SECURITY AND PRIVACY IN EUROPEAN EHRS
Should Portugal Follow Denmark and Sweden’s Examples?
Catarina Travassos
1,2
, Inês C. Moreira
1,2,3
, Patrícia Ferreira
1,2
and Gustavo Bacelar-Silva
1,2,3,4
1
Faculdade de Medicina da Universidade do Porto, Al. Prof. Hernâni Monteiro, Porto, Portugal
2
Faculdade de Ciências da Universidade do Porto, Rua do Campo Alegre, Porto, Portugal
3
Escola Superior de Tecnologia da Saúde do Porto, Rua Valente Perfeito, Vila Nova de Gaia, Portugal
4
CINTESIS, Al. Prof. Hernâni Monteiro, Porto, Portugal
Keywords: Electronic health record, Health data privacy, Health data security, Portugal, Denmark, Sweden.
Abstract: EHR implementation is an important yet challenging technology that provides better patient care by
allowing and providing more accurate and available patient information. An efficient digital health service
should ensure not only the quality of data processing, but also the confidentiality and safety of patient data.
Portugal is now designing a national EHR and discussing its main characteristics and contents. Our study
analyses the experiences of two countries where EHRs were implemented: Denmark and Sweden. The aim
was to compare them when it comes to measures taken regarding privacy and security of data and also to
what Portugal has planned to achieve as described in available documentation.
1 INTRODUCTION
Privacy and security are considered as being major
concerns in EHRs (Thakkar and Davis, 2006). As
privacy is defined as the control of collection of
information, security can be defined as the
restriction of data to authorized parts (Bhagat et al.,
2010). Also, a key aspect of data security is assuring
that confidentiality, integrity and availability
(security components) are preserved. As
confidentiality ensures that data or information can
only be read by the intended or authorized recipient
integrity assures the recipient (and the originator)
that the data has not been altered in transit. Also, the
availability component guarantees that the systems
are accessible when needed and by who needs them
(Edwards, 2003).
Considering that Denmark has a history e-health
strategies ranging back to 1996, and that Sweden,
although being a more recent example (EHR
implementation in 2009) is also, in our opinion, a
good example of a successful EHR implementation,
it is our belief that the gathering of both examples
could provide valuable options to the Portuguese
future EHR.
2 METHODS
The information about the EHR projects, their
information models and the implementation has
been collected. Literature search was undertaken by
consulting electronic databases as well as hand
searching reference lists in published papers. In
addition, Danish and Swedish legislation and
established requirements on security standards were
also searched in government as well as national
authorities’ websites and official documentation.
Regarding Portuguese EHR planning projects, the
available documentation on the information models
creating the basis for the EHR applications has been
studied. In this paper, we identify 6 security issues
and 4 privacy topics in the analysed projects and will
discuss them in more detail.
3 EHR IN DENMARK
Denmark national strategy is based on 3 specific
action plans: 1) A staff tool for supporting
healthcare quality and productivity; 2) Improving
services and involving citizens and patients and 3)
Common infrastructure. The latter action plan
involves security and privacy, which help to ensure
354
Travassos C., C. Moreira I., Ferreira P. and Bacelar-Silva G..
SECURITY AND PRIVACY IN EUROPEAN EHRS - Should Portugal Follow Denmark and Sweden’s Examples?.
DOI: 10.5220/0003735003540357
In Proceedings of the International Conference on Health Informatics (HEALTHINF-2012), pages 354-357
ISBN: 978-989-8425-88-1
Copyright
c
2012 SCITEPRESS (Science and Technology Publications, Lda.)
interaction between the individual solutions
(National Strategy for Digitalisation of the Danish
Healthcare Service, 2007). Security is at the very
core of the Danish Health Data Network. In fact,
Denmark implemented the DS 484 security standard
as the basis for security activities (National Strategy
for Digitalisation of the Danish Healthcare Service,
2008-2012). DS 484, is the national equivalent to the
ISO 27002 Code of practice for information security
management, modified to suit Danish conditions
(ISO 27000, 2008).
As patients expect their data to be confidential
and protected from unauthorized access, it is also
important to assure than enough information is
provided to clinicians so that they can perform a
well-supported clinical decision. In Denmark,
although patients do not own their data, they are
offered two different privacy regimes. They can opt-
in or opt-in with restrictions. Opt-in means that they
allow use of personal information, but require
consent before data can be disclosed to third parties.
Most patients choose opt-in, over opt-in with
restrictions that are not specified (Deutsch &
Turisco, 2009). The “break the glass” system is
allowed in emergency situations.
