future health status
Still not entirely clear!
Not sure how this will work out in practice!
Article 4, 31 and 32 GDPR are alike!
Data protection and data integrity
DATA PROTECTION &
20 April 2016, Paperless Lab
Sofie van der Meulen
• From DPD to GDPR: personal data
• Anonymisation & pseudonomysation
• Research data
• Data transfers
• New rules on data breaches
Time to say goodbye…
to the Data Protection Directive!
• 2012: EC proposed GDPR
• Council position 6 April = latest available text GDPR
• Adopted in plenary on 14 April 2016
• Currently: waiting for publication in the Official Journal of the
European Union (OJEU)
• Entry into force: 20 days after the date of publication in the OJEU,
• Apply from: 2 years after the date of its entry into force (2018)
Personal data under DPD:
any information relating to an identified or identifiable natural
person ('data subject'); whether directly or indirectly identifiable.
“data relates to an individual if it refers to the identity, characteristics
or behaviour of an individual or if such information is used to
determine or influence the way in which that person is treated or
Future scope of ‘personal data’ under GDPR?
Personal data under GDPR
• Data concerning health – (sensitive data)
• Genetic data – (sensitive data)
• Biometric data
• Personal data:
Recital 26 GDPR:
‘The principles of data protection should not apply to anonymous
information, namely information which does not relate to an
identified or identifiable natural person or to personal data rendered
anonymous in such a manner that the data subject is not or no
This Regulation does not therefore concern the processing of such
anonymous information, including for statistical or research
Zip code, Date of Birth &
Gender are sufficient to
identify a large part of the
Anonymisation criteria WP29 Opinion 05/2014:
• Is it still possible to single out an individual?
• Is it still possible to link records relating to an individual?
• Can information about an individual be inferred?
Outcome after technique is applied: be as permanent as erasure of
the personal data – it should make processing of personal data
impossible. <- Realistic?
Absolute anonymisation is impossible -> focus on mitigating risks of
It’s not a one off exercise!
GDPR: processing of personal data in such a manner that the
personal data can
• no longer be attributed to a specific data subject
• without the use of additional information,
• provided that such additional information is kept separately and
• is subject to technical and organizational measures to ensure
that the personal data are not attributed to an identified or
identifiable natural person
= security measure to reduce the linkability of a dataset to the
original identity of a data subject
‘GDPR: ‘means any freely given, specific,
informed and unambiguous indication of the
data subject's wishes by which he or she, by a statement or by a
clear affirmative action, signifies agreement to the processing of
personal data relating to him or her’
Recitals 32 and 42 GDPR:
• silence, pre-ticked boxes or inactivity -> do not constitute
• Processing more purposes? Consent should be given for all of
• Controller should be able to demonstrate consent.
DPD: health data
Health data is special category of data - processing prohibited
Medical treatment exemption:
Processing of the data is required for the purposes of preventive
medicine, medical diagnosis, the provision of care or treatment or
the management of health-care services, and those data are
processed by a health professional subject under national law or
rules established by national competent bodies to the obligation of
professional secrecy or by another person also subject to an
equivalent obligation of secrecy.
DPD: Scope of ‘health data’?
European Court of Justice in Case C-101/01 (Lindqvist):
‘In the light of the purpose of the directive, the expression “data
concerning health” used in Article 8(1) thereof must be given a wide
interpretation so as to include information concerning all aspects,
both physical and mental, of the health of an individual.’
Letter of WP29 of 5 February 2015 on data collected by mHealth
apps. Health data includes:
• Medical data: ‘data about the physical or mental health status of
a data subject (…) generated in a professional, medical context
• Health related data used in an administrative context
(information to public entities)
• Data about the purchase of medical products and services
provided that the health status can be determined
Health data case
Performance data becomes health data
Data minimisation should be ensured
Research – ‘Right to be forgotten’
Article 17 (1) GDPR: The data subject has the right to obtain the
erasure of personal without undue delay from the controller.
Last year: risk that statistical analyses will be “depowered” as a
result of exercise of right to withdraw consent and erasure of data.
Result, clinical trials and clinical investigations will be
conducted outside Europe to avoid any such risk.
Now: the ‘right to be forgotten’ does not apply if the processing takes
‘for archiving purposes in the public interest, scientific or historical
research purposes or statistical purposes in accordance with
Article 89(1) in so far as the right referred to in paragraph 1 is likely
to render impossible or seriously impair the achievement of the
objectives of that processing.’
Data transfer outside EU & security
• Surveillance practices (PRISM)
Safe harbor for transfer to US?
Safe Harbor Certification merely means that the transfer of personal
data to the US is allowed in principle because it demonstrates the
adequacy of the US as jurisdiction
• Facebook case (Schrems, C-362/14) invalidates Safe Harbor
• Data transfer agreement based on European
Commission’s standard contractual clauses
• Binding corporate rules blessed by a DPA
• “Privacy Shield” still not up and running
Data controllers and processors should implement appropriate
technical & organizational measures to protect data from loss or
any form of unlawful processing.
Security measures should take into account:
• Nature of the data to be protected
• State of the art
• Aim to prevent unnecessary collection and further processing of
• Overriding principle: Plan-Do-Check-Act
NL: Legislative proposal adopted amending the Data Protection
Act and Telecommunications Act by incorporating a notification
obligation for data controllers in case of data breaches.
Until now: hundreds of notifications!
The Data Protection Authority can impose administrative fines up to
EUR 820.000 in case of violation of the notification obligation.
Notification obligation applies if:
• Security breach
• Entity in public or private sector (companies, governmental
• The infringement leads to a significant risk of adverse impact on
the protection of personal data processed by the organization
(theft, loss or abuse of personal data).
GDPR – Data breaches
Recital 85 & 86 GDPR:
• If not addressed a data breach may lead to damage to natural
persons such as loss over control over their personal data,
financial loss, unauthorized reversal of pseudonymisation,
damage to reputation and loss of confidentiality.
• Communicating a data breach to the person concerned in case
of high risk of damage. -> person can take precautions.
• Otherwise: notify supervisory authority.
Sofie van der Meulen
Piet Heinkade 183
1019 HC Amsterdam
+31 88 650 6500
+31 6 53 44 05 67
THANK YOU FOR YOUR ATTENTION!
• The information in this presentation is provided for information
• The information is not exhaustive. While every endeavour is made
to ensure that the information is correct at the time of publication,
the legal position may change as a result of matters including new
legislative developments, new case law, local implementation
variations or other developments.
• The information does not take into account the specifics of any
person's position and may be wholly inappropriate for your
• The information is not intended to be legal advice, cannot be
relied on as legal advice and should not be a substitute for legal