보건복지부 「진료기록 열람 및 사본발급 업무 지침」(2022)의 법적 타당성에 대한 검토

우정민 한국의료법학회 2023 한국의료법학회지 Vol.31 No.2

Guidelines for reading and issuing copies of medical records are established by the Ministry of Health and Welfare and distributed to each local government and medical institution, and each local government officer and medical institution worker apply them to the practice of reading medical records and issuing copies. Since reading and issuing copies of medical records deals with medical and personal information of patients, they are strictly applied in accordance with Article 21 of the Medical Law and Article 13-3 of the Enforcement Regulations of the same Act. However, some of the guidelines for viewing and issuing copies of medical records are new and not previously applied to the practice of local governments and medical institutions. Even if it causes confusion in related work, it is appropriate to apply it if it is applied anew and the practice is improved. However, it is assessed that some of the contents of the business guidelines for viewing and issuing copies of medical records are not so. The main content of this paper is the issuance of patient records generated and brought in by external medical institutions as the scope of records for patients covered by Article 21 of the Medical Act. And it is a matter of whether it is possible and how to send it when the legitimate requester requests to send it to a third party by the method of providing a copy of the medical record. Unlike the Ministry of Health and Welfare's authoritative interpretation of medical records access and copy issuance, this paper examined the validity by applying the legal principles of contracts such as medical contracts together. In addition, the difference between the issuance of medical records under the Medical Act and the Personal Information Protection Act was discussed, and based on the contents of the review, a partial revision of the business guidelines for viewing and issuing copies of medical records was proposed. 진료기록 열람 및 사본발급 업무 지침은 보건복지부가 제정하여 각 지자체와 의료기관에 배부하며, 각 지자체 담당자와 의료기관 종사자는 이를 진료기록 열람 및 사본발급 실무에 적용하고 있다. 진료기록의 열람 및 사본발급은 환자의 의료정보와 개인정보를 다루는 것이므로 의료법 제21조 및 동법 시행규칙 제13조의3에 따라 엄격하게 적용하여 행하여지고 있다. 하지만 진료기록 열람 및 사본발급 업무 지침의 일부 내용은 기존에 각 지자체와 의료기관의 실무에 적용된 내용이 아닌 새로운 것이다. 비록 관련 업무에 혼선을 주더라도 새롭게 적용하여 관행을 개선해 나간다면 적용하는 것이 마땅하다. 그러나 진료기록 열람 및 사본발급 업무 지침의 일부 내용은 그러하지 않은 것으로 평가된다. 본 논문의 주요 논의 내용은 의료법 제21조가 적용되는 환자에 대한 기록의 범위로서 외부 의료기관에서 생성되어 유입된 환자의 기록에 대한 발급이다. 그리고 진료기록 사본의 제공방식으로 적법한 발급요청자가 제3자에게 송부를 요청할 시 가능 여부와 송부방식의 문제이다. 본 논문은 보건복지부가 진료기록 열람 및 사본발급에 대하여 의료법을 중심으로 유권해석한 방식과 달리 진료계약 등 계약의 법리를 같이 적용하여 타당성을 검토하였다. 또한, 의료법과 개인정보 보호법상 진료기록 발급의 차이에 대하여 논하였으며, 검토한 내용을 토대로 진료기록 열람 및 사본발급 업무 지침의 일부개정을 제안하였다.

