• Journal of Arbitration Studies
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• v.32 no.4
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• pp.3-31
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• 2022

In the past, there has not been a law with the main purpose of preventing or preventing a risk in advance in order to protect the safety of patients in relation to medical services. It is evaluated that the enactment of the Patient Safety Act has a very important meaning in protecting patient safety as the top priority and further improving the quality of medical care. However, looking at the status of patient safety accidents reported to the Patient Safety Reporting System after the Patient Safety Act was enacted and implemented, various types of risk factors for patient safety still exist in the medical field. Meanwhile, Korea Consumer Agency and Korea Medical Dispute Mediation and Arbitration Agency, the existing domestic ADR specialized agencies, have been operating reasonable damage relief procedures such as recommendation of settlement, mediation, and arbitration according to the purpose of their establishment. Therefore, with the aimof broadening the choice of compensation system for patients, we propose the establishment and revision of ADR-related laws to apply the damage relief procedures of both institutions.

• Journal of Korean Clinical Nursing Research
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• v.17 no.2
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• pp.138-149
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• 2011

Purpose: The objective of this research was to explore levels of patient safety and safe nursing activities depending on the level of nurse staffing, in order to provide effective management of nurse personnel. Methods: The research was conducted with 455 nurses from eight hospitals in B city. Data were collected according to the level of nurse personnel from second (nurse vs. patient ratio of 2.0-2.5) to fifth (ratio of 3.5-4.0) rank. The survey tools were, 'Questionnaire on Patient Safety, a Hospital Survey on Patient Safety Culture developed by AHRQ (2007), and 'Questionnaire on Patient Safety Nursing Act, in which the questions were selected from nursing-related items (Medication 6 & Safety Nursing Assurance Act 4) in the Safety Evaluation developed by Evaluation Institute of Medical Institution. Data were analyzed with SPSS PC 12.0 program using descriptive statistics, $x^2$ test, ANCOVA and $Scheff{\grave{e}}$. Results: The nurses' overall cognition level on patient safety and safe nursing activities showed that nurses who are in the second and third rank had higher scores than those in lower ranks. Conclusion: The results of this study indicate that hospitals need a higher ratio level for nurse personnel in order to assure patient safety and safe nursing activities.

• The Journal of the Korea Contents Association
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• v.21 no.1
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• pp.92-104
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• 2021

This study aims to analyze online news articles to identify social issues related to patient safety and compare the changes in these issues before and after the implementation of the Patient Safety Act. This study performed text mining through the R program, wherein 7,600 online news articles were collected from January 1, 2010, to March 5, 2020, and examined using keyword analysis, topic modeling, and word co-occurrence network analysis. A total of 2,609 keywords were categorized into 8 topics: "medical practice", "medical personnel", "infection and facilities", "comprehensive nursing service", "medicine and medical supplies", "system development and establishment for improvement", "Patient Safety Act" and "healthcare accreditation". The study revealed that keywords such as "patient safety awareness", "infection control" and "healthcare accreditation" appeared before the implementation of the Patient Safety Act. Meanwhile, keywords such as "patient safety culture". and "administration and injection" appeared after the act's implementation with improved ranking of importance pertaining to nursing-related terminology. Interest in patient safety has increased in the medical community as well as among the public. In particular, nursing plays an important role in improving patient safety. Therefore, the recognition of patient safety as a core competency of nursing and the persistent education of the public are vital and inevitable.

