본 연구에서는 미국의 보건의료데이터 관련 주요 법령으로 HIPAA/HITECH, 21세기 치료법, 공통규칙, 주법 등을 검토, 데이터의 보호 및 활용 관점에서 관련 법령의 발전과정, 구체적 쟁점에 관한 입법방침을 검토하였으며, 다음과 같은 시사점을 도출하였다. 첫째, 미국의 경우 개인의료정보에 관한 단일법제를 통하여 보호와 활용 기준을 비교적 명확하게 규율하고 있다. 미국의 경우 1996년 의료정보보호에 관한 기본법으로 HIPAA를 도입, 의료정보를 개인식별정보, 비식별정보, 한정데이터세트로 구분하여 PHI의 경우 목적에 따른 활용범위를 규정하였으며, 의료정보의 비식별조치 방식 규정, 한정데이터세트의 삭제정보 대상, 데이터 재식별 금지합의서 등에 관하여 규정하였다. 한편, 연구목적 의약품 및 의료기기 혁신 촉진을 위하여 제정된 21세기 치료법에서는 정보의 공유와 정보접근성 강화를 위하여 데이터 공유를 위한 상호호환성, 데이터 차단 금지, 정보주체의 접근성 강화를 규정하였으며, 공통규칙에서는 포괄적 동의제도를 도입, 절차를 명확하게 규정하고 있다. 우리나라의 경우 개인정보보호법을 기초로 하되, 보건의료데이터를 규율하는 일관된 법제를 제정한다면 규제체계와 내용을 보다 명확히 하여 정보소유자와 이용자에게 정보이용에 대한 신뢰를 높일 수 있을 것으로 생각된다. 둘째, 미국의 경우 의료정보의 활용 측면에서 규제체계를 비교적 간소화하고 명확하게 규정하고 있다는 점에서 의미가 있는 것으로 생각된다. 구체적으로 식별가능 의료정보의 익명조치 방안으로 전문가 합의 방식과 세이프 하버 방식을 규정하고, 구체적인 방법을 규정하고 있다. 특히 세이프하버 방식의 경우 18가지 식별자를 제거하면 비식별조치가 된 것으로 판단하고 있어 비식별조치 방식과 절차를 명확하게 규정하고 있다는 점, 전문가 합의 방식도 전문가 판단기준, 절차 등을 규정하고 있어 판단절차에 대한 신뢰를 높이고 있다는 점에서 의미가 있다. 보건의료데이터의 경우 치료목적, 연구목적 등으로 활용될 경우 그 가치가 증가될 것으로 생각되므로 보다 간소하고 명확한 기준을 제안함으로써 정보보호와 활용의 목적을 달성할 수 있을 것으로 생각된다. 셋째, 미국의 경우 정보주체의 권리보호 방안을 구체화하되, 설명의무를 상세히 규정하되 식별정보에 대한 소비자의 정보권한(옵트아웃 절차)를 명시하고 있다. 구체적으로 HHS 규칙과 FDA 규정에서 인간대상 연구에 대하여는 포괄적 동의제도를 인정하되 공통규칙을 통하여 동의절차, 방법, 요건을 규정하고 있다. 특히 정보주체에 대한 고지의무, 옵트아웃 제도, 삭제요구권 등에 관하여 규정하고 있으며, 동의절차에서 동의 대상자가 쉽고 명확하게(8th grade reading level 기준) 이해할 수 있도록 하며, 최신성·편의성을 유지하도록 하고 있다. 특히 최근 미국 주법(뉴욕, 캘리포니아 주 등)은 데이터 보호 및 활용에 관한 법령을 제정하면서 정보접근권, 삭제요구권, 옵트아웃 제도, 정보처리 동의의 투명성 강화조치 마련 등을 규정하여 데이터 활용에 있어서 정보주체의 권리를 보장하고 있다. 정보주체의 권리 보호는 정보의 가치보존과 활용 측면에서 가장 중요한 전제요건이 될 것이므로 우리나라의 입법에서도 참조할 수 있을 것으로 생각된다. 넷째, 미국의 경우 보건의료데이터 법제 전반에서 신뢰기반 제도를 활용하고 있다는 점은 중요한 의미가 있을 것으로 생각된다. 예컨대 HIPAA에서는 Limited Data Set의 경우 연구자의 재식별금지 합의서를 전제로 정보를 활용할 수 있도록 규정하고 있으며, 익명조치를 전문가 합의, 세이프하버 방식 등으로 간소화하여 연구목적 정보이용을 활성화하는 방안, 동의제도를 간소화하는 방안도 정보주체와 정보이용자간 신뢰에 기반한 것으로 볼 수 있다. 의료정보는 정보주체, 생성·보관·활용자가 모두 신뢰에 기반하여 협력할 때 그 가치가 나타날 수 있을 것으로 생각되므로 정보주체의 권리보장을 전제로 하되, 정보이용자가 당해 정보를 보다 가치 있게 이용(meaningful use)하도록 하는 신뢰에 기반한 법제도 마련이 필요할 것으로 생각된다.
Much has teed changed in the field of hospital administration in the It wake of the rapid development of sciences, techniques ana systematic hospital management. However, we still have a long way to go in organization, in the quality of hospital employees and hospital equipment and facilities, and in financial support in order to achieve proper hospital management. The above factors greatly effect the ability of hospitals to fulfill their obligation in patient care and nursing services. The purpose of this study is to determine the optimal methods of standardization and quality nursing so as to improve present nursing services through investigations and analyses of various problems concerning nursing administration. This study has been undertaken during the six month period from October 1971 to March 1972. The 41 comprehensive hospitals have been selected iron amongst the 139 in the whole country. These have been categorized according-to the specific purposes of their establishment, such as 7 university hospitals, 18 national or public hospitals, 12 religious hospitals and 4 enterprise ones. The following conclusions have been acquired thus far from information obtained through interviews with nursing directors who are in charge of the nursing administration in each hospital, and further investigations concerning the purposes of establishment, the organization, personnel arrangements, working conditions, practices of service, and budgets of the nursing service department. 1. The nursing administration along with its activities in this country has been uncritical1y adopted from that of the developed countries. It is necessary for us to re-establish a new medical and nursing system which is adequate for our social environments through continuous study and research. 2. The survey shows that the 7 university hospitals were chiefly concerned with education, medical care and research; the 18 national or public hospitals with medical care, public health and charity work; the 2 religious hospitals with medical care, charity and missionary works; and the 4 enterprise hospitals with public health, medical care and charity works. In general, the main purposes of the hospitals were those of charity organizations in the pursuit of medical care, education and public benefits. 