4 EHR IN SWEDEN
The Swedish project, known as NPÖ aims to
improve patient security and quality of care by
developing the national electronic health record in
stages. Sweden implemented the SS-ISO/IEC
27001:2006 security standard (SS-ISO/IEC
27001:2006) as the basis for security activities. A
digital communication system, “Sjunet,” ensures that
physicians use a special electronic ID card to log in,
and keeps track of each instance that a health record
is accessed. Patients not only have the option of
restricting which professionals can access their
record, but they can also restrict the period of time
after the visit that the health professional can
continue to access it. As in Denmark, the system has
a “break the glass” option, allowing healthcare
professionals to access the record in an emergency.
5 EHR IN PORTUGAL
The documents that plan the future implementation
of the Portuguese EHR recommend a security policy
based on principles and norms relevant for IT
systems as ISO 27799 based on ISO 27002 (RSE-
R1, 2009) (RSE-R2A, 2009). The plan of operations
for Portugal’s 2010, refers several aspects in which
is stated the harmonization of legal bases to assure
permission, privacy, confidentiality and safety when
accessing and treating information. One of the topics
is Legal harmonization and it includes activities that
aim to obtain a legal consensus that allows EHR
implementation, assuring also that all matters of
confidentiality, access security, transfer and data use
are completed (RSE – PO, 2010). According to the
Portuguese legislation, the patient is the owner of his
own health data, and the health institutions are the
keepers of that information. In Portugal, two types
of privacy regimes will be possible: opt-in and opt-
out. In the first option, the patient won’t have his
data included in the EHR by default, being necessary
the patient to state his intention of including his data
in the EHR. In the latter, the patient will have his
health data in the EHR repository by default and
may request for selected data not to be included in
the EHR. The “break the glass” policy has also been
considered as it happens in Denmark and Sweden.
6 COMPARING PORTUGAL TO
DENMARK AND SWEDEN
As previously mentioned, these countries present
some differences about privacy and security
concerns. These differences regarding privacy are
presented in more detail in Table 1, 2, 3 and 4.
Table 1: Comparison in terms of data use restriction.
Restriction of data use
Denmark
Privacy laws do not restrict data use to improve
quality and for public reporting.
Sweden
The law aims to allow patients to decide who
can access their medical record, while allowing
care providers to communicate permitted patient
data in the exchange securely.
Portugal
As part of citizen rights over their own data, it
has been found necessary for the citizen to
control who can view his information, and
whose property would exams, diagnosis results
and reports be. While medical exams and
diagnosis results are property of the patient,
whichever reports come from those results are
intellectual property of the physician.
SECURITY AND PRIVACY IN EUROPEAN EHRS - Should Portugal Follow Denmark and Sweden's Examples?
355
Table 2: Comparison in terms of health professional
choice.
Choose the health professionals that
can access data
Denmark
Privacy is protected by a requirement
that all health professionals get
patients’ consent to look at their health
information, with the exception of
medication profiles, which are
accessible to all physicians.
Sweden
Access by the prescriber or pharmacist
to information in the database must
require the patient’s consent.
Portugal
Health care providers require
authorization of the patient, to access
information.
Patient authorization should have a
well established validity, meaning that
it should be expirable and able to be
renewed or not.
Table 3: Comparison in terms of health professionals that
can access data.
Choose the health professionals that can
access data
Denmark According to DS484 this is included.
Sweden
According to SS 627799 this is included.
The Social Services Act and the Health
Records Act contain provisions designed to
protect access to patient information.
Portugal Not mentioned.
Table 4: Comparison in terms of privacy regimes.
Privacy regimes
Denmark Opt-in or Opt-in with restrictions.
Sweden
To meet the goal of the legislation, the
Swedish system uses an opt-in with
restrictions consent model.
Portugal Opt-in or Opt-out.
Differences regarding security can be consulted
in tables 5, 6, 7, 8, 9 and 10.
Table 5: Comparison in terms of availability.
Availability
Denmark
Available citizen services are: electronic
booking of appointments, access to one's
own medical records, prescription
renewals, health appointment calendars.
Sweden Not mentioned.
Portugal
User’s access needs should be taken into
account.
Table 6: Comparison in terms of confidentiality.
Confidentiality
Denmark
“Information and services must be
accessible and protected so that everyone
can rest assured that the information is
correct and reliable and that due
confidentiality is maintained”.
Sweden
Predicted in laws governing the use of
information, such as the Secrecy Act
(sekretesslagen, 1980:100), the Personal
Data Act, the Care Registers Act (lagen om
vårdregister, 1998:544) and several other
acts concerning registries.
Portugal
According to the Ethics code the law,
health professionals are obliged to secrecy
in order to keep information security.
Table 7: Comparison in terms of integrity.
Integrity
Denmark
Not mentioned.
Sweden
Not mentioned.
Portugal
Availability of versions for modified and
registered data.
