The document summarizes key points from a seminar on data protection and the new General Data Protection Regulation (GDPR). It discusses definitions of personal data and health data, consent requirements, privacy by design, data transfers, security obligations, data breaches, the data protection officer role, and impact assessments. The new GDPR brings significant changes including tougher consent standards, higher fines for violations, additional rights for data subjects, and new responsibilities for processors. Member states still have flexibility in some implementation areas, and full compliance will require preparation.

1. DATA PROTECTION
SEMINAR
14 July 2016 Sofie van der Meulen
www.axonadvocaten.nl

2. 2
What is privacy?

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. 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

6. Time to say goodbye…
6
to the Data Protection Directive!

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

9. 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

10. 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.’

11. 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

12. 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?

13. 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

14. 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.

15. 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

16. Health data case
study
Performance data becomes health data

17. Future scope of ‘health data’

18. 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

19. 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)

20. 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

21. Anonymous?
21
Zip code, Date of Birth &
Gender are sufficient to
identify a large part of the
population..

22. 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

23. 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

24. 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

25. Consent participation clinical
studies = different legal basis!

26. GDPR: Research
Consent & research purposes:
26

27. GDPR: Research
Purpose limitation:
27

28. GDPR: Research
Data minimisation should be ensured
28

29. 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!

30. 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

31. 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.

32. 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).

33. 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

34. 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

35. 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

36. 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

37. On our way to Snowden 2.0?

38. The Guardian 18 February 2016

39. 26 February 2016

40. 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).

41. 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

42. 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

43. Impact Assessment

44. 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

45. Data portability right
• Controller must inform data subject about right, and:

46. 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))

47. 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

48. 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

49. 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

50. Case studies
• Personalized home-based HTN care
• Employee wellness programs
• Consumer Health Home monitoring
• Data for research vs data for commercial development

51. Questions
• Personal data? Sensitive data?
• Data subjects?
• Act of processing?
• For which purposes?
• Consent?
• Profiling?
• Sharing data? Export?
• Storage?
• Security?
• Vulnerabilities?
• Data breaches?

52. 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!

53. 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.