DATA PROTECTION & DATA INTEGRITY

20 April 2016, Paperless Lab AcademySofie van der Meulenwww.axonlawyers.com

#PaperlessLabAcademy @sofievdmeulen

Overview• From DPD to GDPR: personal data• Anonymisation & pseudonomysation• Consent• Research data• Data transfers• Security• New rules on data breaches

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Time to say goodbye…

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to the Data Protection Directive!

Well… almost.

• 2012: EC proposed GDPR  • Council position 6 April = latest available text GDPR http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=consil:ST_5419_2016_INIT

• 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,

the Regulation • Apply from: 2 years after the date of its entry into force (2018)

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Personal data?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 evaluated” (WP136)

Future scope of ‘personal data’ under GDPR?

Personal data under GDPR

Definitions for: • Data concerning health – (sensitive data)• Genetic data – (sensitive data)• Biometric data• Personal data:

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Anonymous information

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 longer identifiable.

This Regulation does not therefore concern the processing of such anonymous information, including for statistical or research purposes.’

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Anonymous?

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Zip code, Date of Birth & Gender are sufficient to identify a large part of the population..

AnonymisationAnonymisation 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 re-identification.

It’s not a one off exercise!

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Pseudonomysation

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

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Consent

‘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

consent.• Processing more purposes? Consent should be given for all of

them!• Controller should be able to demonstrate consent.

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DPD: health dataHealth data is special category of data - processing prohibited UNLESS

Explicit consent

OR

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 studyPerformance data becomes health data

Future scope of ‘health data’

GDPR: Research

Consent & research purposes:

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GDPR: ResearchPurpose limitation:

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GDPR: Research

Data minimisation should be ensured

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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 place:

‘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 transfer mechanism

Alternatives:• 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

SecurityData 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

personal data• Overriding principle: Plan-Do-Check-Act

The Guardian 18 February 2016

26 February 2016

Data breachesNL: 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

organizations) • 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.

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Sofie van der MeulenAxon AdvocatenPiet Heinkade 1831019 HC Amsterdam

+31 88 650 6500+31 6 53 44 05 67sofie.vandermeulen@axonlawyers.com

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