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International health regulation

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https://www.readbyqxmd.com/read/28095468/evaluating-hospital-based-surveillance-for-outbreak-detection-in-bangladesh-analysis-of-healthcare-utilization-data
#1
Birgit Nikolay, Henrik Salje, Katharine Sturm-Ramirez, Eduardo Azziz-Baumgartner, Nusrat Homaira, Makhdum Ahmed, A Danielle Iuliano, Repon C Paul, Mahmudur Rahman, M Jahangir Hossain, Stephen P Luby, Simon Cauchemez, Emily S Gurley
BACKGROUND: The International Health Regulations outline core requirements to ensure the detection of public health threats of international concern. Assessing the capacity of surveillance systems to detect these threats is crucial for evaluating a country's ability to meet these requirements. METHODS AND FINDINGS: We propose a framework to evaluate the sensitivity and representativeness of hospital-based surveillance and apply it to severe neurological infectious diseases and fatal respiratory infectious diseases in Bangladesh...
January 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28095290/study-of-the-microbiological-quality-of-bulgarian-bottled-water-in-terms-of-its-contamination-with-pseudomonas-aeruginosa
#2
Vesela Georgieva, Yulia Dimitrova
BACKGROUND: Due to the widespread use of bottled water, it is important from a hygienic point of view to ensure that these products have good quality and meet the requirements set out in regulations. METHODS: In the period 2000-2013, a large-scale study (2,500 samples) was carried out on the quality of Bulgarian bottled water as per the microbiological parameters laid down in the European and Bulgarian legislation. Standard microbiological methods were applied. RESULTS: There is strong evidence that the most frequently isolated contaminant in these products was Pseudomonas aeruginosa...
December 2016: Central European Journal of Public Health
https://www.readbyqxmd.com/read/28088583/environmental-carcinogenesis-and-ph-homeostasis-not-only-a-matter-of-dysregulated-metabolism
#3
REVIEW
Kévin Hardonnière, Laurence Huc, Odile Sergent, Jørn A Holme, Dominique Lagadic-Gossmann
According to the World Health Organization, around 20% of all cancers would be due to environmental factors. Among these factors, several chemicals are indeed well recognized carcinogens. The widespread contaminant benzo[a]pyrene (B[a]P), an often used model carcinogen of the polycyclic aromatic hydrocarbons' family, has been suggested to target most, if not all, cancer hallmarks described by Hanahan and Weinberg. It is classified as a group I carcinogen by the International Agency for Research on Cancer; however, the precise intracellular mechanisms underlying its carcinogenic properties remain yet to be thoroughly defined...
January 11, 2017: Seminars in Cancer Biology
https://www.readbyqxmd.com/read/28080966/active-interoceptive-inference-and-the-emotional-brain
#4
REVIEW
Anil K Seth, Karl J Friston
We review a recent shift in conceptions of interoception and its relationship to hierarchical inference in the brain. The notion of interoceptive inference means that bodily states are regulated by autonomic reflexes that are enslaved by descending predictions from deep generative models of our internal and external milieu. This re-conceptualization illuminates several issues in cognitive and clinical neuroscience with implications for experiences of selfhood and emotion. We first contextualize interoception in terms of active (Bayesian) inference in the brain, highlighting its enactivist (embodied) aspects...
November 19, 2016: Philosophical Transactions of the Royal Society of London. Series B, Biological Sciences
https://www.readbyqxmd.com/read/28077911/a-decade-of-data-protection-for-innovative-drugs-in-canada-issues-limitations-and-time-for-a-reassessment
#5
Megan Kendall, Declan Hamill
Drug regulators in Canada and in other nations require innovative pharmaceutical companies to submit undisclosed clinical or other data as a condition of approving the marketing of new pharmaceutical products-the origination of which involves considerable effort and investment. Data protection regulations were enacted in Canada in 2006, which-to some extent-closed a loophole in intellectual property law that had previously left innovative companies with no effective data protection for their clinical data. Although the regulations were intended to clarify and effectively implement Canada's international treaty obligations in the spirit of innovation, a review of Canada's first decade of effective data protection shows that Health Canada and Canadian courts have interpreted the scope of data protection for innovative drugs in a narrow manner that undermines and is inconsistent with the intent of the regulations...
