Three years have passed since the Korea Medical Dispute Mediation and Arbitration Agency (KMDMAA) was established. In this time, its performance has fallen far short of expectations. Currently, both the KMDMAA and the Korea Consumer Agency (KCA) are responsible for alternative medical dispute resolution in Korea. In the most recent National Assembly administration inspection, Rep. Kim Jae Won of the Saenuri Party made the criticism that in 2013 the KMDMAA spent more than 13 times the budget of the KCA, but did not achieve significantly improved results. An analysis of the relevant law reveals that the KMDMAA has a much more advantageous legal and financial position than the KCA. Mediation takes the form of alternative dispute resolution in place of court adjudication. Mediation is a voluntary process and generally only succeeds when both parties agree. The mediator must be impartial and should aid parties in arriving at a mutually agreed-upon outcome. However, the KMDMAA has failed to build a trusting relationship with medical professionals, and has instead sought power to rule over them. The agency should be aware that power over medical personnel might deter mediation processes, which are based on the spontaneity and trust of both parties. The Department of Health and Human Services and the National Assembly also need to understand the essence of this problem and seek to remedy it.
Budgets ; Dissent and Disputes* ; Jurisprudence ; Korea ; Negotiating* ; United States Dept. of Health and Human Services

On October 27th, 2005, The Constitutional Court repealed the old law regarding advertising by the medical industry. Because the old law had been repealed, it was necessary to create a new law to take its place. Under the previous law on medical advertisement, both the advertisers and the industry were less regulated. Thus there was a concern about the potential widespread damage because of the lax controls regarding the advertisement of medical products. On January 3rd, 2007, a new law was passed to put tighter restrictions on medical advertising. The new law allows for higher quality advertising, allowing the consumers to make a more reasonable and safer decision, while stopping advertisements trying to exaggerate the functions or efficacies of certain medical products. The new system has been developed to better protect both the patients and the medical institutes. For this system to work, the cooperation and self regulation of the Korean Medical Association, Korean Dentist Association, and the Association of Korean Oriental Medicine is needed along with the cooperation of the Department of Health and Human Services.
Academies and Institutes ; Dentists ; Humans ; Jurisprudence ; Medicine, East Asian Traditional ; Self-Control ; United States Dept. of Health and Human Services

According to the World Medical Association Declaration of Madrid on Professionally-led Regulation, physicians have been granted a high degree of professional autonomy, which is an essential component of high quality medical care. As a result, physicians have a continuing responsibility to be self-regulating. Historically, credible self-regulation has required maintaining professional competence, identifying problem physicians and conflicts of interest, and taking appropriate action. Recently, our society had two incidents that gave patients strong doubts about the professional expertise of physicians. The Korean Medical Association should consider the following in promoting its self-regulatory policies. First, if the structure of the self-regulation of lawyers is instructive, self-regulation completely independent from the government is unlikely to be realized. KMA or independent bodies should exercise primary authority and responsibility for self-regulation, and if this is not implemented well, it is reasonable that the Department of Health and Human Services should intervene. Second, the Ethics Committee of KMA should avoid political disputes between members and devote itself solely to establishing the core ethics of the medical profession. Third, KMA should inform its members that the ultimate beneficiaries of self-regulation are physicians and patients. KMA must determine the objectives it has in common with the Department of Health and Human Services and create a model of self-regulation.
Dissent and Disputes ; Ethics ; Ethics Committees ; Financing, Organized ; Humans ; Korea ; Lawyers ; Professional Autonomy ; Professional Competence ; Self-Control* ; United States Dept. of Health and Human Services

According to the World Medical Association Declaration of Madrid on Professionally-led Regulation, physicians have been granted a high degree of professional autonomy, which is an essential component of high quality medical care. As a result, physicians have a continuing responsibility to be self-regulating. Historically, credible self-regulation has required maintaining professional competence, identifying problem physicians and conflicts of interest, and taking appropriate action. Recently, our society had two incidents that gave patients strong doubts about the professional expertise of physicians. The Korean Medical Association should consider the following in promoting its self-regulatory policies. First, if the structure of the self-regulation of lawyers is instructive, self-regulation completely independent from the government is unlikely to be realized. KMA or independent bodies should exercise primary authority and responsibility for self-regulation, and if this is not implemented well, it is reasonable that the Department of Health and Human Services should intervene. Second, the Ethics Committee of KMA should avoid political disputes between members and devote itself solely to establishing the core ethics of the medical profession. Third, KMA should inform its members that the ultimate beneficiaries of self-regulation are physicians and patients. KMA must determine the objectives it has in common with the Department of Health and Human Services and create a model of self-regulation.
Dissent and Disputes ; Ethics ; Ethics Committees ; Financing, Organized ; Humans ; Korea ; Lawyers ; Professional Autonomy ; Professional Competence ; Self-Control* ; United States Dept. of Health and Human Services

