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Development of Test Toolkit of Hard Review to Evaluate a Random Clinical Decision Support System and the Evaluation Technology for Security for the Management of Chronic Adult Diseases

만성성인질환 관리 임상진단지원시스템의 임상적 유효성 검사 toolkit 및 보안 평가기술 개발

초록/요약

Over 30% of Korean population suffers from chronic diseases, and the management cost of this portion of the population is estimated to be more than 7% of the gross domestic product and is expected to continue to increase with the aging of society. The ubiquitous healthcare (u-health)-based home healthcare service has been emerging as a solution to this issue. Clinical decision support system (CDSS) is software that provides professional medical knowledge to help people make medical decisions, and is required for the efficient operation of u-health as a core technology. U-health-based CDSS is meant to improve accessibility of medical information for the public, but it at the same time carries a substantial risk of misuse. Hence, a certain level of standards and specifications is required to guarantee the quality of u-health-based CDSS to protect public health. At the same time, the on-line healthcare accompanies the risk of the leakage of personal medical information, thus requiring the assurance of certain level of protecting privacy and security. In this context, this project aimed to develop a total solution for the evaluation of clinical efficacy and safety of CDSS as well as protection of privacy and security of personal medical information in the operation of u-health system dealing with diabetes and hypertension. As a result, this study created a test toolkit to evaluate random CDSS with a function to confirm results obtained from CDSS performance evaluation technologies. Results of CDSS were obtained based on screening test items. The design descriptions are defined as (1) creation of test scenario to test CDSS, (2) grading function using returned answers to CDSS, and (3) confirmation of test result. The functions of the test toolkit are divided into two types. (1) Test scenarios and the answers to the scenarios are created by reading and fabricating standard scenarios from the DB based on test items input by the evaluator. (2) Appraisal CDSS creates a file of result values using a given test scenario file, and then a CDSS evaluation report, classified by test item, is formed by comparing answers to those found in (1). It should be noted that functions (1) and (2) are completely independent. Collectively, we developed a toolkit to evaluate clinical reliabilities and software stabilities of CDSS for healthcare free from misjudgments caused by human factors and to speed up overall evaluation processes tremendously and efficiently. This toolkit will ensure proper usage of CDSS by the public for health benefits. In parallel, the present study developed security evaluation methodology and criteria for u-health system. For the purpose, first, we classified the components of u-health system. Second, security core technologies were selected that can be applied to u-health system in three aspects such as administrative safeguard dealing with operator, policy, document, system and user education, physical safeguard dealing with control of entrance and exit, screen or shared instrument, and technical safeguard dealing with computer system-related technological elements. Then, each security core technology was assigned to each component of u-health system, and relative significance of which was determined. Lastly, the methodology and criteria for the evaluation of security and privacy was developed. Conclusively, the outcome is to be utilized for the enhancement of clinical efficacy and safety of CDSS as well as security level in the design of u-health system and setting the authentication standard for authorization process for u-health-based CDSS and security.

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목차

ABSTRACT 1
CHAPTER 1. Introduction 4
CHAPTER 2. Materials and Methods 9
CHAPTER 3. Results 21
CHAPTER 4. Discussion 30
References 34
Tables and Figures 37
Annexation 40

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