December 1, 2016: Biotechnology Law Report
https://www.readbyqxmd.com/read/28074269/varied-exposure-to-carcinogenic-mutagenic-and-reprotoxic-cmr-chemicals-in-occupational-settings-in-france
#6
Nathalie Havet, Alexis Penot, Magali Morelle, Lionel Perrier, Barbara Charbotel, Béatrice Fervers
PURPOSE: To explore varied exposure to carcinogenic, mutagenic, and reprotoxic chemicals (CMR) for French employees. METHODS: Our study assessed data from the French national cross-sectional survey of occupational risks (SUMER) that was conducted in 2010 in a national representative sample of employees. We selected 28 CMR agents that were classified by the International Agency for Research on Cancer or European Union as being known or presumed to have CMR potential in humans...
January 10, 2017: International Archives of Occupational and Environmental Health
https://www.readbyqxmd.com/read/28073749/cost-effectiveness-of-a-government-supported-policy-strategy-to-decrease-sodium-intake-global-analysis-across-183-nations
#7
Michael Webb, Saman Fahimi, Gitanjali M Singh, Shahab Khatibzadeh, Renata Micha, John Powles, Dariush Mozaffarian
OBJECTIVE:  To quantify the cost effectiveness of a government policy combining targeted industry agreements and public education to reduce sodium intake in 183 countries worldwide. DESIGN:  Global modeling study. SETTING:  183 countries. POPULATION:  Full adult population in each country. INTERVENTION:  A "soft regulation" national policy that combines targeted industry agreements, government monitoring, and public education to reduce population sodium intake, modeled on the recent successful UK program...
January 10, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28069306/nitrated-polycyclic-aromatic-hydrocarbons-nitro-pahs-in-the-environment-a-review
#8
REVIEW
Benjamin A Musa Bandowe, Hannah Meusel
Nitrated polycyclic aromatic hydrocarbons (nitro-PAHs) are derivatives of PAHs with at least one nitro-functional group (-NO2) on the aromatic ring. The toxic effects of several nitro-PAHs are more pronounced than those of PAHs. Some nitro-PAHs are classified as possible or probable human carcinogens by the International Agency for Research on Cancer. Nitro-PAHs are released into the environment from combustion of carbonaceous materials (e.g. fossil fuels, biomass, waste) and post-emission transformation of PAHs...
January 6, 2017: Science of the Total Environment
https://www.readbyqxmd.com/read/28067194/mapping-actions-to-improve-access-to-medicines-for-mental-disorders-in-low-and-middle-income-countries
#9
C Barbui, T Dua, K Kolappa, B Saraceno, S Saxena
AIMS: In recent years a number of intergovernmental initiatives have been activated in order to enhance the capacity of countries to improve access to essential medicines, particularly for mental disorders. In May 2013 the 66th World Health Assembly adopted the World Health Organization (WHO) Comprehensive Mental Health Action Plan 2013-2020, which builds upon the work of WHO's Mental Health Gap Action Programme. Within this programme, evidence-based guidelines for mental disorders were developed, including recommendations on appropriate use of medicines...
January 9, 2017: Epidemiology and Psychiatric Sciences
https://www.readbyqxmd.com/read/28065902/princess-privacy-protecting-rare-disease-international-network-collaboration-via-encryption-through-software-guard-extensions
#10
Feng Chen, Shuang Wang, Xiaoqian Jiang, Sijie Ding, Yao Lu, Jihoon Kim, S Cenk Sahinalp, Chisato Shimizu, Jane C Burns, Victoria J Wright, Eileen Png, Martin L Hibberd, David D Lloyd, Hai Yang, Amalio Telenti, Cinnamon S Bloss, Dov Fox, Kristin Lauter, Lucila Ohno-Machado
MOTIVATION: We introduce PRINCESS, a privacy-preserving international collaboration framework for analyzing rare disease genetic data that are distributed across different continents. PRINCESS leverages Software Guard Extensions (SGX) and hardware for trustworthy computation. Unlike a traditional international collaboration model, where individual-level patient DNA are physically centralized at a single site, PRINCESS performs a secure and distributed computation over encrypted data, fulfilling institutional policies and regulations for protected health information...
