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DATA PROTECTION
SEMINAR
14 July 2016 Sofie van der Meulen
www.axonadvocaten.nl
2
What is privacy?
“I was Patient Zero,” said Lewinsky, now 41, to an auditorium full of 1,000-
plus high-achieving millennials at Forbes’ in...
You want a piece of me?
• Privacy policy
Tell people WHY you want their data, tell them HOW you handle the data
and WHAT y...
5
Time to say goodbye…
6
to the Data Protection Directive!
And hi to the new General Data
Protection Regulation 2016/679
• Virtually everything we currently do will become more
comp...
Impact on healthcare?
Healthcare business related top 8 points of
attention:
1. Informed consent criteria
2. Data concerni...
GDPR: processing of personal data
Definition of ‘processing’:
‘means any operation or set of operations which is performed...
Parties involved in processing
• Controller:
The natural or legal person, public authority, agency or other body
which, al...
Personal data?
Personal data under DPD:
any information relating to an identified or identifiable natural
person ('data su...
Personal data under GDPR
Definitions for:
• Data concerning health – (sensitive data)
• Genetic data – (sensitive data)
• ...
DPD: Health data
Health data is special category of data - processing prohibited
UNLESS
Explicit consent
OR
Medical treatm...
Scope of ‘health data’?
European Court of Justice in Case C-101/01 (Lindqvist):
‘In the light of the purpose of the direct...
Health data case
study
Performance data becomes health data
Future scope of ‘health data’
Biological samples?
• Recitals 13, 34 and 35: Genetic data should be defined as
personal data relating to the inherited or...
Privacy principles – art. 5 GDPR
1. Lawfulness, fairness and transparency
2. Purpose limitation
3. Data minimisation (adeq...
Anonymous information
Recital 26 GDPR:
‘The principles of data protection should not apply to anonymous
information, namel...
Anonymous?
21
Zip code, Date of Birth &
Gender are sufficient to
identify a large part of the
population..
Anonymisation
Anonymisation criteria WP29 Opinion 05/2014:
• Is it still possible to single out an individual?
• Is it sti...
Pseudonomysation
GDPR: processing of personal data in such a manner that the
personal data can
• no longer be attributed t...
Consent-based
business model tricky
‘GDPR: ‘means any freely given, specific,
informed and unambiguous indication of the
d...
Consent participation clinical
studies = different legal basis!
GDPR: Research
Consent & research purposes:
26
GDPR: Research
Purpose limitation:
27
GDPR: Research
Data minimisation should be ensured
28
Research – ‘Right to be forgotten’
Article 17 (1) GDPR: The data subject has the right to obtain the
erasure of personal w...
Privacy by design
• Know what to design for: do a PIA to identify and reduce risks of projects
• Designing projects, proce...
Privacy by design (art. 25 GDPR)
• Privacy by design requirements requires designing compliant policies,
procedures and sy...
Privacy by default
• 'Privacy by default' requires that controllers implement appropriate
technical and organisational mea...
Practical things
Practical measures to take (for example):
• implementing a privacy impact assessment template that the bu...
Export
Export only with legal basis:
• Appropriate safeguards (BCR and SCCs) ensuring third party
rights for data subjects...
Data transfer outside EU
• Surveillance practices (PRISM)
Safe harbor for transfer to US?
Safe Harbor Certification merely...
Security
Data controllers and processors should implement appropriate
technical & organizational measures to protect data ...
On our way to Snowden 2.0?
The Guardian 18 February 2016
26 February 2016
Data breaches
NL: Legislative proposal adopted amending the Data Protection
Act and Telecommunications Act by incorporatin...
Data Protection Officer (art. 37)
The controller and the processor shall designate a data protection
officer in any case w...
Impact Assessment
Article 35
• PIA prior to processing – similar operations with similar risks can be
grouped
• Count on a...
Impact Assessment
Profiling requirements
• Profiling based on health data -> always PIA
• 'profiling' means any form of automated processing...
Data portability right
• Controller must inform data subject about right, and:
New responsibilities data
processor
• controller shall use only processors providing sufficient
guarantees to implement ap...
