醫療人工智能政策法律分析及對策研究
文章(zhang)來源:中(zhong)國數字(zi)醫學
18/02
2022
國外相關政策及法律 歐盟 在醫(yi)(yi)療(liao)(liao)(liao)人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)隱私(si)保(bao)護(hu)方(fang)面(mian),歐(ou)(ou)盟(meng)(meng)2016年(nian)4月通(tong)(tong)過《一般數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)保(bao)護(hu)條例(li)》取(qu)代(dai)1995年(nian)《歐(ou)(ou)盟(meng)(meng)數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)保(bao)護(hu)指令》,規(gui)(gui)定了數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)的(de)合(he)法性(xing)要求、個人(ren)(ren)(ren)(ren)特殊(shu)數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)的(de)處理(li)(li)方(fang)式、數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)主體(ti)(ti)的(de)訪問(wen)權(quan)(quan)、數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)糾正(zheng)權(quan)(quan)、數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)遷(qian)移權(quan)(quan)、數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)刪除權(quan)(quan)、數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)泄露通(tong)(tong)知義務等(deng),可(ke)規(gui)(gui)范(fan)醫(yi)(yi)療(liao)(liao)(liao)人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)的(de)數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)隱私(si)保(bao)護(hu)。2017年(nian)2月歐(ou)(ou)盟(meng)(meng)通(tong)(tong)過《歐(ou)(ou)盟(meng)(meng)機(ji)(ji)器(qi)(qi)(qi)人(ren)(ren)(ren)(ren)民事法律規(gui)(gui)則(ze)(ze)(ze)》,提(ti)(ti)(ti)出(chu)人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)必須符合(he)隱私(si)和數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)保(bao)護(hu)規(gui)(gui)則(ze)(ze)(ze),確(que)保(bao)數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)獲取(qu)、數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)流(liu)(liu)通(tong)(tong)、數(shu)(shu)(shu)(shu)據(ju)(ju)(ju)使用的(de)合(he)法性(xing)。在醫(yi)(yi)療(liao)(liao)(liao)人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)產品應(ying)用方(fang)面(mian),2014年(nian)歐(ou)(ou)盟(meng)(meng)發(fa)(fa)布(bu)《2014—2020歐(ou)(ou)洲機(ji)(ji)器(qi)(qi)(qi)人(ren)(ren)(ren)(ren)技(ji)術(shu)戰(zhan)略研(yan)究計劃》《歐(ou)(ou)盟(meng)(meng)機(ji)(ji)器(qi)(qi)(qi)人(ren)(ren)(ren)(ren)研(yan)發(fa)(fa)計劃》,重(zhong)點關注(zhu)醫(yi)(yi)療(liao)(liao)(liao)機(ji)(ji)器(qi)(qi)(qi)人(ren)(ren)(ren)(ren)發(fa)(fa)展(zhan),包括利(li)用微(wei)型機(ji)(ji)器(qi)(qi)(qi)人(ren)(ren)(ren)(ren)進(jin)行外科手術(shu)和急救,利(li)用康復機(ji)(ji)器(qi)(qi)(qi)人(ren)(ren)(ren)(ren)輔助治療(liao)(liao)(liao)等(deng)。2018年(nian)3月歐(ou)(ou)洲政(zheng)治戰(zhan)略中心發(fa)(fa)布(bu)《人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)時代(dai):確(que)立(li)以(yi)人(ren)(ren)(ren)(ren)為(wei)本的(de)歐(ou)(ou)洲戰(zhan)略》,提(ti)(ti)(ti)出(chu)將(jiang)人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)技(ji)術(shu)應(ying)用于精準(zhun)(zhun)(zhun)醫(yi)(yi)療(liao)(liao)(liao)服務以(yi)及健(jian)康監(jian)(jian)測與(yu)管理(li)(li)。歐(ou)(ou)盟(meng)(meng)2017版《醫(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)(qi)械條例(li)》新增(zeng)了醫(yi)(yi)療(liao)(liao)(liao)人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)產品準(zhun)(zhun)(zhun)入標(biao)準(zhun)(zhun)(zhun),符合(he)標(biao)準(zhun)(zhun)(zhun)的(de)產品可(ke)申請(qing)CE認證,在歐(ou)(ou)洲市(shi)場自由流(liu)(liu)通(tong)(tong)。在醫(yi)(yi)療(liao)(liao)(liao)人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)倫(lun)理(li)(li)道德方(fang)面(mian),2017年(nian)《歐(ou)(ou)盟(meng)(meng)機(ji)(ji)器(qi)(qi)(qi)人(ren)(ren)(ren)(ren)民事法律規(gui)(gui)則(ze)(ze)(ze)》建議成立(li)專(zhuan)門的(de)人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)監(jian)(jian)管機(ji)(ji)構,提(ti)(ti)(ti)出(chu)人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)技(ji)術(shu)使用的(de)權(quan)(quan)責規(gui)(gui)范(fan)、倫(lun)理(li)(li)原則(ze)(ze)(ze)、監(jian)(jian)管原則(ze)(ze)(ze)等(deng)。