3. The survey shows that in general hospital facilities rate 64 per cent and medical care 60 per-cent against a 100 per cent optimum basis in accordance with the medical treatment law and approved criteria for training hospitals. In these respects, university hospitals have achieved the highest standards, followed by religious ones, enterprise ones, and national or public ones in that order. 4. The ages of nursing directors range from 30 to 50. The level of education achieved by most of the directors is that of graduation from a nursing technical high school and a three year nursing junior college; a very few have graduated from college or have taken graduate courses. 5. As for the career tenure of nurses in the hospitals: one-third of the nurses, or 38 per cent, have worked less than one year; those in the category of one year to two represent 24 pet cent. This means that a total of 62 per cent of the career nurses have been practicing their profession for less than two years. Career nurses with over 5 years experience number only 16 per cent: therefore the efficiency of nursing services has been rated very low. 6. As for the standard of education of the nurses: 62 per cent of them have taken a three year course of nursing in junior colleges, and 22 per cent in nursing technical high schools. College graduate nurses come up to only 15 per cent; and those with graduate course only 0.4 per cent. This indicates that most of the nurses are front nursing technical high schools and three year nursing junior colleges. Accordingly, it is advisable that nursing services be divided according to their functions, such as professional, technical nurses and nurse's aides. 7. The survey also shows that the purpose of nursing service administration in the hospitals has been regulated in writing in 74 per cent of the hospitals and not regulated in writing in 26 per cent of the hospitals. The general purposes of nursing are as follows: patient care, assistance in medical care and education. The main purpose of these nursing services is to establish proper operational and personnel management which focus on in-service education. 8. The nursing service departments belong to the medical departments in almost 60 per cent of the hospitals. Even though the nursing service department is formally separated, about 24 per cent of the hospitals regard it as a functional unit in the medical department. Only 5 per cent of the hospitals keep the department as a separate one. To the contrary, approximately 12 per cent of the hospitals have not established a nursing service department at all but surbodinate it to the other department. In this respect, it is required that a new hospital organization be made to acknowledge the independent function of the nursing department. In 76 per cent of the hospitals they have advisory committees under the nursing department, such as a dormitory self·regulating committee, an in-service education committee and a nursing procedure and policy committee. 9. Personnel arrangement and working conditions of nurses 1) The ratio of nurses to patients is as follows: In university hospitals, 1 to 2.9 for hospitalized patients and 1 to 4.0 for out-patients; in religious hospitals, 1 to 2.3 for hospitalized patients and 1 to 5.4 for out-patients. Grouped together this indicates that one nurse covers 2.2 hospitalized patients and 4.3 out-patients on a daily basis. The current medical treatment law stipulates that one nurse should care for 2.5 hospitalized patients or 30.0 out-patients. Therefore the statistics indicate that nursing services are being peformed with an insufficient number of nurses to cover out-patients. The current law concerns the minimum number of nurses and disregards the required number of nurses for operation rooms, recovery rooms, delivery rooms, new-born baby rooms, central supply rooms and emergency rooms. Accordingly, tile medical treatment law has been requested to be amended. 2) The ratio of doctors to nurses: In university hospitals, the ratio is 1 to 1.1; in national of public hospitals, 1 to 0.8; in religious hospitals 1 to 0.5; and in private hospitals 1 to 0.7. The average ratio is 1 to 0.8; generally the ideal ratio is 3 to 1. Since the number of doctors working in hospitals has been recently increasing, the nursing services have consequently teen overloaded, sacrificing the services to the patients. 3) The ratio of nurses to clerical staff is 1 to 0.4. However, the ideal ratio is 5 to 1, that is, 1 to 0.2. This means that clerical personnel far outnumber the nursing staff. 