What changes?
• Fines/penalties for breach
• Up to 4% of annual worldwide turnover for serious breaches
(eg requirements r...
What changes?
• Consent requirements tougher
• Pseudonymous data remains personal data regardless of the
number and nature...
Known unknowns and wide open
doors
• This means that member states can still require geofencing, hosting
accreditation and...
Case studies
• Personalized home-based HTN care
• Employee wellness programs
• Consumer Health Home monitoring
• Data for ...
Questions
• Personal data? Sensitive data?
• Data subjects?
• Act of processing?
• For which purposes?
• Consent?
• Profil...
Sofie van der Meulen
Axon Advocaten
Piet Heinkade 183
1019 HC Amsterdam
+31 88 650 6500
+31 6 53 44 05 67
sofie.vandermeul...
Legal stuff
• The information in this presentation is provided for information
purposes only.
• The information is not exh...
Seminar General Data Protection Regulation
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Seminar General Data Protection Regulation

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Seminar on the GDPR of the Amsterdam Health and Technology Institute

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Seminar General Data Protection Regulation

  1. 1. DATA PROTECTION SEMINAR 14 July 2016 Sofie van der Meulen www.axonadvocaten.nl
  2. 2. 2 What is privacy?
  3. 3. “I was Patient Zero,” said Lewinsky, now 41, to an auditorium full of 1,000- plus high-achieving millennials at Forbes’ inaugural 30 Under 30 summit in Philadelphia. “The first person to have their reputation completely destroyed worldwide via the Internet.” https://www.ted.com/talks/monica_lewinsky_the_price_of_shame?languag e=en ‘(…)…Don't matter if I step on the scene Or sneak away to the Philippines They still gon' put pictures of my derriere in the magazine You want a piece of me? You want a piece of me’ (Britney Spears – Lyrics ‘Piece of me’) Ask Monica Lewinsky… Ask Britney Spears… Ask Jennifer Lawrence…
  4. 4. You want a piece of me? • Privacy policy Tell people WHY you want their data, tell them HOW you handle the data and WHAT you are going to do with it. • Privacy by design Make privacy and security part of the development of your products.
  5. 5. 5
  6. 6. Time to say goodbye… 6 to the Data Protection Directive!
  7. 7. And hi to the new General Data Protection Regulation 2016/679 • Virtually everything we currently do will become more complicated, more expensive, more administratively burdensome • 261 pages, 108 of Recitals • Regulation shall apply from 25 May 2018 • Regulation enters into force on 24 May 2016 (published in the Journal on 4 May), but two year transition • No grandfathering of existing consents etc • Many clients target compliance by May 2017 to allow stress testing of systems Prepare now! 7
  8. 8. Impact on healthcare? Healthcare business related top 8 points of attention: 1. Informed consent criteria 2. Data concerning health scope 3. Right to be forgotten (applies to commercial collection of health data) 4. Impact assessment • For data concerning health • In case of profiling 5. Profiling requirements • including right to object if processing significantly affects data subject 6. Data portability right of user 7. Security requirements 8. Export of data to extra-EU jurisdictions
  9. 9. GDPR: processing of personal data Definition of ‘processing’: ‘means any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.’
  10. 10. Parties involved in processing • Controller: The natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by Union or Member State law, the controller or the specific criteria for its nomination may be provided for by Union or Member State law’ • Processor: ‘means a natural or legal person, public authority, agency or other body which processes personal data on behalf of the controller’ • Third party • Data subject - Right to access - Right to correction - Right to erasure - Right to objection
  11. 11. 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?
  12. 12. Personal data under GDPR Definitions for: • Data concerning health – (sensitive data) • Genetic data – (sensitive data) • Biometric data • Personal data: ‘personal data’ means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person’ 13
  13. 13. DPD: Health data Health 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.
