보건의료 데이터 활용 가이드라인의 내용과 한계에 관한 연구

이기호,김계현 한남대학교 과학기술법연구원 2020 과학기술법연구 Vol.26 No.4

This study analyzed the main contents of the recently published 'Guideline for Utilization of Healthcare Data'. We wanted to present the problems and improvement measures of the guidelines that could be raised in the utilization of healthcare data. The results of this study are as follows. First of all, the scope of personal information among healthcare data has been clarified due to the revision of the "Data 3 Act," and the scope of utilization has been expanded as healthcare data can be changed to alias information. At the same time, however, the possibility of rights violations by information subjects has also increased. Therefore, in order to protect the rights of information subjects to the fullest extent, guidelines should supplement the functions of inducing in-purpose use of data and managing and supervising its use within-purpose. In addition, procedures for disposal and deletion should be supplemented after data is utilized. Next, the guidelines give the internal review committee or the Institutional Review Board the role of deliberating the safety of data combination and utilization methods in the process of combining or utilizing alias information. But it is difficult to supervise these committees. Therefore, for thorough and rigorous deliberation, the authority and responsibilities of the review committee should be clarified, and specialized institutions should be established to judge data safety. Healthcare data can also translate alias and anonymous information into personally identifiable information using the latest analysis technology. As a result, future policy directions are more important for post-management and evaluation of the information used. Accordingly, measures for follow-up management and evaluation of the use of personal information and data in the health and medical sectors should be strengthened in the current guidelines. Finally, the 'Guideline for Utilization of Healthcare Data' provides practical guidance on the interpretation and application of the current Personal Information Protection Act due to its nature. This is not legally effective, and if data utilization becomes more active, guidelines may be limited. Therefore, it is necessary to supplement the guidelines in the short term, and in the long term, it is necessary to seek separate legislative measures, such as Japan's ‘Next Generation Medical-Based Act’. 본 연구는 데이터 3법의 개요와 의미, 이중 보건의료 데이터와 가장 밀접한 관련이 있는「개인정보보호법」의 주요 내용을 검토하고, 최근 발표된 ‘보건의료 데이터 활용 가이드라인’의 주요 내용을 분석함으로서, 보건의료 데이터 활용에서 제기될 수 있는 가이드라인의 한계와 개선방안을 제시하고자 하였다. 본 연구의 결과는 다음과 같다. 먼저 ‘데이터 3법’의 개정으로 보건의료 데이터 중에서 개인정보의 범위가 기존보다는 명확하게 설정되었고, 보건의료 데이터를 가명정보로 바꾸어 활용할 수 있어 그 활용범위는 확대되었으나, 동시에 정보주체의 권리침해 가능성도 높아지게 되었다. 이에 최대한 정보주체의 권리 보호를 강화하기 위해서는 가이드라인에서 데이터의 목적 내 활용을 유도하고, 목적 내 활용이 되었는지 관리・감독 기능을 보완해야 하며, 데이터 활용 후 폐기, 삭제에 대한 절차의 보완을 제안하였다. 또한 가이드라인에서는 가명정보의 결합이나 활용 절차에서 데이터 결합과 활용 방법의 안전성 등을 심의하는 매우 중요한 역할을 내부 심의위원회나 기관생명윤리위원회에 부여하고 있었다. 이에 보다 철저하고 엄격한 심의를 위해 심의위원회의 권한과 책임을 명확히 하고, 데이터 안전성을 판단할 수 있는 전문기관을 확보하는 방안을 제안하였다. 보건의료 데이터의 경우 최신의 분석기술을 활용하면 가명, 익명의 정보도 충분히 개인 식별 가능 정보로 전환될 가능성이 있다. 이로 인해 향후 정책적 방향은 활용된 정보에 대한 사후 관리와 평가, 정책적 환류가 더 중요하다. 이에 현행 가이드라인에서 개인정보 및 보건의료분야 데이터 활용에 대한 사후관리・평가에 대한 조치가 강화될 필요가 있다. 마지막으로 ‘보건의료 데이터 활용 가이드라인’은 그 성격상 현행 개인정보 보호법제의 해석 및 적용 실무상의 지침을 제시한 것으로 법적 효력이나, 해석상의 한계, 실제 관련 데이터의 활용과 제3자 제공 등이 더 활발해질 경우 가이드라인만으로 해결되기 어려울 수 있다. 또한 기술의 발달 및 관련 법률이 다양하여 가이드라인의 한계는 더욱 확대될 수 있다. 이에 단기적으로는 가이드라인을 보완하거나 세분화하되, 장기적으로는 일본의「차세대의료기반법」과 같은 보건의료분야에 특화된 입법방안을 모색할 필요가 있다.