2018年(nian)4月歐(ou)(ou)盟(meng)(meng)委員會(hui)發(fa)(fa)布(bu)《歐(ou)(ou)洲人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)》報告,提(ti)(ti)(ti)出(chu)制(zhi)定人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)道德準(zhun)(zhun)(zhun)則(ze)(ze)(ze)與(yu)法律體(ti)(ti)系(xi)。2019年(nian)4月歐(ou)(ou)盟(meng)(meng)《可(ke)信賴(lai)的(de)人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)道德準(zhun)(zhun)(zhun)則(ze)(ze)(ze)》提(ti)(ti)(ti)出(chu)在人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)倫(lun)理(li)(li)方(fang)面(mian)制(zhi)定相應(ying)的(de)準(zhun)(zhun)(zhun)入政(zheng)策,提(ti)(ti)(ti)升公眾對(dui)人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)的(de)信任。在醫(yi)(yi)療(liao)(liao)(liao)人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)人(ren)(ren)(ren)(ren)才培(pei)養(yang)方(fang)面(mian),2018年(nian)《歐(ou)(ou)洲人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)》提(ti)(ti)(ti)出(chu)促進(jin)教育和培(pei)訓體(ti)(ti)系(xi)改革,增(zeng)強對(dui)人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)行業的(de)適應(ying)力。2018年(nian)《人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)時代(dai):確(que)立(li)以(yi)人(ren)(ren)(ren)(ren)為(wei)本的(de)歐(ou)(ou)洲戰(zhan)略》提(ti)(ti)(ti)出(chu)歐(ou)(ou)洲面(mian)臨人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)人(ren)(ren)(ren)(ren)才的(de)嚴重(zhong)短缺,需(xu)增(zeng)強人(ren)(ren)(ren)(ren)工(gong)智能(neng)(neng)(neng)(neng)(neng)(neng)(neng)技(ji)能(neng)(neng)(neng)(neng)(neng)(neng)(neng)培(pei)訓。 英國 在醫(yi)療(liao)(liao)人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)隱(yin)私(si)保護(hu)方(fang)面,2016年(nian)(nian)11月《人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng):未來(lai)決策(ce)(ce)的(de)機(ji)會(hui)與(yu)影響》和(he)2017年(nian)(nian)10月《在英(ying)國發(fa)(fa)展(zhan)(zhan)人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)》對數(shu)據合理獲取、個人(ren)(ren)(ren)(ren)隱(yin)私(si)保護(hu)等提(ti)(ti)出(chu)(chu)明確(que)要求。在醫(yi)療(liao)(liao)人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)產品應(ying)(ying)用方(fang)面,2016年(nian)(nian)《人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng):未來(lai)決策(ce)(ce)的(de)機(ji)會(hui)與(yu)影響》提(ti)(ti)出(chu)(chu)利(li)用人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)進行健康服務需求預測和(he)精準醫(yi)療(liao)(liao)服務。2017年(nian)(nian)《在英(ying)國發(fa)(fa)展(zhan)(zhan)人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)》報告指出(chu)(chu)醫(yi)療(liao)(liao)人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)行業(ye)最具有(you)潛力的(de)3個發(fa)(fa)展(zhan)(zhan)方(fang)向:醫(yi)療(liao)(liao)影像(xiang)分析、醫(yi)療(liao)(liao)輔(fu)助診斷(duan)和(he)流行病的(de)早期發(fa)(fa)現與(yu)追蹤(zong)。在醫(yi)療(liao)(liao)人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)倫(lun)理道(dao)德方(fang)面,2016年(nian)(nian)10月《機(ji)器(qi)人(ren)(ren)(ren)(ren)技術和(he)人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)》提(ti)(ti)出(chu)(chu)人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)可能(neng)(neng)(neng)引發(fa)(fa)的(de)道(dao)德與(yu)法(fa)律問(wen)題,倡導成立專門的(de)監管機(ji)構,以應(ying)(ying)對倫(lun)理道(dao)德與(yu)監管挑戰。在醫(yi)療(liao)(liao)人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)人(ren)(ren)(ren)(ren)才培養方(fang)面,2017年(nian)(nian)《在英(ying)國發(fa)(fa)展(zhan)(zhan)人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)》提(ti)(ti)出(chu)(chu)英(ying)國每年(nian)(nian)資助部分學(xue)生攻讀人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)碩士學(xue)位(wei),增設博士學(xue)位(wei),開(kai)設人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)相關課程,并(bing)重視(shi)人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)人(ren)(ren)(ren)(ren)才的(de)國際引進。2018年(nian)(nian)4月發(fa)(fa)布《人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)行業(ye)新政》提(ti)(ti)出(chu)(chu)增加(jia)教育投資,開(kai)展(zhan)(zhan)轉換課程促進人(ren)(ren)(ren)(ren)才轉型,更(geng)改移民(min)政策(ce)(ce)吸引國際人(ren)(ren)(ren)(ren)工(gong)(gong)(gong)智(zhi)(zhi)(zhi)能(neng)(neng)(neng)人(ren)(ren)(ren)(ren)才。 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