  14. 14. 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
  15. 15. Health data case study Performance data becomes health data
  16. 16. Future scope of ‘health data’
  17. 17. Biological samples? • Recitals 13, 34 and 35: Genetic data should be defined as personal data relating to the inherited or acquired genetic characteristics of a natural person which result from the analysis of a biological sample from the natural person in question. Prior to analysis: is person identifiable? Personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question. • Genetic data is regarded as personal data concerning health, and is included among the special categories of data. • Netherlands: Federa ‘Code Goed Gebruik’ - Secondary use for research/scientific purposes (no ‘objection’) - Secondary use for commercial purposes (consent) 18
  18. 18. Privacy principles – art. 5 GDPR 1. Lawfulness, fairness and transparency 2. Purpose limitation 3. Data minimisation (adequate, relevant and limited) 4. Storage limitation 5. Integrity & confidentiality 6. Accountability (controller is responsible for compliance)
  19. 19. 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.’ 20
  20. 20. Anonymous? 21 Zip code, Date of Birth & Gender are sufficient to identify a large part of the population..
  21. 21. Anonymisation 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 re-identification. It’s not a one off exercise! 22
  22. 22. 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 23
  23. 23. Consent-based business model tricky ‘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, 42 and 43 GDPR • silence, pre-ticked boxes or inactivity do not constitute consent • Processing for multiple purposes? Consent should be given for all of them! • Controller must be able to prove valid consent was obtained and provide intelligible consent language • Consent invalid “in a specific case where there is a clear imbalance between the data subject and the controller” 24
  24. 24. Consent participation clinical studies = different legal basis!
  25. 25. GDPR: Research Consent & research purposes: 26
  26. 26. GDPR: Research Purpose limitation: 27
  27. 27. GDPR: Research Data minimisation should be ensured 28
  28. 28. 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. Now: the ‘right to be forgotten’ ONLY 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.’ Right to be forgotten does apply in all commercial processing of health data!
  29. 29. Privacy by design • Know what to design for: do a PIA to identify and reduce risks of projects • Designing projects, processes, products or systems with privacy in mind at the outset can lead to benefits which include: • Potential problems are identified at an early stage, when addressing them will often be simpler and less costly • Increased awareness of privacy and data protection across an organisation • Organisations are more likely to meet their legal obligations and less likely to breach the GDPR • Actions are less likely to be privacy intrusive and have a negative impact on individuals
  30. 30. Privacy by design (art. 25 GDPR) • Privacy by design requirements requires designing compliant policies, procedures and systems at the outset of any product or process development.
  31. 31. Privacy by default • 'Privacy by default' requires that controllers implement appropriate technical and organisational measures to ensure that, by default, only personal data which are necessary for each specific purpose of the processing are processed • Implement appropriate technical and organisational measures to ensure that, by default, only personal data which are necessary for each specific purpose of the processing are processed (e.g. amount collected, extent of processing, storage period and accessibility).
  32. 32. Practical things Practical measures to take (for example): • implementing a privacy impact assessment template that the business can populate each time it designs, procures or implements a new system • revising standard contracts with data processors to set out how risk/liability will be apportioned between the parties in relation to the implementation of 'privacy by design' and 'privacy by default' requirements • revisiting data collection forms/web-pages to ensure that excessive data is not collected
  33. 33. Export Export only with legal basis: • Appropriate safeguards (BCR and SCCs) ensuring third party rights for data subjects, approved code or certification mechanism • Privacy Shield • Specific situation • informed consent • necessary for performance of contract
  34. 34. Data transfer outside EU • 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 • Adequacy decision? • “Privacy Shield” – text adopted by European Commission
  35. 35. Security Data controllers and processors should implement appropriate technical & organizational measures to protect data from loss or any form of unlawful processing • Article 32 defines security principles Security measures must take into account (recital 78): • Nature of the data to be protected and consequences of security breach • State of the art • Security by design • Aim to prevent unnecessary collection and further processing of personal data • Overriding principle: Plan-Do-Check-Act • Data breach notification (article 33/34) • to DPA (<72 hours) and to data subject • processor must inform controller
  36. 36. On our way to Snowden 2.0?
