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In the matter of the General Data Protection Regulation

DPC Case Reference: IN-19-9-1

In the matter of The Health Service Executive (HSE South)

Decision of the Data Protection Commission made pursuant to Section 111 of the Data Protection Act
2018

Further to an own-volition inquiry commenced pursuant to Section 110 of the Data Protection Act 2018

DECISION

Decision-Maker for the Commission:

18 August 2020

Helen Dixon
Commissioner for Data Protection

Data Protection Commission
2 Fitzwilliam Square South
Dublin 2, Ireland

Contents
1. Introduction .................................................................................................................................... 3
2. Legal Framework for the Inquiry and the Decision......................................................................... 3
i. Legal Basis for the Inquiry ........................................................................................................... 3
ii. Data Controller............................................................................................................................ 4
iii. Legal Basis for the Decision......................................................................................................... 4
3. Factual Background ......................................................................................................................... 4
4. Scope of the Inquiry and the Application of the GDPR ................................................................... 6
5. Analysis and Findings ...................................................................................................................... 8
i. Assessing Risk .............................................................................................................................. 9
ii. Security Measures Implemented by the HSE............................................................................ 12
iii. The Appropriate Level of Security............................................................................................. 15
iv. Finding ....................................................................................................................................... 18
6. Corrective Powers ......................................................................................................................... 18
A. Order to Bring Processing into Compliance .............................................................................. 18
B. Reprimand................................................................................................................................. 19
C. Administrative Fine ................................................................................................................... 20
i. Decision to Impose an Administrative Fine .......................................................................... 20
ii. The Same or Linked Processing Operations .......................................................................... 26
iii. The Permitted Range ............................................................................................................ 26
iv. Calculating the Administrative Fine ...................................................................................... 28
7. Right of Appeal.............................................................................................................................. 29
Appendix: Schedule of Materials Considered for the Purposes of this Decision ............................... 30

1. Introduction

1.1 This document (“the Decision”) is the decision made by the Data Protection Commission (“the
DPC”) in accordance with Section 111 of the Data Protection Act 2018 (“the 2018 Act”). I make
this Decision having considered the information obtained in the separate own volition inquiry
(“the Inquiry”) conducted by an Authorised Officer of the DPC (“the Case Officer”) pursuant
to Section 110 of the 2018 Act. The Case Officer provided the Health Service Executive (“the
HSE”) with the Draft Inquiry Report and the Final Inquiry Report. The scope of the Inquiry is
to examine whether or not the HSE has discharged its obligations in connection with the
subject matter of personal data breach BN-19-6-237 and determine whether or not any
provision(s) of the Act and/or the General Data Protection Regulation (“the GDPR”) has been
contravened by the HSE in that context.

1.2 The HSE was provided with the Draft Decision on this Inquiry on 23 July 2020 to provide it with
a final opportunity to make submissions. The Decision is being provided to the HSE pursuant
to Section 116(1)(a) of the 2018 Act in order to give the HSE notice of the Decision and the
reasons for it, and the corrective powers that I have decided to exercise. This Decision contains
corrective powers under Section 115 of the 2018 Act and Article 58(2) of the GDPR arising
from the infringements that have been identified herein. The HSE is required to comply with
these corrective powers, and it is open to this office to serve an enforcement notice on the
HSE in accordance with Section 133 of the 2018 Act.

2. Legal Framework for the Inquiry and the Decision

i. Legal Basis for the Inquiry

2.1 The GDPR is the legal regime covering the processing of personal data in the European Union.
As a regulation, the GDPR is directly applicable in EU member states. The GDPR is given further
effect in Irish law by the 2018 Act. As stated above, the Inquiry was commenced pursuant to
Section 110 of the 2018 Act. By way of background in this regard, under Part 6 of the 2018
Act, the Commission has the power to commence an inquiry on several bases, including on
foot of a complaint, or of its own volition.

2.2 Section 110(1) of the 2018 Act provides that the Commission may, for the purpose of Section
109(5)(e) or Section 113(2) of the 2018 Act, or of its own volition, cause such inquiry as it
thinks fit to be conducted, in order to ascertain whether an infringement has occurred or is
occurring of the GDPR or a provision of the 2018 Act, or regulation under the Act, that gives
further effect to the GDPR. Section 110(2) of the 2018 Act provides that the Commission may,
for the purposes of Section 110(1), where it considers it appropriate to do so, cause any of its
powers under Chapter 4 of Part 6 of the 2018 Act (excluding Section 135 of the 2018 Act) to
be exercised and / or cause an investigation under Chapter 5 of Part 6 of the 2018 Act to be
carried out.

ii. Data Controller

2.3 In commencing the Inquiry, the Case Officer considered that the HSE may be the controller,
within the meaning of Article 4(7) of the GDPR, in respect of the personal data that was the
subject of Breach BN-19-6-237. In this regard, the HSE confirmed that it was the controller,
both in its notification to the Commission on 14 June 2019 and in correspondence to the
Commission during the course of the Inquiry1.

iii. Legal Basis for the Decision

2.4 The decision-making process for the Inquiry which applies to this case is provided for under
Section 111 of the 2018 Act, and requires that the Commission must consider the information
obtained during the Inquiry; to decide whether an infringement is occurring or has occurred;
and if so, to decide on the corrective powers, if any, to be exercised. As the sole member of
the Commission, I perform this function in my role as the decision-maker in the Commission.
In so doing, I am required to carry out an independent assessment of all of the materials
provided to me by the Case Officer as well as any other materials which have been furnished
to me by HSE, and any other materials which I consider to be relevant, in the course of the
decision-making process

2.5 The Final Inquiry Report was transmitted to me on 27 April 2020, together with the Case
Officer’s file, containing copies of all correspondence exchanged between the Case Officer
and the HSE; and copies of all submissions made by the HSE, including the submissions made
by the HSE in respect of the Draft Inquiry Report. A full schedule of all documentation
considered by me for the purpose of my preparation of this Decision is appended hereto. I
issued a letter to the HSE on 23 June 2020 to notify it of the commencement of the decision-
making process.

2.6 Having reviewed the Final Inquiry Report, and the other materials provided to me by the Case
Officer (including the submissions made by the HSE), I was satisfied that the Inquiry was
correctly conducted and that fair procedures were followed throughout, including, but not
limited to, notifications to the controller and opportunities for the controller to comment on
the Draft Inquiry Report before it was submitted to me as decision-maker.

3. Factual Background

3.1 The HSE notified the DPC of personal data breach BN-19-6-237 on 14 June 2019. This personal
data breach occurred on 4 June 2019 when a student on work placement disposed of
documentation containing the personal data of 78 individuals, including special category
personal data in respect of 6 of those data subjects, in a public recycling centre. The list was
created in Cork University Maternity Hospital, but was discovered by a member of the public
in a public recycling area in Cork County. The HSE became aware of the breach on 12 June
2019 when that member of the public notified them.

1
Correspondence dated 7 February 2020.

3.2 The Case Officer informed the HSE of the commencement of the Inquiry by way of a Notice of
Commencement of Inquiry dated 17 October 2019 (“the Notice”). The Notice set out the
scope and legal basis of the Inquiry. The decision to commence the Inquiry was taken having
regard to the circumstances of personal data breach BN-19-6-237. The Notice informed the
HSE that the Inquiry would examine whether or not the HSE discharged its obligations in
connection with the subject matter of that personal data breach and determine whether or
not any provision(s) of the 2018 Act and/or the GDPR has been contravened by the HSE in that
context. In this regard, the scope of the Inquiry was expressly stated to include Articles 5(1)(f)
and 32(1) of the GDPR, with focus on the areas of Data Protection Governance, Training and
Awareness, Records Management, and Security of Personal Data. The Notice also noted that
personal data breach BN-19-6-237 was the fourth such occurrence involving inappropriate
disposal of patient records in the HSE South region. It also noted that the HSE had also notified
the DPC of four further personal data breaches concerning the loss of paper records. The
Notice set out that the Inquiry would formally document the facts as they relate to the subject
of the Inquiry. The facts, as established during the course of the Inquiry, are set out below.

3.3 The HSE acknowledged receipt of the Notice on 22 October 2019 and nominated a point of
contact. The Case Officer wrote to the HSE on 6 November 2019 inviting submissions of any
additional information. The HSE made comprehensive submissions on 26 November 2019, in
which it also accepted that the background provided in the Notice was an accurate account.

3.4 In its submissions dated 26 November 2019, the HSE “outlined the technical and
organisational measures which the HSE have in place to meet the requirements of the GDPR
principles”. The submissions outlined policies, codes, and procedures that the HSE has in place
in relation to data protection governance. It also referred to certain codes and guidance
provided by the Nurse and Midwifery Board of Ireland. The submissions detailed the steps
that the HSE has taken to provide training and awareness to staff to ensure compliance with
the GDPR. The submissions also set out security measures implemented that are specific to
the loss of documents in the breaches considered in the Inquiry, including the policy on the
availability of confidential waste bins, and steps taken to encourage staff to handle personal
data appropriately. The submissions also appended a number of documents, which are
considered throughout this Decision.

3.5 Having received the HSE’s submissions, the Case Officer proceeded to prepare the Draft
Inquiry Report, which set out the Case Officer’s provisional views as to the facts identified and
views as to whether the HSE had complied with its obligations under the 2018 Act and the
GDPR. The Case Officer furnished the HSE with the Draft Inquiry Report on 12 December 2019
and invited the HSE’s submissions on the issues contained therein.

