In recent years, emerging technology medical devices have developed rapidly. How to more scientifically and more efficiently regulate these novel medical devices so as to improve access to advanced medical technology while ensuring safety and effectiveness is a new challenge faced by regulatory authorities, and is also the core topic of regulatory science. New tools, new standards and new methods are important means to achieve regulatory science. "Medical Device Development Tool" proposed by the U.S. FDA is a novel medical device regulatory science tool, which can help medical device developers to predict and evaluate product performance more efficiently. It is also helpful for regulatory authorities to make regulatory decisions more efficiently. This study introduces the concept, qualification process, role of MDDT in medical device regulation and MDDT examples, and makes some discussion on the device evaluation from the perspective of reliability and validity. MDDT can facilitate the developing of novel medical device.
United States ; Medical Device Legislation ; Reproducibility of Results ; United States Food and Drug Administration ; Technology ; Device Approval

This paper studies the necessity of the current legislation on the supervision of medical devices in China from the perspectives of strengthening administration according to law, protecting public health, perfecting the legal system of medicine and promoting the development of the medical device industry. This study analyzes and summarizes the legislative experiences and forms in the field of medical device regulation in the United States, the European Union, Japan and other countries and regions, at present, the conditions of carrying out the legislation of medical device supervision in China are quite mature, and some policy suggestions are put forward for the enactment of the law of medical device management in China.
Equipment and Supplies ; European Union ; Feasibility Studies ; Industry ; Medical Device Legislation ; United States ; United States Food and Drug Administration

Objective: A multi-phase, sequential mixed methods study aimed to determine acceptable age-appropriate physical intimate behaviors shared between Filipino parents and children that are related to hygiene, affection and privacy. Methods: Following an exploratory qualitative phase (Phase 1) and an instrumentation phase (Phase 2), the quantitative survey phase (Phase 3) utilized the resultant Filipino Family Behavior Questionnaire (FFBQ). A total of 145 participants from Cabuyao, Laguna and selected urban communities in Metro Manila were comprised of 72 parents and 73 adult children. Results: Parents and adult children view the affection-related behaviors of hugging (magyakapan/ magyapusan) and kissing on the cheeks (humalik sa pisngi) as most acceptable among the list of parent-child intimate behaviors in the FFBQ, and is allowed without any age limit set for children (up to age 18 years). The lowest accepted age-appropriate intimate behaviors were hygiene related, specifically on washing genitalia (median 5 years, range 0,18), co-bathing (3 years, range 0,18), and holding/kissing genitals (0, range 0,17). Generally, adult children accept higher age-limits compared to parent participants. Both groups placed higher age-acceptable limits on mothers compared to fathers. When comparing parent-child pairs, same-gender pairs have significantly higher age-acceptable limits compared to mixed gender pairs. Ranked in order of highest to lowest age-acceptable limits, the most accepted gender pair in performing intimate behavior is mother-daughter; father-son; mother-son; and father-daughter. Perceptions of acceptable age limits were comparable between parents with adverse childhood experiences (ACEs) compared to those without ACE, except for hugging between mother-daughter (17.21 vs 18 years, p=0.04) and father-daughter (17.21 vs 14.22 years, p<0.01) as well as co-dressing of mother-son (3.76 vs 2.19 years, p=0.02).For children, differences in perception were noted only for hugging between mother and son (17.95 vs 15.37 years, p<0.01), and kissing on lips between father and son (5.33 vs 8.94 years, p=0.03). Respondents in Phase 4 believe that mothers are seen as nurturing and caring towards children, thus rendering acceptance of higher age limits for engaging in intimate behavior, specifically for hygiene and privacy. Similar-gender pairs tend to be more at ease with each other, hence the persistence of intimate behavior even at older ages. Conclusion This study was able to identify Filipino intimate behaviors of parents and children including their age-appropriateness. Parents and adult children had similar valuations for healthy boundaries in intimate behavior, as evidenced by the older perceived mean ages for hugging, kissing on the cheek (affection) and co-sleeping (privacy), as well as younger perceived mean ages for hygiene-related intimate behavior such as holding/kissing genitalia, washing genitalia and co-bathing. Parent-child intimate behavior is more acceptable for same-gender pairs, and is least appropriate for older ages in father-daughter pairs. Moreover, adult children appear to be more permissible in exhibiting lower cutoffs for age limits of acceptability compared to parents.
Hygiene ; Affection ; Privacy

