BEST LAW-ETHICAL PRACTICE MODEL
FOR EASTERN EUROPE

By: Department of Informatics and Telemedicine of Donetsk R&D Institute of Traumatology and Orthopedics (Donetsk, Ukraine)( http://www.telemed.org.ua )

Published/Source: ISFT – International Society for Telemedicine ( www.isft.net )

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 the following 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" opies 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 ? 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 ?2801-XII)
Link (ukr.):
http://zakon.rada.gov.ua/cgi-bin/laws/main.cgi?nreg=2801%2D12
“On Communication” (Law of Ukraine 16.05.1995 ? 160/95- ?? )
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 ? 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 ?74/98-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 ? 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