3.6 The HSE made submissions on the Draft Inquiry Report on 16 January 2020. The HSE submitted
that its National Director of Internal Audit included data protection audits within the annual
HSE Internal Audit Programme in 2019, and that two such audits have taken place, in the
Human Resource Investigation Unit and a large acute hospital. The submissions also detailed
the HSE Internal Controls Assurance Function, which places responsibility on managers to

confirm that data protection policies and procedures are fully applied in their area of
responsibility. The submissions also provided that the HSE uses a document management
system to ensure that the most updated version of documents are available to staff. The HSE
confirmed that the staff member who removed the personal data in BN-19-6-237 had signed
a Practice Placement Agreement. The HSE also made submissions on the role of the Nurse and
Midwifery Board of Ireland in regulating, monitoring and enforcing standards imposed on
nurses, midwives, and students. The submissions also appended the HSE External Review
process.

3.7 The Case Officer identified additional information that was required in light of the submissions
and wrote to the HSE on 20 January 2020 requesting that information. The HSE made further
submissions on 7 February 2020. Those submissions clarified matters pertaining to the HSE’s
Internal Audit function, the Controls Assurance Process, and External Review Process. The HSE
also emphasised the importance of collaboration with the training schools, while accepting
that responsibility for providing security of personal data rests with the HSE.

3.8 On 3 March 2020, the Case Officer invited submissions from the HSE regarding the measures
that were in place at the time of the personal data breach to comply with Article 32 GDPR and
by reference to the principle set down in Article 5(1)(f) GDPR. In particular, this request
concerned the HSE’s assessment of risk and measures for ensuring and testing the security of
processing. The HSE replied on 6 April 2020 confirming that the measures outlined in previous
submissions were in place at the time of the personal data breach.

3.9 On 27 April 2020, the Case Officer completed the final Inquiry Report and submitted it to me
as decision-maker. I have considered the Inquiry Report and all relevant correspondence and
submissions. The HSE was provided with my Draft Decision on 23 July 2020 was afforded the
opportunity to make submissions on the infringements that were provisionally identified
therein and the corrective powers that I proposed to exercise. On 12 August 2020, the HSE
confirmed that it has commenced a process in conjunction with the National Director of Acute
Operations to re-focus efforts in relation to mitigation of risks associated with the
management of paper records and, in particular patient lists. The HSE stated that it would not
be making any further submissions in relation to this Inquiry. I have reached final conclusions
that infringements of data protection legislation have occurred and that it is necessary to
exercise certain corrective powers. Those infringements and corrective powers are set out in
this Decision.

4. Scope of the Inquiry and the Application of the GDPR

4.1 The scope of the Inquiry, which was set out in the Notice of the Commencement of the
Inquiry, is to examine whether or not the HSE has discharged its obligations in connection
with the subject matter of personal data breach BN-19-6-237 and determine whether or not
any provision(s) of the Act and/or the GDPR has been contravened by the HSE in that context.
In this regard, the Notice of Commencement of Inquiry specified that the Inquiry would focus
on Data Protection Governance; Training and Awareness; Records Management; and
Security of Personal Data.

4.2 Personal data breach BN-19-6-237 occurred when a student nurse took an inpatient list
outside of Cork University Maternity Hospital and disposed of it in a public recycling area. A
member of the public found the document and reported it to the HSE. The inpatient list
contained the personal data of 78 patients, including personal data concerning health in
respect of 6 data subjects. In line with the subject matter of this personal data breach, this
Decision considers the HSE’s obligations under Articles 5(1)(f) and 32(1) in respect of its use
and disposal of hardcopy documents containing patients’ personal data. The HSE is obliged
to implement an appropriate level of security in respect of those processing operations.

4.3 The Notice of Commencement of Inquiry referred to 7 other personal data breaches notified
by the HSE to the DPC. The information obtained in relation to those personal data breaches
are relevant to the scope of the Inquiry insofar as they detail the level of security
implemented by the HSE regarding its use and disposal of hardcopy documents. BN-19-1-
281, BN-19-3-68, BN-19-3-233, BN-19-3-381, BN-19-5-5, and BN-19-6-237 all concern
instances where hardcopy documents containing personal data concerning health were
found outside of the hospital by members of the public or other hospital staff. BN-19-5-323
occurred when hardcopy files containing personal data were misplaced during a department
move to a new building. There was no special category data involved in this breach. BN-19-
2-219 occurred when a quantity of hardcopy documents were found on a disused hospital
site. This was reported to the DPC, however it was later confirmed that the documents did
not contain personal data.

4.4 Article 2(1) of the GDPR defines the Regulation’s scope as follows:

“This Regulation applies to the processing of personal data wholly or partly by
automated means and to the processing other than by automated means of personal
data which form part of a filing system or are intended to form part of a filing system.”

4.5 The manual processing of hardcopy documents falls within the scope of the GDPR only if the
personal data within those documents form part of a filing system or are intended to form
part of a filing system.

4.6 Article 4(6) of the GDPR defines “filing system”:

“‘filing system’ means any structured set of personal data which are accessible
according to specific criteria, whether centralised, decentralised or dispersed on a
functional or geographical basis;”

4.7 Recital 15 provides guidance for interpreting the material scope of the GDPR:

“In order to prevent creating a serious risk of circumvention, the protection of natural
persons should be technologically neutral and should not depend on the techniques
used. The protection of natural persons should apply to the processing of personal
data by automated means, as well as to manual processing, if the personal data are
contained or are intended to be contained in a filing system. Files or sets of files, as

well as their cover pages, which are not structured according to specific criteria should
not fall within the scope of this Regulation.”

4.8 Medical files form part of a “filing system” because they contain the personal data of patients
and are accessible according to specific criteria, such as the patient’s name or other
identifier. Therefore, any personal data processed by the HSE that are intended to form part
of medical files fall within the scope of the GDPR, regardless of whether such personal data
are actually stored in such files. This prevents controllers from attempting to circumvent the
GDPR by processing personal data manually and/or outside of their usual filing systems. The
hardcopy documents in BN-19-1-28, BN-19-3-68, BN-19-3-233, BN-19-3-381, BN-19-5-5 and
BN-19-6-237 all contained special category personal data concerning health. Therefore, I am
satisfied that some of the personal data on the handover lists and inpatient lists are also
intended to be recorded separately in a filing system. Therefore, even where that personal
data are recorded separate to the filing system, the GDPR is applicable on the basis that the
personal data concerning health is intended to be recorded in the medical files.

4.9 BN-19-5-323 did not involve special category health data. This personal data breach occurred
when files were misplaced during a department’s move to a new building. The personal data
in the files included the names, surnames and dates of birth of two vulnerable data subjects.
Both of the files were eventually found by the HSE, however, they were missing for 8 months
and 10 months respectively. The HSE did not utilise any audit trails during the department’s
move between buildings, meaning that there was no record of how the files were transferred
or lost. I am satisfied that these hardcopy files contain personal data and form part of a filing
system. Therefore, they fall within the scope of the GDPR.

4.10 The HSE initially assumed that the files found in BN-19-2-219 contained personal data.
However, following analysis by an expert company, the HSE confirmed that the files, in fact,
did not. Therefore, those hardcopy documents fall outside the scope of the GDPR and the
information obtained in BN-19-2-219 is not relevant for the purposes of this Decision. As
outlined above, the processing of personal data in the remaining 7 personal data breaches
falls within the scope of the GDPR and the information obtained in relation to those breaches
are relevant to this Decision.

5. Analysis and Findings

5.1 Having reviewed the Inquiry Report and the other materials provided to me, I consider that
the issue in respect of which I must make a decision is whether the HSE has complied with its
obligations under Articles 5(1)(f) and 32(1) of the GDPR in connection with its use and disposal
of hardcopy documents containing patients’ personal data. I must determine whether the HSE
implemented appropriate technical and organisational measures in respect of those
processing operations.

5.2 Article 5(1)(f) of the GDPR provides for the principle of integrity and confidentiality. It requires
that personal data shall be:

“processed in a manner that ensures appropriate security of the personal data,
including protection against unauthorised or unlawful processing and against
accidental loss, destruction or damage, using appropriate technical or organisational
measures”

5.3 Article 32(1) of the GDPR elaborates on the principle in Article 5(1)(f) by setting out criteria
for assessing what constitutes “appropriate security” and “appropriate technical or
organisational measures”:

“Taking into account the state of the art, the costs of implementation and the nature,
scope, context and purposes of processing as well as the risk of varying likelihood and
severity for the rights and freedoms of natural persons, the controller and the
processor shall implement appropriate technical and organisational measures to
ensure a level of security appropriate to the risk, including inter alia as appropriate:

(a) the pseudonymisation and encryption of personal data;

(b) the ability to ensure the ongoing confidentiality, integrity, availability and
resilience of processing systems and services;

(c) the ability to restore the availability and access to personal data in a timely
manner in the event of a physical or technical incident;

(d) a process for regularly testing, assessing and evaluating the effectiveness of
technical and organisational measures for ensuring the security of the
processing.”

5.4 Articles 5(1)(f) and 32(1) of the GDPR oblige controllers and processors to implement a level
of security appropriate to the risks presented by its processing of personal data. The
processing operations within the scope of this Decision concern the HSE’s use and disposal of
hardcopy documents containing patients’ details. In considering the technical and
organisational measures that the HSE was obliged to implement, regard must be had to the
risk presented to the rights and freedoms of natural persons by those processing operations.
Therefore, the first step is to assess this risk. The HSE did not document any such risk
assessment before the personal data breaches occurred.

i. Assessing Risk

5.5 The HSE’s use and disposal of hardcopy documents containing patients’ personal data creates
the risk of an unauthorised disclosure of personal data to third parties where the documents
are not stored or disposed of securely. The technical and organisational measures that the
HSE is obliged to implement must be appropriate to this risk.