• The Korean Society of Law and Medicine
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• v.19 no.1
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• pp.81-111
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• 2018

Recently in Korea, public interest about patient safety has increased because patient safety incidents occurred continuously. In addition, as the way of coping with medical personnel and medical institutions after occurrence of patient safety incident became controversial, the necessity of introducing apology law and disclosure law was raised. We analyzed the contents of apology law and disclosure law in U.S.A and critically examined the legislative movements in Korea. First, the Apology law requires that a medical personnel provide apology, consolation, sympathy to the patient for discomfort, pain, damage or death, and that the expression of apology shall be inadmissible as evidence of an admission of liability in civil action or administrative proceeding. The Apology law is divided into 'full apology law' and 'partial apology law' depending on whether mistake, error, fault, liability, and legal liability shall be inadmissible. Meanwhile, Disclosure law enforces or voluntarily enforces the law to communicate with the patient regarding the disclosure of the incident, the cause of incident, the compensation plan, and the measures to prevent the recurrence in the adverse incident that serious harm to the patient. In Korea, the concern about patient safety incidents has been amplified, and as the importance of communication between the medical personnel and patient has been recognized, the revision bill for the "Patient Safety Act", which adopted the U.S.A apology or disclosure law, was submitted to the National Assembly. The purpose of this study was to critically review the contents of the revised legislation based on the analysis of the apology law and disclosure law in U.S.A. and to provide implications for future legislative direction.

• Journal of Yeungnam Medical Science
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• v.35 no.1
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• pp.36-39
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• 2018

In the personalized medicine era, utilizing paraffin blocks in pathology archives for investigating human diseases has come into the limelight. This archived material with clinical data will reduce the research time and could prevent new patient recruitment to obtain tissue for research. However, the clause indicating the necessity of consent from human material providers in the Korean Bioethics and Safety Act has made the Institutional Review Board (IRB) deny permission to use paraffin blocks for research without consent, and alternatively to get the same before starting an experiment. Written consent may be waived off in studies using paraffin blocks with anonymous status or conditions not linked to personal information by applying the paragraph 3, article 16 of the current Bioethics and Safety Act. Also, the IRB should recommend researchers to preserve the blocks as medical records of patients in long-term archives.

• Journal of radiological science and technology
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• v.30 no.4
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• pp.313-320
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• 2007

There are the Medical Radiation Health and Safety Act(the Patient Radiation Health and Safety Act, the Radiologic Technologist Act), the Medical Laboratory Technologist Act, the Physical Therapy Practice Act, and the Dental Hygienist Act, etc in America. However, Korea has only one Act for a medical radiologic technologist(including radiation therapy technologist, nuclear medicine technologist), medical laboratory technologist, physical therapist, occupational therapy examiner, dental hygienist, and so on. It is the Medical Technologist Act. Therefore, the Medical Radiation Health and Safety Act for a radiologic technologist(including radiation therapy technologist, nuclear medicine technologist) has to be enacted independently in Korea. It is the purpose of this Act to provide for the appropriate certification of persons using radioactive materials, equipment emitting ionizing radiation on humans or performing medical imaging for diagnostic and therapeutic purposes. In Korea, the radiologic technologist is a "fusion technologist" who is a person other than a licensed practitioner as a radiographer, radiation therapist, nuclear medicine technologist, computed tomography technologist, magnetic resonance technologist, mammographer, sonographer, medical dosimetrist, quality management technologist, etc. This Act will have some provisions related to the definitions, reserved title, scope of practice, specialized technologist, application for licensure, radiologic technology council, renewal, continuing education, the radiation control advisory commission, etc. This Act will ensure that quality radiation therapy treatments are delivered and that quality diagnostic information is presented for interpretation, which will lead to accurate diagnosis, treatment and cure. Accurate diagnosis can be provided only when a personnel is properly educated in technique, equipment operation and radiation safety. In the end, this Act will protect the civil right to health. By regulating the personnel responsible for performing those procedures, this Act will mean improved care for patients-higher quality images, improved accuracy, and less exposure to radiation.

