급성 약물중독 환자에서 위세척의 의료법학적 고찰 -대법원 2005.1.28, 2003다14119 판결을 중심으로-

배현아 ( Hyuna Bae ) 대한임상독성학회 2005 대한임상독성학회지 Vol.3 No.1

Gastric lavage is now known to be ineffective, unnecessary or hazardous in some circumstances where it used to be performed as a routine. This article concerns the medico-legal aspect of forced gastric lavage. The Supreme Court 2005.1.28, 2003da14119 is the case where a patient, who ingested the organophosphate insecticide to attempt suicide and refused lavage. At first we discuss the effectiveness or hazards of lavage because a very high degree of proof -of negligence, not error of clinical judgment - would be required. Lavage, with or without the informed consent, performed negligently which result in harm could, of course, give rise to a claim in negligence. A doctor might also be held negligent in failing to perform an act which he/she had a duty to perform.

연구논문 : 새로운 과학기술도입과 의료기기 해당성 판단

배현아 ( Hyuna Bae ) 한남대학교 과학기술법연구원 2015 과학기술법연구 Vol.21 No.3

의료기기 해당성 판단은 사람이나 동물에게 단독 또는 조합하여 사용되는 기구·기계·장치·재료 또는 이와 유사한 제품으로서 질병을 진단·치료·경감·처치 또는 예방할 목적으로 사용되는 제품, 상해(傷害) 또는 장애를 진단·치료·경감 또는 보정할 목적으로 사용되는 제품, 구조 또는 기능을 검사·대체 또는 변형할 목적으로 사용되는 제품 그리고 임신을 조절할 목적으로 사용되는 제품으로 정의된 의료기기법과 이에 대한 법원의 해석을 근간으로 이루어진다. 또한 의료기기 해당성 판단은 연구과정과 제조를 위한 인허가, 임상 시험의 필요성, 국민건강보험 제도에서의 체계, 의료광고의 대상 등 이후 보건의료법체계에서의 규제 내용과 그 대상 범위를 결정하는 의의를 가진다. 그러나 의료기기 해당성 판단은 다양하고 전문화 된 생명과학기술과 정보통신 기술 등 과학기술의 발전을 즉각적으로 반영할 수 없는 입법 기술 상의 한계로 인하여 기술발전과 사회의 변화를 고려하여 개별적으로 이루어질 수밖에 없다. 이 때 의료기기 해당성 판단의 ‘목적성’ 에 근간을 둔 일반적인 원칙과 함께 개별 기기의 위험성과 특수성을 고려한 평가가 이루어져야 한다. The Medical Device Act defines the term "medical device" as an instrument, machine, device, material, or any other similar product alone or in combination for human beings or animals such as a product used for the purpose of diagnosing, curing, alleviating, treating, or preventing a disease; a product used for the purpose of diagnosing, curing, alleviating, or correcting an injury or impairment; a product used for the purpose of testing, replacing, or transforming a structure or function; a product used for birth control. To determine whether the Medical Device Act regulates specific use of certain products or devices, the court’s interpretation is required. The applicability of the term "medical device" in Medical Device Act has been developed, interpreted and refined by the rulings of the Supreme Court. Interpreting and, thus, deciding whether the Medical Device Act shall be applied in specific cases plays crucial roles in shaping thescope and subject of the regulation of the medico-legal system; including regulatory approval for developing and producing medical products, clinical trials as well as regulating medical advertisements. The question of whether a device or product shall be regulated as a medical device can only be answered individually taking into account the development of society and technologies because of the inherent limitations on legislative techniques. Legislation cannot spontaneously reflect the rapid development of medical technologies as well as bio-technologies and information technologies. Thus, when deciding applicability of the term “medical device” in certain use of a device or product, one should take the general principle of objective of the law into account as well as risks and peculiarities of individual devices.