5.6 Recital 76 of the GDPR provides guidance as to how risk should be evaluated:

“The likelihood and severity of the risk to the rights and freedoms of the data subject
should be determined by reference to the nature, scope, context and purposes of the
processing. Risk should be evaluated on the basis of an objective assessment, by which
it is established whether data processing operations involve a risk or a high risk.”

5.7 Digital Rights Ireland v Minister for Communications, Marine and Natural Resources and
others2 provides further guidance on this risk assessment. In this case, the CJEU declared the
Data Retention Directive3 invalid. The Directive required electronic communication service
providers to retain certain data for a period of time. The Court held that the directive did not
ensure effective protection of the data retained against the risk of abuse and unlawful access
in circumstances where it did not lay down specific rules in relation to (i) the vast quantity of
data retained, (ii) the sensitive nature of the data, and (iii) the risk of unlawful access.

5.8 Risk is assessed objectively by reference to (i) the likelihood of the risk to the rights and
freedoms of natural persons, and (ii) the severity of that risk. Hence, the risk assessment must
consider, first, the likelihood of unauthorised disclosure of, or access to, hardcopy documents
containing patients’ personal data, and, second, the severity of that risk in respect of the rights
and freedoms of the data subjects. These objective assessments are made by reference to the
nature, scope, context and purposes of the processing. In considering these factors, regard
must also be had to the quantity of personal data processed and the sensitivity of that data.

5.9 The quantity of patients’ personal data processed by the HSE in hardcopy documents is at the
higher end of the scale. The quantity of personal data on a given document varies according
to the circumstances. For example, the personal data in BN-19-5-323 concerned the names
and dates of birth of 2 data subjects. However, the personal data in BN-19-6-237 concerned
the personal data of 78 data subjects, including data concerning health regarding 6 of those
data subjects. The HSE’s investigation into this personal data breach found that the personal
data on the list included patient name, consultant name, patient current medical situation,
previous background history, and a list of upcoming plans for assessments and treatment.
Further, there is a significant possibility of one of the 78 data subjects being identifiable to
the member of the public who found the list in light of the number of data subjects and that
the list was found in the same county as the hospital. The quantity of documents generated
by the HSE containing personal data is high. In addition to the patient files in BN 19-9-1, the
personal data breaches concerned handover lists and impatient lists. The HSE’s investigation
into BN-19-6-237 details how it generates the lists to identify patients who come under staff
care at each shift change and how the lists are necessary for continuing patient care and

2
Joined Cases C-293/12 and C-594/12, Digital Rights Ireland Ltd v Minister for Communications, Marine and
Natural Resources, Minister for Justice, Equality and Law Reform, Commissioner of the Garda Síochána,
Ireland, The Attorney General, intervener: Irish Human Rights Commission, and Kärntner Landesregierung,
Michael Seitlinger, Christof Tschohl and others, judgment of 8 April 2014 (ECLI:EU:C:2014:238).
3
Directive 2006/24/EC of the European Parliament and of the Council of 15 March 2006 on the retention of
data generated or processed in connection with the provision of publicly available electronic communications
services or of public communications networks and amending Directive 2002/58/EC

treatment. These lists can contain a large quantity of sensitive personal data4. The speed at
which the HSE generates and disposes of the lists creates a higher risk of unauthorised
disclosure and access.

5.10 The sensitivity of the personal data processed by the HSE in hardcopy form is also at the higher
end of the scale. 6 out of the 7 personal data breaches relevant to this Decision involved
special category personal data. Data concerning health5 is special category personal data
pursuant to Article 9 of the GDPR. This personal data, by its very nature, is particularly
sensitive with regard to the fundamental rights and freedoms of data subjects.

5.11 It is necessary to turn now to the nature, scope, context and purposes of the processing. The
nature of the HSE’s use and disposal of hardcopy documents containing patients’ personal
data is highly sensitive in circumstances where it includes data concerning health. The HSE
has statutory responsibility for the management and delivery of health and personal social
services to the population of Ireland and describes itself as the largest employer in the State6.
It is clear that the HSE has a significant body of staff who are required to handle hardcopy
documentation containing sensitive personal data, including students on work placement7.

5.12 The scope of the HSE’s processing is broad. Handover lists and impatient lists may contain
contemporaneous accounts of the medical care provided to a large number of patients. The
scope of processing in patient files may include patients’ comprehensive medical histories.

5.13 The context of the HSE’s processing is inherently transient in some instances. The HSE creates
handover lists and inpatient lists daily for the purpose of shift changes. This means that the
lists may remain relevant for a short time-period before becoming superseded. This creates a
higher risk that staff may fail to store or dispose of the lists securely in the absence of
appropriate measures. It also increases the likelihood of staff accidentally taking the lists
outside the hospital at shift changes. This contrasts with the context in which personal data
in patient files are processed. Patient files are more permanent, which may result in a lower
risk of them being taken outside the hospital or disposed of without an appropriate level of
security.

5.14 The purposes of the HSE’s use and disposal of hardcopy documents containing patients’
personal data relates to the HSE’s functions of managing and delivering health and personal
social services. Such purposes may justify significant processing operations concerning
sensitive personal data. These purposes may also require the sharing of personal data among
a large team of staff in the HSE in order to deliver medical care. This heightens the risk to the
rights and freedoms of data subjects.

4
For example, the list in BN-19-3-68 contained clinical information concerning 14 data subjects, the list in BN-
19-6-237 contained clinical information concerning 6 of the 78 data subjects affected, and the list in BN-19-3-
381 contained clinical information concerning 55 data subjects.
5
Article 4(15) of the GDPR provides: data concerning health’ means personal data related to the physical or
mental health of a natural person, including the provision of health care services, which reveal information
about his or her health status.
6
Appendix 9 to HSE’s submissions on 26th November 2019.
7
See BN-19-6-237.

5.15 I find that there is a high risk, both in likelihood and severity, to the rights and freedoms of
natural persons, from the HSE’s use and disposal of hardcopy documents containing patients’
personal data. In particular, the risk relates to the potential for an unauthorised disclosure of
patient personal data where hardcopy documents are not stored or disposed of securely. The
number of staff, the quantity of documentation that they are required to handle, and the
transient nature of some of that documentation creates a high risk that the documents may
not be stored or disposed of securely. A risk of unauthorised disclosure naturally follows from
this risk. The high severity of the risk to the rights and freedoms of natural persons occurs due
to the sensitive nature of the processing that the HSE undertakes and the purposes for which
it is undertaken. The provision of health and personal social services is intrinsically linked to
the rights and freedoms of patients, and unauthorised disclosures of health data has
significant capacity to infringe those rights and freedoms.

ii. Security Measures Implemented by the HSE

5.16 The HSE’s submissions outline the technical and organisational measures that it had in place
at the time of personal data breach BN-19-6-237. The measures relevant to the HSE’s use and
disposal of hardcopy documents containing patients’ personal data can be categorised as:

a) Policies and Procedures,
b) Training and Awareness, and
c) Testing, Assessing and Evaluating the Effectiveness of its Measures.

(a) Policies and Procedures

5.17 The HSE’s Data Protection Policy, Version 1.0, dated 25 May 2018, was in place at the time of
the notified personal data breaches. The Policy applies to all HSE staff, students, interns and
work experience candidates, amongst others. Section 6.8 provides:

“All persons covered under this policy are prohibited from disclosing a data subject’s
confidential information (including personal data or special categories of personal
data), unless this policy or a legal basis allows for such disclosures.”

5.18 The HSE Waste Management Awareness Handbook, Rev A, dated 2014, sets out polices for
various types of waste. It requires that confidential paper files and documents are shredded
before recycling8. Furthermore, the HSE submitted that it has increased the number of
confidential waste bins available at strategic locations. However, the Waste Management
Awareness Handbook, and the other documents submitted, do not set out any procedure for
how confidential shredding is to be implemented by the HSE in its hospitals. There is no
process that determines how confidential waste is to be stored pending its disposal,
responsibility for ensuring secure disposal, or how waste paper consoles are installed and
maintained. Furthermore, the HSE does not have any standard operating procedure that

8
At page 17.

determines how the particularly high-risk handover lists and inpatient lists must be created,
used, and disposed of.

5.19 Cork University Hospital’s booklet titled “Clincal Placement Information for BSc (Hons) Nursing
Students” provides guidance to students regarding clinical placements. This includes guidance
regarding confidentiality at section 7.1:

“Confidentiality: Information regarding a patient’s history, treatment and state of
health is privileged and confidential information (Code of Professional Conduct and
Ethics for Registered Nurses and Midwives, NMBI 2014. All enquiries regarding
patients/clients must be referred to qualified staff. Patient/clients details must not be
discussed outside the ward environment. Please discard carefully all hand written
notes pertaining to patients at the end of your shift in the confidentiality bin.”

5.20 Cork University Hospital’s Hospital booklet titled “Hospital Orientation Information for BSc
Undergraduate Nursing Students”, dated November 2019, repeats that patient information
must be kept confidential and that confidential reports should be discarded in the
confidentiality bins provided9.

