Datainspektionen - DI-2019-3844

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Datainspektionen - DI-2019-3844
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Authority: Datainspektionen (Sweden)
Jurisdiction: Sweden
Relevant Law: Article 5(1)(f) GDPR
Article 5(2) GDPR
Article 32(1) GDPR
Article 32(2) GDPR
Patientdatalagen (2008:355)
Type: Investigation
Outcome: Violation Found
Decided: 02.12.2020
Published: 02.12.2020
Fine: 15000000 SEK
Parties: Aleris Sjukvård AB
National Case Number/Name: DI-2019-3844
European Case Law Identifier: n/a
Appeal: n/a
Original Language(s): Swedish
Original Source: Datainspektionen (in SV)
Initial Contributor: Elisavet Dravalou

The Swedish DPA (Datainspektionen) imposed a €1.466 million (approximately) fine on the healthcare provider "Aleris Sjukvård AB" for not carrying out the risk assessments required by the Patient Data Act and for granting their employees access to all personal data in the patients' journal system in breach of Article 32 GDPR.

English Summary[edit | edit source]

Facts[edit | edit source]

The audit to Aleris Sjukvård AB from the Swedish DPA was initiated in May 2019. Aleris is a healthcare provider and uses a system named "TakeCare" as the main journal keeping system where they store and maintain the patients' journals. According to the Patient Data Act, a caregiver must conduct a needs and risk analysis before allocating access rights in the patients' journals.

Dispute[edit | edit source]

Holding[edit | edit source]

The DPA found that Aleris Sjukvård AB did not carry out these assessments and it has granted access to patients' journal to all employees apart from the technicians. By doing so, Aleris Sjukvård AB breached the obligation to apply appropriate technical and organisational measures to ensure the security of the personal data, imposed to controllers by Article 32 GDPR.

The DPA imposed a fine of 15 millions SEK (approximately €1466000).

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English Machine Translation of the Decision[edit | edit source]

The decision below is a machine translation of the Swedish original. Please refer to the Swedish original for more details.

                                                             Decision Diary No. 1 (30)
                                                             2020-12-02 DI-2019-3844







                                                             Aleris Sjukvård AB
                                                             c / o Aleris Specialist Care Sabbatsberg

                                                             Box 6401
                                                             113 82 Stockholm

                                                             Stockholm County


                    Supervision under the Data Protection Regulation and

                    Patient Data Act- needs and risk analysis and

                    questions about access in journal systems


                    Table of Contents

                    The Data Inspectorate's decision ................................................ ..................................... 2
                    Report on the supervisory matter ............................................... .............................. 3

                      What has emerged in the case ............................................. .......................... 3

                      Internal privacy ................................................ .................................................. ... 5

                      Consolidated record keeping ................................................ ............................ 8

                      Documentation of access (logs) ............................................ ............... 9

                      Aleris opinion on the Data Inspectorate's letter .......................................... 9

                    Motivation for decision ............................................... ............................................. 10

                      Applicable rules................................................ ........................................... 10

                      The Data Inspectorate's assessment ................................................ ....................... 15

                      Choice of intervention ............................................... .............................................. 23

                      Appendix ................................................. .................................................. ............. 29
                      Copy for knowledge of .............................................. ................................... 29

                    How to appeal............................................... ........................................... 29















Postal address: Box 8114, 104 20 Stockholm E-mail: datainspektionen@datainspektionen.se
Website: www.datainspektionen.se Phone: 08-657 61 00
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                   The Data Inspectorate's decision

                   During a review on April 8, 2019, the Data Inspectorate has established that Aleris
                   Sjukvård AB processes personal data in violation of Article 5 (1) (f) and (2) and

                   Article 32 (1) and (2) of the Data Protection Regulation by


                       1. Aleris Sjukvård AB has not carried out a needs and risk analysis

                           before the allocation of permissions takes place in the journal system TakeCare, i
                           in accordance with ch. 4 § 2 and ch. 6 Section 7 of the Patient Data Act (2008: 355)

                           and ch. 4 Section 2 The National Board of Health and Welfare's regulations and general advice on
                           record keeping and processing of personal data in health and

                           healthcare (HSLF-FS 2016: 40). This means that Aleris Sjukvård AB
                           have not taken appropriate organizational measures to be able to

                           ensure and be able to show that the processing of personal data has
                           a security that is appropriate in relation to the risks.


                       2. Aleris Sjukvård AB does not limit users' permissions for

                           access to the TakeCare journal system for what is only needed for
                           that the user should be able to fulfill his tasks in the health

                           and healthcare according to ch. 4 § 2 and ch. 6 Section 7 of the Patient Data Act and 4
                           Cape. 2 § HSLF-FS 2016: 40. This means that Aleris Sjukvård AB does not have

                           taken measures to be able to ensure and be able to show a suitable

                           security of personal data.


                   The Data Inspectorate decides on the basis of Articles 58 (2) and 83 i
                   the Data Protection Ordinance to Aleris Sjukvård AB, for violation of

                   Article 5 (1) (f) and (2) and Article 32 (1) and (2) of the Data Protection Regulation;
                   shall pay an administrative penalty fee of 15,000,000 (fifteen

                   million).


                   The Data Inspectorate submits pursuant to Article 58 (2) (d) i
                   data protection ordinance Aleris Sjukvård AB to implement and document

                   required needs and risk analysis for the TakeCare medical record system and that
                   then, based on the needs and risk analysis, assign each user



                   1 REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016

                   on the protection of individuals with regard to the processing of personal data and on that
                   free flow of such data and repealing Directive 95/46 / EC (General
                   Data Protection Regulation).







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                  individual access to personal data restricted to

                  only what is needed for the individual to be able to fulfill his
                  duties in health care, in accordance with Article 5 (1) (f) and

                  Article 32 (1) and (2) of the Data Protection Ordinance, Chapter 4 § 2 and ch. 6 § 7
                  the Patient Data Act and Chapter 4 2 § HSLF-FS 2016: 40.




                  Report on the supervisory matter
                  The Data Inspectorate's inspection began with an inspection letter on 22 March

                  2019 and has taken place both in writing and through on-site inspection on April 8
                  2019. The audit has been intended to control whether Aleris Sjukvård AB's (hereinafter referred to as

                  Aleris) decision on the allocation of authorizations has been preceded by a need and
                  risk analysis. The supervision has also included how Aleris has granted authorizations

                  for access to the TakeCare master journal system, and which
                  access opportunities the granted privileges provide within both the framework of

                  the internal secrecy according to ch. the Patient Data Act, as the cohesive one
                  record keeping according to ch. 6 patient data law. In addition to this has

                  The Data Inspectorate examined which documentation of access (logs) as
                  is in the journal system.


                  The Data Inspectorate has only examined the user's access to

                  the journal system, i.e. what care documentation the user can actually take
                  part of and read. The supervision has not included which functions were included in

                  the competence, ie. what the user can actually do in the journal system
                  (eg issuing prescriptions, writing referrals, etc.).


                  The inspection is one of several inspections within the framework of a self-initiated
                  supervisory project at the Swedish Data Inspectorate, where i.a. Karolinska

                  The university hospital has been included. Due to what has emerged about
                  Aleri's view on the technical possibilities to limit

                  readability for its users in TakeCare, Aleris was asked in particular
                  comment on an opinion from Karolinska University Hospital, which also

                  uses TakeCare, where the technical possibilities regarding TakeCare
                  was described.


