醫療人工智能政策法律分析及對策研究
文章來源(yuan):中國數字(zi)醫學(xue)
18/02
2022
國外相關政策及法律 歐盟 在(zai)(zai)(zai)醫(yi)(yi)療(liao)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)隱(yin)私(si)(si)保(bao)(bao)護(hu)(hu)方(fang)面(mian)(mian),歐(ou)(ou)(ou)盟(meng)2016年(nian)(nian)(nian)4月(yue)(yue)通過(guo)《一(yi)般數(shu)(shu)據(ju)(ju)(ju)(ju)保(bao)(bao)護(hu)(hu)條例(li)(li)》取(qu)代1995年(nian)(nian)(nian)《歐(ou)(ou)(ou)盟(meng)數(shu)(shu)據(ju)(ju)(ju)(ju)保(bao)(bao)護(hu)(hu)指(zhi)令》,規(gui)(gui)定了數(shu)(shu)據(ju)(ju)(ju)(ju)的(de)(de)(de)(de)(de)合(he)法(fa)性(xing)要求、個(ge)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)特殊(shu)數(shu)(shu)據(ju)(ju)(ju)(ju)的(de)(de)(de)(de)(de)處理(li)方(fang)式、數(shu)(shu)據(ju)(ju)(ju)(ju)主體(ti)的(de)(de)(de)(de)(de)訪問權(quan)、數(shu)(shu)據(ju)(ju)(ju)(ju)糾正權(quan)、數(shu)(shu)據(ju)(ju)(ju)(ju)遷移(yi)權(quan)、數(shu)(shu)據(ju)(ju)(ju)(ju)刪除(chu)權(quan)、數(shu)(shu)據(ju)(ju)(ju)(ju)泄(xie)露(lu)通知義務(wu)等,可規(gui)(gui)范醫(yi)(yi)療(liao)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)的(de)(de)(de)(de)(de)數(shu)(shu)據(ju)(ju)(ju)(ju)隱(yin)私(si)(si)保(bao)(bao)護(hu)(hu)。2017年(nian)(nian)(nian)2月(yue)(yue)歐(ou)(ou)(ou)盟(meng)通過(guo)《歐(ou)(ou)(ou)盟(meng)機(ji)(ji)(ji)器人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)民(min)(min)事法(fa)律規(gui)(gui)則(ze)》,提(ti)(ti)(ti)(ti)(ti)出(chu)(chu)(chu)(chu)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)必須符合(he)隱(yin)私(si)(si)和(he)(he)數(shu)(shu)據(ju)(ju)(ju)(ju)保(bao)(bao)護(hu)(hu)規(gui)(gui)則(ze),確(que)保(bao)(bao)數(shu)(shu)據(ju)(ju)(ju)(ju)獲取(qu)、數(shu)(shu)據(ju)(ju)(ju)(ju)流通、數(shu)(shu)據(ju)(ju)(ju)(ju)使用(yong)(yong)的(de)(de)(de)(de)(de)合(he)法(fa)性(xing)。在(zai)(zai)(zai)醫(yi)(yi)療(liao)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)產(chan)品應用(yong)(yong)方(fang)面(mian)(mian),2014年(nian)(nian)(nian)歐(ou)(ou)(ou)盟(meng)發布(bu)《2014—2020歐(ou)(ou)(ou)洲機(ji)(ji)(ji)器人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)技(ji)術(shu)(shu)戰略(lve)研(yan)究計劃》《歐(ou)(ou)(ou)盟(meng)機(ji)(ji)(ji)器人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)研(yan)發計劃》,重點關注(zhu)醫(yi)(yi)療(liao)機(ji)(ji)(ji)器人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)發展,包括利(li)用(yong)(yong)微型機(ji)(ji)(ji)器人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)進(jin)行外科(ke)手術(shu)(shu)和(he)(he)急救,利(li)用(yong)(yong)康復機(ji)(ji)(ji)器人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)輔助治(zhi)療(liao)等。2018年(nian)(nian)(nian)3月(yue)(yue)歐(ou)(ou)(ou)洲政治(zhi)戰略(lve)中心發布(bu)《人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)時(shi)代:確(que)立以(yi)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)為(wei)本(ben)的(de)(de)(de)(de)(de)歐(ou)(ou)(ou)洲戰略(lve)》,提(ti)(ti)(ti)(ti)(ti)出(chu)(chu)(chu)(chu)將人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)技(ji)術(shu)(shu)應用(yong)(yong)于精準(zhun)醫(yi)(yi)療(liao)服務(wu)以(yi)及健康監測(ce)與(yu)(yu)管理(li)。歐(ou)(ou)(ou)盟(meng)2017版《醫(yi)(yi)療(liao)器械條例(li)(li)》新增了醫(yi)(yi)療(liao)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)產(chan)品準(zhun)入(ru)標準(zhun),符合(he)標準(zhun)的(de)(de)(de)(de)(de)產(chan)品可申請CE認證,在(zai)(zai)(zai)歐(ou)(ou)(ou)洲市場自由流通。在(zai)(zai)(zai)醫(yi)(yi)療(liao)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)倫(lun)(lun)(lun)理(li)道(dao)(dao)德(de)方(fang)面(mian)(mian),2017年(nian)(nian)(nian)《歐(ou)(ou)(ou)盟(meng)機(ji)(ji)(ji)器人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)民(min)(min)事法(fa)律規(gui)(gui)則(ze)》建議(yi)成立專(zhuan)門的(de)(de)(de)(de)(de)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)監管機(ji)(ji)(ji)構,提(ti)(ti)(ti)(ti)(ti)出(chu)(chu)(chu)(chu)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)技(ji)術(shu)(shu)使用(yong)(yong)的(de)(de)(de)(de)(de)權(quan)責規(gui)(gui)范、倫(lun)(lun)(lun)理(li)原則(ze)、監管原則(ze)等。2018年(nian)(nian)(nian)4月(yue)(yue)歐(ou)(ou)(ou)盟(meng)委員(yuan)會(hui)發布(bu)《歐(ou)(ou)(ou)洲人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)》報告,提(ti)(ti)(ti)(ti)(ti)出(chu)(chu)(chu)(chu)制定人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)道(dao)(dao)德(de)準(zhun)則(ze)與(yu)(yu)法(fa)律體(ti)系(xi)。