Along with the steady growth of health functional food (HFF) markets, research evaluating the human effects of HFF has been expanding. In this study, we investigated the regulatory and management system of human study on HFF in the USA, Japan and UK, and the Korean domestic regulations on HHF, medicines, medical devices, cosmetics and biotechnology in order to improve the domestic management system. In these four countries, institutional review board (IRB) or research ethics committee (REC) approvals are required for on human study of HHF, but regulatory and management systems differ from country to country. In the USA, human studies on HFF for structure/function claims do not require the FDA's prior approval but clinical trials of the disease treatment effects of HHF require prior approval from the FDA. In the USA, IRBs are managed by the Department of Health and Human Services (DHHS) rather than the FDA, and IRBs in those institutions which would execute the clinical trials requiring prior approval from the FDA or human studies funded by the USA federal government are required to be registered on the DHHS. In the UK, although the government does not require prior approval of human study, authorized RECs managed by the National Research Ethics Service (NRES) and other independent RECs review the human study. In Japan, human study for HFF must conform with "Ethical guidelines for epidemiological research" and IRB registration has not been required. In Korean domestic regulations, the responsibilities, compositions, functions and operations of IRBs on medicines, medical devices and biotechnology are legally specified, but not those of IRB on HHF. These foreign statuses for the management of human study on HFF and comparisons with Korean regulations are expected to be used as basic data to improve the domestic legal system.
Biotechnology ; Cosmetics ; Ethics Committees, Research ; Ethics, Research ; Federal Government ; Financial Management ; Functional Food ; Humans ; Japan ; Social Control, Formal ; United States Dept. of Health and Human Services

BACKGROUND: Alcohol Use Disorders Identification Test (AUDIT) is effective in identifying problem drinking. This study purposed to evaluate the usefulness of AUDIT in identifying problem drinking among Korean university students whose drinking characteristic is different from adults. METHODS: The subjects were 235 students who had visited the Health Service Center of Chungnam National University. All subjects had a diagnostic interview for the presence of at-risk drinking and alcohol use disorder. At-risk drinking was defined according to the criteria of the National Institute on Alcohol Abuse and Alcoholism. Alcohol use disorder was diagnosed by the criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV TR). At-risk drinking or alcohol use disorder was classified into problem drinking. At the same time, a survey was conducted using three screening tools: AUDIT, cut down, annoyed, guilty feelings, eye opener (CAGE), and cut down, under influence, guilty feelings, eye opener (CUGE). Area under receiver operating characteristic curve (AUROC) of the questionnaires to the results of interviews were compared. RESULTS: Seventy one students were at-risk drinkers and 46 had alcohol use disorder, and 75 were classified into problem drinkers. For identification of problem drinking, AUROC of AUDIT was 0.970 in men and 0.989 in women. For CAGE, it was 0.650 in men and 0.747 in women. For CUGE, it was 0.689 in men and 0.745 in women. CONCLUSION: Above results suggest that AUDIT is most effective in identifying university students' problem drinking.
Diagnostic and Statistical Manual of Mental Disorders ; Drinking ; Eye ; Female ; Health Services ; Humans ; Male ; Mass Screening ; National Institute on Alcohol Abuse and Alcoholism (U.S.) ; ROC Curve

It is sufficient to justify distinguishing age-appropriate and age-inappropriate forms of age-related memory decline. The former, of which AAMI is an example, represents a normal age-related phenomenon, whereas the latter, the true descendent of benign senescent forgetfulness, is by definition abnormal and possibly, pathological. Whether age-inappropriate forgetfulness is progressive, whether it can be distinguished from other concepts of mild cognitive decline by virtue of being specific to memory, and whether it is qualitatively different from normal memory or merely worse is not yet certain. The prevalence of age-inappropriate forgetfulness is undetermined, but it is certainly less common than AAMI. The construct of AAMI was introduced by an NIMH work group. It was the group's declared intention to facilitate communication and stimulate research into late-life memory loss, particularly its treatment. Completely satisfactory diagnostic criteria do not yet exist for AAMI. Improved criteria would take an individual's overall level of intellectual functioning or educational background into account when setting the standard against which to rate memory, distinguish age-appropriate from age-inappropriate decline. AAMI differs from BSF in several points. First, the AAMI criteria define impairment with respect to healthy young adult levels, not to those of the older individual's age peers as was implied in the description of BSF. Second, the term AAMI is non-specific with regard to etiology and does not necessarily imply that the disorder is non-progressive. Thus, patients whose memory impairment is subsequently shown to be the earliest stage of a dementing illness are not necessarily excluded from the category of AAMI, and it is sensible to ask how often AAMI is, in fact, a dementia prodrome.
Aging ; Dementia ; Humans ; Intention ; Memory Disorders ; Memory* ; National Institute of Mental Health (U.S.) ; Prevalence ; Virtues ; Young Adult

