• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.117-157
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• 2021

This research reviewed the HIPAA/HITECH, 21st Century Cures Act, Common Law, and private Guidances from the perspectives in protecting and utilitizing the medical data, while implications were followed. First, the standards for protection and utilization are relatively clearly regulated through single law on personal medical information in the United States. The HIPAA has been introduced in 1996 as fundamental act on protection of medical data. Medical data was divided into personally identifiable information, non-identifying information, and limited dataset under HIPAA. Regulations on de-identification measures for medical information, objects for deletion of limited data sets, and agreement on prohibition of data re-identification were stipulated. Moreover, in the 21st Century Cures Act regulated mutual compatibility for data sharing, prohibition of data blocking, and strengthening of accessibility of data subjects. Common Law introduced comprehensive consent system and clearly stipulates procedures. Second, the regulatory system is relatively simplified and clearly stipulated in the United States. To be specific, the expert consensus and the safe harbor system were introduced as an anonymity measure for identifiable medical information, which clearly defines the process while increasing trust. Third, the protection of the rights of the data subject is specified, the duty of explanation is specified in detail, while the information right of the consumer (opt-out procedure) for identification information is specified. For instance, the HHS rule and FDA regulations recognize the comprehensive consent system for human research, but the consent procedure, method, and requirements are stipulated through the common rule. Fourth, in the case of the United States, a trust-based system is being used throughout the health and medical data legislation. To be specific, Limited Data Sets are allowed to use in condition to the researcher's agreement to prohibit re-identification, and de-identification or consent process is simplified under the system.

• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.315-346
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• 2016

With the development of big data processing technology, the potential value of healthcare big data has attracted much attention. In order to realize these potential values, various research using the healthcare big data are essential. However, the big data regulatory system centered on the Personal Information Protection Act does not take into account the aspect of big data as an economic material and causes many obstacles to utilize it as a research purpose. The regulatory system of healthcare information, centered on the primary purpose of patient treatment, should be improved in a way that is compatible with the development of technology and easy to use for public interest. To this end, it is necessary to examine the trends of overseas legal system reflecting the concerns about the balance of protection and utilization of personal information. Based on the implications of the overseas legal system, we can derive improvement points in the following directions from our legal system. First, a legal system that specializes in healthcare information and encompasses protection and utilization is needed. De-identification, which is an exception to the Privacy Act, should also clearly define its level. It is necessary to establish a legal basis for linking healthcare big data to create synergy effects in research. It is also necessary to examine the introduction of the opt-out system on the basis of the discussion on the foreign debate and social consensus. But most importantly, it is the people's trust in these systems.

• The Korean Society of Law and Medicine
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• v.23 no.4
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• pp.29-74
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• 2022

As social disasters occur under the Disaster Management Act, which can damage the people's "life, body, and property" due to the rapid spread and spread of unexpected COVID-19 infectious diseases in 2020, information collected through inspection and reporting of infectious disease pathogens (Article 11), epidemiological investigation (Article 18), epidemiological investigation for vaccination (Article 29), artificial technology, and prevention policy Decision), (3) It was used as an important basis for decision-making in the context of an infectious disease crisis, such as promoting vaccination and understanding the current status of damage. In addition, medical policy decisions using infectious disease data contribute to quarantine policy decisions, information provision, drug development, and research technology development, and interest in the legal scope and limitations of using infectious disease data has increased worldwide. The use of infectious disease data can be classified for the purpose of spreading and blocking infectious diseases, prevention, management, and treatment of infectious diseases, and the use of information will be more widely made in the context of an infectious disease crisis. In particular, as the serious stage of the Disaster Management Act continues, the processing of personal identification information and sensitive information becomes an important issue. Information on "medical records, vaccination drugs, vaccination, underlying diseases, health rankings, long-term care recognition grades, pregnancy, etc." needs to be interpreted. In the case of "prevention, management, and treatment of infectious diseases", it is difficult to clearly define the concept of medical practicesThe types of actions are judged based on "legislative purposes, academic principles, expertise, and social norms," but the balance of legal interests should be based on the need for data use in quarantine policies and urgent judgment in public health crises. Specifically, the speed and degree of transmission of infectious diseases in a crisis, whether the purpose can be achieved without processing sensitive information, whether it unfairly violates the interests of third parties or information subjects, and the effectiveness of introducing quarantine policies through processing sensitive information can be used as major evaluation factors. On the other hand, the collection, provision, and use of infectious disease data for research purposes will be used through pseudonym processing under the Personal Information Protection Act, consent under the Bioethics Act and deliberation by the Institutional Bioethics Committee, and data provision deliberation committee. Therefore, the use of research purposes is recognized as long as procedural validity is secured as it is reviewed by the pseudonym processing and data review committee, the consent of the information subject, and the institutional bioethics review committee. However, the burden on research managers should be reduced by clarifying the pseudonymization or anonymization procedures, the introduction or consent procedures of the comprehensive consent system and the opt-out system should be clearly prepared, and the procedure for re-identifying or securing security that may arise from technological development should be clearly defined.