일개 대학병원에서 입원 환자 의무기록의 충실도

김연철,박기흠,정휘수,이동욱 동국대학교 의학연구소 2008 東國醫學 Vol.15 No.1

Medical records show the present illness, medical history and other informations of a patient. Thus, accurate medical records are important. This study was designed to analyze medical records of residents who first meet and acquire information from patients, and learn the completeness of medical records. From 2005 to 2007, medical students were lectured on medical records, and reviewed medical records of all the admitted patients, except the department of neuropsychiatry. 677 charts were reviewed. 144 were excluded due to inadequate checklists and 533 were analyzed. The checklist included the department the patient was admitted to, year of residency, chief complaint, present illness, medical history, family history and social history. Chief complaint was in 518(97.2%) records, and 231(43.3%) recorded the time of onset. Among 7 items expressing the symptoms, the mean number of items included was 3.05±1.40. Records on location was in 383(71.9%) cases, but modifying factors was recorded in 38(7.1%) cases, being the lowest. Medical history was in 430(80.7%) cases, and 67(12.6%) included family history. Smoking history in pack years was in 63(11.9%) cases, and alcohol recorded by type, amount, and frequency was in 46(8.6%) cases, and occupation was in 16(3%) cases. Chief complaint and medical history was recorded well, but records on present illness, family history, smoking, alcohol, and occupation was inefficient. Among 7 items expressing the symptoms, a mean number of 3 were included in the present illness; the location was recorded most sufficiently, and modifying factors was recorded most insufficiently. 의무기록을 보면 환자의 현병력 및 기타 병력 그리고 여러 정보를 알 수 있다. 그러므로 정확한 의무기록이 중요하다. 처음으로 환자를 대하고 정보를 얻어내는 전공의들의 의무기록을 분석하여 의무기록의 충실도를 알아보고자 하였다. 2005년부터 2007년까지 매년 모 의과대학 의학과 1학년들에게 의무기록 작성에 대한 강의를 실시한 후 실습시간을 이용하여 학생들과 병동을 방문하여 정신과를 제외한 당일 1개 병원의 입원 환자 전체의 의무기록을 하루 동안 조사하였다. 3년간 677명을 조사하였고, 이 중 점검표가 제대로 작성되지 않은 144개를 제외한 533개를 분석하였다. 의무기록 조사용 점검표는 환자의 입원과, 전공의 년차, 주소, 현병력, 과거력, 가족력, 사회력으로 구성되었다. 의무기록 중 주소는 518예(97.2%)에서 기록되어 있었고, 발생 시간을 내원 시간 기준으로 기록한 경우는 231예(43.3%)였다. 현병력의 증상표현에 대한 7가지 항목 중 평균 포함 갯수는 3.05±1.40개였다. 이 중 부위에 대한 기록은 383예(71.9%)로 전체적으로 높았으나 조절인자에 대해서는 38예(7.1%)로 가장 낮았다. 과거력과 가족력은 각각 430예(80.7%) 및 67예(12.6%)에서 기록되었다. 사회력에서는 흡연력을 갑년으로 표시한 경우는 63예(11.9%), 음주력을 술의 종류, 횟수, 음주량 등으로 기록한 경우는 46예(8.6%)이었다. 직업력은 16예(3%)에서 기록되었다. 주소 및 과거력에 대한 의무기록은 잘되었으나 현병력, 가족력, 흡연력, 음주력 및 직업력에 대한 기록은 미비하였다. 현병력 증상표현의 7가지 항목의 평균 포함 개수는 3개였으며, 이 중 부위가 가장 잘 기록되었다.

일개 교육병원에서 의무기록의 충실도에 대한 조사

박석건,김흥태,김광환,서순원 한국의료QA학회 1997 한국의료질향상학회지 Vol.4 No.2

Background : Medical records thought to be reflecting the quality of medicine. By this ground, examination of medical records can be served to evaluate, and to improve the quality of medical care. To examine the medical records, we need some standards or checklists which can be used to sort out the problems. Methods : We developed checklists for medical records evaluation. We studied 1,677 medical records about its completeness using this checklists in one educational hospital. Survey was completed by 5 well trained staffs of medical record department. Results are analyzed. SPSS/PC+ program was used for statistics. Results : 13.8% of discharge summary was incomplete. Recording of the demographic information was also poor in incomplete medical records compared to complete ones. Progress note was recorded average 4.16 times during 11.9 hospital days. After 4th hospital day, recording rate of progress note dropped sharply. Rate of professor’s signature on operation records was poor(27%). He or she who described the discharge summary well also wrote progress note well. Conclusions : Fill-up of demographic data should be stressed during medical record education program. Strategy to create the environment emphasizing the responsibility of professor on quality medical record should be made. Vile suggest new index(number of records/hospital stay) for the evaluation of completeness of progress note.

전자의무기록 관리시스템 관련 기록관리 메타데이터 요소들에 대한 의무기록 관리자의 중요도 평가 연구

이은미,김명,임진희 한국기록관리학회 2013 한국기록관리학회지 Vol.13 No.3

To comprehend the importance and necessity of record management metadata standard implemented in an electronic medical records system, a survey was undertaken to 50 medical records managers in charge of 5 major hospitals in Seoul. Analysis of the survey results was performed by averaging the responses given by those who answered the survey. SPSS was utilized for statistical analysis. Managers of medical records placed importance on metadata that are related to security of records, such as “levels of security”, “types of access to medical records”, “levels of authorization granted to personnel”, and “users accessing medical records”. It shows that these managers need the functions of privacy protection in ERMS. Metadata on “external disclosure” had the lowest level but those surveyed with more than 7 years of experience placed greater importance in this area more those surveyed with less than 7 years of experience in a hospital. This shows that managers need the functions of external disclosure to meet the needs of third partiesfor medical research and medical education. 본 연구는 서울 시내 5개 대학병원의 의무기록 관리자들이 생각하는 전자의무기록시스템 구현 시 기록관리 메타데이터 표준 요소의 중요도를 설문조사하였다. SPSS 20.0(ver)을 이용하여 중요도 점수는 5점 척도의 평균으로 도출하여 순위를 정하였고 응답자 특성에 따른 중요도 차이를 분석하였다. 90%의 응답자가 국가기록원에서 기록관리 메타데이터 표준을 고시하고 있음을 모르고 있었다. 가장 중요도가 높은 요소는 ‘비밀등급 설정’ 이었으며 ‘의무기록 접근행위종류’, ‘내부직원 권한 설정’, ‘의무기록 이용접근자’ 요소가 그 다음 순위를 보여 기록정보보호 측면에서의 관리 기능 강화를 필요로 함을 알 수 있다. 개인 프라이버시 보호를 위하여 ‘외부공개’는 중요도가 낮은 관리요소로 평가되었으나, 전자의무기록 도입 7년 이상인 기관의 관리자들은 7년 미만의 관리자 보다 유의하게 이 세 가지 요소의 중요도를 높게 평가하였다. 이는 정보 축적에 따라 의학연구, 의학교육 등에서의 정보 이용에 대한 관리 기준과 시스템상의 적용이 필요함을 보여준다.