In this paper, we reviewed the history of the registration and classification changes of traditional Chinese medicines(TCM) since the establishment of China's drug regulatory agency, and put forward relevant suggestions. Although China's drug regulatory agency has gone through 22 years, the whole regulatory system was gradually built on the basis of the generic pharmaceutical industry at that time and through continuous exploration and summary of simply experience from foreign regulatory agencies. To a certain extent, the supervision of TCM drugs was also affected by some immature supervision ideas during this period. Based on the newly issued Drug Administration Law and Provisions for Drug Registration, the author puts forward some personal thoughts on the classifications of TCM drug registration. It is hoped that experts in the industry and regulatory agencies will work together to explore and improve the relevant system of TCM registration administration.
China ; Drugs, Chinese Herbal ; Legislation, Drug ; Medicine, Chinese Traditional ; Pharmaceutical Preparations

It aimed to present the definition of personal information based on Korean laws that protect personal information and the process of protection of personal information in journal publishing based on the guidelines of the International Committee of Medical Journal Editors and Committee of Publication Ethics. Two Korean laws relate to the protection of personal information in human subject research: the Personal Information Protection Act and the Bioethics and Safety Act. These laws were enacted to prevent the unauthorized use of Koreans’ personal information including medical information. Personal information can be divided into personally identifiable information including resident registration numbers and sensitive information including health information. To protect personal information in journal publishing, institutional review board (IRB) approval and obtaining informed consent from patients is recommended or mandatory in clinical studies. However, retrospective chart reviews may be exempted from IRB approval, while obtaining informed consent is recommended for all case reports. Journal policies may vary with regard to whether a copy of the informed consent form is collected from authors, since the Committee of Publication Ethics guideline does not specifically recommend collecting it. In discussions of adopting clinical data-sharing policies, transfer of data including nonidentifiable personal information to another country is an unresolved issue. Furthermore, a public data repository site should be established in Korea for data to be deposited. To protect subjects’ privacy and to prevent legal issues potentially arising from privacy concerns, editors and publishers should do their best to publish articles with appropriate oversight on subjects’ personal information.
Bioethics ; Computer Security ; Consent Forms ; Ethics ; Ethics Committees, Research ; Humans ; Informed Consent ; Jurisprudence ; Korea ; Personally Identifiable Information ; Privacy ; Publications ; Republic of Korea ; Retrospective Studies

PURPOSE: The importance of human dignity in care is well-recognized. Care recipients' experiences with undignified care have been reported in many countries. However, few studies have measured these situations quantitatively, especially as there are no tools applicable to inpatients receiving ordinary daily care. This study aimed to develop a valid and reliable Inpatient Dignity Scale (IPDS) that can measure inpatients' expectations of and satisfaction with dignity in daily care. METHODS: We conducted a three-phase research project: item generation and a preliminary survey with 47 items related to patients' dignity in Japan, a main survey with 36 items with deliberate translation into English in Singapore, and a confirmatory survey with 35 items in England, with 442, 430, and 500 inpatients as participants in questionnaire surveys, respectively. Data from each survey were processed using factor analysis. RESULTS: Authors obtained a scale with a four-factor structure with acceptable reliability: (F1) respect as a human being, (F2) respect for personal feelings and time, (F3) respect for privacy, and (F4) respect for autonomy. CONCLUSION: The Inpatient Dignity Scale can be periodically used by hospital administrators or nurses to preserve inpatients' dignity in daily care by monitoring inpatients' views regarding their expectations of and satisfaction with dignity.
England ; Great Britain ; Hospital Administrators ; Humans ; Inpatients ; Japan ; Nursing ; Personhood ; Privacy ; Psychometrics ; Singapore

OBJECTIVES: Home-based nursing care services have increased over the past decade. However, accountability and privacy issues as well as security concerns become more challenging during care provider visits. Because of the heterogeneous combination of mobile and stationary assistive medical care devices, conventional systems lack architectural consistency, which leads to inherent time delays and inaccuracies in sharing information. The goal of our study is to develop an architecture that meets the competing goals of accountability and privacy and enhances security in distributed home-based care systems. METHODS: We realized this by using a context-aware approach to manage access to remote data. Our architecture uses a public certification service for individuals, the Japanese Public Key Infrastructure and Health Informatics-PKI to identify and validate the attributes of medical personnel. Both PKI mechanisms are provided by using separate smart cards issued by the government. RESULTS: Context-awareness enables users to have appropriate data access in home-based nursing environments. Our architecture ensures that healthcare providers perform the needed home care services by accessing patient data online and recording transactions. CONCLUSIONS: The proposed method aims to enhance healthcare data access and secure information delivery to preserve user's privacy. We implemented a prototype system and confirmed its feasibility by experimental evaluation. Our research can contribute to reducing patient neglect and wrongful treatment, and thus reduce health insurance costs by ensuring correct insurance claims. Our study can provide a baseline towards building distinctive intelligent treatment options to clinicians and serve as a model for home-based nursing care.
Asian Continental Ancestry Group ; Certification ; Computer Security ; Delivery of Health Care ; Electronic Health Records ; Health Information Exchange ; Health Personnel ; Health Smart Cards ; Home Care Services ; Home Health Nursing ; Humans ; Information Dissemination ; Insurance ; Insurance, Health ; Methods ; Nursing ; Nursing Care ; Privacy ; Social Responsibility

