{"id":31780,"date":"2025-10-16T00:00:12","date_gmt":"2025-10-15T16:00:12","guid":{"rendered":"https:\/\/naipnews.naipo.com\/?p=31780"},"modified":"2025-10-09T11:41:49","modified_gmt":"2025-10-09T03:41:49","slug":"%e3%80%8a%e6%ac%a7%e6%b4%b2%e5%81%a5%e5%ba%b7%e6%95%b0%e6%8d%ae%e7%a9%ba%e9%97%b4%e8%a7%84%e5%88%99%e3%80%8b%e7%ab%8b%e6%b3%95%e6%9e%b6%e6%9e%84%e4%b8%8e%e5%ae%9e%e6%96%bd%e6%97%b6%e7%a8%8b%e6%b5%85","status":"publish","type":"post","link":"https:\/\/naipnews.naipo.com\/zh-hans\/31780\/","title":{"rendered":"\u300a\u6b27\u6d32\u5065\u5eb7\u6570\u636e\u7a7a\u95f4\u89c4\u5219\u300b\u7acb\u6cd5\u67b6\u6784\u4e0e\u5b9e\u65bd\u65f6\u7a0b\u6d45\u4ecb"},"content":{"rendered":"<blockquote><p>2025\u5e743\u670826\u65e5\u751f\u6548\u4e4b\u300a\u6b27\u6d32\u5065\u5eb7\u6570\u636e\u7a7a\u95f4\u89c4\u5219\u300b\uff08European Health Data Space Regulation, EHDSR\uff09\uff0c\u65e8\u5728\u4e3a\u6b27\u6d32\u4e2a\u4eba\u7535\u5b50\u5065\u5eb7\u6570\u636e\u4e4b\u53d6\u7528\u4e0e\u63a7\u5236\u5efa\u7acb\u4e00\u822c\u6027\u67b6\u6784\u3002\u6b27\u6d32\u5065\u5eb7\u6570\u636e\u7a7a\u95f4\uff08European Health Data Space, EHDS\uff09\u4e0d\u4ec5\u662f\u6b27\u6d32\u536b\u751f\u8054\u76df\uff08European Health Union\uff09\u4e4b\u57fa\u77f3\uff0c\u4ea6\u662f\u300c\u6b27\u6d32\u6570\u5b57\u7b56\u7565\u300d\uff08European Data Strategy\uff09\u5e95\u4e0b\u9996\u4e2a\u6b27\u6d32\u5171\u540c\u6570\u636e\u7a7a\u95f4\uff08Common European Data Spaces\uff09\u3002<\/p><\/blockquote>\n<figure id=\"attachment_2657\" aria-describedby=\"caption-attachment-2657\" style=\"width: 1024px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-2657\" src=\"https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2025\/01\/F1-4.jpg\" alt=\"\" width=\"1024\" height=\"683\" \/><figcaption id=\"caption-attachment-2657\" class=\"wp-caption-text\">\u56fe\u7247\u6765\u6e90 : shutterstock\u3001\u8fbe\u5fd7\u5f71\u50cf<\/figcaption><\/figure>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_69_1 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">\u76ee\u9304<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" 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class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/31780\/#%E5%AE%9E%E6%96%BD%E6%97%B6%E7%A8%8B\" title=\"\u5b9e\u65bd\u65f6\u7a0b\">\u5b9e\u65bd\u65f6\u7a0b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/31780\/#%E7%BB%93%E8%AF%AD\" title=\"\u7ed3\u8bed\">\u7ed3\u8bed<\/a><\/li><\/ul><\/nav><\/div>\n<h1><span