5.21 The HSE also made submissions on codes and manuals implemented by the Nursing and
Midwifery Board of Ireland (the “NMBI”). The NMBI is a statutory body that regulates the
nursing and midwifery professions in Ireland and registration with the NMBI is a pre-requisite
to employment with the HSE as a nurse or midwife. NMBI Codes and manuals are not
measures implemented by the HSE and the HSE, as data controller, is ultimately responsible
for ensuring an appropriate level of security. However, in assessing the appropriate level of
security, it is appropriate to have regard to the context in which the processing occurs.
Therefore, I consider that binding professional standards imposed on members of regulated
professions may be relevant to a controller’s assessment of the technical and organisational
measures that it is obliged to implement. Without prejudice to the obligation on the HSE, as
controller, to implement an appropriate level of security, in assessing the appropriate
technical and organisational measures that must be implemented, I accept that I must have
regard to collaboration between the HSE, training schools, and the regulated professions.
However, as acknowledged by the HSE in its submissions dated 7 February 2020, while this
context is relevant to assessing the measures that are appropriate to the risk, the HSE, as data
controller, is responsible for ensuring that appropriate security measures are implemented.

5.22 The HSE submitted the NMBI’s “Code of Professional Conduct and Ethics for Registered Nurses
and Registered Midwives”, dated December 2014. The code details the principle of trust and
confidentiality and provides that “Patients have a right to expect that their personal
information remains private”10. The HSE also submitted the NMBI’s professional guidance
“Recording Clinical Practice”, dated November 2015. This document sets out records
management practices for nurses and midwives and provides that “Confidentiality concerning

9
At page 9.
10
At page 23.

the patient record is an expression of the trust inherent in the therapeutic relationship with a
patient”11.

5.23 The HSE also submitted its Information Technology Security Policy12 and Access Control
Policy13. These policies concern information technology security and resources. These policies
are not applicable to the risk presented by the HSE’s use and disposal of hardcopy documents
containing patients’ personal data. Therefore, the content of those policies fall outside the
scope of this Decision.

(b) Training and Awareness

5.24 The HSE implemented an online “Fundamentals of GDPR” training programme. The
programme provides a comprehensive introduction to the GDPR and was made available to
all staff. As of 26th November 2019, 40,000 staff had completed the programme. The HSE also
provided customised GDPR Awareness sessions to hospitals and community services. The HSE
promotes GDPR training with its staff using national broadcast emails and on the HSE intranet.
It facilitated a number of “town hall” style GDPR awareness sessions in hospitals to improve
data privacy vigilance.

5.25 The HSE implemented a template Practice Placement Agreement between the HSE, University
College Cork, and students on the BSc Nursing Programme. Nursing students agree to act
according to NMBI’s Code of Professional Conduct and Ethics for Registered Nurses and
Midwives. In this agreement, students also undertake to familiarise themselves and comply
with the HSE’s policies. Clause 10 of the agreement provides:

“I understand and accept to be bound by the principle of confidentiality of individuals’
records and data. I will therefore take all necessary precautions to ensure that any
personal data concerning individuals, which I have learned by virtue of my position as
a nursing student, will be kept confidential. I confirm that I will not discuss individuals
with any other party outside the clinical setting, except anonymously. When recording
data or discussing care outside the clinical setting, I will ensure that individuals cannot
be identified by others. I will respect all Health Service Providers’ and individuals’
records.”

5.26 The HSE implemented a management system for its policies, procedures, protocols and
guidelines. This system makes the most up to date versions of data protection related policies
available to staff. The Department of Nurse Practice and Development in Cork University
Hospital require nursing staff to maintain a Practice Development Record, which includes the
review of data protection policies and procedures.

11
At page 5.
12
HSE Information Technology (I.T.) Security Policy, Version 3.0, dated February 2013.
13
HSE Access Control Policy, Version 3.0, dated February 2013.

5.27 The HSE has strategically placed confidential waste bins to make it easier for employees to
dispose of documents securely. It also placed posters in staff areas and exits to encourage
staff to dispose of personal data before leaving their department at the end of each shift.

5.28 The HSE Internal Audit Programme commenced in 2019 and data protection audits have taken
place in the Human Resource Investigation Unit and Connolly Hospital, Blanchardstown. The
audit findings are not available because the audits have not been finalised.

5.29 The HSE seeks assurance from its managers regarding compliance with its Data Protection
Policy through annual Controls Assurance Statements. These statements ask managers to
confirm as follows:

“I am aware of the data protection requirements that affect my area of responsibility
and in compliance with the revised HSE Data Protection Policy and revised Subject
Access Request Procedure and Data Breach Reporting Procedures following the
introduction of the Data Protection 2018 (GDPR).”

iii. The Appropriate Level of Security

5.30 Having regard to the high risk to the rights and freedoms of data subjects, in terms of both
likelihood and severity, presented by the HSE’s use and disposal of hardcopy documents
containing patients’ personal data, an appropriate level of security must include a standard
operating procedure setting out how secure shredding is to be implemented. I note the HSE’s
policy that confidential paper files and documents must be shredded before being disposed
of. However, in light of the quantity of sensitive hardcopy documents that the HSE handles, a
standard operating procedure for putting this policy into action is appropriate to the risk. This
procedure should set out accountability for ensuring secure disposal of confidential waste,
how confidential waste is to be stored pending its disposal, and how waste paper consoles
are located and maintained.

5.31 Having regard to the particularly high risk presented by the HSE’s use and disposal of handover
lists and inpatient lists, I find that an appropriate level of security must also include a standard
operating procedure that sets out responsibility for the secure creation, use and disposal of
those lists. The HSE cited various policies during the Inquiry concerning the confidentiality of
patients’ health data. For example, the Data Protection Policy prohibits the disclosure of
personal data without a legal basis. However, there remains a significant risk that staff may
inadvertently disclose or lose handover lists and inpatient lists. General prohibitions on
unlawful disclosures are not sufficient to protect against this risk. A specific process that
incorporates data secure practices is appropriate in light of the sensitivity of personal data
contained on the lists and the speed at which the HSE generates and disposes of the lists. This
procedure, once implemented, must be communicated to all relevant staff.

5.32 The HSE must determine the provisions of the standard operating procedures based on its
own risk assessment and in light of its own functions. I note that the HSE is currently
considering an IT solution or another solution for identifying staff responsibility in respect of
printed lists14 and that it has commenced a process to further mitigate the risks associated
with the management of paper records and, in particular patient lists15. Another measure that
may be considered is a sign-off sheet where staff confirm that they have safely disposed of
lists16. Whether these measures are adopted, and the precise content of the procedures, must
be determined by the HSE in light of a broader assessment of its functions and the risk.
However, the handover and inpatient lists procedure must provide clear instructions to staff
as to how the lists can be shared, when and how they must be disposed of, and responsibility
for ensuring they are disposed of securely. The HSE’s investigation into personal data breach
BN-19-6-237 found that the list was “inadvertently disposed of”. Therefore, in addition to the
requirement that confidential documents must be shredded, the risk could be mitigated by a
rule that prohibits the removal of handover lists and inpatient lists from the hospital premises
and that mandates that secure shredding must occur on site. The procedure should also set
out the managerial responsibility for bringing the procedure to the attention of staff
members. I have had regard to the state of the art and the cost of implementing standard
operating procedures for handover inpatient lists, and for secure shredding. I am satisfied that
implementing the procedures would not impose a cost that is disproportionate to the risk.
Therefore, the failure to implement procedures infringes Article 5(1)(f) and 32(1) of the GDPR
in the circumstances.

5.33 Creating policies and processes is essential to implementing an appropriate level of security.
However, where staff handle sensitive personal data, the provision of appropriate staff
training and awareness is also essential. An appropriate level of security includes
organisational measures to ensure that staff members give effect to the HSE’s policies and
processes. I find that the organisational measures implemented by the HSE regarding staff
training and awareness were not appropriate to the risk. The HSE provided online
“Fundamentals of GDPR” training, supplemented by broadcast emails and “town hall” style
sessions. The amount and nature of the training provided was not appropriate to the HSE’s
high risk processing. The Inquiry found no evidence of measures in place to ensure completion
of the “Fundamentals of GDPR”. As of 26th November 2019, over 18 months after the GDPR
came into force, a majority of the national HSE workforce had not completed the training17.
The Inquiry found no evidence of regular refresher training for staff. Regular refresher training
is appropriate in light of the high risk presented by the processing, in particular the frequency
with which staff are required to handle highly sensitive personal data in hardcopy form.
Furthermore, the Inquiry found no evidence of data protection training provided to students.
The HSE’s duty regarding training and awareness is not limited to permanent staff, and
extends to all persons at the place of work. In light of the sensitivity of the personal data
handled by students, I find that an appropriate level of security must include training on data

14
HSE Investigation Report on BN-19-3-68 at page 3.
15
HSE email to the DPC dated 12 August 2020.
16
This recommendation was made by the Special Investigations Unit of the DPC in its report, “Data Protection
Investigation in the Hospital Sector”, dated May 2018.
17
As noted in the Inquiry Report, 40,000 staff represents 39% of the national HSE workforce.

protection to those students. The undertaking in the Practice Placement Agreement, requiring
nursing students to familiarise themselves and comply with the HSE’s policies, is not sufficient
to address the risk and this must be supplemented by training.

5.34 I have had regard to the cost of implementing measures to ensure the completion of existing
HSE training, regular refresher training, and training to students. I find that such measures
would not impose a cost that is disproportionate to the risk presented by the HSE’s processing.
Therefore, the HSE’s failure to implement these measures infringes Articles 5(1)(f) and 32(1)
of the GDPR.