OBJECTIVES: This study analyzed the health technology trends and sentiments of users using Twitter data in an attempt to examine the public's opinions and identify their needs. METHODS: Twitter data related to health technology, from January 2010 to October 2016, were collected. An ontology related to health technology was developed. Frequently occurring keywords were analyzed and visualized with the word cloud technique. The keywords were then reclassified and analyzed using the developed ontology and sentiment dictionary. Python and the R program were used for crawling, natural language processing, and sentiment analysis. RESULTS: In the developed ontology, the keywords are divided into ‘health technology‘ and ‘health information‘. Under health technology, there are are six subcategories, namely, health technology, wearable technology, biotechnology, mobile health, medical technology, and telemedicine. Under health information, there are four subcategories, namely, health information, privacy, clinical informatics, and consumer health informatics. The number of tweets about health technology has consistently increased since 2010; the number of posts in 2014 was double that in 2010, which was about 150 thousand posts. Posts about mHealth accounted for the majority, and the dominant words were ‘care‘, ‘new‘, ‘mental‘, and ‘fitness‘. Sentiment analysis by subcategory showed that most of the posts in nearly all subcategories had a positive tone with a positive score. CONCLUSIONS: Interests in mHealth have risen recently, and consequently, posts about mHealth were the most frequent. Examining social media users' responses to new health technology can be a useful method to understand the trends in rapidly evolving fields.
Biomedical Technology ; Biotechnology ; Boidae ; Data Mining ; Informatics ; Medical Informatics ; Methods ; Natural Language Processing ; Privacy ; Public Opinion ; Social Media ; Telemedicine

OBJECTIVES: We analyzed Korea's data privacy regime in the context of protecting and utilizing health and medical big data and tried to draw policy implications from the analyses. METHODS: We conducted comparative analyses of the legal and regulatory environments governing health and medical big data with a view to drawing policy implications for Korea. The legal and regulatory regimes considered include the following: the European Union, the United Kingdom, France, the United States, and Japan. We reviewed relevant statutory materials as well as various non-statutory materials and guidelines issued by public authorities. Where available, we also examined policy measures implemented by government agencies. RESULTS: In this study, we investigated how various jurisdictions deal with legal and regulatory issues that may arise from the use of health and medical information with regard to the protection of data subjects' rights and the protection of personal information. We compared and analyzed various forms of legislation in various jurisdictions and also considered technical methods, such as de-identification. The main findings include the following: there is a need to streamline the relationship between the general data privacy regime and the regulatory regime governing health and medical big data; the regulatory and institutional structure for data governance should be more clearly delineated; and regulation should encourage the development of suitable methodologies for the de-identification of data and, in doing so, a principle-based and risk-based approach should be taken. CONCLUSIONS: Following our comparative legal analyses, implications were drawn. The main conclusion is that the relationship between the legal requirements imposed for purposes of personal information protection and the regulatory requirements governing the use of health and medical data is complicated and multi-faceted and, as such, their relationship should be more clearly streamlined and delineated.
Computer Security ; European Union ; France ; Government Agencies ; Great Britain ; Humans ; Japan ; Korea ; Privacy ; United States

Recent advances in new technologies such as artificial intelligence, big data, and virtual reality have led to significant innovations in various industries. Artificial intelligence, particularly in applications using deep learning algorithms, has shown performance superior to that of humans in several contexts. Accordingly, many researchers and companies have tried to apply artificial intelligence to the healthcare system, with applications including image interpretation, voice recognition, clinical decision support, risk prediction, drug discovery, medical robotics, and workflow improvement. However, several important technical, ethical, and social barriers must be overcome, such as overfitting, lack of interpretability, privacy, security, and safety. Doctors should be prepared to play a key role in applying artificial intelligence through the full course of development, validation, clinical performance, and monitoring.
Artificial Intelligence ; Decision Support Systems, Clinical ; Delivery of Health Care ; Drug Discovery ; Humans ; Learning ; Machine Learning ; Privacy ; Robotics ; Voice