2019年(nian)(nian)(nian)4月(yue)(yue)歐(ou)(ou)(ou)盟(meng)《可信(xin)賴的(de)(de)(de)(de)(de)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)道(dao)(dao)德(de)準(zhun)則(ze)》提(ti)(ti)(ti)(ti)(ti)出(chu)(chu)(chu)(chu)在(zai)(zai)(zai)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)倫(lun)(lun)(lun)理(li)方(fang)面(mian)(mian)制定相應的(de)(de)(de)(de)(de)準(zhun)入(ru)政策,提(ti)(ti)(ti)(ti)(ti)升公眾對人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)的(de)(de)(de)(de)(de)信(xin)任。在(zai)(zai)(zai)醫(yi)(yi)療(liao)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)才(cai)培養方(fang)面(mian)(mian),2018年(nian)(nian)(nian)《歐(ou)(ou)(ou)洲人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)》提(ti)(ti)(ti)(ti)(ti)出(chu)(chu)(chu)(chu)促進(jin)教育(yu)和(he)(he)培訓體(ti)系(xi)改(gai)革,增強對人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)行業的(de)(de)(de)(de)(de)適(shi)應力。2018年(nian)(nian)(nian)《人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)時(shi)代:確(que)立以(yi)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)為(wei)本(ben)的(de)(de)(de)(de)(de)歐(ou)(ou)(ou)洲戰略(lve)》提(ti)(ti)(ti)(ti)(ti)出(chu)(chu)(chu)(chu)歐(ou)(ou)(ou)洲面(mian)(mian)臨人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)才(cai)的(de)(de)(de)(de)(de)嚴重短缺,需(xu)增強人(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)(ren)工(gong)(gong)(gong)(gong)(gong)(gong)(gong)智(zhi)(zhi)能(neng)(neng)(neng)技(ji)能(neng)(neng)(neng)培訓。 英國 在醫(yi)療(liao)人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能隱私保護方(fang)(fang)面(mian),2016年(nian)(nian)11月《人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能:未來決策(ce)(ce)(ce)的(de)(de)機(ji)會與影響》和(he)2017年(nian)(nian)10月《在英(ying)國發(fa)(fa)展(zhan)(zhan)人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能》對數據合理(li)獲取(qu)、個(ge)人(ren)(ren)(ren)隱私保護等提出(chu)明確(que)要(yao)求(qiu)。在醫(yi)療(liao)人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能產品(pin)應用方(fang)(fang)面(mian),2016年(nian)(nian)《人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能:未來決策(ce)(ce)(ce)的(de)(de)機(ji)會與影響》提出(chu)利用人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能進行(xing)健康(kang)服(fu)務需求(qiu)預測和(he)精準醫(yi)療(liao)服(fu)務。2017年(nian)(nian)《在英(ying)國發(fa)(fa)展(zhan)(zhan)人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能》報告(gao)指(zhi)出(chu)醫(yi)療(liao)人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能行(xing)業(ye)最具(ju)有潛(qian)力(li)的(de)(de)3個(ge)發(fa)(fa)展(zhan)(zhan)方(fang)(fang)向:醫(yi)療(liao)影像(xiang)分析、醫(yi)療(liao)輔助(zhu)診斷(duan)和(he)流行(xing)病的(de)(de)早期發(fa)(fa)現(xian)與追蹤。在醫(yi)療(liao)人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能倫理(li)道德(de)方(fang)(fang)面(mian),2016年(nian)(nian)10月《機(ji)器人(ren)(ren)(ren)技術和(he)人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能》提出(chu)人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能可能引發(fa)(fa)的(de)(de)道德(de)與法(fa)律問(wen)題,倡導(dao)成立(li)專門(men)的(de)(de)監管(guan)機(ji)構,以應對倫理(li)道德(de)與監管(guan)挑戰。在醫(yi)療(liao)人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能人(ren)(ren)(ren)才培養方(fang)(fang)面(mian),2017年(nian)(nian)《在英(ying)國發(fa)(fa)展(zhan)(zhan)人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能》提出(chu)英(ying)國每(mei)年(nian)(nian)資(zi)助(zhu)部分學(xue)(xue)生攻讀人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能碩士(shi)學(xue)(xue)位,增設(she)博(bo)士(shi)學(xue)(xue)位,開設(she)人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能相關課程,并重視人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能人(ren)(ren)(ren)才的(de)(de)國際引進。2018年(nian)(nian)4月發(fa)(fa)布《人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能行(xing)業(ye)新政》提出(chu)增加(jia)教育投資(zi),開展(zhan)(zhan)轉換課程促進人(ren)(ren)(ren)才轉型,更改移民政策(ce)(ce)(ce)吸引國際人(ren)(ren)(ren)工(gong)(gong)(gong)(gong)智(zhi)(zhi)(zhi)能人(ren)(ren)(ren)才。 我國相關政策及法律 國內外政策法律比較分析 對策與建議