5.35 Article 32(1)(d) specifies that appropriate technical and organisational measures may include
processes for testing, assessing and evaluating the effectiveness of existing measures. Such
testing, assessing and evaluating applies to both technical and organisational measures.
Personal data breaches may cause significant harm to data subjects and, pursuant to Article
32(1)(d), controllers must take the initiative to test, assess, and evaluate their security
measures. As outlined above, the HSE included two data protection audits in its Internal Audit
Programme in 2019. The HSE also requires managers to confirm compliance with data
protection requirements in their areas of responsibility.

5.36 I find that the HSE failed to implement an adequate process for regularly testing, assessing
and evaluating those measures. The HSE has identified staff failure to apply existing policies
as a cause of a number of the personal data breaches18. However, the Inquiry found no
evidence of any processes in place to test staff awareness of, and compliance with, the HSE
policies. Such testing could have identified ineffectiveness in the HSE’s policies and training
before the breaches occurred. This could have resulted in amendments to existing policies,
the adoption of new policies, and additional training for staff. Appropriate testing could have
taken the form of generalised surveys or more formal testing. I find that a process for regularly
testing staff awareness of, and compliance with, HSE policies would not impose a cost that is
disproportionate to the risk. Therefore, I find that the HSE’s failure to implement such
measures infringes Articles 5(1)(f) and 32(1) of the GDPR in the circumstances.

5.37 Department moves present a risk to the security of personal data where hardcopy documents
are moved from one building to another. In BN-19-5-323 the HSE lost 2 files for 8 months and
10 months respectively during a department move. The HSE did not document the location of
the files during the move, nor did it document accountability for the files. The files in question
were moved to a certain location, but could not be found due to the lack of such records. I
find that an appropriate level of security during such office moves requires the
implementation of measures for recording the location of, and accountability for, files
containing personal data. The HSE’s failure to record the location of the files during the move,
in the circumstances, constitutes and infringement of Articles 5(1)(f) and 32(1) of the GDPR.

18
For example, HSE Investigation Report BN-19-6-237 concludes that “there is a breach of HSE Waste
Management Policy and HSE Data Protection Policy”. Breach notifications BN-19-5-5 and BN-19-6-237 identify
the causes of those personal data breaches as “non-compliance with organisation records management policy”
and “employee error or omission” respectively.

iv. Finding

5.38 I find that the HSE infringed Articles 5(1)(f) and 32(1) of the GDPR by failing to implement
appropriate technical and organisational measures to ensure a level of security appropriate
to the risk presented by its use and disposal of hardcopy documents containing patients’
personal data. The measures that ought to have been implemented include: a standard
operating procedure setting out how secure shredding is to be implemented in hospitals; a
standard operating procedure that sets out responsibility for the secure creation, use and
disposal of handover lists and inpatient lists; the implementation of measures to ensure
completion of existing HSE data protection training, regular refresher data protection training,
and data protection training to students; a process for regularly testing, assessing and
evaluating the effectiveness of its existing security measures; and the implementation of
measures for recording the location of, and accountability for, hardcopy documents
containing personal data throughout future office moves.

6. Corrective Powers

6.1 I have set out above, pursuant to Section 111(1)(a) of the 2018 Act, my decision to the effect
that the HSE has infringed Articles 5(1)(f) and 32(1) of the GDPR. Under Section 111(2) of the
2018 Act, where the Commission makes a decision (in accordance with Section 111(1)(a)), it
must, in addition, make a decision as to whether a corrective power should be exercised in
respect of the controller or processor concerned and, if so, the corrective power to be
exercised. Having carefully considered the infringements, identified in this Decision, I have
decided to exercise corrective powers in accordance with Section 115 of the 2018 Act and
Article 58(2) of the GDPR. I set out below the corrective powers that are appropriate to
address the infringements and are effective, proportionate and dissuasive in the particular
circumstances, and the reasons for that decision, having considered all of the corrective
powers set out in Article 58(2):

(i) Article 58(2)(d) – I have decided to order the HSE to bring its processing into compliance
with Articles 5(1)(f) and 32(1) of the GDPR,
(ii) Article 58(2)(b) – I have decided to issue a reprimand to the HSE in respect of its
infringements of Articles 5(1)(f) and 32(1) of the GPPR, and
(iii) Article 58(2)(i) – I have decided to impose an administrative fine, pursuant to Article 83,
in respect of the HSE’s infringements of Articles 5(1)(f) and 32(1) of the GDPR.

A. Order to Bring Processing into Compliance

6.2 In accordance with Article 58(2)(d) of the GDPR, I have decided to order the HSE to bring its
processing operations regarding the use and disposal of hardcopy documents containing
patients’ personal data into compliance with Articles 5(1)(f) and 32(1) of the GDPR. This order
requires the HSE to implement appropriate technical and organisational measures to ensure
a level of security appropriate to the risk.

6.3 My decision to impose this order is made to ensure that full effect is given to the HSE’s
obligation to implement appropriate technical and organisational measures. In deciding that
an order is appropriate to achieve this end, I have had particular regard to the high quantity

of highly sensitive personal data processed by the HSE. The HSE must perform the necessary
risk assessment to inform the measures that it must implement. However, as outlined above,
those measures must include:

a) A standard operating procedure setting out how secure shredding is to be
implemented in hospitals;
b) A standard operating procedure that sets out responsibility for the secure creation,
use and disposal of handover lists and inpatient lists;
c) The implementation of measures to ensure completion of existing HSE data
protection training, regular refresher data protection training, and data protection
training to students;
d) A process for regularly testing, assessing and evaluating the effectiveness of its
existing security measures; and
e) The implementation of measures for recording the location of, and accountability
for, hardcopy documents containing personal data throughout future office moves.

6.4 I direct the HSE to submit a report to the DPC outlining the steps it has taken in respect of
each of these measures on or before 18 December 2020.
. It must be noted that implementing
these measures does not relieve the HSE of its obligation to continually evaluate the
effectiveness of its measures and the measures that are necessary to ensure a level of
security that is appropriate to the dynamic risk presented by use and disposal of hardcopy
documents containing patients’ personal data.

B. Reprimand

6.5 I issue the HSE with a reprimand in respect of its infringements of Article 5(1)(f) and 32(1) of
the GDPR. Article 58(2)(b) provides that a supervisory authority shall have the power to “issue
reprimands to a controller or processor where processing operations have infringed provisions
of this Regulation.” In imposing a corrective power, and in accordance with Recital 129, I must
ensure that it is “…necessary and proportionate in view of ensuring compliance with this
Regulation, taking into account the circumstances of each individual case…”.

6.6 Recital 148 is provides:

“In order to strengthen the enforcement of the rules of this Regulation, penalties,
including administrative fines should be imposed for any infringement of this
Regulation, in addition to, or instead of appropriate measures imposed by the
supervisory authority pursuant to this Regulation. In a case of a minor infringement
or if the fine likely to be imposed would constitute a disproportionate burden to a
natural person, a reprimand may be issued instead of a fine.”

6.7 Accordingly, it is clear from the GDPR that a reprimand does not have to be issued in isolation
to the exercise of any other corrective power. In this respect, I consider it necessary and
proportionate to impose a reprimand in addition to the order in Part 6(A) of this Decision and
the administrative fine detailed below. The decision to impose a reprimand is based on the
nature of the infringements of Articles 5(1)(f) and 32(1). The objective of these Articles is to
ensure that controllers and processors implement a level of security that is appropriate to
the risk presented by their processing operations. The HSE’s infringements of these Articles
is particularly serious in light of the sensitivity of personal data that it processes. I consider
that the imposition of a reprimand is both necessary and proportionate in light of the

importance of ensuring compliance with Articles 5(1)(f) and 32(1) in the context of protecting
the fundamental rights and freedoms of data subjects. I consider that it is necessary and
proportionate to recognise the seriousness of non-compliance of this nature with a
reprimand in light of that objective of ensuring compliance with Articles 5(1)(f) and 32(1).

C. Administrative Fine

6.8 In addition to the corrective powers under Article 58(2)(b) & (d), I have also decided to
impose an administrative fine on the HSE for its infringements of Articles 5(1)(f) and 32(1) of
the GDPR.

i. Decision to Impose an Administrative Fine

6.9 In order to determine whether an administrative fine should be imposed under Article
58(2)(i) GPDR, and to decide on the value of the fine(s) if applicable, I must give due regard
to the criteria set out in Article 83(2) GDPR:

“Administrative fines shall, depending on the circumstances of each individual case, be
imposed in addition to, or instead of, measures referred to in points (a) to (h) and (j) of
Article 58(2). When deciding whether to impose an administrative fine and deciding on
the amount of the administrative fine in each individual case due regard shall be given
to the following:

(a) the nature, gravity and duration of the infringement taking into account the nature
scope or purpose of the processing concerned as well as the number of data subjects
affected and the level of damage suffered by them;

(b) the intentional or negligent character of the infringement;

(d) the degree of responsibility of the controller or processor taking into account
technical and organisational measures implemented by them pursuant to Articles 25
and 32;

(e) any relevant previous infringements by the controller or processor;

(f) the degree of cooperation with the supervisory authority, in order to remedy the
infringement and mitigate the possible adverse effects of the infringement;

(g) the categories of personal data affected by the infringement;

(h) the manner in which the infringement became known to the supervisory authority,
in particular whether, and if so to what extent, the controller or processor notified the
infringement;

(i) where measures referred to in Article 58(2) have previously been ordered against the
controller or processor concerned with regard to the same subject-matter, compliance
with those measures;

(j) adherence to approved codes of conduct pursuant to Article 40 or approved
certification mechanisms pursuant to Article 42; and

(k) any other aggravating or mitigating factor applicable to the circumstances of the
case, such as financial benefits gained, or losses avoided, directly or indirectly, from the
infringement.”

