A Study on Legal Protection, Inspection and Delivery of the Copies of Health & Medical Data (보건의료정보의 법적 보호와 열람.교부)
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- The Korean Society of Law and Medicine
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- v.13 no.1
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- pp.359-395
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- 2012
In a broad term, health and medical data means all patient information that has been generated or circulated in government health and medical policies, such as medical research and public health, and all sorts of health and medical fields as well as patients' personal data, referred as medical data (filled out as medical record forms) by medical institutions. The kinds of health and medical data in medical records are prescribed by Articles on required medical data and the terms of recordkeeping in the Enforcement Decree of the Medical Service Act. As EMR, OCS, LIS, telemedicine and u-health emerges, sharing and protecting digital health and medical data is at issue in these days. At medical institutions, health and medical data, such as medical records, is classified as "sensitive information" and thus is protected strictly. However, due to the circulative property of information, health and medical data can be public as well as being private. The legal grounds of health and medical data as such are based on the right to informational self-determination, which is one of the fundamental rights derived from the Constitution. In there, patients' rights to refuse the collection of information, to control recordkeeping (to demand access, correction or deletion) and to control using and sharing of information are rooted. In any processing of health and medical data, such as generating, recording, storing, using or disposing, privacy can be violated in many ways, including the leakage, forgery, falsification or abuse of information. That is why laws, such as the Medical Service Act and the Personal Data Protection Law, and the Guideline for Protection of Personal Data at Medical Institutions (by the Ministry of Health and Welfare) provide for technical, physical, administrative and legal safeguards on those who handle personal data (health and medical information-processing personnel and medical institutions). The Personal Data Protection Law provides for the collection, use and sharing of personal data, and the regulation thereon, the disposal of information, the means of receiving consent, and the regulation of processing of personal data. On the contrary, health and medical data can be inspected or delivered of the copies, based on the principle of restriction on fundamental rights prescribed by the Constitution. For instance, Article 21(Access to Record) of the Medical Service Act, and the Personal Data Protection Law prescribe self-disclosure, the release of information by family members or by laws, the exchange of medical data due to patient transfer, the secondary use of medical data, such as medical research, and the release of information and the release of information required by the Personal Data Protection Law.
There were also many medical-related rulings in 2021, among which the rulings reviewed in this paper are as follows. The first relates to a case in which the medical record, which is the primary judgment data regarding the presence or absence of medical negligence, has been modified. The court judged whether there was negligence on the basis of the first written medical record without considering the contents of the medical record that was later modified. Next, the ruling on the case of asking for liability for damages for prescription of anti-obesity drugs recognized negligence related to prescription, but denied liability for property damage by denying a causal relationship, and recognized only alimony for violation of the duty of explanation. The a full-bench ruling on the scope of subrogation of the National Health Insurance Corporation, which subrogates the claims for compensation for medical expenses against the perpetrator of the patient, changed the existing precedent that had taken the 'deduction method after offsetting negligence' and judged it as 'the method of offsetting negligence after deduction'. In addition, in the ruling on whether or not there was negligence, the court was not bound by the medical record appraisal result. Lastly, in relation to the National Health Insurance Service's disposition of reimbursement for medical care benefit costs, we reviewed the ruling that discretion should be exercised even when a non-medical person makes a refund to a medical institution opened by a non-medical person. And we also reviewed the ruling that the scope of reimbursement for medical institutions jointly using facilities and manpower specifically should be determined.