                  What has emerged in the case

                  Aleris has essentially stated the following.








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                  Personal data responsibility

                  Aleris is the care provider and personal data manager.


                  The business
                  Aleri's ownership structure has changed after the Data Inspectorate's review

                  initiated. Aleris 'new ownership structure is shown in Aleris' supplement from 16
                  November 2020. The supplement states, among other things, the following.


                  Aleris has been part of the newly formed Group Parent Company since October 1, 2019,

                  Aleris Group AB (corporate identity number 559210-7550), and is a subsidiary of Aleris
                  Healthcare AB (org.nr. 556598–6782). Aleris Group AB is owned by Triton.


                  Group sales for Aleris Group AB amounted to SEK 1,215,385,000
                  between October 1, 2019 and December 31, 2019. Since Aleris Group

                  AB was formed in connection with the change of ownership when Aleris Healthcare AB joined
                  subsidiaries were acquired, only turnover figures are available for this

                  period.


                  The annual turnover for Aleris Healthcare AB amounted to SEK 30,223,866
                  during 2019.


                  Journal system

                  Aleris has been using TakeCare as its main record system since 28 May 2012
                  for internal secrecy and within the framework of the cohesive

                  record keeping.


                  Federation Collaboration TakeCare (FSTC) is the customer of the medical record system
                  TakeCare and CompuGroup Medical (CGM) are suppliers of the medical record system

                  and is responsible for the functions that the system has to control permissions.


                  All functions in the journal system are created by CGM, but it is Aleris who
                  chooses which functions a certain staff category should have access to among
                  the functions that are entered. Aleris has no technical possibilities to do

                  changes in TakeCare because Aleris has no control over
                  the journal system. Aleris is only a user of the system.


                  Aleris has not been able to make any demands on CGM in the procurement of

                  the journal system. The company has, for example, pointed out that there have been problems
                  with the record system consisting of, as far as the allocation of competences is concerned, that






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                   the system cannot separate read and print permissions for a read function.

                   CGM has not been interested in changing this despite comments from
                   Aleris.


                   It is FSTC that can order changes to the functions and that is then

                   up to CGM if they want to make the changes or not. Aleris has one
                   representative in FSTC who can express Aleri's wishes. However, Aleris has not

                   received some hearing for the company's views.


                   Number of patients and employees
                   Aleris had 796,350 unique patients in TakeCare as of May 20, 2019. How

                   however, many of those who died could not be retrieved.

                   In May 2019, there were 1,058 active users, 807 active accounts and 63

                   units in the journal system TakeCare. The number of active users (ie employees
                   and consultants who may have access to TakeCare) have been calculated by

                   calculate the number of active AD accounts at relevant cost centers.


                   Internal secrecy

                   Aleris has essentially stated the following.


                   Needs and risk analysis
                   Aleris has stated that needs and risk analyzes aimed at TakeCare are performed
                   by a designated risk analysis team for the purpose of reviewing the applicable authorization allocation

                   and possibly determine new conditions for granting eligibility. Permissions
                   is always limited to what is needed for the employee to be able to perform

                   their work and contribute to safe care. The need versus the risk of improperness
                   access is always weighed against each other before permissions are granted. General

                   authorization profiles are available, specific authorizations are assigned if necessary. The
                   later examined in particular in the subsequent analysis of the designated risk analysis team. What

                   What is especially considered are the risks that can arise if an employee has
                   too broad eligibility versus too low eligibility and thus not access to

                   relevant patient information. The result from the needs and risk analysis is
                   then the basis for selecting the authorization profile used in the assignment

                   of competencies within Aleris.


                   Eligibility for TakeCare is ordered by the responsible manager, as stated in
                   the document, “TakeCare Authorization Management”. The document also states

                   that the competence is personal and that its scope is based on





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                   the user's professional role and organizational domicile. Furthermore, it appears that

                   the care provider must ensure that the authority for access to patient data
                   limited to what a user needs to be able to perform their

                   tasks in health care.


                   Aleris has a document called "Needs and Risk Analysis-TakeCare".
                   The document has looked like it does today since May 28, 2012 when TakeCare

                   was introduced and applies both to internal secrecy and within its framework
                   coherent record keeping. The document shows the different profiles,

                   so-called authority groups. The document shows, among other things
                   the reading rights and the writing rights for each authority group.

                   All profiles except technicians have been granted read access to the data in
                   TakeCare. The eligibility for each group has been justified. The doctors are going to
                   examples be able to perform their duties and are responsible for

                   patient information, while the system administrator must be able to troubleshoot,
                   manage and set up users, systems and local administrators.

                   Under the heading "Risk of restricted access" it is stated that the user "cannot
                   perform their duties in full ”. This justification is stated for all

                   profiles (except for the local administrators where the motivation is “Can not
                   manage permissions and implement corrective actions ”). During

                   The heading “Risk of extensive access” states, among other things, that “There is one
                   risk of disclosure of patient information '. Similar justification is given for everyone

                   profiles.


                   Authorization of access to personal data about patients
                   Aleris has stated that it is the system administrator who has the highest

                   the level of competence, ie full authorization, in TakeCare. The local
                   the administrator has access to his own device and is the one who assigns

                   permissions within the device. What privileges an administrator imposes
                   a user depends on the business to which the user belongs and on

                   the user's tasks. All users get the “minimum they should have
                   to cope ”in terms of accessibility. Access can, however
                   expanded if necessary. There are basic profiles for, for example, assistant nurses,

                   who are given the qualifications needed to carry out their duties
                   tasks. If the manager considers that the assistant nurses need one

                   extended privileges, local administrators ensure that privileges
                   "Hangs up" the basic profile. If the extended authorization is not needed, it can be taken

                   away from the basic profile.







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                   Aleris has stated that all accounts within Aleris are individual and that

                   authorizations are granted on the basis of the document, ‘Needs and risk analysis
                   TakeCare ”. As previously mentioned, it appears from the document that everyone

                   professional profiles in addition to technicians have been granted reading access to the data in
                   TakeCare.


                   However, Aleris has stated that all users have different read permissions in

                   the journal system based on which system functions they have access to
                   Aleris. According to Aleris, it is possible to steer away access opportunities to TakeCare

                   by giving different staff access to different functions. Each
                   staff category only gets access to the functions they need for

                   to be able to perform their work. Technicians, for example, have limited qualifications
                   depending on what they are going to do in the system. They only get reading permission if they
                   need it in their work. Another example concerns users who only

                   will be at the checkout and thus do not need a reading license.
                   There is no staff that only has the task of managing the cash register

                   the current situation.


                   By choosing different functions for different users, a difference is made in
                   what different users can do in the system, e.g. as regards verify, sign,

                   etc. In total, there are 640 different system functions that you can choose to provide
                   authority to. Among these features, Aleris has selected the features that

                   different staff categories need to have access to in order to operate safely
                   patient work. The document "Profiles and permissions" shows the different ones

                   permissions that each category of staff has been assigned in TakeCare, e.g.
                   dictate audio files, read activities, sign, read emergency information, read journal text,

                   vidimering, read referral, administer drug prescription, read scanned
                   documents and approve care sessions. The document states, among other things

                   that all profiles ie. doctors, nurses, assistant nurses,
                   paramedics, secretaries, "administrative", students and "Receptionist

                   Rehab "has the authority to" read journal text "and that everyone except
                   "Receptionist Rehab" is authorized to "read scanned documents" in
                   TakeCare. It also appears that only doctors are authorized to “read

                   emergency tasks ”and that all profiles except assistant nurse and
                   "Administrative" can "read diagnoses" in TakeCare.