6.10 I will now proceed to consider each of these criteria in turn in respect of the HSE’s
infringements of Articles 5(1)(f) and 32(1) of the GDPR:

a) the nature, gravity and duration of the infringement taking into account the nature scope
or purpose of the processing concerned as well as the number of data subjects affected and
the level of damage suffered by them;

6.11 The nature of the HSE’s infringements of Articles 5(1)(f) and 32(1) comprise a failure to
comply with its obligation to implement an appropriate level of security in respect of its
processing operations concerning the use and disposal of hardcopy documents containing
patients’ personal data. The objective of Articles 5(1)(f) and 32(1) is to protect the rights and
freedoms of natural persons by ensuring that their personal data are processed in a manner
that ensures appropriate security. A failure to implement an appropriate level of security
increases the risk of personal data breaches. This, in turn, poses a threat to the rights and
freedoms of data subjects because of the potential for damage to data subjects where
personal data breaches occur. Therefore, compliance with Articles 5(1)(f) and 32(1) is central
to the protection of the rights and freedoms of natural persons pursuant to the GDPR. As
such, non-compliance with this obligation has serious consequences in that it has the
potential to result in damage to data subjects.

6.12 The gravity of the infringements of Articles 5(1)(f) and 32(1) is serious in circumstances where
the infringements resulted in 7 personal data breaches. A significant number of data subjects
were affected, with BN-19-3-381 and BN-19-6-237 affecting 55 and 78 data subjects
respectively19. Assessed objectively, I consider that the level of damage suffered by the data
subjects had the potential to be high when considered in light of the scope and purpose of
the HSE’s processing. As outlined above, the scope of the processing of personal data in the
personal data breaches is broad and includes special category data concerning health in 6 of
the breaches. The purposes of the processing relates to the HSE’s functions of managing and
delivering health and personal social services. In this context, personal data breaches have
the inherent capacity to cause damage to data subjects. In this regard, 5 of the personal data
breaches occurred when documents were found by members of the public20. The inadvertent
disclosure of personal data to members of the public entails a serious infringement on the
rights and freedoms of the data subjects. Furthermore, BN-19-5-5 resulted in a non-redacted
photograph of the personal data, including special category personal data, being published
in a national daily newspaper. In light of the personal data breaches that flowed from the
HSE’s infringements of Articles 5(1)(f) and 32(1), I assess those infringements to be on the
high end of the scale of gravity.

6.13 Regarding the duration of the infringements of Articles 5(1)(f) and 32(1), it is significant that
the breaches occurred between 15th January 2019 and 4th June 2019. It is also clear that the

19
The Breach Notification originally assessed this figure at 71, however the subsequent HSE investigation
reassessed the figure to 55.
20
BN-19-1-281, BN-19-3-68, BN-19-3-381, BN-19-5-5, and BN-19-6-237.

infringements of Articles 5(1)(f) and 32(1) commenced at the enactment of the GDPR in May
2018. This Decision considers the security measures that the HSE implemented at the time
of the personal data breaches and it does not make findings in relation to the level of security
that it currently implements. Therefore, the duration of the infringements, for the purposes
of this Decision, must be assessed as commencing at 25th May 2018 and ending on the date
of the latest personal data breach on 4th June 2019. Therefore, the duration is just over 1 year
in length.

b) the intentional or negligent character of the infringement;

6.14 The Article 29 Working Party Guidelines on the application and setting of administrative fines
for the purposes of Regulation 2016/679 provide that:

“In general, “intent” includes both knowledge and wilfulness in relation to the
characteristics of an offence, whereas “unintentional” means that there was no
intention to cause the infringement although the controller/processor breached the
duty of care which is required in the law.”21

6.15 I do not consider that there was “intent” on the part of the HSE in respect of its infringements
of Articles 5(1)(f) and 32(1) in the sense that there was “knowledge” or “wilfulness’” on the
their part in respect of their failure to implement an appropriate level of security. In this
regard, I have had regard to the measures that were implemented by the HSE, including its
strategic placement of confidential waste bins and posters. However, I am satisfied that the
HSE was negligent and breached the duty of care required of it by omitting to carry out a risk
assessment to assess the risks of varying likelihood and severity associated with processing
of personal data in hardcopy form and in failing to implement a level of security appropriate
to those risks. In the circumstances, I consider that there was a negligent character to the
HSE’s infringements of Articles 5(1)(f) and 32(1).

c) Any action taken by the controller or processor to mitigate the damage suffered by data
subjects;

6.16 The infringements of Articles 5(1)(f) and 32(1) resulted in 7 personal data breaches. The
personal data was retrieved in each instance. In most instances, members of the public found
the personal data and handed it in to the HSE. This cannot be considered mitigating.
However, in BN-19-3-233, a HSE staff member retrieved the documents soon after another
staff member had lost them. This significantly reduced the potential for unauthorised access
to that personal data and is mitigating in the HSE’s favour. In BN-19-6-237, the HSE conducted
a full search of the area in which the documents were found by a member of the public to
ensure all of the personal data was retrieved. The HSE also sought confirmation from the
individual who found the documents that the contents were not copied or disclosed to third
parties.

6.17 The HSE took steps to reduce the likelihood of similar personal data breaches occurring again.
The HSE circulated reminders to staff to create awareness of keeping personal data secure
and installed additional posters and secure waste bins. It also carried out investigations in
relation to BN-19-3-381, BN-19-3-68, and BN-19-6-237. The investigations made findings in

21
Article 29 Data Protection Working Party ‘Guidelines on the application and setting of administrative fines
for the purposes of Regulation 2016/679, at page 11.

relation to the causes of the breaches and made recommendations to mitigate the risk going
forward.

6.18 The HSE also contacted some of the data subjects pursuant to its obligation under Article 34
of the GDPR. Action, taken by a controller where it is mandated to do so on foot of an
obligation under the GDPR cannot be viewed as a mitigating factor. Therefore, I do not
consider these notifications mitigating in the circumstances.

d) the degree of responsibility of the controller or processor taking into account technical and
organisational measures implemented by them pursuant to Articles 25 and 32;

6.19 As outlined above, the HSE infringed Articles 5(1)(f) and 32(1) of the GDPR by failing to
implement appropriate technical and organisational measures regarding its use and disposal
of hardcopy documents containing patients’ personal data. I consider that the HSE holds a
high degree of responsibility for this failure and that the absence of such measures must be
deterred. However, in circumstances where this factor forms the basis for the finding of the
infringements of Articles 5(1)(f) and 32(1) against the HSE, this factor cannot be considered
aggravating in respect of those infringements.

e) any relevant previous infringements by the controller or processor;

6.20 There are no relevant previous infringements by the HSE.

f) the degree of cooperation with the supervisory authority, in order to remedy the
infringement and mitigate the possible adverse effects of the infringement;

6.21 The HSE cooperated fully with the DPC to remedy the infringements and to mitigate their
adverse effects. In its breach notifications and breach investigations, it illustrated the steps
that it had taken and was in the course of taking to remedy the infringements and the possible
adverse effects. These steps included, amongst others, notifying the data subjects, circulating
emails to staff advising them of accountability regarding the disposal of confidential waste,
the provision of signage and posters, and its consideration of IT solutions to mitigate the risk.
After receipt of the Draft Decision, the HSE confirmed that it has commenced a process to re-
focus efforts in relation to mitigation of risks associated with the management of paper
records and, in particular patient lists.

g) the categories of personal data affected by the infringement;

6.22 The categories of personal data affected by the infringements are highly sensitive. The HSE’s
use and disposal of hardcopy documents containing patients’ personal data is likely to include
special category data in most instances, which is reflected in how 6 of the 7 personal data
breaches included data concerning health. This is in line the nature of the HSE’s functions and
how the processing of personal data concerning health is intrinsic to those functions. This
aggravates the HSE’s failure to implement an appropriate level of security. Unauthorised
disclosures of personal data concerning health is high risk and can cause immediate damage
and distress to data subjects.

h) The manner in which the infringement became known to the supervisory authority, in
particular whether, and if so to what extent, the controller or processor notified the
infringement;

6.23 The Inquiry was conducted to examine whether or not the HSE has discharged its obligations
in connection with the subject matter of personal data breach BN-19-6-237. The Notice of
the Commencement of the Inquiry also referred to 7 other personal data breaches notified
to the DPC. Hence, the HSE’s notification of the personal data breaches contributed to the
infringements becoming known to the DPC. I am satisfied that the HSE fully complied with its
obligation, under Article 33 of the GDPR, to notify the DPC without undue delay after
becoming aware of those personal data breaches, in respect of all 7 personal data breach
notifications.

6.24 The Administrative Fines Guidelines consider the relevance of such notifications regarding
administrative fines:

“The controller has an obligation according to the Regulation to notify the supervisory
authority about personal data breaches. Where the controller merely fulfils this
obligation, compliance with the obligation cannot be interpreted as an attenuating/
mitigating factor.”22

6.25 The HSE’s compliance with its own obligation to notify personal data breaches under Article
33(1) cannot be considered mitigating in respect of the infringements of Articles 5(1)(f) and
32(1).

i) Where measures referred to in Article 58(2) have previously been ordered against the
controller or processor concerned with regard to the same subject-matter, compliance with
those measures;

6.26 Corrective powers have not previously been ordered against the HSE with regard to the
subject-matter of this Decision

j) adherence to approved codes of conduct pursuant to Article 40 or approved certification
mechanisms pursuant to Article 42;

6.27 Not applicable.

k) Any other aggravating or mitigating factor applicable to the circumstances of the case, such
as financial benefits gained, or losses avoided, directly or indirectly, from the infringement.