The International Atomic Energy Agency's Statute in Article III.A.5 allows it“to establish and administer safeguards designed to ensure that special fissionable and other materials, services, equipment, facilities and information made available by the Agency or at its request or under its supervision or control are not used in such a way as to further any military purpose; and to apply safeguards, at the request of the parties, to any bilateral or multilateral arrangement, or at the request of a State, to any of that State's activities in the field of atomic energy”. Safeguards are essentially a technical means of verifying the fulfilment of political obligations undertaken by States and given a legal force in international agreements relating to the peaceful uses of nuclear energy. The main political objectives are: to assure the international community that States are complying with their non-proliferation and other peaceful undertakings; and to deter (a) the diversion of afeguarded nuclear materials to the production of nuclear explosives or for military purposes and (b) the misuse of safeguarded facilities with the aim of producing unsafeguarded nuclear material. It is clear that no international safeguards system can physically prevent diversion. The IAEA safeguards system is basically a verification measure designed to provide assurance in those cases in which diversion has not occurred. Verification is accomplished by two basic means: material accountancy and containment and surveillance measures. Nuclear material accountancy is the fundamental IAEA safeguards mechanism, while containment and surveillance serve as important complementary measures. Material accountancy refers to a collection of measurements and other determinations which enable the State and the Agency to maintain a current picture of the location and movement of nuclear material into and out of material balance areas, i. e. areas where all material entering or leaving is measurab e. A containment measure is one that is designed by taking advantage of structural characteristics, such as containers, tanks or pipes, etc. To establish the physical integrity of an area or item by preventing the undetected movement of nuclear material or equipment. Such measures involve the application of tamper-indicating or surveillance devices. Surveillance refers to both human and instrumental observation aimed at indicating the movement of nuclear material. The verification process consists of three over-lapping elements: (a) Provision by the State of information such as - design information describing nuclear installations; - accounting reports listing nuclear material inventories, receipts and shipments; - documents amplifying and clarifying reports, as applicable; - notification of international transfers of nuclear material. (b) Collection by the IAEA of information through inspection activities such as - verification of design information - examination of records and repo ts - measurement of nuclear material - examination of containment and surveillance measures - follow-up activities in case of unusual findings. (c) Evaluation of the information provided by the State and of that collected by inspectors to determine the completeness, accuracy and validity of the information provided by the State and to resolve any anomalies and discrepancies. To design an effective verification system, one must identify possible ways and means by which nuclear material could be diverted from peaceful uses, including means to conceal such diversions. These theoretical ways and means, which have become known as diversion strategies, are used as one of the basic inputs for the development of safeguards procedures, equipment and instrumentation. For analysis of implementation strategy purposes, it is assumed that non-compliance cannot be excluded a priori and that consequently there is a low but non-zero probability that a diversion could be attempted in all safeguards ituations. An important element of diversion strategies is the identification of various possible diversion paths; the amount, type and location of nuclear material involved, the physical route and conversion of the material that may take place, rate of removal and concealment methods, as appropriate. With regard to the physical route and conversion of nuclear material the following main categories may be considered: - unreported removal of nuclear material from an installation or during transit - unreported introduction of nuclear material into an installation - unreported transfer of nuclear material from one material balance area to another - unreported production of nuclear material, e. g. enrichment of uranium or production of plutonium - undeclared uses of the material within the installation. With respect to the amount of nuclear material that might be diverted in a given time (the diversion rate), the continuum between the following two limiting cases is cons dered: - one significant quantity or more in a short time, often known as abrupt diversion; and - one significant quantity or more per year, for example, by accumulation of smaller amounts each time to add up to a significant quantity over a period of one year, often called protracted diversion. Concealment methods may include: - restriction of access of inspectors - falsification of records, reports and other material balance areas - replacement of nuclear material, e. g. use of dummy objects - falsification of measurements or of their evaluation - interference with IAEA installed equipment.As a result of diversion and its concealment or other actions, anomalies will occur. All reasonable diversion routes, scenarios/strategies and concealment methods have to be taken into account in designing safeguards implementation strategies so as to provide sufficient opportunities for the IAEA to observe such anomalies. The safeguards approach for each facility will make a different use of these procedures, equipment and instrumentation according to the various diversion strategies which could be applicable to that facility and according to the detection and inspection goals which are applied. Postulated pathways sets of scenarios comprise those elements of diversion strategies which might be carried out at a facility or across a State's fuel cycle with declared or undeclared activities. All such factors, however, contain a degree of fuzziness that need a human judgment to make the ultimate conclusion that all material is being used for peaceful purposes. Safeguards has been traditionally based on verification of declared material and facilities using material accountancy as a fundamental measure. The strength of material accountancy is based on the fact that it allows to detect any diversion independent of the diversion route taken. Material accountancy detects a diversion after it actually happened and thus is powerless to physically prevent it and can only deter by the risk of early detection any contemplation by State authorities to carry out a diversion. Recently the IAEA has been faced with new challenges. To deal with these, various measures are being reconsidered to strengthen the safeguards system such as enhanced assessment of the completeness of the State's initial declaration of nuclear material and installations under its jurisdiction enhanced monitoring and analysis of open information and analysis of open information that may indicate inconsistencies with the State's safeguards obligations. Precise information vital for such enhanced assessments and analyses is normally not available or, if available, difficult and expensive collection of information would be necessary. Above all, realistic appraisal of truth needs sound human judgment.