직장가입자와 지역가입자의 외래의료이용 영향요인

김재원(Kim, JaeWon) 서울대학교 보건환경연구소 2018 보건학논집 Vol.55 No.1

Objectives: This research aimed to identify affecting factors to outpatient healthcare utilization depending enrollment type (the self-employed and the employee) and to find out barriers to healthcare access. Methods: The study used Andersen model (1968) to examine healthcare utilization, and determinants including predisposing, enabling, need factors and health behaviors were analyzed. The data were from the 4th wave of Korea Health Panel (KHP) and the two-part model was applied to determine factors affecting outpatient healthcare utilization itself and the volume. Results: Subjective health status and chronic disease were common important affecting factors. Other factors like education level, marital status and health behaviors had partial influence on healthcare utilization. Income level showed a significant impact only for the employee group. On the other hand, economic participation showed a significant impact only for the self-employed group. The result implies that each group has different affecting factors as per one’s enrollment type, i.e. the type of labor in Korean setting. Conclusion: Based on the findings, this study suggests that each sub-group experiences different barriers to healthcare access. Thus, it is important for health policy makers to understand and take account of those differences when developing policies to enhance accessibility to healthcare.

주요국 보건의료 데이터 이차 활용 법제의 주요 내용과 시사점

김계현 아주대학교 법학연구소 2023 아주법학 Vol.17 No.3

보건의료 분야의 데이터는 타 분야보다 중요하고, 유용할 수 있다. 그러나 보건의료 정보는 민감정보를 포함하고 있어 그 활용이나 정보 유출에 우려의 입장이 많다. 그럼에도 불구하고 시대적 상황에 맞물려 보건의료분야 데이터를 세심하게 보호하면서 안전하게 활용할 수 있는 법적·제도적 방안의 모색은 더욱 중요해졌다. 이러한 목적으로 주요 국가들이 선택한 입법 방안은 데이터의 2차 사용에 대한 별도 규정이나 법률을 마련하는 것이다. 본 연구는 보건의료 데이터 2차 사용에 관한 별도의 법률을 가진 주요국의 관련 법체계와 2차 사용법의 주요 내용, 데이터의 처리 및 관리, 감독 체계 등을 검토하여 우리나라 관련 법제, 정책 등에 시사점을 도출하고자 하였다. 주요국의 보건의료 데이터 2차 사용법은 개인정보의 보호를 핵심으로 주로 2차 사용의 목적과 범위를 규정하고, 데이터 처리와 결합, 관리, 감독을 전담하는 조직을 설치하며, 데이터의 안전한 접근과 처리를 보장하고 있었다. 전담 조직이 없을 경우 의료정보, 가공정보를 안전하게 생성하고 취급할 수 있도록 관련 요건, 인증요건 등을 확립하고 있었다. 즉 주요국은 보건의료 데이터 2차 사용을 위해 별도 법체계를 통해 관련 거버너스를 확립하고 데이터 활용에 안정성을 확보하고 있었다. 우리나라도 보건의료 데이터의 안전한 활용을 위해 별도 법체계를 고려함에 있어 보건의료 데이터의 고유한 특성을 우선적으로 고려하고, 데이터의 활용과 보호 전과정에 걸쳐 적용되는 데이터 거버넌스를 확립할 필요가 있다. 또한 전담조직을 규정하여 데이터 질 관리와 데이터 활용 전과정에 안전성을 확보할 필요가 있음을 확인하였다. Healthcare data is very important and useful. However, health care information contains sensitive information, so there are more problems in use or information leakage than in other fields. It is important to prepare legal and institutional measures to carefully protect and safely utilize health care data in accordance with the circumstances of the times. For this reason, major countries have enacted laws on secondary use of data. This study reviewed the relevant legal systems of major countries with separate laws on secondary use of healthcare data, the main contents of the laws, data processing and management, and supervision systems. Protection of personal information is the key to the secondary use of healthcare data in major countries. Based on this, the purpose and scope of secondary data use were defined, and an organization dedicated to data processing, combination, management, and supervision was established. It was also ensuring secure access and processing of data. In other words, major countries were establishing related governance through separate laws for the second use of healthcare data and securing stability in data utilization. The following matters should be considered to improve the legal system in Korea. The unique characteristics of healthcare data should be considered first. In addition, it is necessary to establish data governance that applies to the entire process of using and protecting healthcare data. In addition, it is necessary to establish a dedicated organization to ensure safety in the data quality management and utilization process.