일개 교육병원에서 의무기록의 충실도의 대한 조사

박석건,김홍태,김광환,서순원,Park, Seok Gun,Kim, Heung Tae,Kim, Kwang Hwan,Seo, Sun Won 한국의료질향상학회 1997 한국의료질향상학회지 Vol.4 No.2

Background : Medical records thought to be reflecting the quality of medicine. By this ground, examination of medical records can be served to evaluate, and to improve the quality of medical care. To examine the medical records, we need some standards or checklists which can be used to sort out the problems. Methods: We developed checklists for medical records evaluation. We studied 1,677 medical records about its completeness using this checklists in one educational hospital. Survey was completed by 5 well trained staffs of medical record department. Results are analyzed. SPSS/PC+ program was used for statistics. Results : 13.8% of discharge summary was incomplete. Recording of the demographic information was also poor in incomplete medical records compared to complete ones. Progress note was recorded average 4.16 times during 11.9 hospital days. After 4th hospital day, recording rate of progress note dropped sharply. Rate of professor's signature on operation records was poor(27%). He or she who described the discharge summary well also wrote progress note well. Conclusions: Fill-up of demographic date should be stressed during medical record education program. Strategy to create the environment emphasizing the responsibility of professor on quality medical record should be made. We suggest new index (number of records/hospital stay) for the evaluation of completeness of progress note.

폐업 의료기관 전자의무기록 관리현황 및 개선방안 연구

최기쁨,김휘언,장지혜,오효정 한국기록관리학회 2020 한국기록관리학회지 Vol.20 No.3

우리나라 대부분의 의료기관이 전자의무기록을 도입하고 있지만, 의료기관이 폐업했을 경우의 기록물 관리 및 보존에 있어서 많은 맹점이 존재한다. 폐업 의료기관의 기록은 적법한 절차에 따라 체계적으로 관리될 필요가 있음에도 불구하고 보건소로 기록을 이관하는 폐업 의료기관의 수가 현저히 적고, 전자의무기록을 사용하는 의료기관마다 사용하는 시스템 및 서식이 상이하기 때문에 이관을 받는 보건소에서도 해당 기록을 열람조차 하지 못하는 경우가 많다. 또한, 보건소의 현실과 전자의무기록이라는 특수성에 부합한 관리기준 및 지침 또한 부재한 상황이다. 최근 폐업 의료기관의 의료기록에 대한 보건소의 보관책임 강화 법안이 통과함에 따라 본 연구에서는 관할 보건소의 효율적인 기록물 관리를 위한 방안 마련에 주목하였다. 이를 위해 관계 법령을 살펴보고 관리⋅보존이 미흡한 폐업 의료기관 전자의무기록 관리 현황을 파악하기 위한 문헌조사를 비롯한 정보공개청구 및 전화인터뷰 등의 조사를 실시하였으며, 그 문제점을 분석하여 제도적⋅기술적⋅행정적인 측면에서의 개선방안을 제안하였다. Although most medical institutions in Korea use electronic medical records (EMR), there are many problems in the management and preservation of records when such medical institutions are closed. Records of closed medical institutions need to be systematically managed; however, the rate of closed medical institutions transferring records to public health centers is significantly low. Given that each medical institution has a different system and format, public health centers often cannot access records. In addition, there are no management standards that suit the reality of public health centers and the specificity of EMR. Recently, a strengthened Medical Law has been passed wherein records of closed medical institutions should be kept by health centers; therefore, this study focused on drawing up measures for efficient records management by public health centers. To this end, the relevant laws and management status were identified and an interview was conducted. After analyzing the problems, improvement plans in institutional, technical, and administrative aspects were proposed.

