Background
Many countries in Eastern Europe have
no special laws for Telemedicine and eHealth activity. But laws about medical
care, preservation of information, ethical and social position in health
care system are very similar. We believe that it’s possible to use our
Best law-ethical practice model not only for Ukraine, but for all involved
countries of Eastern Europe.
Main goals
There are next main goals for this model:
- preservation of medical information;
- preservation patients’ rights to privacy;
- confidentiality of any telemedical and
eHealth system;
- responsibility for the patient.
Decisions
1). Observance of a principle of the informed
consent.
Before carrying out of any telemedical
procedure the physician should give the patient the precise and intelligible
explanatories concerning necessity or desirability of telemedical procedure,
and also its opportunities and restrictions. The physician is obliged to
receive the written agreement of the patient on sending of personal health
information by telesystem.
2). Observance of confidentiality and anonymity.
The technicians should give a subscription
about performance of norms, requirements and the rules of organizational
and technical character concerning protection of the processable medical
information, and also on its nondisclosure.
At transfer of the medical information
it is necessary to observe medical secret; the information on the patient
is sent only in an anonymous kind;
personal information (a surname, number
of the case record, etc.) should be "erased" from all images (xrays, tomograms
etc.)
All personal computers of a telemedical
workstation should have only the authorized access (login/password). Folders
and the local disks containing materials of teleconsultation, should be
closed for direct access by any network.
3). Observance of laws and ethical norms.
Teleconsultation is used for the help
in acceptance of the clinical decision. Last decision must be accepted
by the attending physician (inquirer). The “face-to-face” physician should
bear the responsibility for changes in conditions of the patient’s health
due to using or not using of recommendations of the distant adviser.
Standartisation and careful recording
of all telemedical procedures, creation of reserve and "hard" copies are
necessary.
Using of the digital signature for identification
of the participant of the telemedical procedures is desirable.
The impossibility of access to the electronic
data on the patient by the third parties, the similar information can be
given only under the letter of enquiry from the state structures (police
etc).
4). Teleconsultation by second-opinion.
It is necessary to explain precisely impossibility
of an objective estimation of a state of health of the patient at such
form of teleconsultation; in the conclusion the general information and
the basic approaches to diagnostics and treatment in the given situation
is stated only; at doubts in completeness of the knowledge, it is necessary
to redirect inquiry to other expert, having notified about it the patient;
it is necessary to recommend for the patient to address to the “face-to-face”
physician.
Laws
Ukrainian laws, which adjust using of
information system in health care in Ukraine:
«On Information» (Law of Ukraine 02.10.1992
¹ 2657-XII)
Link (eng.):
http://www.welcometo.kiev.ua/ili/ilic.frame_law_result2.show?p_arg_names=law_id&p_arg_values=223
«Basis of laws of Ukraine on Health Care
System» (Law of Ukraine 19.11.1992 ¹2801-XII)
Link (ukr.):
http://zakon.rada.gov.ua/cgi-bin/laws/main.cgi?nreg=2801%2D12
“On Communication” (Law of Ukraine 16.05.1995
¹ 160/95-ÂÐ)
Link (eng.):
http://www.welcometo.kiev.ua/ili/ilic.frame_law_result2.show?p_arg_names=law_id&p_arg_values=169
«On Protection Information in Automatic
System» (Law of Ukraine 05.07.1994 ¹ 80/94-BP)
Link (ukr.) :
http://zakon.rada.gov.ua/cgi-bin/laws/main.cgi?nreg=80%2F94%2D%E2%F0
«On National Informatisation System» (Law
of Ukraine 04.02.1998 ¹74/98-BP)
Link (ukr.) :
http://zakon.rada.gov.ua/cgi-bin/laws/main.cgi?nreg=74%2F98%2D%E2%F0
«On Immediate Measures to Reinforce the
Protection of Intellectual Property Rights in the Process of Production,
Export, Import and Distribution of Disks for Laser-Readable Systems» (Decree
of the President of Ukraine 30.01.2002 ¹ 85/2002)
Link (eng.):
http://www.welcometo.kiev.ua/ili/ilic.frame_law_result2.show?p_arg_names=law_id&p_arg_values=196
A few laws about Electronic Digital Signature
Link (ukr.):
http://zakon.rada.gov.ua/cgi-bin/laws/main.cgi?nreg=1452%2D2004%2D%EF
Contact
Anton Vladzymyrskyy,
M.D., Regional Telemedicine Director,
Head of Dep.of Informatics and Telemedicine,
R&D Institute of Traumatology and Orthophedics,
Deputy-editor of “Ukrainian Journal of Telemedicine
and Medical Telematics”
ul.Artema,106, 83048 Donetsk, Ukraine
E-mail: avv@telemed.org.ua
ICQ: 94280429