환자만족이 의료이용에 미치는 영향-환자-의사 커뮤니케이션 만족을 중심으로

윤혜정,유명순 한국병원경영학회 2019 병원경영학회지 Vol.24 No.4

Purpose: Importance of patient satisfaction related to patient-centeredness has been emphasized, and it is known to have effect on various health outcomes including health resource utilization. However, the effect of patient satisfaction has been discussed mostly in terms of hospital marketing in Korea. This study aims to examine the effect of patient satisfaction in patient-physician communication on healthcare utilization in a nationally representative adult population of South Korea. Method: Patient satisfaction with physician communication is assessed using 4 items in the 2011 Korea Health Panel Survey. Generalized linear regression analysis is conducted using 9,325 adultsʼ healthcare utilization in 2012. Findings: Adjusting for the socio-demographic, economic factors, individual health status, health behaviors and healthcare utilization in 2011, more satisfied individuals, more likely to utilize the outpatient service, especially in clinical setting. Practical Implications: The study findings suggests that in context of South Korea healthcare system such as insufficient medical consultation time and the absence of health delivery system, patient satisfaction as a subjective healthcare quality indicator would have effect on the individualʼs outpatient visit. This study contributes to stimulate patient satisfaction research and discussion in South Korea to further explore its relationship with potential and various health related outcomes. Further implications of the study are discussed.

외래 본인부담률 인상이 상급종합병원과 종합병원 외래 의료이용에 미친 영향

김효정,김영훈,김한성,우정식,오수진 한국보건행정학회 2013 보건행정학회지 Vol.23 No.1

Background: The study describes the changes resulted from imposition on tertiary hospital outpatient coinsurance rate rise policy and in tertiary or general hospital drug coverage rise policy on healthcare service utilization. Methods: Accordingly, the hypothesis about outpatient healthcare utilization after rise policy in outpatient coinsurance rate and drug coverage was established, using interrupted time-series analysis and segmented regression analysis to test the hypothesis. 5-year analysis period (2007. 3-2012. 3) from the outset year was designated, the data about most common 10 high-ranking of the main diseases targeting visiting patient from age of 6 to 64 were collected. Results: The summary on the major research is followed. First, the medical expense and duration of treatment tends to be increased in case of imposition about rise policy in outpatient coinsurance rate in the tertiary hospital under the interrupted time-series analysis. It showed temporary increase and slow down on account of influenza A even after the policy enforcement. In segmented regression analysis, duration of visit and medical expense in the tertiary hospital increased temporally right after the policy implementation and the decreased rapidly depends on period. Both rise and fall is statistically significant. The second, In case of tertiary or general hospital outpatient drug coverage rise policy, all of the tertiary hospital healthcare service utilization variables by the interrupted time-series analysis, drug coverage policy in the general hospital deeply declined according to decreasing trend before policy implementation. The third, in case of segmented regression analysis, the visit duration and medical expense statistically declined right after the policy implementation in both the tertiary and general hospital. Meanwhile, administration day was statistically meaningful only for the decrease right after the policy implementation. Otherwise, general hospital changes are not statistically meaningful. And the medicine cost was statistically, meaningfully decreased after the increase in drug coverage. Conclusion: Finally, the result demonstrated according to the analysis is only 1 hypothesis is denied, the other 2 are partially supported. Then, tertiary hospital outpatient coinsurance rate increase policy comparatively makes decrease effect on long-term healthcare utilization, and tertiary or general hospital outpatient drug coverage policy showed partially short-term effect is assured.

