人肉搜索、蒐集個資 將違法??!!

人肉搜索將成絕響？　未來外洩個人資料恐觸法 優活健康資訊網╱uho新聞中心 2011-10-27   前陣子台大醫院移植愛滋器官事件演的轟轟烈烈。針對此事件，衛生署認為，器官勸募小組醫師應該要負全部的責任，事件中柯文哲醫師雖沒有實際參與勸募過程，但在沒有查詢檢驗報告的情況下，卻授權他人開立檢驗單，不僅沒有盡到醫生該有的職責，甚至連病人的病歷資料恐怕遭到洩漏。根據《護理人員法》第28條規定，醫療機構和醫護人員「因業務持有病人病情或健康資訊，不得無故洩漏」。為了要讓個人資料有更周全的保護，法務部昨日在網站上公布「個人資料保護法施行細則修正案」，除了避免人格權受到侵害，也讓個人資料有合理的利用，因此日後隨意的人肉搜索可能也會觸法。個人資料保護法細則修正重點除了定義個人的醫療、基因、性生活、健康檢查及等資料屬於敏感個資外，關於個人性生活、整形、變性、隆乳等醫療資料，屬於特種個資，也是敏感個資，以上資料都不能擅加蒐集，否則就是犯法。若真的要蒐集某一人的個人資料，原則上應該要有特定目的或是和增進公共利益有關。例如警方基於偵辦需要而蒐集，或是新聞媒體的報導等等，才可以蒐集相關個資。一般人如果要蒐集個人資料，要以書面、電話、傳真、電子文件或其他適當方式，盡告知義務通知對方，才不會有觸法的可能。

避孕藥drospirenone血管栓塞風險增加1.5倍

避孕藥致血栓 國內尚無通報 2011-11-11 中國時報　衛生署食品藥物管理局昨提醒，含「屈螺酮」（drospirenone）成分的避孕藥有升高血管栓塞風險，國內尚無血栓不良反應通報，但提醒使用後要注意是否有胸痛、腹痛、腿痛或呼吸短促等症狀。目前將收集國內外資訊後，評估藥品風險。食品藥物管理局藥品組簡任技正戴雪詠表示，美國食品藥物管理局（ＦＤＡ）流行病學資料顯示，女性服用含「屈螺酮」成分避孕藥，發生血栓靜脈炎風險為其他荷爾蒙避孕藥的一．五倍。國內共核准三張藥品許可證，包括「悅姿錠（Yaz）」、「悅己膜衣錠（Yasmin）」、「安吉麗（Angeliq）」，皆為處方用藥，藥品仿單已刊載可能增加栓塞風險等警語。國內目前有兩件藥品不良反應通報，一件為使用後懷孕，抱怨無效；一件為懷孕時不慎使用流產，尚無血栓通報。　戴雪詠說，現正收集彙整國內外藥品資料，對此類藥品進行整體風險評估，ＦＤＡ也將在十二月八日開會討論。婦產科專科醫師中國醫藥大學附設醫院內湖分院副院長尹長生提醒，若出現頭痛、胸痛、腹痛、腳痛、腿痛等症狀，應立即停藥，找專科醫師檢查。

Taiwan Fertilizer to spin off biotech unit next year

 Riding on the healthcare industry's rapid expansion, Taiwan Fertilizer Co (台灣肥料) is planning to spin off its biotechnology division in the first half of next year to market its own-brand health supplements. The new subsidiary will have capital of NT$100 million (US$3.3 million), a report by the Chinese-language United Evening News said on Thursday. Taiwan Fertilizer ventured into the biotech sector in 2008 and introduced its first range of own-brand health supplements on Tuesday, which went on sale at Watsons, Taiwan's largest cosmetics and drugstore operator. To expand their exposure, the firm plans to sell these supplements through other retail networks such as Carrefour Corp Taiwan (家樂福), Far Eastern Geant Co (愛買量販) and other drug store chains. It is also considering setting up dedicated counters in department stores. Furthermore, the firm has long-term plans to market its products in China and Southeast Asia, the report said. Meanwhile, Taiwan Salt Co (台鹽) last month said it was in talks with a Japanese beauty care and drugstore operator to establish retail outlets in China selling its branded healthcare products. The company — which has made multiple forays into the biotech sector by producing detergents, cosmetics and health supplements in recent years — currently has three sales outlets in China, with the potential partnership helping to increase its presence in the Chinese market.