                   Aleris has stated that the starting point is that one user on one device only

                   has read access to the patient records available on the device. One
                   users who need to read journal entries from another device must






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                   make an active choice in the system. By active choices is meant that the user is allowed to do

                   a number of "clicks" and select the current device (this function is called
                   journal filter). Authorization to be able to use the journal filter is given to them

                   users who need this to be able to perform their work.
                   The user can never accidentally read one patient record from another

                   unit.


                   Aleris has stated that there are features in TakeCare to a caregiver
                   should be able to "isolate" one care unit and thereby "shut out" others

                   caregivers 'and care units' access possibilities to the unit's
                   care documentation, so-called protected units. However, Aleris does not operate

                   any activity that requires protected devices and has therefore not used
                   of this function.


                   Coherent record keeping

                   Aleris has essentially stated the following.


                   Needs and risk analysis
                   The document “Needs and risk analysis - TakeCare” also applies to the system for

                   coherent record keeping.


                   Authorization of access to personal data about patients
                   The allocation of authority takes place in the same way as within the framework of the internal
                   secrecy.


                   Within the framework of coherent record keeping in TakeCare, users can take

                   part of all care documentation with other care providers included in the system.
                   The user can initially see if a patient is current with other care providers,

                   but not which. To be able to see who these caregivers are, the user must
                   click on in the system, ie. make active choices. The user must then

                   click in the box "consent" or "emergency access" to access it
                   specific caregiver records.


                   Aleris has stated the following due to Karolinska

                   The University Hospital in a statement has stated that there are opportunities to
                   restrict access in TakeCare.


                   There is a function to "isolate" a care unit and thereby close

                   access to other care providers and care units (so-called





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                   protected devices). A care provider can thus from a technical perspective

                   restrict other care providers' access to their own care documentation.
                   However, Aleris has assessed that the company does not conduct any business as

                   need to be blocked and that it is more patient safe to let the patient information
                   at Aleri's units be available to other care providers. According to Aleris, it is

                   moreover, not allowed to implement such restrictions if one
                   caregivers use the TakeCare medical record system and at the same time are part of

                   coherent record keeping. This following a decision from the Stockholm Region. The
                   means that all users of Aleris have access to all patient data

                   at the other care providers in TakeCare, except when patients have requested to
                   get their information blocked (a so-called caregiver block).


                   According to Aleris, from a patient safety perspective, this is not practically possible

                   to opt out of individual care providers' access to their own care documentation
                   in TakeCare (except for protected devices). Either is the caregiver

                   included in the system for coherent record keeping or not. It is not possible to
                   restrict access for competent persons to the information of other care providers

                   and at the same time in a meaningful way participate in coherent record keeping.
                   According to Aleris, it is not possible to determine in advance which data are in one

                   certain cases may be important for patient-safe care. Aleris has therefore decided
                   not to actively block other caregivers' records. However, such as

                   mentioned, a caregiver himself blocks other caregivers' access to TakeCare there
                   these have made the assessment that their patients' medical records should not be

                   available to other caregivers. These devices are marked in TakeCare
                   with an asterisk. In this way, a selection of care units has already been made

                   Aleri's staff do not have access to.


                   Documentation of access (logs)

                   Aleri's log documentation states, among other things: the user's and
                   patient's identity, care unit, date, time, information to the user

                   has documented in the journal during the last 18 months as well as information
                   that the patient has had contact with the care unit during the last 18

                   months.


                   Aleris has the ability to perform targeted log checks. That means Aleris
                   can see exactly what a user has done in the system. About the patient or Aleris

                   suspects data breaches, Aleris can also perform an in-depth log check.








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                  Also all activities that take place within the framework of coherent record keeping

                  logged in the system. It also means that all active selections are logged in the system. If
                  the user, for example, has selected "consent" or "emergency access" to be able to take

                  part of a patient's information to another care provider, this will be
                  appear from the log documentation.


                  Aleri's opinion on the Data Inspectorate's letter

                  Aleris has in comments on the letter Final communication before decision as
                  received by the Swedish Data Inspectorate on 20 March 2020 stated the following, among other things.

                  The Data Inspectorate should take into account the figures for the economic unit where they
                  The alleged shortcomings have taken place, ie Aleris Sjukvård AB.


                  Aleris has actively worked to continuously strengthen the interior and exterior

                  confidentiality, including the functionality of TakeCare. When Aleris took over
                  adequate measures to strengthen, through FSTC, the integrity of TakeCare

                  actual deficiencies in TakeCare should not be considered to be Aleris' fault.



                  Justification of decision


                  Applicable rules


                  The Data Protection Regulation is the primary source of law

                  The Data Protection Regulation, often abbreviated GDPR, was introduced on 25 May 2018 and
                  is the primary legal regulation in the processing of personal data. This

                  also applies to health care.


                  The basic principles for the processing of personal data are set out in
                  Article 5 of the Data Protection Regulation. A basic principle is the requirement

                  security pursuant to Article 5 (1) (f), which states that personal data shall be processed
                  in a way that ensures adequate security for personal data,

                  including protection against unauthorized or unauthorized treatment and against loss,
                  destruction or damage by accident, using appropriate

                  technical or organizational measures.


                  Article 5 (2) states the so-called liability, ie. that it
                  “Personal data controllers must be responsible for and be able to show that they

                  the basic principles of paragraph 1 are complied with ".






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                   Article 24 deals with the responsibility of the controller. Of Article 24 (1)
                   it appears that the person responsible for personal data is responsible for implementing appropriate

                   technical and organizational measures to ensure and demonstrate that
                   the processing is performed in accordance with the Data Protection Regulation. The measures shall

                   carried out taking into account the nature, scope, context of the treatment
                   and purposes and the risks, of varying degrees of probability and severity, for

                   freedoms and rights of natural persons. The measures must be reviewed and updated
                   if necessary.


                   Article 32 regulates the security associated with the processing. According to paragraph 1

                   the personal data controller and the personal data assistant shall take into account
                   of the latest developments, implementation costs and treatment
                   nature, scope, context and purpose as well as the risks, of varying

                   probability and seriousness, for the rights and freedoms of natural persons shall
                   the personal data controller and the personal data assistant take appropriate

                   technical and organizational measures to ensure a level of security
                   which is appropriate in relation to the risk (…). According to paragraph 2, at

                   the assessment of the appropriate level of safety, special consideration shall be given to the risks involved
                   the treatment entails, in particular from accidental or unlawful destruction,

                   loss or alteration or to unauthorized disclosure of or unauthorized access to
                   the personal data transferred, stored or otherwise processed.


                   Recital 75 states that in assessing the risk to natural persons

                   rights and freedoms, various factors must be taken into account. Among other things mentioned
                   personal data covered by professional secrecy, health data or

                   sexual life, if the processing of personal data concerning vulnerable physical persons takes place
                   persons, especially children, or if the treatment involves a large number

                   personal data and applies to a large number of registered persons.