6.28 I consider that the matters considered under Article 83(2)(a) – (j) reflect an exhaustive
account of both the aggravating and mitigating factors applicable in the circumstances of the
case. Given the specific circumstances of the case at hand, and having particular regard to
the matters discussed under Article 83(2)(a) – (j) cumulatively, I consider it appropriate to

22
Article 29 Data Protection Working Party ‘Guidelines on the application and setting of administrative fines
for the purposes of Regulation 2016/679, at page 15.

impose an administrative fine in addition to the order and reprimand imposed at parts 6(A)
& (B) of this Decision.

6.29 When imposing corrective measure(s), I am obliged to select the measure(s) that are
effective, proportionate and dissuasive in response to the particular infringements. The
assessment of what is effective, proportionate and dissuasive must be made in the context
of the objective pursued by the corrective measures. Administrative Fines Guidelines provide
that:

“The assessment of what is effective, proportional and dissuasive in each case will
have to also reflect the objective pursued by the corrective measure chosen, that is
either to reestablish compliance with the rules, or to punish unlawful behavior (or
both).”23

6.30 I find that an administrative fine is necessary in order to effectively pursue the objective of
re-establishing compliance with the Articles 5(1)(f) and 32(1) of the GDPR and in providing an
effective, proportionate and dissuasive response in the particular circumstances of this case.
In order to re-establish compliance with Articles 5(1)(f) and 32(1), it is necessary to dissuade
non-compliance.

6.31 In reaching the Decision to impose an administrative fine, I have had regard to all of the
corrective powers available to me as set out in Article 58(2) of the GDPR. In particular, I have
had regard to the order and reprimand made in parts 6(A) and (B) of this Decision. The order
has significant value in re-establishing compliance because it obliges the HSE to take certain
specified steps in implementing technical and organisational measures. The reprimand, on
the other hand, is of significant value in dissuading future non-compliance. This formal
recognition of the seriousness of the HSE’s infringements is likely contribute to ensuring an
appropriate level of security going forward.

6.32 However, having regard to the nature of the infringements of Articles 5(1)(f) and 32(1), I find
that those corrective powers alone are not effective and proportionate in re-establishing
compliance and in dissuading future non-compliance. Articles 5(1)(f) and 32(1) place a
continuous obligation on controllers and processors to regularly test, assess and evaluate the
effectiveness of the technical and organisational measures that it has implemented.
Furthermore, the appropriate level of security must be continually re-assessed in light of the
dynamic risk presented by the HSE’s processing and the state of the art. Therefore,
compliance with the order in Part 6(A) of this Decision alone cannot ensure perpetual
compliance with Articles 5(1)(f)and 32(1) going forward, as the risk changes and as new
measures emerge in respect of these processing operations. Furthermore, I do not consider
that the reprimand alone is an effective and proportionate response to the infringements in
light of the need to re-establish compliance and to dissuade non-compliance. In coming to
the conclusion that an administrative fine is necessary, I have particular regard to the highly
sensitive categories of personal data processed by the HSE in hardcopy form (as assessed in
accordance with Article 83(2)(g) above) and the nature of the infringements. Those
infringements pose a threat to the rights and freedoms of data subjects because of the
potential for damage to data subjects where personal data breaches occur (as assessed in
accordance with Article 83(2)(a) above). I consider that an administrative fine is necessary in
light of the potential for damage to data subjects by such non-compliance. This is because an

23
Article 29 Data Protection Working Party ‘Guidelines on the application and setting of administrative fines
for the purposes of Regulation 2016/679, at page 11.

administrative fine is necessary to effectively protect those rights by re-establishing
compliance and to deterring future non-compliance.

6.33 Having decided that the infringements identified warrant the imposition of an administrative
fine in the circumstances of this case, I must next proceed to decide on the amount of the
administrative fine.

ii. The Same or Linked Processing Operations

6.34 Article 83(3) of the GDPR provides:

“If a controller or processor intentionally or negligently, for the same or linked
processing operations, infringes several provisions of this Regulation, the total amount
of the administrative fine shall not exceed the amount specified for the gravest
infringement.”

6.35 The findings of infringements of Articles 5(1)(f) and 32(1) relate to the same processing
operations regarding the HSE’s use and disposal of hardcopy documents containing patients’
personal data. Article 32(1) elaborates on the requirement for appropriate security in Article
5(1)(f). In the circumstances, the infringements of Articles 5(1)(f) and 32(1) arise from the
same omission on the part of the HSE to implement an appropriate level of security.
Therefore, the limit in Article 83(3) is applicable and the total amount of the administrative
fine must not exceed the amount for the gravest infringement. In those circumstances, it is
appropriate to calculate and apply a single administrative fine. Therefore, the fine will be
calculated by reference to the infringement of Article 5(1)(f) only.

iii. The Permitted Range

6.36 It is necessary now to consider the appropriate cap for the fine as a matter of law. This cap
determines the permitted range for the fine, from a range of zero to the cap. However, the
cap is not a starting point for the fine. After identifying the permitted range, this Decision will
calculate the figure for the fine.

6.37 Section 141(4) of the 2018 Act provides a cap on administrative fines concerning public
bodies that do not act as undertakings:

“Where the Commission decides to impose an administrative fine on a controller or
processor that—

(a) is a public authority or a public body, but

(b) is not a public authority or a public body that acts as an undertaking within the
meaning of the Competition Act 2002 ,

the amount of the administrative fine concerned shall not exceed €1,000,000.”

6.38 Section 3 of the Competition Act 2002 defines “undertaking” as:

“a person being an individual, a body corporate or an unincorporated body of persons
engaged for gain in the production, supply or distribution of goods or the provision of

a service and, where the context so admits, shall include an association of
undertakings.”

6.39 The HSE is a body corporate24 that is engaged in the provision of health services to the
population of Ireland. However, in order to meet the definition of “undertaking”, the HSE
must be “engaged for gain” in providing those services. In Deane and others v VHI25 the
Supreme Court held that the expression “engaged for gain” does not require the provision
of those goods or services for profit. Finlay C.J. held that:

“I am, therefore, driven to the conclusion that the true construction of this section is
that the words ‘for gain’ connote merely an activity carried on or a service supplied,
as it is in this case, which is done in return for a charge or payment…”26

6.40 An entity may fulfil the definition of “undertaking” in respect of some of its activity, while
also not fulfilling that definition in respect of other activity. This is illustrated in two High
Court judgments regarding the HSE’s activities concerning the provision of ambulances. In
Lifeline Ambulance Services v HSE27 Cooke J held:

“…in the particular circumstances of the operation of ambulance services in the State
a clear distinction for competition law purposes has to be made between on the one
hand, emergency services and the services for the transport of public patients for
which the HSE has a statutory responsibility; and on the other, services provided for
the transport of private patients in respect of which there is a distinct market as was
held in the Medicall case.”28

6.41 In this case, the Court held that the HSE was not engaged for gain in the provision of a service
when using its fleet of ambulances for emergency services and for the transport of public
patients. However, in line with the judgment in Medicall Ambulance Limited v HSE29, the HSE
fulfils the definition of “undertaking” in respect of its activity of providing its fleet of
ambulances on the commercial market for private ambulance services for which it made a
non-profit charge. Therefore, I am satisfied that the HSE fulfils the definition of “undertaking”
in respect of some, but not all of its activity.

6.42 Section 141(4) of the 2018 Act excludes public authorities30 that act as undertakings from the
cap provided for in that subsection. Once a public body acts as an undertaking in respect of
any of its activities, the cap in Section 141(4) cannot apply. Therefore, the cap in Section
141(4) is not applicable to the HSE.

6.43 The permitted range for the administrative fine must, therefore, be calculated on the basis
of Article 83(5) of the GDPR, which provides that infringements of the basic principles for
processing under Article 5 of the GDPR:

24
See section 6(2) Health Act 2004.
25
[1992] 2 I.R. 319.
26
Ibid.
27
[2012] IEHC 432.
28
Ibid.
29
[2011] IEHC76.
30
The HSE is a public authority. Public authority is defined in Section 2 of the 2018 Act as including “any other
person established by or under an enactment (other than the Act of 2014 or a former enactment relating to
companies within the meaning of section 5 of that Act)”. The HSE was established by Ministerial Order in
accordance with the provisions of the Health Act 2004.