의료이용의 지역적 불균형에 대한 연구 -공간종속성을 중심으로-

박경돈 ( Kyoungdon Park ) 한국정책학회 2012 韓國政策學會報 Vol.21 No.3

고령사회와 복지국가로의 트렌드 하에서 과도한 의료이용은 복지재정확충에 대한 장애물로 작용한다는 우려에 대한 해답을 찾고자 의료자원의 비효율적 이용과 의료비용증가에 영향을 미치는 지역적인 의료이용의 불균형 문제를 연구하였다. 기존 연구처럼 개인을 분석단위하지 않고 정책적 함의를 지니는 중범위수준의 기초자치단체를 분석단위로 하고, 공간종속성을 감안한 공간회귀분석의 지체모형과 지리가중모형을 구성하여 실증적 분석을 하였다.국민건강보험공단의 지역의료이용통계 자료(2010년도)를 분석한 결과, 지방정부 단위별로 관외의료이용의 불균형도가 높았으며, 관내 및 관외의료이용이 모두 높은 곳은 수도권으로 비수도권과의 지역적 차이가 컸다. 특히 수도권의 초과공급은 관외의료이용에서 두드러졌지만 수도권에서조차도 초과수요가 발생한 지역이 많아 의료이용의 불균형이 심하였다. 비수도권에서는 의료자원의 공급이 부족하여 필요한 의료서비스를 수도권에서 관외이용을 통해 해소하고 있어 수도권 내 또는 비수도권 지역의 의료자원의 공간적 분포와 이용에 대한 정책적 고려가 절실하다. This research aims at analyzing the regional variations in healthcare utilization. Since the disparities may affect an increased public costs through the inefficient use of medical resources, given that Korea moves toward the aged society. In order to draw the policy implications, the paper employs not individual but local government as the unit of analysis, while applying the statistical techniques of both Spatial Regression with spatial lag and Geographical Weighted Regression. Data obtained from the National Health Insurance Corporation are used to test regional disparities in healthcare utilization. A geographic variation in medical use is much higher for outpatient medical utilization than for inpatient medical utilization, while it is greater in the Capital Area near Seoul than in the Non-Capital Area. Especially, the over-supply and under-demand for medical resources is prominent in the Capital Area, leading to the regional unbalance in healthcare utilization. Policy alternatives are needed to resolve the under-supply of the medical services in the Capital Area and to change the geographic distribution of medical utilization and medical resource in consideration of spatial dependence.

희귀난치성질환자에서 사회경제적 수준이 의료이용에 미치는 영향

임준,임정수,오대규,김명희 한국보건행정학회 2009 보건행정학회지 Vol.19 No.4

This study aims to examine the effect of socioeconomic status (hereafter, SES) on healthcare utilization of the patients with rare and incurable diseases. Information of 2,973 patients who were self-employed insured and utilized healthcare service in 2007 was drawn from the National Health Insurance (hereafter, NHI) claim data. SES was set as four groups based on the monthly contribution. Outcome variable was the expense for outpatient and in-hospital services, which was log-transformed and square-rooted in oder to obtain normal distribution. Covariates included age, gender, residence and diagnosis. To examine the effects after controlling for covariates, we employed generalized estimating equation model, since patients with the same diagnosis are likely to have similar characteristics of demographics and healthcare utilization. Univariate statistics showed that lower SES was associated with less utilization of healthcare services. After controlling for covariates, a significantly smaller amount of money was expended for the lowest SES group compared to the highest one. Rural residence was associated with less utilization, except that residents in Seoul significantly more utilized outpatient services in tertiary hospitals. Considering that there is a subsidy program for the low income patients, such differences in healthcare utilization according to SES seems to result from the burden of out-of-pocket payments for uncovered services of the NHI.

치과의료 이용의 수평적 형평성 분석

안은숙 ( Eun Suk Ahn ),김민영 ( Min Young Kim ),신호성 ( Ho Sung Shin ) 대한예방치과·구강보건학회 2015 大韓口腔保健學會誌 Vol.39 No.1

Objectives: Health inequity across social classes is closely associated with unequal healthcare utilization, and there have been sustained efforts to improve healthcare accessibility. Public healthcare insurance is one attempt to eliminate such health inequities. The purpose of this study was to examine a horizontal equity index for dental service utilization, which included diverse factors affecting health inequity, such as personal health and social context variables. Methods: The 2008 to 2011 outpatient datasets of the Korean Healthcare Panel were analyzed. Zeroinflated negative binomial regression (ZINB) was conducted to estimate need-adjusted healthcare use with the following independent variables: health outcome (EQ-5D), chronic disease, and the Composite Deprivation Index. The concentration index and horizontal inequality index were calculated for the actual use of dental services and resource use-based dental visits. Results: The ZINB regression analysis showed that age and personal health level on the EQ-5D were significant predictors, and the Composite Deprivation Index was influential. The concentration index for dental service utilization indicated that there was inequity favoring high-income brackets, but there was inequity favoring low-income groups when health level was taken into account. Overall, the horizontal equity index for dental service utilization estimated based on the two values was positive, meaning that there was inequity favoring high-income groups. Conclusions: The use of dental services has been steadily on the rise, and dental service accessibility and public healthcare coverage seem to have expanded. However, when the horizontal equity index for dental service utilization was estimated based on health level, there was inequity, with high-income groups making more use of dental services. Thus, equal access to dental services is not guaranteed, despite the adjustment for need. Methods of increasing dental service use in different income brackets must be carefully considered to remove disparities in the use of dental services.