class=\"ez-toc-section\" id=\"%E8%A7%84%E8%8C%83%E7%9B%AE%E6%A0%87\"><\/span><span style=\"color: #026292;\">\u89c4\u8303\u76ee\u6807<\/span><span class=\"ez-toc-section-end\"><\/span><\/h1>\n<p>\u6b27\u76df\uff08EU\uff09\u300a\u8de8\u5883\u533b\u7597\u4fdd\u5065\u6307\u4ee4\u300b\uff08Cross-Border Healthcare Directive\uff09\u7b2c14\u6761\u8981\u6c42\u5efa\u7acb\u81ea\u613f\u6027\u4e4b\u7535\u5b50\u5065\u5eb7\u7f51\u7edc\uff08eHealth network\uff09\uff0c\u65e8\u5728\u4fc3\u8fdb\u5404\u6210\u5458\u56fd\u5065\u5eb7\u8d44\u6599\u4e4b\u4ea4\u4e92\u6027\uff0c\u85c9\u6b64\u63d0\u9ad8\u533b\u7597\u4fdd\u5065\u670d\u52a1\u4e4b\u8d28\u91cf\u3001\u5b89\u5168\u53ca\u7167\u62a4\u8fde\u7eed\u6027\u3002\u60df\u5728\u5b9e\u8df5\u4e0a\uff0c\u6b64\u7c7b\u6570\u636e\u4ecd\u5b58\u5728\u4e0d\u5c11\u683c\u5f0f\u76f8\u5f02\u3001\u6b20\u7f3a\u5b8c\u6574\u6027\u6216\u5c1a\u672a\u6570\u5b57\u5316\u4e4b\u95ee\u9898\uff0c\u6545EU\u8fdb\u4e00\u6b65\u63a8\u51faEHDS\uff0c\u671f\u671b\u5b9e\u73b0\u4e09\u5927\u76ee\u6807\u5982\u4e0b<a href=\"#_ftn1\" name=\"_ftnref1\">[1]<\/a>\uff1a<\/p>\n<ul>\n<li>\u4f7f\u4e2a\u4eba\u6709\u6743\u63a7\u5236\u5176\u5065\u5eb7\u6570\u636e\u5e76\u4fc3\u8fdb\u6570\u636e\u8de8\u5883\u4ea4\u6362\uff0c\u4ea6\u5373\u5065\u5eb7\u6570\u636e\u4e4b<strong>\u539f\u59cb\u5229\u7528<\/strong>\uff08primary use\uff09\u3002<\/li>\n<li>\u63d0\u4f9b\u4e00\u81f4\u4e14\u53ef\u9760\u4e4b\u5065\u5eb7\u6570\u636e<strong>\u4e8c\u6b21\u5229\u7528<\/strong>\uff08secondary use\uff09\u7cfb\u7edf\uff0c\u4ee5\u534f\u52a9\u76f8\u5173\u7814\u7a76\u3001\u521b\u65b0\u3001\u51b3\u7b56\u4e0e\u76d1\u7ba1\u3002<\/li>\n<li>\u50ac\u751f\u7535\u5b50\u5065\u5eb7\u8bb0\u5f55\u7cfb\u7edf\ufe5delectronic health record \uff08EHR\uff09 systems\ufe5e\u4e4b\u5355\u4e00\u5e02\u573a\u3002<\/li>\n<\/ul>\n<h1><span class=\"ez-toc-section\" id=\"%E6%9E%B6%E6%9E%84%E8%AE%BE%E8%AE%A1\"><\/span><span style=\"color: #026292;\">\u67b6\u6784\u8bbe\u8ba1<\/span><span class=\"ez-toc-section-end\"><\/span><\/h1>\n<p>\u4f9d\u636e\u4e0d\u540c\u8d44\u6599\u7528\u9014\uff0c\u5e76\u7ed3\u5408EHDSR\u4e4b\u53d7\u76ca\u5bf9\u8c61\uff08\u6216\u79f0\u5229\u5bb3\u5173\u7cfb\u8005\uff09\uff0c\u5176\u89c4\u8303\u53ef\u5206\u4e3a\u56db\u5927\u533a\u5757<a