Sinovac Biotech reports positive phase 2 results for EV71 vaccine, prepares for phase 3

 Sinovac Biotech (NASDAQ:SVA) posted Wednesday preliminary phase two trial results for EV71, the biopharmaceutical company's hand, foot and mouth disease vaccine, which elicited a positive immune response and showed a favourable safety profile. According to results, the EV71 vaccine showed "good immunogenicity" and a favourable safety profile, with no vaccine-related serious adverse events. In the phase two trial, about 540 subjects, comprised of infants from six months to thirty-five months old, were enrolled in the placebo-controlled study. Results have provided reference data for a phase three clinical trial, including a vaccination schedule and proper dosage levels. The phase three trial will evaluate the efficacy of protection against hand, foot and mouth disease and will be designed as a multi-centre, randomized and controlled study. Sinovac said it expects to initiate the trial in the coming months and aims to finish the study in one year. "The positive phase two results are a significant milestone in the development of our EV71 vaccine to address a significant unmet medical need in that area," chief executive Weidong Yi said in a statement. "We have started the preparation work for the phase three clinical trial, including determining the phase three clinical trial proposal, selecting the clinical sites and preparing for the vaccines to be used." Hand-foot-and-mouth disease is a mild and contagious viral infection. It is characterized by sores in the mouth and a rash on the hands and feet. More than 90 percent of reported cases of hand, foot and mouth disease occur in children under five, the company said in a statement. Since 1997, the number of reported cases associated with severe neurological symptoms caused by EV71, as well as deaths, has risen across the Asia-Pacific region. Outbreaks have been seen in Vietnam, Malaysia, Taiwan, mainland China, Australia and Singapore. According to the Chinese Ministry of Health's data available for the period from January 1 to September 30, 2011, the disease caused 399 deaths in China and roughly 1.2 million were infected in a nine-month period, as reported by health authorities. In August of 2011, over 32,000 infectious cases were reported in Vietnam with 81 deaths. Currently, there are no specific treatments or vaccines available. In addition, the company said it is working on setting up a manufacturing site for its EV71 vaccine and aims to finish construction and good manufacturing practices certification in 2013. The Beijing, China-based company's shares rose four cents, or 1.70 percent, reaching $2.39 Wednesday on the Nasdaq.

台灣醫材產業銷售額928億元 (Year 2010)

蔡清彥：醫材列入重點產業【2011/11/10 經濟日報】工研院董事長蔡清彥昨（9）日表示，工研院研發能量、跨領域的技術優勢，以及與國際合作的經驗；在兩岸經濟協議（ECFA）簽訂簽後，積極展開「LED照明及冷鏈物流技術的試點計畫」等，台灣已成為中國大陸與日本之間「新黃金三角」的重要樞紐與角色；而醫療電子與器材將是接下來要全力發展的重點產業。 經濟部工業局表示，全球人口高齡化趨勢，促使醫療器材與醫療照護服務的需求與日俱增，根據英國市調公司Espicom研究指出，2010年全球醫材市場規模已達2,456億美元（約新台幣7.3兆元），並以年複合成長率7.3%持續增加。 隨著美國與大陸相繼推出高達9,400億美元（約新台幣28.2兆元）與人民幣8,500億元（約新台幣4兆元）的醫療改革方案，加上印度、中南美洲等地需求日益增加，估計未來市場主要的成長動能，將與新興市場醫療政策所驅動的醫療建設密切相關。 受惠於景氣復甦與國內銷售增加，2010年我國醫材產業銷售額達928億元，較2009年成長12.5%，並成為我國生技產業營業額的最大領域、占40%。目前約有580家廠商投入，隨著產業高值化，陸續有重量級的電子廠商投入醫療器材領域，將是未來市場成長主力。 蔡清彥指出，近年行政院推動「台灣生技起飛鑽石行動方案」，也有重大進展。海外生技諮詢委員蘇懷仁已回台參與建立台灣生技超級育成中心（SIC），政府並進一步延攬旅美生技專家張有德領軍、已獲得國發基金投資的TMF創投基金（Taiwan Medtech Fund），預估將可帶動更多資金流入生技醫材產業。蔡清彥強調，面對國際多變的經濟情勢，全球市場版圖也在劇烈轉變。當國際目光由歐美市場轉移到新興區域時，也意味著其中有許多新興商機。