• Journal of radiological science and technology
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• v.44 no.5
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• pp.503-512
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• 2021

The purpose of this study is to check the extent to which "instruction of physician or dentist" defined in the Medical Service Technologists, etc. Act is applied in relation to radiography examination procedures for radiological technologists. In addition, it is intended to present basic data on the requirement to revise the Medical Service Technologists, etc. Act in the radiological technologist's duty area and scope of work, The subjects of this study were radiological technologists with license, and the response data were collected after sending the questionnaire link written on the online questionnaire form. The final number of respondents were 1,018, and the response rate was 6.8%. Most of the negative responses were "I have never received 'instruction' for radiologic examination by a physician or dentist, including a radiologist in a medical environment." There were a high perception that "the professionalism in radiation examination on radiological technologists are higher than that of a physician or dentist." They answered that the current continuing education has a great impact on maintaining and continuing professionalism and learning new knowledge in the radiology field. In addition, the radiological technologists provide a very high level of education in areas related to radiography procedure ethics such as patient care, patient safety, and patient privacy protection, as well as specialized fields such as radiation-related examination methods, radiography examination dose, and patient exposure dose. Radiological technologists replied that they were receiving it consistently. In conclusion, in the current medical environment, the 'instruction' of a physician or dentist cannot be seen as being realistically performed. The phrase 'instruction' of a physician or dentist as defined in the Medical Service Technologists, etc. Act is considered inappropriate in respect of the fact that the state recognizes the qualifications of the medical service technologist through a license. It is thought that revision to a new term suitable for the current medical environment is necessary.

• The Journal of the Convergence on Culture Technology
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• v.4 no.2
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• pp.33-42
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• 2018

The Patient Safety Act was enacted on July 26, 2016. Patient safety law is a method to prevent harm by collecting and accumulating various errors through the reporting system. Therefore, in order for this law to be successfully implemented, it is necessary to vitalize 'the autonomous reporting and reporting learning system of patient safety accidents'. And In order for this system to be activated, a large amount of reporting data accumulation is a prerequisite. Nevertheless, there were only two reports in about 17 months. In this paper, I will criticize the validity of the current autonomous reporting system and the two proposed amendments, I would like to propose the introduction of a partial obligation reporting system.

• KSII Transactions on Internet and Information Systems (TIIS)
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• v.14 no.1
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• pp.437-454
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• 2020

According to the privacy regulations of the health insurance portability and accountability act (HIPAA), patients' control over electronic health data is one of the major concern issues. Currently, remote access authorization is considered as the best solution to guarantee the patients' control over their health data. In this paper, a new biometric-based key management scheme is proposed to facilitate remote access authorization anytime and anywhere. First, patients and doctors can use their biometric information to verify the authenticity of communication partners through real-time video communication technology. Second, a safety channel is provided in delivering their access authorization and secret data between patient and doctor. In the designed scheme, the user's public key is authenticated by the corresponding biometric information without the help of public key infrastructure (PKI). Therefore, our proposed scheme does not have the costs of certificate storage, certificate delivery, and certificate revocation. In addition, the implementation time of our proposed system can be significantly reduced.

• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.159-184
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• 2021

The significance of the enactment of the 「Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products」 is to break away from the regulation of the Pharmaceutical Affairs Act and expand patient treatment opportunities through a medical technology approach to regenerative medicine, which is essentially a medical practice called 'transplantation'. However, more than a year after the law was enacted, clinical study has not been activated, with not a single high-risk study approved by the Ministry of Food and Drug Safety being approved. The reason is that despite the legal purpose of expanding patient treatment opportunities, the data requirements for clinical study approval are set in connection with drug development despite the insufficient legal basis, making it difficult for many researchers to meet the data requirements. Prior to the enactment of the Act, submitted data for clinical study on cell therapy products within the Pharmaceutical Affairs Act were cosiderably exempted from quality and non-clinical test data, but with the enforcement of the Advanced Regenerative Bio Act, quality and non-clinical test data are required in accordance with pharmaceuticals when applying for approval of a clinical study plan. To rectify this, when considering the identity of clinical study on advanced regenerative medicine to expand treatment opportunities, recognize that there are limitations in connection with drug development. And it is necessary to preserve the identity of clinical study on advanced regenerative medicine, and on the other hand, in the case of drug product approval, clinical study results should be utilized while specifying usage requirements. Therefore, with the power of the market and the voluntary motive of the clinical researcher, it is necessary to prepare the necessary data by themselves rather than the basic requirements for clinical study approval.