href=\"#_ftn2\" name=\"_ftnref2\">[2]<\/a>\uff1a<\/p>\n<ul>\n<li>\u7b2c\u4e8c\u7ae0\u300c\u539f\u59cb\u5229\u7528\u300d\uff1a<strong>\u9488\u5bf9\u75c5\u60a3<\/strong>\uff0c\u8d4b\u4e88\u76f8\u5173\u4e2a\u4eba\u6743\u5229\uff0c\u5e76\u8981\u6c42\u6210\u5458\u56fd\u5efa\u7acb\u65b9\u4fbf\u533b\u7597\u670d\u52a1\u63d0\u4f9b\u5546\u8fde\u63a5\u4e4b\u5fc5\u8981\u6280\u672f\u57fa\u7840\u8bbe\u65bd\u3002<\/li>\n<li>\u7b2c\u4e09\u7ae0\u300cEHR\u7cfb\u7edf\u300d\uff1a<strong>\u9488\u5bf9\u5236\u9020\u5546\u53ca\u5176\u4ed6<\/strong><strong>EHR\u7cfb\u7edf\u4f9b\u5e94\u4e1a\u8005<\/strong>\uff0c\u8981\u6c42\u8be5\u7cfb\u7edf\u5177\u5907\u4e92\u64cd\u4f5c\u6027\u4e0e\u8bb0\u5f55\u50a8\u5b58\uff08logging\uff09\u80fd\u529b\uff0c\u540c\u65f6\u5efa\u7acbEHR\u7cfb\u7edf\u5e02\u573a\u76d1\u7763\u673a\u5236\u3002<\/li>\n<li>\u7b2c\u56db\u7ae0\u300c\u4e8c\u6b21\u5229\u7528\u300d\uff1a<strong>\u9488\u5bf9\u5065\u5eb7\u6570\u636e\u6301\u6709\u8005\u53ca\u7528\u6237<\/strong>\uff0c\u660e\u5b9a\u6301\u6709\u8005\u4e4b\u63d0\u4f9b\u6570\u636e\u4e49\u52a1\u4ee5\u53ca\u6570\u636e\u5229\u7528\u65b9\u5f0f\uff0c\u540c\u65f6\u8bbe\u7acb\u5065\u5eb7\u6570\u636e\u5b58\u53d6\u673a\u6784\uff08Health Data Access Bodies, HDAB\uff09\u4e0e\u5fc5\u8981\u57fa\u7840\u8bbe\u65bd\u3002<\/li>\n<li>\u5176\u4ed6\u7ae0\u8282\uff1a\u5305\u62ec\u8bbe\u7acbEHDS\u59d4\u5458\u4f1a\uff08EHDS Board\uff09\u7b49\u6cbb\u7406\u89c4\u5b9a\u3001\u56fd\u9645\u95f4\u4e8b\u52a1\u53ca\u5176\u4ed6\u76f8\u5173\u8bae\u9898\u3002<\/li>\n<\/ul>\n<p>\u6574\u4f53\u800c\u8a00\uff0cEHDSR\u671f\u671b\u5efa\u7acb\u5229\u76ca\u5404\u65b9\u4e4b\u7535\u5b50\u5065\u5eb7\u6570\u636e\u5229\u7528\u73af\u5883\uff0c\u5927\u81f4\u5982\u4e0b\u56fe\u6240\u793a\uff1a<\/p>\n<figure id=\"attachment_31781\" aria-describedby=\"caption-attachment-31781\" style=\"width: 1023px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-31781\" src=\"https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2024\/10\/1.jpg\" alt=\"\" width=\"1023\" height=\"472\" srcset=\"https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2024\/10\/1.jpg 1023w, https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2024\/10\/1-768x354.jpg 768w\" sizes=\"auto, (max-width: 1023px) 100vw, 1023px\" \/><figcaption id=\"caption-attachment-31781\" class=\"wp-caption-text\">\u56fe1. EHDSR\u6b32\u5efa\u7acb\u7684\u7535\u5b50\u5065\u5eb7\u6570\u636e\u5229\u7528\u73af\u5883\uff1b\u6570\u636e\u6e90\uff1a<a href=\"https:\/\/health.ec.europa.eu\/ehealth-digital-health-and-care\/digital-health-and-care_en\" target=\"_blank\" rel=\"noopener\">Digital health and care<\/a>. EC.