  37. 37. The Guardian 18 February 2016
  38. 38. 26 February 2016
  39. 39. Data breaches 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 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).
  40. 40. Data Protection Officer (art. 37) The controller and the processor shall designate a data protection officer in any case where: (a)[…] (b)the core activities of the controller or the processor consist of processing operations which, by virtue of their nature, their scope and/or their purposes, require regular and systematic monitoring of data subjects on a large scale; or (c) the core activities of the controller or the processor consist of processing on a large scale of special categories of data pursuant to Article 9 (data concerning health). • A group of undertakings may appoint a single data protection officer provided that a data protection officer is easily accessible from each establishment • May be employed or consultant • Details to be notified to DPA
  41. 41. Impact Assessment Article 35 • PIA prior to processing – similar operations with similar risks can be grouped • Count on all grant funded projects and clinical trails or investigations or registries that require ethics approval needing PIA • Authorities will make lists of operations subject to PIA
  42. 42. Impact Assessment
  43. 43. Profiling requirements • Profiling based on health data -> always PIA • 'profiling' means any form of automated processing of personal data consisting of the use of personal data to evaluate certain personal aspects relating to a natural person, in particular to analyse or predict aspects concerning that natural person's performance at work, economic situation, health, personal preferences, interests, reliability, behaviour, location or movements; • Data subject must be informed • Article 22: right not to be subject to a decision based solely on automated processing, including profiling, which produces legal effects concerning him or her or similarly significantly affects him or her, unless • decision is necessary for performance or entering into contract • decision is based on explicit consent • AND: • explicit consent in case of profiling based on health data • Implement suitable measures to safeguard the data subject's rights and freedoms and legitimate interests are in place
  44. 44. Data portability right • Controller must inform data subject about right, and:
  45. 45. New responsibilities data processor • controller shall use only processors providing sufficient guarantees to implement appropriate technical and organizational measures in such a manner that processing will meet the requirements of this Regulation and ensure the protection of the rights of the data subject • processor not allowed to engage another processor without prior specific or general written authorisation of the controller and without contract • processor must also designate DPO (art. 37 (1))
  46. 46. What changes? • Fines/penalties for breach • Up to 4% of annual worldwide turnover for serious breaches (eg requirements relating to international transfers or the basic principles for processing) • Up to 2% of annual worldwide turnover for other breaches • Data protection becomes a fundamental right • More access rights (e.g. data portability) • Impact Assessments required • Prior approval of impact assessment of each act of processing (sets of similar processing can be grouped) • Profiling requirements • Explanation of automated processing logic
  47. 47. What changes? • Consent requirements tougher • Pseudonymous data remains personal data regardless of the number and nature of steps taken to key code • Biological samples = identifiable data? • Exemptions for processing without consent • Exemptions not suited for outsourced processing in eHealth / mHealth services and not drafted for regulatory clinical data obligations or health technology assessments • Technical standards • Commission can issue technical standards related to implementation of GDPR requirements • Mandatory Privacy Officer
  48. 48. Known unknowns and wide open doors • This means that member states can still require geofencing, hosting accreditation and things like that for processing of genetic, biometric and/or health data! • Only restriction is that these cannot be contrary to the requirements of the internal market and must be proportionate
  49. 49. Case studies • Personalized home-based HTN care • Employee wellness programs • Consumer Health Home monitoring • Data for research vs data for commercial development
  50. 50. Questions • Personal data? Sensitive data? • Data subjects? • Act of processing? • For which purposes? • Consent? • Profiling? • Sharing data? Export? • Storage? • Security? • Vulnerabilities? • Data breaches?
  51. 51. Sofie van der Meulen Axon Advocaten Piet Heinkade 183 1019 HC Amsterdam +31 88 650 6500 +31 6 53 44 05 67 sofie.vandermeulen@axonlawyers.com THANK YOU FOR YOUR ATTENTION!
  52. 52. Legal stuff • The information in this presentation is provided for information purposes only. • 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 particular circumstances. • The information is not intended to be legal advice, cannot be relied on as legal advice and should not be a substitute for legal advice.

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