원격의료의 법적 문제에 관한 고찰

정용엽,Jeong, Yong-Yeop 대한병원협회 2003 대한병원협회지 Vol.32 No.2

의료사고피해구제법안상 무과실책임주의 도입 문제

정용엽 대한의료법학회 2006 의료법학 Vol.7 No.2

In the situation of bringing out of social problem about the medical accident and medical dispute, from 1988 the enactment activity for a legislative bill on conciliation of dispute has promoted, a legislative bill on prevention and relief of medical accident was again proposed in December, 2005. This bill has been faced rough going in review process of National Assembly. Because the purpose of this legislative bill is the conciliation of interest of between medical service consumer and medical service supplier, an item of issues of law is no-fault compensation scheme. However, as no-fault compensation scheme runs counter to the principle liability with fault in our civil law, as expected, whether the inducement is valid or, if induced, the problem is not must be totally reviewed. First of all, the general of principle liability without fault and especially the medical system in foreign countries are reviewed, by reviewing an issue and the pros and cons of the inducement of no-fault compensation scheme, this article draws the conclusion. After all, considering that the necessity adapting Gefahrdungschftung in medical accident as much as other industrial fields exists, the many provisions of the principle liability without fault exists in civil law and special law of our law system, and no-fault compensation scheme let legislative purpose be, to what extent, achieved by conciliating patient and doctor, the inducement of principle liability without fault in medical field is reasonable in the aspect of politic and legal system.

遠隔醫療契約의 法理에 관한 硏究

정용엽 경희대학교 국제법무대학원 2003 國際法務硏究 Vol.7 No.1

The rapid development of computer and telecommunication technology give rise to new types of medicine all over the world. One example is telemedicine practices, which uses telecommunications technology to provide, enhance and expedite health care services.It needs to have access to off-site databases, link clinics or physicians' offices to central hospitals, and transmit xrays or other diagnostic images for examination at a remote site. The telemedicine technology has been approved and legalized in Korea by the amendment to the Law of Medicine which comes into force on March 31,2003 The affected provisions are Article 30-2(Telemedicine),Article 21-2(Electronic Medical Records), and Article 18-2(Electronic Prescription). In Principle, the doctors and patients who are engaged in the process of telemedicine make and enter into telemedicine agreements. Accordingly ,all the telemedicine treatment and disputs thereon, if any, shall be governed by the agreements. However, the complexity and remoteness of the treatment process, and electronic employed process necessitate a brand new Principle of law. It should be noted that the newly arnended law, in particular,Article 30-2, address only the practicing physician, but skips such cases as home health care, cyber hospital, etc. On the other hand, the vertical and horizontal separation of medical practices has been accelerated. So the physicians who are subject to civil liabilities are regulated by this law. The telemedicine practices will be generalized in line with the newly revised law although there remain possible malpractices because of the intrinsic attributes of telemedicine. So telemedicine infrastructure is the key element of such remote treatment. Therefore, necessary medical equipment and facilities should be enumerated by the regulations under the new law. Also the standards and criteria of medical charges should be established to stave off unnecessary disputes.

원격의료의 법률관계 및 법제개선방안

정용엽 대한의료법학회 2006 의료법학 Vol.7 No.1

보건의료정보의 법적 보호와 열람ㆍ교부

정용엽 대한의료법학회 2012 의료법학 Vol.13 No.1

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.