\uff1b\u7531\u5317\u7f8e\u667a\u6743\u62a5\uff0f\u8bb8\u6148\u771f\u7ffb\u8bd1<\/figcaption><\/figure>\n<h1><span class=\"ez-toc-section\" id=\"%E4%BB%A5%E4%BF%A1%E8%B5%96%E4%B8%8E%E5%AE%89%E5%85%A8%E4%B8%BA%E6%A0%B8%E5%BF%83%E4%BB%B7%E5%80%BC\"><\/span><span style=\"color: #026292;\">\u4ee5\u4fe1\u8d56\u4e0e\u5b89\u5168\u4e3a\u6838\u5fc3\u4ef7\u503c<\/span><span class=\"ez-toc-section-end\"><\/span><\/h1>\n<p>EHDSR\u7cfb\u5960\u57fa\u4e8eEU\u65e2\u6709\u8d44\u6599\u89c4\u8303<a href=\"#_ftn3\" name=\"_ftnref3\">[3]<\/a>\u4e4b\u4e0a\uff0c\u5e76\u4f9d\u636e\u5065\u5eb7\u8d44\u6599\u4e4b\u7279\u6b8a\u6027\u52a0\u4ee5\u8865\u5145\uff1b\u5176\u91cd\u70b9\u5305\u62ec<a href=\"#_ftn4\" name=\"_ftnref4\">[4]<\/a>\uff1a<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E5%8E%9F%E5%A7%8B%E5%88%A9%E7%94%A8%E4%B9%8B%E4%BF%9D%E9%9A%9C\"><\/span><strong>\u539f\u59cb\u5229\u7528\u4e4b\u4fdd\u969c<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u75c5\u60a3\u5f97\u9650\u5236\u533b\u7597\u4e13\u4e1a\u4eba\u5458\u5b58\u53d6\u5176\u7535\u5b50\u5065\u5eb7\u6570\u636e\uff08Art.8\uff09<a href=\"#_ftn5\" name=\"_ftnref5\">[5]<\/a>\uff0c\u5e76\u4eab\u6709\u53ef\u9006\uff08reversible\uff09\u4e4b\u9000\u51fa\u9009\u62e9\u6743\uff08opt-out option\uff09\uff08Art.10\uff09\uff1b\u60df\u5982\u4e3a\u4fdd\u62a4\u6570\u636e\u4e3b\u4f53\u6216GDPR\u7b2c9(2)(c)\u6761\u5176\u4ed6\u81ea\u7136\u4eba\u4e4b\u5207\u8eab\u5229\u76ca\uff08vital interests\uff09\uff0c\u5219\u4f8b\u5916\u5141\u8bb8\u5b58\u53d6\u3002\u8be5\u9000\u51fa\u6743\u5e76\u4e0d\u5f71\u54cd\u56fd\u5bb6\u533b\u7597\u7167\u62a4\u7cfb\u7edf\u6570\u5b57\u5316\uff0c\u56fd\u5bb6\u4ecd\u5f97\u4ee5\u6570\u5b57\u65b9\u5f0f\u50a8\u5b58\u5e76\u5904\u7406\u6b64\u7c7b\u8d44\u6599\u3002<\/p>\n<p>\u7531\u4e8e\u5065\u5eb7\u6570\u636e\u5fc5\u987b\u53ca\u65f6\u63d0\u4f9b\uff0c\u4e14\u901a\u5e38\u662f\u900f\u8fc7\u81ea\u52a9\u670d\u52a1\u5165\u53e3\u7f51\u7ad9\u5b58\u53d6\u800c\u6bcb\u987b\u7ecf\u4eba\u5de5\u641c\u5bfb\u3001\u6574\u7406\u3002\u56e0\u6b64\uff0cGDPR\u7b2c12(4)\u6761\u53ca\u7b2c12(5)\u6761\u300c\u4e00\u4e2a\u6708\u56de\u590d\u671f\u9650\u300d\u3001\u300c\u62d2\u7edd\u5904\u7406\u660e\u663e\u65e0\u7406\u7531\u6216\u8fc7\u5ea6\u91cd\u590d\u4e4b\u8bf7\u6c42\u300d\u6216\u300c\u6536\u53d6\u76f8\u5173\u8d39\u7528\u300d\u7b49\u89c4\u5b9a\uff0c\u5728\u6b64\u5e76\u4e0d\u9002\u7528\u3002\u4ea6\u5373\uff0c\u6570\u636e\u63a7\u5236\u8005\u6216\