급성 충수염과 관련된 의료 소송

배현아(Hyuna Bae),노현(Hyun Noh),장혜영(Hye Young Jang),정구영(Koo Young Jung) 대한외과학회 2007 Annals of Surgical Treatment and Research(ASRT) Vol.72 No.3

Purpose: We wanted to describe the characteristics of the malpractice claims related to acute appendicitis and to identify medico-legal problems and potential preventability of such claims. Methods: A retrospective study was performed by reviewing the records at websites that furnishes judicial precedents. The records on closed malpractice claims involving acute appendicitis were abstracted from the files that were available for analysis. The records were reviewed and analyzed to determine the causes of the lawsuits, the preand post-operative diagnoses, the comorbid conditions of the patient, the causes of death or post-operative complications, the results of the lawsuits and the factors associated with a successful defense. Results: Twelve closed claims involving acute appendicitis were founded in the malpractice data. Two claims were Supreme Court decisions and ten were district court decisions. The causes of lawsuit were categorized as follows: delay in diagnosis or operation, mistakes during operation, inappropriate management of postoperative complications and problems related to general anesthesia. 3 claims were assigned to each of the 4 particular causes of lawsuits. The most common causes of death were abscess with peritonitis and sepsis, and ten of which resulted in indemnity payments. Conclusion: Appropriate explanation and attention in the diagnosis/progress of appendicitis, getting an informed consent from the patient, the patients’ comorbid conditions, early decision making in diagnosis/operation and proper care in the operation were critical for preventing lawsuits related to acute appendicitis.

바이오기술과 생명윤리 법정책의 쟁점과 개선방향: 유전자 치료 연구를 중심으로

배현아(Hyuna Bae) 한국바이오경제학회 2018 바이오경제연구 Vol.1 No.2

I. 들어가며: 생명윤리 법정책 II. 바이오기술과 생명윤리 법정책 III. 생명윤리법정책의 쟁점: 유전자 치료 관련 법제의 예 IV. 결론: 새로운 과학기술 도입과 생명윤리법정책의 방향 생명윤리법정책은 의학과 생명과학의 새로운 지식체계에 대하여 사회적 함의와 정당성을 비판적 으로 고찰하여 그 결과를 생명윤리의 쟁점이나 그로 인한 사회적 갈등을 해소하기 위한 규범체계 마련을 위한 법적 접근을 의미한다. 생명윤리법정책의 근간이 되는 생명윤리법제는 법률의 경직성으로 인해 매우 빠르게 발전하는 생명과학기술이 즉각적으로 반영되지 못하는 입법 기술상의 한계가 있어 현실과의 간극이 존재한다. 이러한 생명윤리법제의 제한점으로 인해 유전자 치료와 같은 첨단 의생명과학기술의 특수성을 고려하고 기존의 안전성 검증체계 적용의 한계 등을 극복할 수 있는 생명윤리법제의 규제 패러다임의 변화가 필요하다. 다만 생명윤리정책의 방향은 바이오기술 도입에 따른 경제성이나 활용가능성에 대한 기대와 기여가능성이 불확실한 위험을 고려한 규제와 균형을 이루고 인간의 존엄성을 포함한 생명윤리적 쟁점에 대한 검토가 함께 이루어져야 한다. 이를 위해 바이오 기술의 가치에 대한 사회적 합의와 공론화가 이루어져야 하고 그 과정에서 과학자뿐 아니라 시민 사회 전체가 주체적으로 그 역할을 수행할 수 있어야 한다.