의료관광의 법적 쟁점 및 제도개선방안

정용엽 경희대학교 법학연구소 2012 경희법학 Vol.47 No.1

우리나라는 2009년 1월 글로벌 헬스케어(의료관광)를 국가신성장동력산업으로 선정하고 5월 의료법상 외국인환자 유치행위가 허용됨으로써 본격적으로 활성화되기 시작했다. 의료관광의 법적 개념과 동향 및 운영상 주요 쟁점사항을 검토함으로써 의료관광정책 및 법제도적인 개선방안을 다음과 같이 제시하고자 한다. (1) 의료관광 또는 외국인환자 유치(글로벌 헬스케어)라는 두 용어를 혼용해서 사용해도 무방하나 법적 문제가 발생한 때에는 의료분야는 의료법상 의료행위 범주 내에서 판단하고 그 이외에는 별도의 법적 판단이 필요하다. (2) 상급종합병원은 병상수의 100분의5 이내로 유치를 제한하고 있으나(의료법 제27조의2 제5항) 각 의료기관의 수용능력에 따라 자율적으로 글로벌 헬스케어 시장원리가 작동될 것으로 생각한다. (3) 유치의료기관·유치업자의 등록요건에 상담ㆍ연락전담인력(국제의료관광코디네이터) 1인 이상 및 보건의료ㆍ출입국법규ㆍ소양교육 등 연간 8시간 교육의무이수제를 법제화하여 의료관광전문인력의 전문화를 도모해야 한다. (4) 인터넷 발달과 국경을 초월한 의료관광에서는 유치의료기관·유치업자에게 모두 의료광고를 허용하고 국내광고 금지조항 폐지, 의료기관 명칭에 외국어·신체기관·질병명 표기 허용 등의 제도개선이 필요하다(의료법 시행규칙 제40조). (5) 2009년 5월 11일 비자발급절차 간소화 차원에서 의료관광비자제도(Medical tourist VISA)를 신설한바 있다(C-3-M: 90일, G-1-M: 1년). (6) 질병완치 등의 특약이 없는 보통 의료계약을 위임계약으로 보는 것이 다수설이지만 의료관광은 유치행위를 전제로 한다는 점에서 도급계약설이 타당하며, 이 때문에 명문화된 외국어 진료계약서를 작성하여 설명 및 서명 받는 절차를 제도화하는 것이 안전한 방법이다(환자의무, 보호자약관, 재판준거법 및 관할법원, 의료분쟁 해결절차, CP 포함). (7) 충분한 상담에 의해 진료비견적서를 작성하고 경쟁국가 진료비와 행위별수가제에 따른 적정원가(진찰료ㆍ입원료ㆍ식대ㆍ행위료ㆍ비급여행위료ㆍ약제료ㆍ재료대ㆍ유치업자수수료 등)를 조사 비교한 후 국제수가를 표준화하는 것이 바람직하다. (8) 외국인환자 의료분쟁에서는 합의 유도 → 의료분쟁조정법 최대 활용 → 중재방법의 진료계약서 포함 또는 유도가 효율적이며 국가별 의료소송제도의 유·불리점을 검토하여 재판준거법ㆍ관할지법원을 결정하는 것이 타당하다. (9) 출국 후 사후관리 단계에서는 퇴원 시 각종 증명서 외국어 발급(의료법 제17조), 현지병원(의사)과 리퍼협약 또는 원격진료ㆍu-헬스 방법(의료법 제34조)으로 예후관리를 하는 것이 효율적이다. (10) 주요 선도국가의 사례와 의료관광산업화형 영리병원의 경제적 효과 분석결과를 볼 때 경제자유구역과 제주특별자치도에 한정해서 영리병원을 도입하여 의료관광 교두보로 활용하는 것이 효과적이다. In January 2009, Korea adopted global healthcare as a new engine industry powering economic growth and activities to “attract foreign patients” (permitted under the Medical Services Act in May) were initiated. We present some suggestions to improve Korea’s global healthcare policies and legal framework by reviewing relevant legal concepts, trends and significant administrative issues in global healthcare. (a) The two terms, “medical tourism” and the “inducement of foreign patients (global healthcare)” may be used interchangeably. However, when legal problems arise, medical issues shall be handled within the scope of medical practice under the Medical Services Act other issues are subject to separate legal decisions. (b) Currently, general hospitals are permitted to admit foreign patients, up to 5% of their total number of beds (Medical Services Act, Article 27-2(5)). However, such restrictions are expected to be lifted as market principles are applied to global healthcare. (c) Registration requirements for global healthcare medical institutions and businesses that facilitating foreign patients shall include the employment of at least one customer supporter (global healthcare coordinator), who has completed an annual mandatory 8-hour training course on healthcare laws, immigration procedures and general affairs (specialization of global healthcare professionals). (d) Due to the advent of the internet and borderless medical travel, legal systems must be revised (Medical Services Act, Enforcement Rules, Article 40) to permit all global healthcare medical institutions and business to post medical advertisements, to abolish domestic advertisement restrictions, and to use foreign languages, body parts and disease names within the names of medical institutions. (e) A medical tourist visa was introduced on May 11, 2009, to simplify visa application procedures (C-3-M: 90 days, G-1-M: one year documents to submit: a copy of previous medical records financial statements to guarantee the costs of treatment and proof of a medical appointment in Korea). (f) In general, medical treatment agreement is considered a delegation, but it is reasonable to view medical travel as a subcontract because of the existence of preconditions and inducement activities. Therefore, medical treatment agreements shall be written in foreign languages and explicitly express the aforesaid matters before being filled out, explained and signed (including the duties of patients, terms for guardians, applicable laws and jurisdictions, medical dispute resolution procedures and CP). (g) It is necessary to provide medical cost estimates during consultations and to standardize international medical fees for researching and comparing for reasonable cost (examinations, in-patient care, insured treatments, uninsured treatments, pharmacies, material costs, and commissions) based on medical examination fees and per treatment fees in competing countries. (h) Inducement of agreement in medical disputes involving foreign patients → full application of the Medical Disputes Mediation Act → In order to increase efficiency, the forms of mediation shall be included in the medical contract, or shall be induced, and applicable laws and court jurisdictions should be decided after reviewing the advantages and disadvantages of each country’s medical litigation system. (i) After departure from Korea, it is necessary to provide post-treatment care and services, such as issuing medical documents written in foreign languages at the time of discharge (Medical Services Act, Article 17), referral agreements with local hospitals (and doctors), remote medical examinations, and U-Health (Medical Services Act, Article 34). (j) Based on case studies in leading countries and analyses of the economic effects of for-profit hospitals aiming to provide global healthcare, it is advisable to introduce for-profit hospitals only within the Free Economic Zone and Jeju Self-Governing Provi...