                   Furthermore, it follows from recital 76 that the probable and serious risk of it
                   data subjects' rights and freedoms should be determined on the basis of processing
                   nature, scope, context and purpose. The risk should be evaluated on

                   on the basis of an objective assessment, which determines whether
                   the data processing involves a risk or a high risk.


                   Recitals 39 and 83 also contain writings that provide guidance on it

                   the meaning of the data protection regulation's requirements for security in
                   Processing of personal data.






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                   The Data Protection Regulation and the relationship with complementary national
                   provisions

                   According to Article 5 (1). a in the Data Protection Regulation, the personal data shall
                   treated in a lawful manner. In order for the treatment to be considered legal, it is required

                   legal basis by fulfilling at least one of the conditions of Article 6 (1).
                   The provision of health care is one such task of general

                   interest referred to in Article 6 (1) (e).


                   In health care, the legal bases can also be legal
                   obligation pursuant to Article 6 (1) (c) and exercise of authority under Article 6 (1) (e)

                   updated.

                   When it comes to the legal bases legal obligation, in general

                   interest or exercise of authority by the Member States, in accordance with Article
                   6.2, maintain or introduce more specific provisions for adaptation

                   the application of the provisions of the Regulation to national circumstances.
                   National law may specify specific requirements for the processing of data

                   and other measures to ensure legal and equitable treatment. But
                   there is not only one possibility to introduce national rules but also one

                   duty; Article 6 (3) states that the basis for the treatment referred to in
                   paragraph 1 (c) and (e) shall be determined in accordance with Union law or

                   national law of the Member States. The legal basis may also include
                   specific provisions to adapt the application of the provisions of

                   the Data Protection Regulation. Union law or the national law of the Member States
                   law must fulfill an objective of general interest and be proportionate to it

                   legitimate goals pursued.


                   Article 9 states that the treatment of specific categories of
                   personal data (so-called sensitive personal data) is prohibited. Sensitive

                   personal data includes data on health. Article 9 (2) states
                   except when sensitive personal data may still be processed.


                   Article 9 (2) (h) states that the processing of sensitive personal data may be repeated
                   the treatment is necessary for reasons related to, among other things

                   the provision of health care on the basis of Union law or
                   national law of the Member States or in accordance with agreements with professionals in

                   the field of health and provided that the conditions and protective measures provided for in
                   referred to in paragraph 3 are met. Article 9 (3) imposes a regulated duty of confidentiality.






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                   This means that both the legal bases of general interest,
                   exercise of authority and legal obligation in the treatment of the vulnerable

                   personal data under the exemption in Article 9 (2) (h)
                   supplementary rules.


                   Supplementary national regulations

                   In the case of Sweden, both the basis for the treatment and those
                   special conditions for the processing of personal data in the field of health and

                   healthcare regulated in the Patient Data Act (2008: 355) and
                   the Patient Data Ordinance (2008: 360). I 1 kap. Section 4 of the Patient Data Act states that

                   the law complements the data protection regulation.

                   The purpose of the Patient Data Act is to provide information in health and

                   healthcare must be organized so as to meet patient safety and
                   good quality and promotes cost efficiency. Its purpose is also to

                   personal data shall be designed and otherwise processed so that patients and
                   the privacy of other data subjects is respected. In addition, must be documented

                   personal data is handled and stored so that unauthorized persons do not have access to it
                   them (Chapter 1, Section 2 of the Patient Data Act).


                   The supplementary provisions in the Patient Data Act aim to:

                   take care of both privacy protection and patient safety. The legislator has
                   thus through the regulation made a balance as to how

                   the information must be processed to meet both the requirements for patient safety
                   as the right to privacy in the processing of personal data.


                   The National Board of Health and Welfare has, with the support of the Patient Data Ordinance, issued regulations

                   and general advice on record keeping and processing of personal data in
                   health care (HSLF-FS 2016: 40). The regulations constitute such

                   supplementary rules, which shall be applied in the care provider's treatment of
                   personal data in health care, see chap. Section 1 of the Patient Data Act.


                   National provisions supplementing the requirements of the Data Protection Regulation
                   safety can be found in Chapters 4 and 6. the Patient Data Act and Chapters 3 and 4 HSLF-FS

                   2016: 40.


                   Requirement to make a needs and risk analysis







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                     According to ch. 4, the care provider must § 2 HSLF-FS 2016: 40 make a needs and

                     risk analysis, before the allocation of authorizations in the system takes place.


                     That the analysis requires both the needs and the risks is clear from the preparatory work

                     to the Patient Data Act, prop. 2007/08: 126 pp. 148-149, as follows.


                     Authorization for staff's electronic access to patient information shall be restricted to
                     what the executive needs to be able to perform his duties in health and

                     healthcare. This includes that authorizations must be followed up and changed or restricted accordingly
                     hand as changes in the tasks of the individual executive give rise to it.
                     The provision corresponds in principle to section 8 of the Health Care Register Act. The purpose of the provision is to

                     imprint the obligation of the responsible caregiver to make active and individual
                     eligibility assignments based on analyzes of which details are different

                     staff categories and different types of activities need. But it's not just needed
                     needs analyzes. Risk analyzes must also be done where different types of risks are taken into account, such as
                     may be associated with an overly availability of certain types of information.

                     Protected personal data that is classified, information about publicly known persons,
                     data from certain clinics or medical specialties are examples of categories such as

                     may require special risk assessments.

                     In general, it can be said that the more comprehensive an information system is, the greater the amount

                     there must be different levels of authorization. Decisive for decisions on eligibility for e.g. various
                     categories of healthcare professionals for electronic access to data in
                     patient records should be that the authority should be limited to what the executive needs

                     for the purpose a good and safe patient care. A more extensive or coarse-meshed
                     competence allocation should - even if it has points from the point of view of efficiency -

                     is considered an unjustified dissemination of journal information within a business and should as such
                     not accepted.


                     Furthermore, data should be stored in different layers so that more sensitive data require active choices or
                     otherwise not as easily accessible to staff as less sensitive tasks. When it
                     applies to personnel who work with business follow-up, statistics production, central

                     financial administration and similar activities that are not individual-oriented, it should be
                     most executives have enough access to information that can only be indirectly derived

                     to individual patients. Electronic access to code keys, social security numbers and others
                     data that directly point out individual patients should be able to be strong in this area
                     limited to individuals.



                     Internal secrecy
                     The provisions in ch. 4 The Patient Data Act concerns internal confidentiality, ie.

                     regulates how privacy protection is to be handled within a care provider's business

                     and in particular employees' opportunities to prepare for access to
                     personal data that is electronically available in a healthcare provider

                     organisation.








                                                          Page 14 of 30Datainspektionen DI-2019-3844 1 5 (30)






                   It appears from ch. Section 2 of the Patient Data Act, that the care provider shall decide

                   conditions for granting access to such data
                   patients who are fully or partially automated. Such authorization shall

                   limited to what is needed for the individual to be able to fulfill theirs
                   tasks in health care.


                   Of ch. 4 § 2 HSLF-FS 2016: 40 follows that the care provider shall be responsible for each

                   users are assigned an individual privilege to access
                   personal data. The caregiver's decision on the allocation of eligibility shall

                   preceded by a needs and risk analysis.