보건의료법제 하에서 인공지능기술의 의료영역 도입의 의의와 법적 문제

배현아 ( Bae Hyuna ) 법조협회 2017 法曹 Vol.66 No.4

인공지능의 의료영역 적용은 기계학습방식으로 의료 데이터를 학습하고 특정패턴을 인식하여 질병을 진단하거나 예후를 예측할 수 있고, 환자에게 가장 적합한 치료법을 제시해주는 방식으로 이루어지기 시작하였다. 의료영역의 인공지능 도입으로 기존의 전통적인 의사-환자 관계의 변화와 함께 의학교육의 변화, 보건의료서비스의 질 향상, 의료오류 발생의 감소와 같은 긍정적인 효과를 기대할 수 있다. 그러나 이러한 인공지능이 의료영역에 도입되고 활발히 활용되기 위해서는 우리나라 보건의료법제 하에서 해당 행위의 법적 성격, 해당 소프트웨어를 포함한 도구의 의료기기성 등에 대한 판단이 필요하다. 또한 의료영역에서 인공지능을 활용하여 진단하거나 치료방법의 선택과 같이 임상적 의사결정에 도움을 받는 경우 그 결과에 대한 책임이 발생할 때 그 판단기준이 필요하다. 이 글은 보건의료법제 하에서 인공지능과 같은 새로운 과학기술을 도입하고 적용함에 있어서 의료정보관리 주체와 같은 제도적 장애와 인공지능의 의료영역 도입에 앞서 고려해야 하는 법적 문제들에 대하여 연구하였다. Artificial intelligence is a branch of computer science capable of analysing complex medical big data. Their potential to exploit meaningful relationship with in a data set can be used in the diagnosis, treatment and predicting outcome in many clinical decision process. Artificial intelligence in medicine could provide more accurate and efficient healthcare for patients and help physicians quickly identify key information in a patient`s medical records, relevant articles and explore treatment options to reduce unwanted variation of care and give time back to their patients. And it will lead to many changes in doctor-patient relationships. For introduction of Artificial Intelligence(A.I.) in medical field, we have to determine whether this is applicable to both health care system and legal system, The question of applicability of A.I under health care system and legal system could only be answered individually taking into account the development of medical technologies because of the inherent limitations on legislative techniques. Legislation cannot spontaneously reflect the rapid development of medical technologies as well as bio-technologies and information technologies, which may cause the changes of the legal perceptions of health and medical practice. Thus, when deciding applicability of the A.I., one should take the general principle of objective of the law into account as well as risks and peculiarities of individual devices and practice. In conclusion, diverse medico-legal approaches should be proposed to implement A.I in Medical field such as error in A.I., physician responsibility, uncertain risk, security of health information. And for the introduction of A.I in medical field, it should be removed the barriers to A.I. implementation considering the Korean healthcare system such as medico-legal issues including information ownership issues and concern related to confidentiality including non-medical practitioners.

의사의 진단서 작성과 관련된 사회적·법적 책임

배현아 이화여자대학교 의과학연구소 2013 EMJ (Ewha medical journal) Vol.36 No.2

Medical certificate, post-mortem examination or certificate guarantee their authenticity of the content through the article 233 of the criminal act. The article 233 of the criminal act states that if a medical or oriental medical doctor, dentist or midwife prepare false medical certificate, postmortem examination or certificate life or death, one shall be punished. To constitute the crime of issuance of falsified medical certificates, it is necessary for the contents of the certificate to be substantially contrary to the truth, as well as it is needed the subjective perception that the contents of the certificate are false. On the article 17 of the medical service act, no one may prepare a medical certificate, a report or certificate of postmortem examination to a patient or public prosecutor in a district public prosecutors’ office, who conducts a medical service and has given the medical treatment or conducted the postmortem examination by him/herself: Provided that, such certificate or report may be issued for a patient without giving any medical treatment, if the patient has died within 48 hours after his/her last medical treatment, while if the medical doctor, dentist or oriental medical doctors who examined a patient or conducted a postmortem examination of the dead patient is unable to issue such certificate or report due to an inevitable cause or event, any other medical doctor, dentist or oriental medical doctor who works for the same medical institution, may issue such certificate or report based on the medical records of the patient.

