This paper gives a brief introduction on the development of recognized consensus standards, the recognition working procedure and the overview of medical devices recognized consensus standards in USA, and analyzes the experience of the recognition management system in USA, aiming at providing a reference for the improvement of the medical device standard management system in China.
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http://dx.doi.org/10.3969/j.issn.1671-7104.2018.02.011 | DOI Listing |
Obstet Gynecol
January 2025
Department of Obstetrics, Gynecology and Reproductive Science, University of California, San Diego, San Diego, California; and the Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai Health System & Icahn School of Medicine at Mount Sinai, New York, and the Department of Obstetrics, Gynecology and Reproductive Science, New York City Health and Hospitals - Elmhurst Hospital Center, Elmhurst, New York.
Although peak serum total bile acid (TBA) levels guide management of intrahepatic cholestasis of pregnancy (ICP), whether ICP progresses in severity and when or how to assess bile acid levels serially remains unclear. We conducted a secondary analysis of a single-institution retrospective cohort study to assess bile acid trends across pregnancy among individuals diagnosed with ICP and to evaluate whether there was progression to higher ICP severity. We defined ICP severity as mild (peak TBA less than 40 micromol/L), moderate (peak TBA between 40 and 100 micromol/L), or severe (peak TBA 100 micromol/L or greater).
View Article and Find Full Text PDFJMIR Hum Factors
January 2025
Women's Health Research Institute, Vancouver, BC, Canada.
Background: Digital health innovations provide an opportunity to improve access to care, information, and quality of care during the perinatal period, a critical period of health for mothers and infants. However, research to develop perinatal digital health solutions needs to be informed by actual patient and health system needs in order to optimize implementation, adoption, and sustainability.
Objective: Our aim was to co-design a research agenda with defined research priorities that reflected health system realities and patient needs.
J Med Internet Res
January 2025
Department High-Tech Business and Entrepreneurship Section, Industrial Engineering and Business Information Systems, University of Twente, Enschede, Overijssel, Netherlands.
Health recommender systems (HRS) have the capability to improve human-centered care and prevention by personalizing content, such as health interventions or health information. HRS, an emerging and developing field, can play a unique role in the digital health field as they can offer relevant recommendations, not only based on what users themselves prefer and may be receptive to, but also using data about wider spheres of influence over human behavior, including peers, families, communities, and societies. We identify and discuss how HRS could play a unique role in decreasing health inequities.
View Article and Find Full Text PDFJMIR Res Protoc
January 2025
Institute for Health Care Management and Research, University of Duisburg-Essen, Essen, Germany.
Background: Artificial intelligence (AI)-based clinical decision support systems (CDSS) have been developed for several diseases. However, despite the potential to improve the quality of care and thereby positively impact patient-relevant outcomes, the majority of AI-based CDSS have not been adopted in standard care. Possible reasons for this include barriers in the implementation and a nonuser-oriented development approach, resulting in reduced user acceptance.
View Article and Find Full Text PDFJ Med Internet Res
January 2025
School of Clinical Sciences, Monash University, Melbourne, Australia.
Background: eHealth interventions can favorably impact health outcomes and encourage health-promoting behaviors in children. More insight is needed from the perspective of children and their families regarding eHealth interventions, including features influencing program effectiveness.
Objective: This review aimed to explore families' experiences with family-focused web-based interventions for improving health.
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