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Short original article
Legal Aspects of Electronic Communication in Telemedicine
1
Otto Dostál
1
First Faculty of Medicine, Charles University in Prague, Czech Republic
Correspondence to:
Otto Dostál
First Faculty of Medicine, Charles University in Prague
Address: Kate°inská 32, 121 08 Prague 2
Email: [email protected]
IJBH 2014; 2(1):35
received: June 16, 2014
accepted: June 30, 2014
published: August 15, 2014
Aims of Research
forcement mechanism though European Court of Human
Rights (which for example the Covenant on Civil and PoThe incorporation of various information technology litical Rights is lacking).
This convention constitutes the right to respect for pritools in medical practice brings the opportunities related
to improvement of quality and availability of services and vate and family life in its article 8. According to it:
other benets. However, the spreading use of the e-Health
1. Everyone has the right to respect for his private and
applications in healthcare also raises questions about the
family life, his home and his correspondence.
legal aspects of this development.
It is a critical aspect which is necessary to have in mind
2. There shall be no interference by a public authority
in the process of deployment of various e-health applicawith the exercise of this right except such as is in
tions and which still arouses various questions. It is for
accordance with the law and is necessary in a demoexample still possible to encounter fears if the legal regcratic society in the interests of national security,
ulation of personal data protection allows some of these
public safety or the economic well-being of the coundeployments and in which way.
try, for the prevention of disorder or crime, for the
The aim of the research is to provide a review of leprotection of health or morals, or for the protection
gal framework in this area and of obligations prescribed
of the rights and freedoms of others.
by it, to help understand its role in the regulation of
telemedicine and to identify and discuss possible issues.
The European Court of Human Rights considers in its
judicature [3] the protection of personal data, in particular respecting the condentiality of health data, to be a
vital principle in the legal systems of all the Contracting
A legal framework exists, consisting of several levels of Parties to the Convention.
The Council of Europe is also responsible for the crelegal sources.
ation
of the Convention for the Protection of Individuals
First, there are the international treaties.
with
regard
to Automatic Processing of Personal Data
Foremost the International Covenant on Civil and Po(also
known
as
the "Convention 108") [4]. This convenlitical Rights has to be mentioned [1]. This multilateral
tion
deals
in
greater
detail with personal data undergoing
treaty, which has been ratied by most countries in the
automatic
processing.
world, deals with privacy in its article 17. According to
Secondly, there is the European law.
it:
As a part of the Lisbon treaty the EU law now includes
1. No one shall be subjected to arbitrary or unlawful the Charter of Fundamental Rights of the European Union
interference with his privacy, family, home or cor- [5].
respondence, nor to unlawful attacks on his honour
The national legislation in EU countries is however
and reputation.
more directly aected by the Directive n. 95/46/ES on
the protection of individuals with regard to the process2. Everyone has the right to the protection of the law
ing of personal data and on the free movement of such
against such interference or attacks.
data [6]. The Directive no. 99/93/ES on a Community
In European context, currently the most crucial treaty framework for electronic signatures is also of importance
to protect human rights and fundamental freedoms is the [10].
European Convention on Human Rights [2]. The imporIt the third place, there is the national constitutional
tance of this treaty is based especially on its strong en- law.
State of the Art
c 2014 EuroMISE s.r.o.
IJBH Volume 2 (2014), Issue 1
4
Dostál O. Legal Aspects of Electronic Communication in Telemedicine
Almost all democratic countries in the world have some
kind of bill of rights where we can look for and usually we
will indeed nd some enactment of the right to privacy.
The bill of rights in the Czech Republic has the form
of Charter of fundamental rights and freedoms [7]. According to its article 10:
Keywords
Personal Data
Denition:
Any information relating to an identied or
identiable natural person.
Synonyms:
personally identiable information
1. Everyone has the right to demand that her human
dignity, personal honour, and good reputation be re- Reference: art. 2 let. a) Directive n. 95/46/ES on the
protection of individuals with regard to the processspected, and that her name be protected.
ing of personal data and on the free movement of
such data
2. Everyone has the right to be protected from any
unauthorized intrusion into her private and family UMLS: life.
SNOMED CT:
3. Everyone has the right to be protected from the unauthorized gathering, public revelation, or other misuse
of her personal data.