                   Coherent record keeping
                   The provisions in ch. 6 the Patient Data Act concerns cohesive record keeping,
                   which means that a care provider - under the conditions specified in § 2 the same

                   chapter of that law - may have direct access to personal data that is processed
                   by other care providers for purposes related to care documentation. The access to

                   information is provided by a healthcare provider making the information about a patient
                   which the care provider registers if the patient is available to other care providers

                   which participates in the cohesive record keeping system (see Bill 2007/08: 126
                   p. 247).


                   Of ch. 6 Section 7 of the Patient Data Act follows that the provisions in Chapter 4 §§ 2 and 3 -
                   also applies to authorization allocation and access control at cohesion

                   record keeping. The requirement that the care provider must perform a needs and risk analysis
                   before the allocation of permissions in the system takes place, thus also applies in systems

                   for coherent record keeping.


                   Documentation of access (logs)
                   Of ch. 4 Section 3 of the Patient Data Act states that a care provider must ensure that

                   access to such data on patients who are kept in whole or in part
                   automatically documented and systematically checked.


                   According to ch. 4 Section 9 HSLF-FS 2016: 40, the care provider shall be responsible for that

                       1. it appears from the documentation of the access (logs) which
                           measures taken with information on a patient,

                       2. it appears from the logs at which care unit or care process
                           measures have been taken,

                       3. the logs indicate the time at which the measures were taken;
                       4. the identity of the user and the patient is stated in the logs.






                                                   Page 15 of 30Datainspektionen DI-2019-3844 1 6 (30)






                  The Data Inspectorate's assessment


                  Personal data controller's responsibility for security

                  As previously described, Article 24 (1) of the Data Protection Regulation provides a
                  general requirement for the personal data controller to take appropriate technical

                  and organizational measures. The requirement is partly to ensure that
                  the processing of personal data is carried out in accordance with

                  the Data Protection Ordinance, and that the data controller must be able to
                  demonstrate that the processing of personal data is carried out in accordance with

                  the Data Protection Regulation.


                  The safety associated with the treatment is regulated more specifically in the articles
                  5.1 f and 32 of the Data Protection Regulation.


                  Article 32 (1) states that the appropriate measures shall be both technical and

                  organizational and they must ensure a level of security that is appropriate in
                  in relation to the risks to the rights and freedoms of natural persons which
                  the treatment entails. It is therefore necessary to identify the possible ones

                  the risks to the data subjects' rights and freedoms and assess
                  the probability of the risks occurring and the severity if they occur.

                  What is appropriate varies not only in relation to the risks but also
                  based on the nature, scope, context and purpose of the treatment. It has

                  thus the significance of what personal data is processed, how many
                  data, it is a question of how many people process the data, etc.


                  The health service has a great need for information in its operations.

                  It is therefore natural that the possibilities of digitalisation are utilized so much
                  as possible in healthcare. Since the Patient Data Act was written, one has a lot

                  extensive digitization has taken place in healthcare. Both the data collections
                  size as the number of people sharing information with each other has increased

                  substantially. At the same time, this increase means that the demands on it increase
                  personal data controller, as the assessment of what is an appropriate

                  safety is affected by the extent of the treatment.


                  It is also a question of sensitive personal data and the data concerns
                  people who are in a situation of dependence when they are in need of care.
                  It is also often a question of a lot of personal information about each of these

                  people and that the data over time may be processed by very







                                                 Page 16 of 30Datainspektionen DI-2019-3844 1 7 (30)






                   many people in healthcare. All in all, this places great demands on it

                   personal data controllers.
                   The data processed must be protected from outside actors as well

                   the business as against unauthorized access from within the business. It can
                   It should be noted that Article 32 (2) states that the controller, at

                   assessment of the appropriate level of safety, in particular taking into account the risks of
                   unintentional or unlawful destruction, loss or unauthorized disclosure or

                   unauthorized access. To be able to know what is an unauthorized access must
                   the data controller must be clear about what an authorized access is.


                   Needs and risk analysis

                   I 4 kap. Section 2 of the National Board of Health and Welfare's regulations (HSLF-FS 2016: 40), which supplement
                   the Patient Data Act, it is stated that the care provider must make a needs and
                   risk analysis before the allocation of authorizations in the system takes place. This means that

                   national law prescribes requirements for an appropriate organizational measure that shall:
                   taken before the allocation of authorizations to journal systems takes place.


                   A needs and risk analysis must include an analysis of the needs and a

                   analysis of the risks from an integrity perspective that may be associated
                   with an overly allotment of access to personal data

                   about patients. Both the needs and the risks must be assessed on the basis of them
                   tasks that need to be processed in the business, what processes it is

                   the question of whether and what risks to the privacy of the individual exist.


                   The assessments of the risks need to be made on the basis of organizational level, there
                   for example, a certain business part or task may be more

                   privacy sensitive than another, but also based on the individual level, if it is
                   the issue of special circumstances that need to be taken into account, such as

                   that it is a question of protected personal data, publicly known persons or
                   otherwise particularly vulnerable persons. The size of the system also affects

                   the risk assessment. The preparatory work for the Patient Data Act shows that the more
                   comprehensive an information system is, the greater the variety
                   eligibility levels must exist (Bill 2007/08: 126 p. 149). It is thus

                   the question of a strategic analysis at the strategic level, which should provide one
                   authorization structure that is adapted to the business and this must be maintained

                   updated.


                   In summary, the regulation requires that the risk analysis identifies
                        different categories of tasks,






                                                  Page 17 of 30Datainspektionen DI-2019-3844 1 8 (30)






                       Categories of data subjects (eg vulnerable natural persons and

                          children), or
                        the scope (eg number of personal data and registered)

                        negative consequences for data subjects (eg injuries,
                          significant social or economic disadvantage, deprivation of rights

                          and freedoms),


                   and how they affect the risk to the rights and freedoms of natural persons
                   Processing of personal data. This applies both within internal secrecy

                   as in coherent record keeping.


                   The risk analysis must also include special risk assessments, for example
                   based on whether there is protected personal data that is

                   classified, information on public figures, information from
                   certain clinics or medical specialties (Bill 2007/08: 126 p. 148-

                   149).


                   The risk analysis must also include an assessment of how probable and serious
                   the risk to the data subjects' rights and freedoms is based on
                   the nature, scope, context and purpose of the treatment (recital 76).


                   It is thus through the needs and risk analysis that it

                   personal data controller finds out who needs access, which
                   information the accessibility shall include, at what times and at what

                   context access is needed, while analyzing the risks to it
                   the freedoms and rights of the individual that the treatment may lead to. The result should

                   then lead to the technical and organizational measures needed to
                   ensure that no one other than the one who needs and

                   the risk analysis shows that it should be justified.


                   When a needs and risk analysis is missing prior to the allocation of qualifications in
                   system, lacks the basis for the personal data controller on a legal

                   be able to assign their users a correct authorization. The
                   the data controller is responsible for, and shall have control over, the

                   personal data processing that takes place within the framework of the business. To
                   assign users a when accessing journal system, without this being founded

                   on a performed needs and risk analysis, means that the person responsible for personal data
                   does not have sufficient control over the personal data processing that takes place in







                                                  Page 18 of 30Datainspektionen DI-2019-3844 1 9 (30)






                   the journal system and also can not show that he has the control that

                   required.