우리나라 전자의무기록의 개선방안

최찬호,Choi, Chan-Ho 대한예방한의학회 2014 대한예방한의학회지 Vol.18 No.3

The rapid development and distribution of information communication industry facilitates the changes of hospital administration, introducing EMR(Electronic Medical Record) instead of paper-based medical record in the medical field. The developed countries such as U.S. have established EMR system after in the middle of 1970s because the primary advantages of EMR is to store and handle vast amounts of records efficiently and increase the quality of health care. Most of health organizations in Korea also apply medical record system to their administration. As the result, they have accomplished a scientific administration system through the use of medical record to handle a variety of patient's information including patient's confidentiality and privacy such as family history, social status, income level, and so on. However, access to and the misuse of EMR causes illegal infringement of patient's information and finally it becomes a very serious medical issue. Potential leakage and misuse of records may seriously infringe patient's privacy rights. In this respect, the related agencies in the public and private sector have been making efforts to prevent patient's records leakages. Especially, the revision bill of Medical Law in 2002 establishes the ways on the security and standards of electronic records. However, it does not provide the proper guidelines which is applied to the rapid changes of the medical environment. One of the most priorities in the hospital administration is the production and maintenance of an accurate medical records fulfilled by medical recorders. Therefore, it is very important for health care providers to hire ethical-based medical recorders. But, unfortunately most of hospitals overlook the importance of their roles. All parts including government, physician and patient must have more concerns on the problems related to EMR. Therefore, this study aims to propose the proper ways to resolve the problems coming from EMR.

An Awareness Survey on the Protection and Use of Personal Health Information Focused on Applicants for Copies of the Medical Record

최은미,서순원,박우성,이미정,김예은,김옥남 대한의료정보학회 2009 Healthcare Informatics Research Vol.15 No.3

Objective: To supplement a previous study on the management of medical records with a view to preparing a system capable of ensuring basic patient rights regarding the protection of confidential medical information. The study objectives are to provide detailed guidelines to regulate the access and protection of medical information by analyzing patients’ understanding and views regarding the dissemination of medical records. Methods: A self-administered questionnaire was administered to 781 patients who visited five University hospitals located in Seoul, Busan, Gyeonggi, Chungnam and Jeonnam from July to September, 2008 and asked for copies of medical records to be issued. Data were analyzed by using the statistical program SPSS 13.0. Results: More than 70% of respondents wanted to access their medical records after confirming the required documents. The highest distribution in the range of persons able to receive copies of medical records without the individual patient’s consent or required documents was ‘only personally’ in each variable. Copies of medical records were issued mostly within 1 hour, while the appropriate time of issuing the copies was within one day. Half of respondents approved of a subscription system that did not require a doctor consultation. The results regarding changes in the ways to request/issue copies of medical records to improve the convenience for applicants differed significantly according to age. Conclusion: Considering the sensitivity of personal health information, medical records should only be issued with the patient’s consent and by confirming the identity of the designated person with required documents. Furthermore, people should be aware of the importance of protecting personal health information, and medical institutes should inform the requirements for bringing the relevant documents. Medical institutes play an important role in protecting personal records, which necessitates generalized guidelines.

전자의무기록의 보관방법에 관한 고찰

황만성 원광대학교 법학연구소 2013 의생명과학과 법 Vol.10 No.-

Medical records are very important records and should not be modified after creation. The current medical records are liable to improper modification. With the development of information technology, electronic medical records (EMR) are used widely. For the EMR, cryptographic primitives may be used to develop techniques to prevent medical record modofication. The introduction of electronic medical records in Korea began in late 1990. Medical Law(Rev. 2002) allowed that electronic documents instead of paper records to be created and kept. The creation and storage of the electronic medical records is an important issue as important in the writing and storage of medical records. Someone proposed that the Trusted Third Party(TTP) may play a important role of ensuring the safety and reliability. But, there are still several problems and anxiety about the storage of Third Party. Medical Law prohibit that non-physician create and keep medical record. And despite of the benefits of digitization of medical records, because of lingering information leakage and hacking, the possibility of modulation, measures to ensure the safety and reliability shoud be still discussed.

전자의무기록의 보관방법에 관한 고찰

황만성(Hwang Man Seong) 원광대학교 법학연구소 2013 의생명과학과 법 Vol.10 No.-

Medical records are very important records and should not be modified after creation. The current medical records are liable to improper modification. With the development of information technology, electronic medical records (EMR) are used widely. For the EMR, cryptographic primitives may be used to develop techniques to prevent medical record modofication. The introduction of electronic medical records in Korea began in late 1990. Medical Law(Rev. 2002) allowed that electronic documents instead of paper records to be created and kept. The creation and storage of the electronic medical records is an important issue as important in the writing and storage of medical records. Someone proposed that the Trusted Third Party(TTP) may play a important role of ensuring the safety and reliability. But, there are still several problems and anxiety about the storage of Third Party. Medical Law prohibit that non-physician create and keep medical record. And despite of the benefits of digitization of medical records, because of lingering information leakage and hacking, the possibility of modulation, measures to ensure the safety and reliability shoud be still discussed.