건강결정요인 파악을 위한 건강영향평가의 정책적 의의

배현아 이화여자대학교 생명의료법연구소 2015 생명윤리정책연구 Vol.9 No.1

건강영향평가란 개발정책 또는 프로젝트와 관련된 건강위해요인과 건강증진요인을 체계적으로 고찰하는 사업으로, 개발활동의 과정으로 인해 변화되는 위해 요인과 기회요인과 관련된 위험요인을 평가하는 과제를 수행하는 것이다. 이러한 근거기반 건강영향평가의 결과로 건강보호와 증진에 대한 정책결정과정에 적용할 수 있는 추천 또는 제안을 하는 것이 건강영향평가의 목표이다. 우리나라 건강영향평가 제도의 법적 근거는 「환경보건법」이며, 대상사업들은 건강에 영향을 줄 수 있는 환경적 측면(건강에 대한 물리적 영향, 사회적 영향, 취약계층에 대한 영향 등)과 관련이 있는 사업들이다. 우리나라 환경부의 「환경보건법」에 근거한 건강영향평가는 그 대상 사업이 제한적이고 물리·환경적 요인에 국한된 평가방법의 한계가 존재한다. 또한 건강영향평가는 절차상 기존의 환경영향평가에 추가하여 협의를 요청하는 절차에 의해 수행되기 때문에 구체적인 건강영향평가의 대상은 환경으로 인한 건강영향을 검토하는 것이고 당해 사업으로 인한 환경영향을 우선적으로 확인하여야 하며 이 확인 과정은 기존의 환경영향평가의 범위 내에서 이루어지는 절차적 제한점이 존재한다. 건강영향평가는 구체적인 보건정책을 계획하고 수행하기 전에 이루어지는 선별적인 조사이지만 최종적으로는 보건정책수립의 의사결정과정에 영향을 주기 위한 목표로 이루어져야 한다. 특히 포괄적인 건강의 개념과 다양한 건강결정요인을 고려하여 다학제 간 구조화된 조사가 이루어져야 하고 그 과정에서 우선순위의 결정 등을 통한 건강영향평가의 실질적이고 구체적인 수행이 필요하고 그 결과가 보건의료정책에 반영될 수 있어야 한다. Health Impact Assessment(HIA) is a combination of procedures, methods and tools by which a policy, program or project may be judged as to its potential effects on the health of population, and the distribution of those effects within population. HIA is an integral part of development and would usually include a broad range of multidisciplinary expertise and various methodologies. Korea has the experiences in Environmental Impact Assessment(EIA) by Environmental Health Act. The Environmental Health Act was enacted to evaluate harmful environmental factors of population and ‘Environmental Impact Assessment Law’ was enacted to control environmental health part. Although EIA includes sanitation-public health factor, considering health impacts, health impacts haven’t been properly considered. Since the HIA is multidisciplinary process within which range of evidence about the health effects of a proposal in structured framework, the increasing awareness on the importance of health impacts has triggered to seek an optimal introduction scheme of HIA. And HIA will be a means of evidence based policy making for improvement in health in the future.

대규모 재난 및 재해 대책 관련 각 주체들의 책임에 대한 연구

배현아 이화여자대학교 생명의료법연구소 2008 생명윤리정책연구 Vol.2 No.1

Disasters by natural as well as man-made can cause fatal damage such as threats to life, safety and property of citizens unless properly controlled by law or otherwise. The government enacted in 2004 ‘Basic Law on Disaster and Safety Management’ for disaster response and control. In disaster preparedness, partnership between government officials, healthcare providers, volunteers is important. this article examines the possibility that can be the problem and liability by them. To health care providers, two kinds of duties such as a duty not to refuse to provide an emergency medical service and a duty to transfer emergency patients conflict. During disaster, that kind of conflict should be solved by specialized way that lowering the requirements of appropriate transfer by law. Especially, layperson and health care volunteers can be claimed with compensation for damage to tort liability due to activity during disaster. To relieve or exempt their liabilities, the author emphasize that the existing laws and regulations should be reformed and interperted in new ways.

정신질환자 비자의 입원과 기본권 제한 : 비자의 입원시 신상정보확인의 적법절차를 중심으로

박지혜,배현아 이화여자대학교 생명의료법연구소 2011 생명윤리정책연구 Vol.5 No.2

In case of involuntary admission and emergency admission, it could be happened that nobody knows who patient with mental illness is. It is required to confirm the information about the patient who wants to take Health care service for recording the medical record and providing proper treatment by doctor. However, when there isn’t any clue for confirming the patient identify except finger print, we have to choose whether using the finger print for searching the patient identity or not. This study is dealing with the necessity of confirming the patients identity when they enter in hospital by the way through involuntary admission or emergency admission. In addition, it could be accepted to use finger print when it is the last way to confirm the patients identity, comparing degree of the liberty of body’s infringe to necessity of taking proper health care service. And in that time, who has the responsibility to the problem which could occur on the process of confirming . In conclusion, this study propose that the way of correcting the informaiont by patient’s finger print should be accepted because of the necessity for provinding proper health care service to the patient with mental illness. And Mayor due to take the responsibility through the whole process of the confirming the information of the patient’s identity.