                   Aleris has stated that the authorizations are granted on the basis of the document, “
                   and risk analysis-TakeCare ”. The document states that all

                   authorization profiles in addition to technicians have been assigned permission to read in the system,
                   and that the risk with restricted access is that the user cannot perform his

                   tasks in full. This justification is stated for all users.
                   It is further stated that the only risk in the event of extensive access is to the user

                   sees information that he / she does not have the right to see which may involve disclosure
                   of patient information. Similar justification is given for all profiles. The

                   means that Aleris makes the same assessment for all profiles regardless
                   the user's task and needs.


                   The Data Inspectorate can state that the document, “Needs and risk analysis
                   TakeCare ”does not contain any analysis of the different profiles' needs

                   access to patients' data. Aleris has only stated what respectively
                   profile "must be able to perform" in the journal system and thus not analyzed which

                   information as it is a question of or what the needs look like in the various
                   the business components and for different professional roles. The document also lacks one

                   analysis of the risks to the individual's freedoms and rights as an excessive
                   eligibility may entail. The needs and risk analysis must be done in a strategic manner

                   level that should provide an authorization structure that is adapted to the business.


                   The information in the document "Needs and risk analysis - TakeCare" is too
                   deficient in relation to the information required for a correct

                   needs and risk analysis must be able to be performed. As stated above, in a
                   needs and risk analysis both the needs and the risks are assessed on the basis of them

                   tasks that need to be processed in the business, what processes it is
                   the question of whether and what risks to the individual's integrity exist as well

                   organizational as well as individual level.

                   In its analysis, Aleris has not taken into account the negative consequences for

                   registered, different categories of data, categories of registered or
                   the extent of the number of personal data and registered affects the risk of

                   the rights and freedoms of natural persons in the treatment of Aleris by
                   personal information in TakeCare. There are also no special risk assessments

                   based on whether there is, for example, protected personal data that is
                   classified, information on public figures, information from






                                                  Page 19 of 30Datainspektionen DI-2019-3844 2 0 (30)






                   certain clinics or medical specialties or other factors such as

                   requires special protective measures. There is also no assessment of how
                   probable and serious risk to the data subjects' rights and freedoms

                   is considered to be.


                   In the light of the above, the Data Inspectorate can state that
                   the document “Needs and risk analysis- TakeCare” does not meet the requirements

                   put on a needs and risk analysis and that Aleris has not been able to show that
                   the company has carried out a needs and risk analysis within the meaning of 4

                   Cape. § 2 HSLF-FS 2016: 40, neither within the framework of internal secrecy
                   according to ch. 4 the Patient Data Act or within the framework of the cohesive

                   record keeping according to ch. 6 Section 7 of the Patient Data Act. That means Aleris does not
                   have taken appropriate organizational measures in accordance with Article 5 (1) (f) and
                   Article 32 (1) and (2) in order to ensure and, in accordance with Article 5 (2),

                   be able to show that the processing of personal data has a security that is
                   appropriate in relation to the risks.


                   Authorization of access to personal data about patients

                   As reported above, a caregiver may have a legitimate interest in having
                   a comprehensive processing of data on the health of individuals. Notwithstanding this shall

                   access to personal data about patients may be limited to
                   what is needed for the individual to be able to fulfill his or her duties.


                   With regard to the allocation of authorization for electronic access according to ch.

                   § 2 and ch. 6 Section 7 of the Patient Data Act states that in the preparatory work, Bill.
                   2007/08: 126 pp. 148-149, i.a. that there should be different eligibility categories in

                   the journal system and that the permissions should be limited to what the user
                   need to provide the patient with good and safe care. It also appears that “a

                   more extensive or coarse-grained eligibility should be considered as one
                   unauthorized dissemination of journal information within a business and should as

                   such is not accepted. "

                   In health care, it is the person who needs the information in their work

                   who may be authorized to access them. This applies both within a
                   caregivers as between caregivers. It is, as already mentioned, through

                   the needs and risk analysis that the person responsible for personal data finds out who
                   who need access, what information the access should include, at which

                   times and in which contexts access is needed, and at the same time
                   analyzes the risks to the individual's freedoms and rights






                                                  Page 20 of 30Datainspektionen DI-2019-3844 2 1 (30)






                   the treatment can lead to. The result should then lead to the technical and

                   organizational measures needed to ensure no allocation
                   of eligibility provides further access opportunities than the one that needs and

                   the risk analysis shows is justified. An important organizational measure is to provide
                   instruction to those who have the authority to assign authorizations on how this

                   should go to and what should be considered so that it, with the needs and risk analysis
                   as a basis, becomes a correct authorization allocation in each individual case.


                   Aleris has stated that there are restrictions regarding users

                   access options in TakeCare then the company by choosing different functions
                   for different users can steer away users' access capabilities in

                   the journal system.

                   According to Aleris, all users have different read permissions in the journal system

                   depending on the system features they have access to. Of the document
                   However, “Needs and risk analysis - TakeCare” states that all professional profiles

                   in addition to technicians, read access has been assigned to the tasks in TakeCare.
                   Furthermore, the document "Profiles and Permissions" states that all

                   occupational profiles, ie. doctors, nurses, assistant nurses, paramedics,
                   secretary, administrative, student and receptionist Rehab has

                   authority to "read journal text". This means that virtually all professional profiles
                   has access to Aleri's personal data about patients in TakeCare. The

                   limitation that has been introduced is that different professional profiles have different
                   reading privileges, for example, doctors, nurses, paramedics can read

                   diagnoses ”or“ read prescriptions ”while other professional profiles, for example
                   "Administratively" do not have those powers. It also appears that doctors are

                   the only ones who have the authority to "read emergency information".


                   The Data Inspectorate considers it positive that Aleris has allocated different
                   read permissions in the system, but that it is not enough because all

                   professional profiles still have access to the journal texts in TakeCare.
                   In addition, the division is rough as it is only a division from the outside
                   occupational categories and not based on, for example, which organizational

                   affiliation, which tasks the user has or which patients
                   personal data that the user needs to access at different times

                   to. Because different users have different tasks within different
                   work areas, users need access to personal data about

                   patients in TakeCare are limited to reflect this.







                                                   Page 21 of 30Datainspektionen DI-2019-3844 2 2 (30)






                   Against this background, the Data Inspectorate can state that Aleris does not have

                   restricted users 'permissions to access patients'
                   personal data in the journal system TakeCare. This in turn means that one

                   majority of the users have had actual access to the care documentation
                   about a large number of patients in TakeCare.


                   The review also shows that Aleris uses so-called active choices

                   for access to personal data about patients and the record filter function.


                   The fact that Aleris uses active choices does not mean that the access option to
                   personal data in the system has been restricted to the user, without the data

                   are still electronically accessible. This means that the active choices are not
                   such an access restriction as referred to in ch. 4 Section 2 of the Patient Data Act,
                   as this provision requires that jurisdiction be limited to what

                   necessary for the individual to be able to fulfill his duties within
                   health care and that only those who need the information should have

                   access. The Data Inspectorate thus considers that Aleri's use of active choices
                   is an integrity enhancing measure but that it does not affect the actual

                   access possibilities.


                   Aleris has further stated that there are features in TakeCare for that one
                   care providers must be able to "isolate" a care unit and thereby "shut out"

                   other care providers 'and care units' access to the unit
                   care documentation, so-called protected units. However, Aleris believes that

                   the company does not conduct any business that requires protected entities and
                   have therefore not used this function.