January 8, 2017: Bioinformatics
https://www.readbyqxmd.com/read/28059698/uk-national-data-guardian-for-health-and-care-s-review-of-data-security-trust-better-security-and-opt-outs
#11
Tom Chan, Concetta Tania Di Iorio, Simon De Lusignan, Daniel Lo Russo, Craig Kuziemsky, Siaw-Teng Liaw
Sharing health and social care data is essential to the delivery of high quality health care as well as disease surveillance, public health, and for conducting research. However, these societal benefits may be constrained by privacy and data protection principles. Hence, societies are striving to find a balance between the two competing public interests. Whilst the spread of IT advancements in recent decades has increased the demand for an increased privacy and data protection in many ways health is a special case...
December 20, 2016: Journal of Innovation in Health Informatics
https://www.readbyqxmd.com/read/28059693/tightrope-walking-towards-maximising-secondary-uses-of-digitised-health-data-a-qualitative-study
#12
Ann R R Robertson, Pam Smith, Harpreet S Sood, Kathrin Cresswell, Ulugbek Nurmatov Nurmatov, Aziz Sheikh
BACKGROUND: Timely progress with attaining benefits from Health Information Technology (HIT) investments requires UK policymakers and others to negotiate challenges in developing structures and processes to catalyse the trustworthy secondary uses of HIT-derived data. AIMS: We aimed to uncover expert insights into perceived barriers and facilitators for maximising safe and secure secondary uses of HIT-derived data in the UK. METHODS: We purposively selected individuals from a range of disciplines in the UK and abroad to participate in a thematically analysed, semi-structured interview study...
October 12, 2016: Journal of Innovation in Health Informatics
https://www.readbyqxmd.com/read/28053363/global-research-priorities-for-interpersonal-violence-prevention-a-modified-delphi-study
#13
Christopher R Mikton, Masako Tanaka, Mark Tomlinson, David L Streiner, Lil Tonmyr, Bandy X Lee, Jane Fisher, Kathy Hegadoren, Joam Evans Pim, Shr-Jie Sharlenna Wang, Harriet L MacMillan
OBJECTIVE: To establish global research priorities for interpersonal violence prevention using a systematic approach. METHODS: Research priorities were identified in a three-round process involving two surveys. In round 1, 95 global experts in violence prevention proposed research questions to be ranked in round 2. Questions were collated and organized according to the four-step public health approach to violence prevention. In round 2, 280 international experts ranked the importance of research in the four steps, and the various substeps, of the public health approach...
January 1, 2017: Bulletin of the World Health Organization
https://www.readbyqxmd.com/read/28053360/countries-response-to-who-s-travel-recommendations-during-the-2013-2016-ebola-outbreak
#14
Wendy Rhymer, Rick Speare
OBJECTIVE: To determine how, during the 2013-2016 Ebola outbreak in western Africa, States Parties to the World Health Organization's (WHO) 2005 International Health Regulations (IHR) followed the IHR's international travel recommendations. METHODS: In 2015, we used the Google search engine to investigate the 196 States Parties to the 2005 IHR. Information detailing Ebola-related travel regulations or restrictions of each State Party was sourced first from official government websites and then from travel and news websites...
January 1, 2017: Bulletin of the World Health Organization
https://www.readbyqxmd.com/read/28048780/tu-ab-204-00-cdrh-fda-regulatory-processes-and-device-science-activities
#15
Anita Nosratieh
: The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28048121/tu-ab-204-01-device-approval-process
#16
J Delfino
: The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28048009/tu-ab-204-03-research-activities-in-medical-physics
#17
A Badano
: The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28047465/tu-ab-204-02-device-adverse-events-and-compliance
#18
S Gonzales
: The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28047346/tu-ab-204-04-partnerships
#19
R Ochs
: The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28043088/fulvestrant-for-hormone-sensitive-metastatic-breast-cancer
#20
REVIEW
Clara I Lee, Annabel Goodwin, Nicholas Wilcken
BACKGROUND: Fulvestrant is a selective oestrogen receptor down-regulator (SERD), which by blocking proliferation of breast cancer cells, is an effective endocrine treatment for women with hormone-sensitive advanced breast cancer. The goal of such systemic therapy in this setting is to reduce symptoms, improve quality of life, and increase survival time. OBJECTIVES: To assess the efficacy and safety of fulvestrant for hormone-sensitive locally advanced or metastatic breast cancer in postmenopausal women, as compared to other standard endocrine agents...
January 3, 2017: Cochrane Database of Systematic Reviews
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