In recent years, various international organizations have raised awareness regarding psychosocial risks and work-related stress. European stakeholders have also taken action on these issues by producing important documents, such as position papers and government regulations, which are reviewed in this article. In particular, 4 European models that have been developed for the assessment and management of work-related stress are considered here. Although important advances have been made in the understanding of work-related stress, there are still gaps in the translation of this knowledge into effective practice at the enterprise level. There are additional problems regarding the methodology in the evaluation of work-related stress. The European models described in this article are based on holistic, global and participatory approaches, where the active role of and involvement of workers are always emphasized. The limitations of these models are in the lack of clarity on preventive intervention and, for two of them, the lack of instrument standardization for risk evaluation. The comparison among the European models to approach work-related stress, although with limitations and socio-cultural differences, offers the possibility for the development of a social dialogue that is important in defining the correct and practical methodology for work stress evaluation and prevention.
Government Regulation ; Risk Assessment

The Korean Transplant Act has been revised five times since 1999, and each revision has resulted in a slight donation rate increased; however, the organ shortage had not been solved. As a result, further revision of the Transplant Act is needed. The current focuses solely on efficiency for transplantation. Therefore, this study suggests a paradigm shift in the revision of the act through the virtuous cycle for activating donation; namely, from an efficiency-based transplant system to a donor-centered transplant system.
Government Regulation ; Transplantation

This paper learned and interpreted the regulations on the supervision and administration of medical devices, carded the thoughts of administrative reform, then put forward the "ten principles", including full supervision, classification supervision, risk classification, safety-effective-save, to encourage innovation, simplified license, scientific-standard, sincerity & self-discipline, clear responsibility, severe punishment, and discussed these priciples.
Device Approval ; Equipment and Supplies ; standards ; Government Regulation

Based on the statistics of 350 technical evaluations of changes in licensing items of class Ⅱ passive and active medical devices completed in Henan province from July 2017 to November 2018, this paper summarized and analysed the common problems and requirements listed in the correction notifications of the technical evaluation, and put forward relevant countermeasures or suggestions, with a view to further speeding up the evaluation and approval of medical devices.
Equipment and Supplies ; standards ; Government Regulation ; Licensure

According to the information of the supervision and inspection of in vitro diagnostic reagents for clinical use, this article analyzed the compliance issues and discussed the methods to solve the problems, to urge medical institutions to reduce the regulatory risk of in vitro diagnostic reagents in use.
Government Regulation ; Indicators and Reagents ; adverse effects ; Risk

Since medical equipment supervision and management regulations (Amendment) started modification in 2005, 7 years have passed. A few days ago, the Legal Affairs Office of the State Council issued Amendment Third Draft. After studied the draft, we feel it suits the medical device regulatory practice, has a new look, and introduces many new regulatory concepts, with innovative administrative license and regulatory design, of course, the new regulatory regime will inevitably initiate many new problems, explore some new system design. Therefore, based on preliminary interpretation, we publish some experiences, throw away a brick in order to get a gem.
Equipment and Supplies ; standards ; Government Regulation ; Publishing ; legislation & jurisprudence ; organization & administration

By comparing new medical device regulations with existing directives in the European Union, the revising ideas of new EU medical device regulations, especially the changes of the classification management concepts, were analyzed to provide clues for the industry to interpret the new EU regulations, and references for the classification management innovation in our country.
Equipment and Supplies ; classification ; European Union ; Government Regulation ; Industry

Recently, digital health has gained the attention of physicians, patients, and healthcare industries. Digital health, a broad umbrella term, can be defined as an emerging health area that uses brand new digital or medical technologies involving genomics, big data, wearables, mobile applications, and artificial intelligence. Digital health has been highlighted as a way of realizing precision medicine, and in addition is expected to become synonymous with health itself with the rapid digitization of all health-related data. In this article, we first define digital health by reviewing the diverse range of definitions among academia and government agencies. Based on these definitions, we then review the current status of digital health, mainly in Korea, suggest points that are missing from the discussion or ought to be added, and provide future directions of digital health in clinical practice by pointing out certain key points.
Artificial Intelligence ; Genomics ; Government Agencies ; Government Regulation ; Health Care Sector ; Humans ; Korea ; Mobile Applications ; Precision Medicine ; Telemedicine

No abstract available.
*Cost Control ; *Government Regulation ; Humans ; Medical Informatics ; Monitoring, Ambulatory ; Republic of Korea ; Societies, Medical/*trends

This review article describes the regulation of proprietary Chinese medicines for the Australian market, which may permit many medicines used in Traditional Chinese Medicine to have a simplified process of market access provided that certain criteria for acceptable public safety are met.
Australia ; Drugs, Chinese Herbal ; Government Regulation ; Humans ; Medicine, Chinese Traditional ; Phytotherapy