U-헬스케어에 있어서 디지털 의료영상정보의 법률적 보호

정용엽,Jeong, Young-Yeub 대한디지털의료영상학회 2005 대한디지털의료영상학회논문지 Vol.7 No.1

원격진료 홈네트워크 아파트 진료용 키오스크 모바일주치의 등으로 대표되는 U-헬스케어에 있어서 기초가 되는 것은 의료정보를 디지털화해서 전자적 자료의 형태로 저장 보관하고 이를 송 수신할 수 있는 기술이라고 할 수 있다. 우리나라의 경우, U-Korea 전략의 하나로 보건복지부가 주축이 되어 2005년 10월 현재 국가보건의료정보화계획(ISP)을 수립하기 위한 작업을 추진중에 있다. 여기서, 예컨대 임상병리검사소견이나 방사선촬영소견 등의 의료정보가 전자적 장치에 의해 디지털화 할 경우 디지털 의료정보가 되는 것이며, 이 가운데 특히 방사선촬영소견 등 방사선분야의 모든 촬영기록이 PACS시스템을 통해 기재되거나 저장 전송될 경우 이를 디지털 의료영상정보라고 할 수 있다. 그런데 오늘날 정보통신기술의 발달로 말미암아 디지털 의료영상정보를 포함한 디지털의료정보는 대량적으로 수집 저장되고 유통 내지 공동활용이 보편화되어 감에 따라 그 의료정보의 보호에 관한 문제가 중요한 이슈로 대두되고 있다. 결론적으로 말하자면, 이러한 디지털 의료영상정보가 전자의무기록(EMR) 형태로 저장 보관되는 경우 이는 전자의무기록에 관한 법률규정이 적용되어 법률적 보호를 받게 되며, 그 보호의 강도는 종래 오프라인 상의 의료정보 보호보다 한층 강화된 규정을 두고 있다. 이와 같은 흐름에 있어서 최근 정부가 국가보건의료정보화계획 수립과 함께 제정작업을 추진하고 있는 가칭 의료정보화촉진 및 개인정보보호에 관한 법률(안)은 시사점이 크다고 보기 때문에 소개하고자 한다.

민간건강보험에 의한 의료기관 피해 실태 및 대처방안

신의철,신은규,정용엽,김용민,박용진,정태영,한재훈,김효진,김경아,최은경,이은환,김종일,오솔휘,김규동 대한의사협회 의료정책연구소 2009 대한의사협회 의료정책연구소 연구보고서 Vol.- No.-