According to its article 13:
MeSH:
no matching results found
no matching results found
Data Subject
Denition:
An identied or identiable natural person;
an identiable person is one who can be identied,
directly or indirectly, in particular by reference to
an identication number or to one or more factors
specic to his physical, physiological, mental, economic, cultural or social identity.
No one may violate the condentiality of letters or
the condentiality of other papers or records, whether privately kept or sent by post or by some other means, except in the cases and in the manner designated by law.
The condentiality of communications sent by telephone,
Reference: art. 2 let. a) Directive n. 95/46/ES on the
telegraph, or by other similar devices is guaranteed in the
protection of individuals with regard to the processsame way.
In the fourth place, there is the national legislation.
Of relevance are some general types of statutes, such
as the Personal Data Protection Act no. 101/2000 Sb. [8],
and the Digital Signature Act no. 227/2000 Sb. [9]. The
core of the legal regulation of health records is incorporated in The Healthcare Services Act [11]. Subsequently
to this Act, a Health Record Order no. 98/2012 Sb. [12]
implementing it was later passed.
Application in Biomedicine and
Healthcare
A legal framework is an important part of the foundations of every e-health project. It represents the obligations and certain limitations, but these are necessary
for building trust in the environment. The lack of trust
makes people hesitant to adopt new services. An insufcient legal framework or knowledge thereof might risk
slowing down the development of innovative uses of new
technologies.
Acknowledgement
The present study was supported by the project SVV
260034 of Charles University in Prague.
IJBH Volume 2 (2014), Issue 1
ing of personal data and on the free movement of
such data
UMLS:
SNOMED CT:
MeSH:
no matching results found
no matching results found
Processing of Personal Data
Denition:
Any operation or set of operations which
is performed upon personal data, whether or not
by automatic means, such as collection, recording,
organization, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available,
alignment or combination, blocking, erasure or destruction.
Reference:
art. 2 let. b) Directive n. 95/46/ES on the
protection of individuals with regard to the processing of personal data and on the free movement of
such data
UMLS:
SNOMED CT:
MeSH:
no matching results found
no matching results found
c 2014 EuroMISE s.r.o.
5
Dostál O. Legal Aspects of Electronic Communication in Telemedicine
Electronic Signature
Denition:
Data in electronic form which are attached
to or logically associated with other electronic data
and which serve as a method of authentication.
Reference:
art. 2 Ÿ1 Directive n. 99/93/ES on a Community framework for electronic signatures
UMLS: SNOMED CT: no matching results found
MeSH: no matching results found
Advanced Electronic Signature
Denition:
An electronic signature which meets the following requirements: (a) it is uniquely linked to the
signatory; (b) it is capable of identifying the signatory; (c) it is created using means that the signatory can maintain under his sole control; and (d) it
is linked to the data to which it relates in such a
manner that any subsequent change of the data is
detectable.
Reference:
art. 2 Ÿ2 Directive n. 99/93/ES on a Community framework for electronic signatures
UMLS: SNOMED CT: no matching results found
MeSH: no matching results found
c 2014 EuroMISE s.r.o.
References
[1] United Nations. International Covenant on Civil and Political
Rights. UNTS. 1976.
[2] Council of Europe. European Convention on Human Rights.
Treaty Ser. 1952.
[3] The European Court of Human Rights. Case of I v. Finland
(Application no. 20511/03). 2008.
[4] Council of Europe ETS no. 108 Convention for the Protection of Individuals with regard to Automatic Processing of
Personal Data. 1981.
[5] European Parliament, Council of the European Union, European Commission. Charter of Fundamental Rights of the European Union. O J Eur Union. 2007;C(303):1â16.
[6] Directive no. 95/46/EC on the protection of individuals with
regard to the processing of personal data and on the free movement of such data. 1995.
[7] Czech Charter of Fundamental Rights and Freedoms no.
2/1993 Sb. 1992.
[8] Czech Personal Data Protection Act no. 101/2000 Sb. 2000.
[9] Czech Digital Signature Act no. 227/2000 Sb. 2000.
[10] Directive no. 99/93/ES on a Community framework for electronic signatures. 1999.
[11] Czech Healthcare Services and Conditions for their Provision
Act no. 372/2011 Sb. 2011.
[12] Czech Health Record Order no. 98/2012 Sb. 2012.
IJBH Volume 2 (2014), Issue 1