Table 8: Comparison in terms of identity.
Identity
Denmark
Digital signature.
Citizens and patients may only access their
own data following individual
authentication via a personal digital
certificate based on the national OCES-
standard. Health professionals may also
access patient data having obtained the
relevant consent and a local authentication.
Sweden
Citizens will need to use smartcards or
similar plastic ID cards to verify their
identity. Users will also be required to sign
up for the service by filling out a number of
security-related documents.
Portugal
National identity card (smart card)
A National Patient Database (Registo
Nacional de Utentes) and a Health
Professionals Database should be created,
and then spread to private institutions; also
create a database for entities that provide
health care.
HEALTHINF 2012 - International Conference on Health Informatics
356
Table 9: Comparison in terms of access control.
Access control
Denmark
Only physicians can see all patient data
Register nurses can see only current
encounter data for patients on their ward.
Restrictions on selected diseases, for
example, HIV lab tests and results are
blanked out (“trusted answer”).
Patients can restrict access by role, facility,
and type of data.
Region laws can override national laws in
certain instances (structure decentralized).
“Break the glass” regime.
Sweden
In order to view any healthcare record,
health care professionals must have a
“patient relation” with the patient,
meaning the patient has given consent for
them to look at his or her health record.
Patients not only have the option of
restricting which professionals can access
their record, they can also restrict the
period of time after the visit that the
professional can continue to access it.
Sweden also restricts health care
professionals on how much of the record
they can see.
County councils and municipalities, not
patients, designate which professionals can
see which parts of the record.
“Break the glass” regime; however, access
will be logged and professionals will have
to explain why they needed to view the
information.
Portugal
Different professional categories should
have different user profiles and restricted
information.
Insurance companies and courts may also
require health information from health care
institutions.
“Break the glass” regime.
Table 10: Comparison in terms of auditability.
Auditability
Denmark Full audit trail for access and updates.
Sweden Health care quality audits available.
Portugal
Audit required to control privacy of patient
data, reduce medical error, assure
responsibility and insert correction
measures.
Subject to access rules and policies as the
data being audited.
Certification and periodic auditing to
verify that security measures are in fact
active.
7 CONCLUSIONS
Based on all documents consulted about the Danish
and the Swedish EHRs implementation, it is our
belief that they managed to create a system with
functional and useful characteristics that is reliable
and considers the most important aspects on patient
data security as well as privacy. It would therefore
be an example to follow in all its extent and detail.
We find that detailed rules provide enough
clarification about all these issues, which in turn
results satisfactory results and in patient satisfaction.
The last public consultation on the EHR proposal
ended on 15th September 2010. If all goes according
to planned, the EHR should be active with basic
functionalities in all national health institutions by
2012, and the complete version should be available
by 2015. Even though technically and as far as
information security is concerned, the Portuguese
EHR is set to be implemented in 2012, this will
depend on future government decisions.
REFERENCES
Appendix C: Select Examples of Exchange in Other
Developed Countries. Denmark Country Report, 2010.
Introduction to ISO 27002 (ISO27002), 2005.
National Strategy for Digitalisation of the Danish
Healthcare Service 2008-2012, 2007.
National Strategy for eHealth: Sweden, 2009.
RSE - PO, 2010. RSE - Registo de Saúde Electrónico. PO:
Plano de Operacionalização.
RSE-R1, 2009. RSE - Registo de Saúde Electrónico. R1:
Documento de Estado da Arte.
RSE-R2A, 2009. RSE - Registo de Saúde Electrónico.
R2A: Orientações para Especificação Funcional e
Técnica do Sistema de RSE.
SS-ISO/IEC 27001:2006, 2006. Swedish standard SS-
ISO/IEC 27001:2006 Information technology -
Security techniques (ISO/IEC 27001:2005, IDT),
SIS/TK 318.
ISO 27000, 2008. The ISO 27000 Directory: Introduction
to ISO 27002 (ISO27002).
Bhagat, S., Fontaine, D. and Gibson, K., 2010. Danish
Healthcare Information Technology - An Analytical
Study of Consumer Issues.
Deutsch, H. and Turisco, F., 2009. Accomplishing
EHR/HIE (eHealth): Lessons from Europe. CSC.
Edwards, R., 2003. Cryptography.
Protti, D. and Johansen, I., 2010. Widespread Adoption of
Information Technology in Primary Care Physician
Offices in Denmark: A Case Study.
Thakkar, M. and Davis, D., 2006. Risks, Barriers, and
Benefits of EHR Systems: A Comparative Study
Based on Size of Hospital. Perspectives in Health
Information Management, p.1-14.
SECURITY AND PRIVACY IN EUROPEAN EHRS - Should Portugal Follow Denmark and Sweden's Examples?
357