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題名:精準醫學趨勢下基因檢驗與消費者保護法律問題
書刊名:月旦醫事法報告
作者:何建志
作者(外文):Ho, Jen-ji
出版日期:2018
卷期:25
頁次:頁32-59
主題關鍵詞:消費者保護基因檢驗精準醫學醫事檢驗師法體外診斷醫療器材Consumer protectionGenetic testingPrecision medicineMedical Technologists ActIn vitro diagnostic device
原始連結:連回原系統網址new window
相關次數:
  • 被引用次數被引用次數:期刊(0) 博士論文(0) 專書(0) 專書論文(0)
  • 排除自我引用排除自我引用:0
  • 共同引用共同引用:21
  • 點閱點閱:1
期刊論文
1.Torga, Gonzalo、Pienta, Kenneth J.(2018)。Patient-Paired Sample Congruence Between 2 Commercial Liquid Biopsy Tests。JAMA Oncology,4,868-870。  new window
2.何建志(20080100)。藥物基因體學之政策與法律議題分析。法律與生命科學,4,1-17。new window  延伸查詢new window
3.何建志(20160900)。精準醫學趨勢下醫藥產業及醫事人員法律責任與政策議題:風險利益分析觀點。法律與生命科學,5(2),11-35。new window  延伸查詢new window
4.Tandy-Connor, Stephany、Guiltinan, Jenna、Krempely, Kate、LaDuca, Holly、Reineke, Patrick、Gutierrez, Stephanie、Gray, Phillip、Davis, Brigette T.(2018)。False-Positive Results Released by Direct-to-Consumer Genetic Tests Highlight the Importance of Clinical Confirmation Testing for Appropriate Patient Care。Genetics in Medcine,20(12),1515-1521。  new window
5.Borry, Pascal、Van Hellemondt, Rachel E.、Sprumont, Dominique、Jales, Camilla F. D.、Rial-Sebbag, Emmanuelle、Spranger, Tade M.、Curren, Liam、Kaye, Jane、Nys, Herman、Howard, Heidi(2012)。Legislation on Direct-to-Consumer Genetic Testing in Seven European Countries。European Journal of Human Genetics,20(7),715-721。  new window
6.Kalokairinou, L.(2018)。Legislation of Direct-to-Consumer Genetic Testing in Europe: A Fragmented Regulatory Landscape。Journal of Community Genetics,9。  new window
7.周晨蕙(20180200)。日本基因醫療法制策略初探。科技法律透析,30(2),43-53。  延伸查詢new window
8.王美仁、林秀娟(20091000)。草擬臺灣基因檢測倫理指導綱領。法律與生命科學,3(4),1-21。new window  延伸查詢new window
圖書
1.何建志(2003)。基因歧視與法律對策之研究。台北:元照。new window  延伸查詢new window
2.何建志(2016)。醫療法律與醫學倫理。元照出版有限公司。  延伸查詢new window
單篇論文
1.Food and Drug Administration(2015)。The Public Health Evidence for FDA Oversight Of Laboratory Developed Tests: 20 Case Studies,http://www.nila-usa.org/images/nila/The%20Public%20Health%20Case%20for%20FDA%20Oversight%20of%20LDTs%20110915(2)_508ed%20(1).pdf。  new window
其他
1.Jolie, Angelina(20130514)。My Medical Choice,http://www.nytimes.com/2013/05/14/opinion/my-medical-choice.html, 。  new window
2.The Secretary's Advisory Committee on Genetics, Health, and Society(2008)。U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services,https://osp.od.nih.gov/wp-content/uploads/2013/11/SACGHS_oversight_report.pdf。  new window
3.Lister Hill National Center for Biomedical Communications,U.S. National Library of Medicine,National Institutes of Health & Department of Health & Human Services(2016)。Precision Medicine,https://ghr.nlm.nih.gov/primer/precisionmedicine/definition。  new window
4.Pitt, Angelina Jolie(20150324)。Diary of a Surgery。  new window
5.陳雨鑫(20160731)。裘莉效應 50歲醫師娘切掉卵巢。  延伸查詢new window
6.高珮莙(20160817)。中青報調查「高科技」基因檢測騙局:一老人被騙30萬後投河,https://www.thepaper.cn/newsDetail_forward_1515291。  延伸查詢new window
7.Center for Biologies Evaluation and Research, Food and Drug Administration。Draft Guidance: Framework for Regulatory Oversight of Laboratory Developed Tests,https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm416685.pdf。  new window
8.FDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Certain Conditions,https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm551185.htm。  new window
圖書論文
1.何建志、陳李魁(2014)。基因檢驗品質法律問題與管理制度檢討。科際整合法學研究:以生醫法及工程法為中心。元照。  延伸查詢new window
 
 
 
 
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