“…shall be subject to administrative fines up to 20 000 000 EUR, or in the case of an
undertaking, up to 4% of the total worldwide annual turnover of the preceding
financial year, whichever is higher…”

6.44 The turnover of the HSE in 2018 was €16,021,179,000, which is calculated by reference to
the total reported income stream in the HSE’s Annual Report and Financial Statements
201831, these being the most recently available figures. As regards the maximum amount (the
“cap”) for the fine which may be imposed in this case, the relevant cap for any fine in respect
of the infringement is €640,847,160 – that is, 4% of the HSE’s turnover. This figure is not a
starting point, but rather the cap on the permitted range as provided for in Article 83(5) of
the GDPR.

iv. Calculating the Administrative Fine

6.45 In the absence of specific EU-level guidelines on the calculation of fines in this context, I am
not bound to apply any particular methodology32. The methodology that I have followed in
calculating the administrative fine is as follows. The first step in calculating the administrative
fine is to consider the permitted range and to locate the infringement on the permitted
range. In this regard, the cap provided for in Article 83(5) is not a starting point for the fine.
Rather, it is relevant to determining the permitted range. The determination of where on the
permitted range the appropriate figure lies is made by reference to nature, gravity, and
duration of the infringement, as considered in relation to Article 83(2)(a) above, and the
other aggravating factors. The determination is made in the context of the objectives of re-
establishing compliance, including through deterrence, and to provide a proportionate
response to the unlawful behaviour. The second step in calculating the administrative fine is
to apply the mitigating factors to reduce the fine where applicable. Finally, the third step is
to consider whether the figure arrived at is “effective, proportionate and dissuasive” in the
circumstances in accordance with Article 83(1) of the GDPR. The Draft Decision set out
proposed ranges for the administrative fines and the factors to be considered, and the
methodology to be used when calculating the fines, in order to provide the HSE with the
opportunity comment in accordance with fair procedures.

6.46 In locating the fine on the permitted range, I have had regard to the nature, gravity and
duration of the infringement as assessed in accordance with Article 83(2)(a) above. I have
also had regard to the aggravating factors, specifically the negligent character of the
infringement and the sensitive categories of personal data affected by the infringement as
assessed in accordance with Article 83(2)(b)&(g) above. I consider that the figure of €130,000
is appropriate in the circumstances of this case before applying the mitigating factors. In
arriving at this figure, I have considered the serious nature of the infringement and the direct
link between deterring such non-compliance and protecting the rights and freedoms of data
subjects. The range also reflects the gravity of the infringement. The potential for a high level
of damage being suffered by the data subjects as a result of the 7 personal data breaches is
relevant to assessing this fine so that the fine provides a proportionate response to the
unlawful behaviour. I have also had regard to the duration of the infringement, which is over
1 year in length, in the context of the need to re-establish compliance. The level of the fine
must have a deterrent effect and it cannot pay off for the HSE to have such a long period of

31
At page 142.
32
See by analogy Electrabel v Commission, T 332/09, ECLI:EU:T:2012:672, para 228, Marine Harvest ASA v
Commission, T-704/14, ECLI:EU:T:2017:753, para 450.

non-compliance. I have had regard to the negligent character of the infringement, as
assessed in accordance with Article 83(2)(b) above. Finally, I have also had regard to the
highly sensitive categories of personal data affected by the infringement, as assessed in
accordance with Article 83(2)(g) above. The high risk caused by the HSE’s infringement, in
light of the sensitivity of the personal data, must be reflected in the starting figure for the
fine in order to provide a proportionate response to the unlawful behaviour and to deter
such future non-compliance.

6.47 I consider that the mitigating factors warrant a significant reduction in the fine. Specifically, I
consider the factors identified above under Articles 83(2)(c), 83(2)(e), and 83(2)(f) of the
GDPR mitigating. To account for the action taken by the HSE to mitigate the damage suffered
by the data subjects, I have reduced the fine by €25,000 in accordance with Article 83(2)(c).
To account for the HSE’s lack of previous infringements, I have reduced the fine by €20,000,
in accordance with Article 83(2)(e). To account for the cooperation that the HSE engaged with
the DPC to remedy the infringement, I have reduced the figure by €20,000 in accordance with
Article 83(2)(f). Thus, the total amount of reductions in light of the mitigating factors is
€65,000.

6.48 Applying the mitigating factors, the figure for this administrative fine is €65,000. I have
considered this figure in light of the requirement in Article 83(1) that administrative fines
shall be “effective, proportionate and dissuasive”. In considering the application of these
principles, I consider that a fine cannot be effective if it does not have significance relative to
the revenue of the data controller. Moreover, the principle of proportionality cannot be
adhered to if the infringement is considered in the abstract, regardless of the impact on the
controller. Therefore, I note the HSE’s turnover in 2018 as identified above. As decision-
maker for the Commission, I consider it important to strongly discourage non-compliance
with the obligation to implement appropriate security measures in relation to the HSE’s use
and disposal of hardcopy documents containing patients’ personal data. I am of the view that
when calculating a fine that is effective, proportionate and dissuasive, the fine must have a
significant element of deterrence, particularly in respect of serious infringements, such as the
infringement in issue. Having regard to the foregoing, I consider that the figure of €65,000
meets the requirements of effectiveness, proportionality and dissuasiveness in respect of the
infringement and data controller in issue.

7. Right of Appeal

7.1 This Decision is issued in accordance with Section 111 of the 2018 Act. Pursuant to Section
150(5) of the 2018 Act, the HSE has the right to appeal against this Decision within 28 days
from the date on which notice of the Decision is received by it. Furthermore, as this Decision
includes a decision to impose an administrative fine, pursuant to Section 142 of the 2018 Act,
the HSE also has the right to appeal against that decision to impose an administrative fine
within 28 days from the date on which notice of the decision is given to it.

Helen Dixon
Commissioner for Data Protection

Appendix: Schedule of Materials Considered for the Purposes
of this Decision
The Case Officer delivered the Final Inquiry Report to me on 27 April 2020. I was also provided with
all of the correspondence and submissions received in compiling the report, including:

i. The DPC’s Final Inquiry Report, Inquiry Reference IN-19-9-01;
ii. Health Service Executive Code of Governance, Chapter 2 (Appendix D.1 to the
Final Inquiry Report);
iii. The 7 Personal Data Breach Notifications submitted to the DPC and their related
email correspondence (Appendix D.1 to the Final Inquiry Report);
iv. HSE Investigation Report concerning BN-19-6-237 (Part of Appendix D.2 to the
Final Inquiry Report);
v. Redacted HSE Investigation Report concerning BN-19-3-68 (Part of Appendix D.2
to the Final Inquiry Report);
vi. Redacted HSE Investigation Report concerning BN-19-3-381 (Part of Appendix D.2
to the Final Inquiry Report);
vii. DPC Notice of Commencement of an Inquiry, dated 17 October 2019 (Appendix
D.3 to the Final Inquiry Report);
viii. Email from the HSE, dated 22 October 2019, acknowledging receipt of the Notice
of Commencement of an Inquiry and nominating a HSE point of contact;
ix. Correspondence from the Case Officer to the HSE, dated 6 November 2019,
inviting submissions from the HSE;
x. HSE submissions in response to the commencement of the Inquiry, dated 26
November 2019 (Appendix D.4 to the Final Inquiry Report);
xi. “Code of Professional Conduct and Ethics for Registered Nurses and Registered
Midwives”, Nursing and Midwifery Board of Ireland, dated December 2014 (Part
of Appendix D.4 to the Final Inquiry Report);
xii. “Recording Clinical Practice Professional Guidance”, Nursing and Midwifery Board
of Ireland, dated November 2015 (Part of Appendix D.4 to the Final Inquiry
Report);
xiii. “Clinical Placement Information For BSc (Hons) Nursing Students”, HSE, dated
September 2016 (Part of Appendix D.4 to the Final Inquiry Report);
xiv. “Hospital Orientation Information for BSc Undergraduate Nursing Students”, HSE,
dated November 2019 (Part of Appendix D.4 to the Final Inquiry Report);
xv. Template Practice Placement Agreement 2019 for Nurses and Midwives (Part of
Appendix D.4 to the Final Inquiry Report);
xvi. The HSE’s Waste Management Awareness Handbook, dated 2014 (Part of
Appendix D.4 to the Final Inquiry Report);
xvii. The HSE’s sample poster from its campaign regarding GDPR in practice (Part of
Appendix D.4 to the Final Inquiry Report);
xviii. HSE document “About Human Resources” (Part of Appendix D.4 to the Final
Inquiry Report);
xix. DPC Report “Data Protection Investigation in the Hospitals Sector”, dated May
2018 (Part of Appendix D.5 to the Final Inquiry Report);

xx. The HSE’s Data Protection Quality Improvement Action Plan, dated October 2017
(Appendix D.6 to the Final Inquiry Report);
xxi. HSE Data Protection Policy, dated 25 May 2018 (Appendix D.7 to the Final Inquiry
Report);
xxii. HSE Information Technology Security Policy, dated February 2013 (Appendix D.8
to the Final Inquiry Report);
xxiii. HSE Access Control Policy, dated February 2013 (Appendix D.9 to the Final Inquiry
Report);
xxiv. HSE submissions on the Draft Inquiry Report, dated 16 January 2019 (in error)
(Appendix D.10 to the Final Inquiry Report);
xxv. HSE External Review Process (Part of Appendix D.10 to the Final Inquiry Report);
xxvi. Letter from the DPC to , dated
20 January 2020 (Appendix D.11 to the Final Inquiry Report);
xxvii. HSE submission, dated 7 February 2020 (Appendix D.12 to the Final Inquiry
Report);
xxviii. Letter from the DPC to , dated
3 March 2020 (Part of Appendix D.13 to the Final Inquiry Report);
xxix. HSE submission, dated 6 April 2020 (Appendix D.14 to the Final Inquiry Report);
xxx. Redacted Practice Placement Agreement, dated 10 September 2018 (Part of
Appendix D.14 to the Final Inquiry Report);
xxxi. Media Report, dated 3rd May 2019 (Appendix D.15 to the Final Inquiry Report);
xxxii. HSE Annual Report and Financial Statements 2018, published May 2019;
xxxiii. The HSE’s email to the DPC, ,
dated 12 August 2020.

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