보건의료데이터 활용의 안정성을 위한 법적 쟁점과 입법방향의 고찰

이하영(Ha-Young Lee),최봉석(Bong-Seok Choi) 경희법학연구소 2023 경희법학 Vol.58 No.4

Efforts are underway to establish a legal foundation for the use of data in the healthcare field through the revision of the Personal Information Protection Act and the issuance of guidelines for the utilization of health care data. However, the current legislative framework for the utilization of health and medical data faces limitations, including conflicts with existing laws, challenges in ensuring the stability and reliability of data utilization, and competition between the necessity for industrial development. The regulatory framework regarding the utilization of health care data, despite having the format of guidelines, is being implemented as if it were actual legislation. In this study, four major legal issues related to the utilization of health and medical data are identified through a comprehensive examination. To promote the activation of health and medical data, it is crucial to ensure the stability of health and medical data utilization. Therefore, the establishment of an independent law is necessary, with a definition of the concept of health and medical data tailored to the practical characteristics of the health and medical field. Regulations should be put in place in the law regarding pseudonymization and pseudonymization procedures to ensure legal stability. The Data Review Committee should be regulated in a direction that secures a legal basis and expertise. Strengthening the legal status of data utilization agencies through permits and approvals, along with enhanced regulations on responsibilities for violations, is essential. In summary, through swift legislative responses and the establishment of a regulatory system, the foundation for the utilization and responsibility of health and medical data should be secured, ensuring successful integration into our society through effective regulation. 「개인정보보호법」의 개정과 「보건의료데이터 활용 가이드라인」제정에도 불구하고, 보건의료데이터의 활용에 관한 규제 체계는 기존 법률과의 상충문제, 데이터 활용의 안정성 신뢰성 확보 문제와 관련 산업 진흥 필요성과의 경합 등의 문제를 지니고 있어 적절한규제 시스템이 자리 잡지 못했다는 한계가 있다. 이 글에서는 보건의료데이터의 활용과 관련하여 제기되는 법적 쟁점과 입법방향을 거시적으로 조망해보았다. 현행 규제 시스템은가이드라인을 중심으로 하여 법적 구속력 확보가 어려움에도 불구하고, 실질적으로는 법률과 같은 규범적 효과를 지니는 체계적 모순이 인정되므로 독립된 법률을 통한 법적 안정성을 제고할 필요성이 있다고 할 것이다. 또한, 보건의료데이터의 개념을 보건의료분야의 실질적 특성이 반영되도록 정의하여야 하며, 가명처리 방법 및 절차에 관한 사항을 법률에 규율하여 법적 안정성을 확보해야 한다. 데이터심의위원회는 법적 근거 확보와 전문성을 담보하는 방향으로 규율되어야 하며, 데이터 활용기관은 허가 및 승인을 통한 법적 지위 확보와 위반행위에 대한 책임 규정의 강화가 필요하다. 즉, 조속한 입법 대응과 규제 시스템 개선을 통해 보건의료데이터의 활용과 책임에 대한 근거를 확보하고, 우리 사회에 성공적인규제로서 안착하여야 할 것이다.

Health Status and Health Service Utilization: Barriers and Facilitators for Korea Medicaid Beneficiaries

Sung-Heui Bae,Eun-Ok Choi,In sook Lee,In Young Lee,Chae min Chun 기초간호학회 2016 Journal of korean biological nursing science Vol.18 No.3

Purpose: This study compares beneficiaries of Korean Medicaid with those under the National Health Insurance program, seeking to understand how each group utilizes their healthcare. Methods: Data were obtained from a Health Promotion Survey in 2005. Health status was measured by the respondents’ perception of health. Health service utilization included the availability of healthcare services, the type of healthcare institution, and intent to revisit. Predisposing and enabling factors, as well as health care needs were used for this study. Results: Compared to National Health Insurance beneficiaries, Medicaid beneficiaries reported lower levels of health status and fewer enabling factors. They had more chronic diseases and disabilities. Education level, existence of chronic diseases, exercise patterns, and disabilities were associated with health status. Conclusion: We found that Medicaid beneficiaries had fewer resources and higher levels of health needs. As Medicaid is reformed, policy makers and administrators should understand healthcare utilization behaviors of Medicaid beneficiaries and the factors hindering access to care.