4) The ratio of nurses to nurse's-aides; The average 2.5 to 1 indicates that most of the nursing service are delegated to nurse's-aides owing to the shortage of registered nurses. This is the main cause of the deterioration in the quality of nursing services. It is a real problem in the guest for better nursing services that certain hospitals employ a disproportionate number of nurse's-aides in order to meet financial requirements. 5) As for the working conditions, most of hospitals employ a three-shift day with 8 hours of duty each. However, certain hospitals still use two shifts a day. 6) As for the working environment, most of the hospitals lack welfare and hygienic facilities. 7) The salary basis is the highest in the private university hospitals, with enterprise hospitals next and religious hospitals and national or public ones lowest. 8) Method of employment is made through paper screening, and further that the appointment of nurses is conditional upon the favorable opinion of the nursing directors. 9) The unemployment ratio for one year in 1971 averaged 29 per cent. The reasons for unemployment indicate that the highest is because of marriage up to 40 per cent, and next is because of overseas employment. This high unemployment ratio further causes the deterioration of efficiency in nursing services and supplementary activities. The hospital authorities concerned should take this matter into a jeep consideration in order to reduce unemployment. 10) The importance of in-service education is well recognized and established. 1% has been noted that on the-job nurses. training has been most active, with nursing directors taking charge of the orientation programs of newly employed nurses. However, it is most necessary that a comprehensive study be made of instructors, contents and methods of education with a separate section for in-service education. 10. Nursing services'activities 1) Division of services and job descriptions are urgently required. 81 per rent of the hospitals keep written regulations of services in accordance with nursing service manuals. 19 per cent of the hospitals do not keep written regulations. Most of hospitals delegate to the nursing directors or certain supervisors the power of stipulating service regulations. In 21 per cent of the total hospitals they have policy committees, standardization committees and advisory committees to proceed with the stipulation of regulations. 2) Approximately 81 per cent of the hospitals have service channels in which directors, supervisors, head nurses and staff nurses perform their appropriate services according to the service plans and make up the service reports. In approximately 19 per cent of the hospitals the staff perform their nursing services without utilizing the above channels. 3) In the performance of nursing services, a ward manual is considered the most important one to be utilized in about 32 percent of hospitals. 25 per cent of hospitals indicate they use a kardex; 17 per cent use ward-rounding, and others take advantage of work sheets or coordination with other departments through conferences. 4) In about 78 per cent of hospitals they have records which indicate the status of personnel, and in 22 per cent they have not. 5) It has been advised that morale among nurses may be increased, ensuring more efficient services, by their being able to exchange opinions and views with each other. 6) The satisfactory performance of nursing services rely on the following factors to the degree indicated: approximately 32 per cent to the systematic nursing activities and services; 27 per cent to the head nurses ability for nursing diagnosis; 22 per cent to an effective supervisory system; 16 per cent to the hospital facilities and proper supply, and 3 per cent to effective in·service education. This means that nurses, supervisors, head nurses and directors play the most important roles in the performance of nursing services. 11. About 87 per cent of the hospitals do not have separate budgets for their nursing departments, and only 13 per cent of the hospitals have separate budgets. It is recommended that the planning and execution of the nursing administration be delegated to the pertinent administrators in order to bring about improved proved performances and activities in nursing services.