                   As for the unified record keeping, all users at Aleris have

                   access to all personal data about patients at the other care providers in
                   TakeCare, except when patients have requested that their data be blocked.

                   It appears from the review that the care provider has an opportunity to actively
                   block the records of other caregivers, but that Aleris has chosen not to do so
                   because the company does not conduct any business that needs to be blocked. Aleris

                   considers it safer to leave the data at Aleri's units
                   available to other caregivers.


                   That the allocation of authorizations has not been preceded by a need and

                   risk analysis means that Aleris has not analyzed users' needs for
                   access to the data, the risks that such access may entail and






                                                  Page 22 of 30Datainspektionen DI-2019-3844 2 3 (30)






                   thus also not identifying which access is justified for the users

                   based on such an analysis. Aleris has thus not used suitable
                   measures, in accordance with Article 32, to restrict users' access to

                   patients' data in the medical record system. This in turn has meant that
                   there has been a risk of unauthorized access and unauthorized distribution of

                   personal data partly within the framework of internal secrecy, partly within the framework
                   for the unified record keeping.


                   Aleris has further stated that the company has no technical possibilities to

                   make changes to TakeCare because Aleris has no control over it
                   the journal system. It also appears that Aleris, within the framework of it

                   coherent record keeping, may not implement certain restrictions
                   with reference to a decision from the Stockholm Region.


                   The basis of the Data Protection Ordinance is that the person responsible for personal data
                   has a responsibility to comply with the obligations set out in the Regulation in order to:

                   be allowed to process personal data in their activities at all. To take
                   appropriate technical and organizational measures to ensure an appropriate

                   security is such an obligation (see Articles 5, 24 and 32 of
                   the Data Protection Regulation). The Data Inspectorate thus considers that Aleris in

                   capacity as personal data controller can not waive the responsibility to
                   take the technical and organizational measures required by the above

                   articles.


                   In light of the above, the Swedish Data Inspectorate can state that Aleris
                   has processed personal data in breach of Article 5 (1) (f) and Article 32 (1) and

                   32.2 of the Data Protection Regulation in that Aleris has not restricted
                   users' permissions for accessing the TakeCare journal system to what

                   which is only needed for the user to be able to fulfill his
                   tasks in health care according to ch. 4 § 2 and ch. 6 § 7

                   the Patient Data Act and Chapter 4 2 § HSLF-FS 2016: 40. That means Aleris does not
                   have taken steps to ensure and, in accordance with Article 5 (2) (i)
                   the Data Protection Regulation, be able to demonstrate appropriate security for

                   personal data.


                   Documentation of access (logs)
                   Of the documentation of access (logs) that arose due to

                   The Data Inspectorate's inspection is as follows: date, time,
                   the identity of the user and the patient, the measures taken and






                                                  Page 23 of 30Datainspektionen DI-2019-3844 2 4 (30)






                   care unit. The same documentation appears when the user takes part

                   tasks within the framework of coherent record keeping.


                   The Data Inspectorate has nothing to recall in this part, because
                   the documentation of the access (logs) in TakeCare is in accordance

                   with the requirements set out in Chapter 4. 9 § HSLF-FS 2016: 40. Aleris has thus
                   have taken appropriate technical measures in accordance with Article 32 i

                   the Data Protection Regulation.


                   Choice of intervention


                   Legal regulation
                   If there has been a violation of the Data Protection Regulation

                   The Data Inspectorate a number of corrective powers available under the article
                   58.2 a-j of the Data Protection Regulation. The supervisory authority can, among other things

                   instruct the data controller to ensure that the processing takes place in
                   in accordance with the Regulation and if required in a specific way and within a

                   specific period.


                   It follows from Article 58 (2) of the Data Protection Regulation that the Data Inspectorate in
                   in accordance with Article 83 shall impose penalty charges in addition to or in lieu of

                   other corrective measures referred to in Article 58 (2),
                   the circumstances of each individual case.


                   Article 83 (2) sets out the factors to be taken into account in determining whether a
                   administrative penalty fee shall be imposed, but also what shall affect

                   the size of the penalty fee. Of central importance for the assessment of
                   the seriousness of the infringement is its nature, severity and duration. If

                   in the case of a minor infringement, the supervisory authority may, according to recitals
                   148 of the Data Protection Regulation, issue a reprimand instead of imposing one

                   penalty fee.


                   Order
                   The health service has a great need for information in its operations. The

                   It is therefore natural that the possibilities of digitalisation are utilized as much as
                   possible in healthcare. Since the Patient Data Act was written, one has a lot

                   extensive digitization has taken place in healthcare. Both the data collections
                   size as the number of people sharing information with each other has increased

                   substantially. At the same time, this increase means that the demands on it increase





                                                  Page 24 of 30Datainspektionen DI-2019-3844 2 5 (30)






                   personal data controller, as the assessment of what is an appropriate

                   safety is affected by the extent of the treatment.


                   In this context, it means that a great deal of responsibility rests on it
                   personal data controller to protect the data from unauthorized access,

                   among other things by having an authorization allocation that is even more
                   comminuted. It is therefore essential that there is a real analysis of the needs

                   based on different activities and different executives. Equally important is that
                   there is an actual analysis of the risks from an integrity perspective

                   may occur in the event of an override of access rights. From
                   this analysis must then restrict the access of the individual executive.

                   This authority must then be followed up and changed or restricted accordingly
                   hand that changes in the tasks of the individual executive provide
                   reason for it.


                   The Data Inspectorate's inspection has shown that Aleris has failed to take appropriate action

                   security measures to provide protection for the personal data in the record system
                   TakeCare by not complying with the requirements set out in the Patient Data Act and

                   The National Board of Health and Welfare's regulations regarding the implementation of needs and
                   risk analysis, before the allocation of authorizations in the system takes place and that not

                   restrict the right of access to what is needed to the individual
                   must be able to fulfill their duties in health care. The

                   means that Aleris has also failed to comply with the requirements of Article 5 (1) (f) and Article
                   32.1 and 32.2 of the Data Protection Regulation. Failure includes it as well

                   internal secrecy according to ch. 4 the Patient Data Act as the cohesive one
                   record keeping according to ch. 6 patient data law.


                   The Data Inspectorate therefore submits pursuant to Article 58 (2) (d) i

                   data protection ordinance Aleris Sjukvård AB to implement and document
                   required needs and risk analysis for the TakeCare medical record system and that

                   then, based on the needs and risk analysis, assign each user
                   individual access to personal data restricted to
                   only what is needed for the individual to be able to fulfill his

                   duties in health care, in accordance with Article 5 (1) (f) and
                   Article 32 (1) and (2) of the Data Protection Ordinance, Chapter 4 § 2 and ch. 6 § 7

                   the Patient Data Act and Chapter 4 2 § HSLF-FS 2016: 40.


                   Penalty fee







                                                   Page 25 of 30Datainspektionen DI-2019-3844 2 6 (30)






                   The Data Inspectorate can state that the infringements basically concern Aleris

                   obligation to take appropriate security measures to provide protection to
                   personal data in accordance with the Data Protection Regulation.


                   In this case, it is a matter of large data collections with sensitive

                   personal data and extensive powers. The caregiver needs to be involved
                   necessity to have a comprehensive processing of data on the health of individuals.

