Since the effectuation of a new bioethical law, the number of registered genetic testing laboratories in Korea has reached about one hundred and seventy, as of June 2006. For the purpose of supervision and quality control of these laboratories the Korean Institute of Genetic Testing and Evaluation (KIGTE) was founded in October 2005 with the support of the Korean Government. KIGTE will perform its task by establishing a proficiency testing program and on-site inspection program in the near future. At this moment, however, the ambiguous definition of genetic testing, hasty entry of research tests into clinical practice, unpreparedness of some non-medical commercial laboratories for systematic quality assurance programs, and the risk of violating privacy related to genetic testing are major issues to be solved.
Genetic Testing* ; Jurisprudence ; Korea* ; Organization and Administration ; Privacy ; Quality Control

As genetic information is not changeable lifelong and might be used as disease predictors in a family, it requires special protection. Private genetic information is kind of individually identifiable health information, also known as 'protected health information (PHI)', which consists of individual identifier and individuals' health information. The removal of individual identifier from PHI is called 'deidentification'. For every institute that deals with PHI, the deidentification process and designation of a privacy official responsible for the implementation of privacy procedures could be urgent and practical strategies for protecting the privacy in genetic testing. However, for better patient care, deidentification would not be recommended when PHI flows among medical staffs.
Genetic Testing* ; Humans ; Medical Staff ; Patient Care ; Privacy*

he successful completion of Human Genome Project (HGP) and further advances in genomic research and technology ushered a new era of genetic medicine in the 21st century. The discovery of a gene-disease association lays the groundwork for the development of a genetic test. Clinical applications of genetic information and tools have provided us with the ability to perform a wide range of DNA testing for the diagnosis of various genetic diseases in patients as well as predicting the disease and disease susceptibility among presymptomatic family members at risk. Thus, the introduction of a new genetic testing may have complex implications for patients, family members, and the society. Guidelines for genetic testing have been developed not only to insure the accuracy of testing with the analytical validity, clinical validity, and clinical utility itself, but also to provide an implicit guide to ethical, legal and social issues (ELSI). Non-directive genetic counseling prior to genetic testing can provide patients with clinical implications of testing in terms of its benefits as well as risks, and help the patient to prepare informed consent, while efforts are made to insure privacy and confidentiality of individual genetic information. Ensuring the appropriate use of genetic testing in Korean health delivery system requires multidisciplinary efforts for the development of practice guidelines and educational programs for clinical genetics professionals including genetic counselors as well as governmental regulatory implementation for ELSI of genetic testing.
Confidentiality ; Counseling ; Diagnosis ; Disease Susceptibility ; DNA ; Genetic Counseling* ; Genetic Testing* ; Genetics ; Human Genome Project ; Humans ; Informed Consent ; Privacy

There have been several success stories in the field of pharmacogenetics in recent years, including the analysis of HER2 amplification for trastuzumab selection in breast cancer and VKORC1 genotyping for warfarin dosing in thrombosis. Encouraging results from these studies suggest that genetic factors may indeed be important determinants of drug response and toxicity for at least some drugs. However, to apply pharmacogenetics appropriately, a thorough understanding of the scope and limitations of this field is required. The challenges include an appreciation of biological variability, logistical issues pertaining to the proper management of information, the need for robust methods and adequate sample quality with well-designed workflows. At the same time, the economics of pharmacogenetic testing from the perspective of clinicians, patients, governments, insurance companies and pharmaceutical companies will play an important role in determining its future use. Ethical considerations such as informed consent and patient privacy, as well as the role of regulatory bodies in addressing these issues, must be fully understood. Only once these issues are properly dealt with can the full benefits of pharmacogenetics begin to be realised.
Antineoplastic Agents ; pharmacology ; Genetic Privacy ; ethics ; Humans ; Informed Consent ; Neoplasms ; drug therapy ; Pharmacogenetics ; ethics ; methods ; Translational Medical Research ; methods

Unlike the classical genetic study which dealt with the mendelian inheritances of relatively small number of patients, the genetic epidemiology study needs the large scaled genetic data base. The main ethical and legal problems of these kinds of studies are research design, informed consent, long term follow-up of research subjects, data sharing and benefit sharing. Classically, the informed consent was an important right but if these kinds of large scaled and long period studies were involved, the newly developing rights should be more stressed. The bioethics and biosafety act and governmental regulations for the genetic study and gene bank also shows those considerations. In EU, the general consent is considered acceptable if the approval of all future projects is fulfilled by a research ethics committee and the participants' right to withdraw samples at any times. In U.S.A., strict restriction is required for future experiments, but if the research involves no more than minimal risk to the subject, the waiver or alternation will not affect adversely the rights and welfare of subjects and the research could not be practicably carried out without the waiver or alteration, the specific future consents could be exempted. Long term follow up of research patients is needed to provide the newly developed information which would be helpful for the patients. Data sharing is needed to prevent the exclusive possession of genetic information. Benefit sharing is the newly coming up debates on how to manage the conflicts of interests between tissue-donors and scientific researchers. The context and inventory of human rights for the research is changing and still under construction.
Bioethics* ; Databases, Genetic ; Epidemiology ; Ethics Committees, Research ; Follow-Up Studies ; Human Rights ; Humans ; Information Dissemination ; Informed Consent ; Molecular Epidemiology* ; Privacy* ; Research Design ; Research Subjects ; Social Control, Formal ; Wills

OBJECTIVES: The prevalence of electronic medical record in Japan varies according to the size of the hospital which is 62.5% in major hospitals, 21.7% in medium, 9.1% in small size hospitals, and 16.5% in clinics. The complete paperless system is very limited, though some major hospitals are aiming at this system. Several regional network systems which connect different platforms of EMRs, have been developing in many districts, while the final picture of a regional network has not been clearly proposed. To develop a whole electronic health record or personal health records system from the regional network data, we have several obstacles to overcome such as standardization, a privacy act, unique national health number. METHODS: Some experimental trials have just been started. The reuse of the accumulated data has also just been initiated. We exploited text mining systems (term frequency-inverse document frequency method) to find similar cases and auto-audit Japanese diagnosis related group (DRG) coding by using discharge summaries. RESULTS: The same or even a more extreme phenomenon of huge data accumulation is occurring in genetic research and confluence of multi-disciplines of informatics is the next step, which has an enormous accumulation of data and discoveries of the relations beyond the dimension of each informatics. CONCLUSIONS: We need another approach to science apart from the conventional method, and data-driven approach with data mining techniques must be brought in for each field. Informaticians have new important roles as coordinators to link up numerous phenomena over dimensions.
Aluminum Hydroxide ; Asian Continental Ancestry Group ; Carbonates ; Clinical Coding ; Data Mining ; Electronic Health Records ; Genetic Research ; Health Records, Personal ; Humans ; Informatics ; Japan ; Patient Discharge ; Prevalence ; Privacy ; Translational Medical Research