Health technology assessment was first introduced to the Republic of Korea in 2006 by amending the Medical Services Act. The Committee of New Health Technology Assessment (CNHTA) is the ministerial committee that has the responsibility of reviewing the safety and effectiveness of new health technology. CNHTA review plays a gatekeeping role for new health technology in Korea, which can increase the burden on patients in Korea, either by out-of pocket payments or co-pays for National Health Insurance covered service. This kind of gatekeeping is a function of the healthcare system in many countries where no financial cap such as a fixed budget or diagnosis-related group payment is applied. However, it has been argued that gatekeeping works against industrial promotion policy. The one-stop service introduced in 2014 is a system similar to US parallel review between the US Food and Drug Administration and Centers for Medicare and Medicaid Services. This service provides a simultaneous process of regulatory review by the Ministry of Food and Drug Safety, identification of existing technology by the Health Insurance Review and Assessment Services, and new health technology assessment by the National Evidence-based Healthcare Collaborating Agency and the Ministry of Health and Welfare. This service is expected to reduce the total review process by 3 to12 months. A limited health technology appointment service was introduced in April 2014. This service designates orphan health technologies and health technologies for rare and incurable diseases and supports evidence development at designated hospitals. Several countries have similar systems: US Coverage with Evidence Development, Canadian Conditionally Funded Field Evaluation, UK Only in Research, and many others. The future direction of Health technology assessment should focus on the life cycle management of health technology. A consistent, continuous, and transformative mechanism to manage from the research and development of health technology to delisting obsolete technology to make room for new innovative technology is warranted.
Biomedical Technology* ; Budgets ; Centers for Medicare and Medicaid Services (U.S.) ; Child ; Child, Orphaned ; Delivery of Health Care ; Diagnosis-Related Groups ; Financial Management ; Gatekeeping ; Humans ; Insurance, Health ; Korea ; Life Cycle Stages ; National Health Programs ; Republic of Korea ; United States Food and Drug Administration

PURPOSE: It is now understood that blood pressure (BP) measurement in the routine pediatric examination is very important because of the relevance of childhood BP to pediatric health care and the development of adult essential hypertension. There hasn't been a reference table of BP for Korean children and adolescents up to now. This study was to make normative BP references and to provide criteria of hypertension for Korean children and adolescents. METHODS: BP measurements were done on 57,433 Koean children and adolescents (male: 29,443, female: 27,990), paged 7 to 20 years, in 2005. Heights and weights were measured simultaneously. Oscillometric devices, Dinamap Procare 200 (GE Inc., Milwaukee, Wi, USA), were used for the measurements. BPs were measured 2 times and mean levels were gathered for the analysis. Outliers of 2,373 subjects with overweight per height, over +3SD, were excluded for the analysis. For the BP centiles adjusted by sex, age and height, fixed modified LMS method which was adopted from the mixed effect model of 2004 Task Force in NHLBI (USA) was used. RESULTS: Normative BP tables for Korean children and adolescents adjusted for height percentiles (5th, 10th, 25th, 50th, 75th, 90th, 95th), gender (male, female) and age(7 to 18 years) were completed. Height centiles of Korean children and adolescents are available from Korean Center for Disease Control and Prevention homepage, http://www.cdc.go.kr/webcdc/. Criteria of hypertension (95th, 99th percentile) and normal range of BP (50th, 90th) adjusted for height percentiles, age and gender were made. CONCLUSION: This is the first study to make normative BP tables and define hypertension for the Korean children and adolescents. Reliability and accuracy of Dinamap Procare 200 oscillometer for BP measurements remains debatable.
Adolescent ; Adult ; Advisory Committees ; Blood Pressure ; Centers for Disease Control and Prevention (U.S.) ; Child ; Delivery of Health Care ; Humans ; Hypertension ; National Heart, Lung, and Blood Institute (U.S.) ; Overweight ; Reference Values ; Weights and Measures

BACKGROUND: Aging and obesity are both positive determinants of chronic disease in the elderly. This study was done to examine the relationship between obesity and functional status and, to examine the relationship between comorbidity and the different levels of BMI among older Koreans. METHODS: A total of 920 community dwelling women and men who completed both the home questionnaire and medical examination that was conducted in 1998 were chosen as subjects. The proportion of subjects with prevalence of obesity-related diseases and functional limitation by NHLBI classifications was determined. Risks for functional limitation associated with comorbidity of obesity-related diseases and fat distribution were examined using multivariate adjusted logistic regression methods. RESULTS: Among 920 subjects studied, 91% were functionally independent. The underweight were one in ten and the overweight were one in four. The overall prevalence of functional limitation in a major activity among underweight was one in ten, but that of overweight or over was one in two. After multivariate adjustment, significant predictors for functional limitation in ADLs and IADLs were vision and hearing impairment, unemployed occupational status, depression, living with spouse, and a history of stroke. Though not significantly shown in the statistics, comorbidity (>or=3) of six obesity-related diseases had odds of 5.4 times and in obese elderly women the odds were 7.9 times. CONCLUSION: We suggest that there is a positive trend between overweight and functional limitation. Although there is no statistical significance, obesity in older Korean women had higher odds for functional limitation in ADLs and IADLs.
Activities of Daily Living ; Aged* ; Aging ; Chronic Disease ; Classification ; Comorbidity ; Cross-Sectional Studies ; Depression ; Employment ; Female ; Hearing Loss ; Humans ; Logistic Models ; Male ; National Heart, Lung, and Blood Institute (U.S.) ; Nutrition Surveys* ; Obesity* ; Overweight ; Prevalence ; Spouses ; Stroke ; Thinness ; Surveys and Questionnaires