                   However, it must not be unrestricted but should be based on what individual
                   employees need to be able to perform their tasks. The Data Inspectorate

                   notes that this is information that includes direct identification
                   by the individual through both name, contact information and social security number,

                   health information, but it may also be other private information about
                   for example, family relationships, sexual life and lifestyle. The patient is addicted
                   of receiving care and is thus in a vulnerable situation. The nature of the data,

                   scope and the patients' position of dependence give caregivers a special
                   responsibility to ensure patients' right to adequate protection for their

                   personal data.


                   Additional aggravating circumstances are the treatment of
                   personal data about patients in the main medical record system belongs to the core of a

                   the activities of caregivers, that the treatment covers many patients and
                   the possibility of access refers to a large proportion of the employees. In this case, stir

                   there are almost 800,000 patients and just over 1,000 active users in
                   the journal system.


                   It is a central task for the person responsible for personal data to take measures

                   to ensure an appropriate level of safety in relation to the risk. At
                   the assessment of the appropriate level of safety, special consideration shall be given to those risks

                   which the treatment entails, in particular from accidental or unlawful destruction,
                   loss or alteration or to unauthorized disclosure of or unauthorized access to

                   the personal data transferred, stored or otherwise processed,
                   pursuant to Article 32 (2) of the Data Protection Regulation. The requirements for health and
                   the healthcare area, regarding current security measures, has been specified in

                   the Patient Data Act and in the National Board of Health and Welfare regulations. Of the preparatory work for
                   The Patient Data Act clearly states that requirements are placed on both strategic analysis and

                   that eligibility is assigned individually and adapted to the current one
                   the situation. That large amounts of sensitive personal data are processed without

                   basic regulations in the field are followed means that the procedure is assessed as
                   more serious.






                                                   Page 26 of 30Datainspektionen DI-2019-3844 2 7 (30)








                   The Data Inspectorate also takes into account that Aleris has not chosen to restrict
                   access in the context of coherent record keeping. According to Aleris

                   is it more patient safe to leave the data at Aleri's units
                   available to other caregivers. This means that Aleris has given priority away

                   the protection of privacy within the coherent record keeping in favor of
                   patient safety, which is particularly serious.


                   The Data Inspectorate has also taken into account that Aleris has used some

                   integrity enhancement measures, performed certain restrictions regarding
                   occupational categories' reading qualifications and documented access to one

                   correct way.

                   In determining the seriousness of the infringements, it can also be stated that

                   the infringements also cover the basic principles set out in Article 5 (i)
                   the Data Protection Regulation, which belongs to the categories of more serious

                   infringements which may give rise to a higher penalty under Article 83 (5) (i)
                   the Data Protection Regulation.


                   Taken together, these factors mean that the infringements, not to implement

                   a needs and risk analysis and not to limit users' permissions
                   to only what is needed for the user to be able to fulfill theirs

                   tasks in health care, is not to be judged as minor
                   infringements without infringements that should lead to an administrative

                   penalty fee.


                   The Data Inspectorate considers that these violations are closely related to
                   each other. That assessment is based on the need and risk analysis

                   form the basis for the allocation of the authorizations. The Data Inspectorate
                   therefore considers that these infringements are so closely linked

                   that they constitute interconnected data processing within the meaning of Article 83 (3) (i)
                   the Data Protection Regulation. The Data Inspectorate therefore decides on a joint
                   penalty fee for these infringements.


                   According to Article 83 (3), the administrative penalty fee may not exceed

                   the amount of the most serious infringement in the case of one or the same
                   data processing or interconnected data processing.

                   The administrative penalty fee shall be effective, proportionate and
                   deterrent. This means that the amount must be determined so that it






                                                  Page 27 of 30Datainspektionen DI-2019-3844 2 8 (30)






                   the administrative penalty fee leads to correction, that it provides a preventive

                   effect and that it is also proportional in relation to both current
                   violations as to the ability of the supervised entity to pay.


                   As regards the calculation of the amount, Article 83 (5) (i)

                   the Data Protection Regulation that companies that commit infringements are the ones in question
                   may be subject to penalty fees of up to EUR 20 million or four

                   percent of total global annual sales in the previous financial year,
                   depending on which value is highest.


                   The term company includes all companies that conduct a financial

                   activity, regardless of the legal status of the entity or the manner in which it operates
                   financed. A company can therefore consist of an individual company in the sentence one
                   legal person, but also by several natural persons or companies. Thus

                   there are situations where an entire group is treated as a company and its
                   total annual turnover shall be used to calculate the amount of a

                   infringement of the Data Protection Regulation by one of its companies.


                   Recital 150 in the Data Protection Ordinance states, among other things
                   following. […] If the administrative penalty fees are imposed on a company,

                   a company for that purpose should be considered a company within the meaning of
                   Articles 101 and 102 of the TFEU […]. This means that the assessment of

                   what constitutes a company must be based on the definitions of competition law.
                   The rules for group liability in EU competition law revolve around

                   the concept of economic unit. A parent company and a subsidiary are considered
                   as part of the same economic entity when the parent company exercises one

                   decisive influence over the subsidiary. The Data Inspectorate therefore adds
                   as a starting point, the turnover for Aleris Group AB as a basis for

                   the calculation of the size of the penalty fee.


                   Aleris Group AB was formed at the end of 2019. Some turnover figures for the whole
                   2019 is thus not available. There is therefore no information on the annual
                   turnover for determining the amount of the penalty fee. Aleris has

                   stated that the group turnover for Aleris Group AB amounted to just over 1.2
                   billion between 1 October 2019 and 31 December 2019.

                   Recalculated for an entire year, this would correspond to a turnover of approximately 4.9
                   billion.









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                  The Data Inspectorate states that the actual annual sales for Aleris

                  Group AB this year will be significantly higher.


                  In the current case, the Data Inspectorate applies a precautionary principle and
                  therefore appreciates that the company's annual turnover at least corresponds to that of

                  the period October - December 2019 recalculated for full year, ie approximately 4.9
                  billion. The maximum sanction amount that can be determined in the current

                  case is EUR 20,000,000, which is just over four percent of the company's estimated
                  revenue.


                  Given the seriousness of the infringements and that the administrative

                  the penalty fee must be effective, proportionate and dissuasive
                  the Data Inspectorate determines the administrative sanction fee for

                   Aleris Sjukvård AB to SEK 15,000,000 (fifteen million).





                  This decision was made by Director General Lena Lindgren Schelin after
                  presentation by the IT security specialist Magnus Bergström. At the final

                  The case is also handled by the General Counsel Hans-Olof Lindblom, the unit managers
                  Katarina Tullstedt and Malin Blixt and the lawyer Linda Hamidi participated.




                  Lena Lindgren Schelin, 2020-12-02 (This is an electronic signature)





                  Appendix

                  How to pay penalty fee


                  Copy for information to
                  The Data Protection Officer
















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                  How to appeal

                  If you want to appeal the decision, you must write to the Data Inspectorate. Enter i
                  the letter which decision you are appealing and the change you are requesting.

                  The appeal must have been received by the Data Inspectorate no later than three weeks from
                  the day you received the decision. If the appeal has been received in due time

                  the Data Inspectorate forwards it to the Administrative Court in Stockholm
                  examination.


                  You can e-mail the appeal to the Data Inspectorate if it does not contain

                  any privacy-sensitive personal data or data that may be covered by
                  secrecy. The authority's contact information can be found on the first page of the decision.















































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