u533b\u7597\u670d\u52a1\u63d0\u4f9b\u5546\u4e0d\u5f97\u4ee5\u8bf7\u6c42\u9891\u7e41\u4e3a\u7531\uff0c\u62d2\u7edd\u5b58\u53d6\u6216\u6536\u53d6\u8d39\u7528\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E4%BA%8C%E6%AC%A1%E5%88%A9%E7%94%A8%E4%B9%8B%E4%BF%9D%E9%9A%9C\"><\/span><strong>\u4e8c\u6b21\u5229\u7528\u4e4b\u4fdd\u969c<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u7535\u5b50\u5065\u5eb7\u6570\u636e\u4e4b\u4e8c\u6b21\u5229\u7528\u5fc5\u987b\u7ecf\u56fd\u5bb6\u6307\u5b9a\u4e4bHDAB\u8bb8\u53ef\uff08Art.68\uff09\uff0c\u4e14\u9650\u4e8e\u5141\u8bb8\u7528\u9014\uff08Art.53-54\uff09\u3002EHDSR\u867d\u5217\u51fa17\u79cd\u6570\u636e\u7c7b\u522b\uff0c\u5404\u6210\u5458\u56fd\u4ecd\u5f97\u81ea\u884c\u589e\u5217\u5176\u8303\u56f4\uff08Art.51\uff09\u3002\u540c\u6837\u5730\uff0c\u75c5\u60a3\u4ea6\u4eab\u6709\u53ef\u9006\u4e4b\u9000\u51fa\u6743\uff08Art.71\uff09\uff0c\u60df\u8bbe\u6709\u4f8b\u5916\u89c4\u5b9a\uff08\u4f8b\u5982\u57fa\u4e8e\u91cd\u5927\u516c\u5171\u5229\u76ca\uff09\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E7%A1%AE%E4%BF%9D%E6%95%B0%E6%8D%AE%E9%9A%90%E7%A7%81%E4%B8%8E%E5%AE%89%E5%85%A8\"><\/span><strong>\u786e\u4fdd\u6570\u636e\u9690\u79c1\u4e0e\u5b89\u5168<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u9274\u4e8e\u5065\u5eb7\u6570\u636e\u4e4b\u654f\u611f\u6027\uff0c\u6570\u636e\u7528\u6237\u4ec5\u80fd\u5728\u7b26\u5408\u9690\u79c1\u53ca\u7f51\u7edc\u5b89\u5168\u9ad8\u6807\u51c6\u4e4b\u73af\u5883\u4e2d\u5904\u7406\u8d44\u6599\uff0c\u4e14\u7981\u6b62\u4e0b\u8f7d\u4e2a\u4eba\u7535\u5b50\u5065\u5eb7\u6570\u636e\uff08Art.73\uff09\uff0c\u4ea6\u4e0d\u5f97\u91cd\u65b0\u8bc6\u522b\u6216\u5c1d\u8bd5\u91cd\u65b0\u8bc6\u522b\u6570\u636e\u4e3b\u4f53\uff08Art.61(3)\uff09\u3002\u518d\u8005\uff0c\u552f\u6709\u7814\u7a76\u8005\u3001\u4f01\u4e1a\u6216\u516c\u5171\u673a\u6784\u8bc1\u660e\u533f\u540d\uff08anonymised\uff09\u6570\u636e\u65e0\u6cd5\u5b9e\u73b0\u5176\u76ee\u7684\u65f6\uff0c\u65b9\u53ef\u5b58\u53d6\u5047\u540d\uff08pseudonymised\uff09\u8d44\u6599\uff08Art.66(3)\uff09\u3002<\/p>\n<p>EHDSR\u4ea6\u5df2\u843d\u5b9eGDPR\u5904\u7406\u5408\u6cd5\u6027\u4e4b\u8981\u6c42\uff0c\u4f8b\u5982\uff1aHDAB\u57fa\u4e8eGDPR\u7b2c6(1)(e)\u6761\u6267\u884c\u516c\u76ca\u4efb\u52a1\u4e4b\u5fc5\u8981\uff0c\u5728\u5b89\u5168\u73af\u5883\u4e2d\u5904\u7406\u6570\u636e\u3002\u53c8\u5982\uff0c\u8d44\u6599\u6301\u6709\u8005\u57fa\u4e8eGDPR\u7b2c6(1)(c)\u6761\u9075\u4ece\u6570\u636e\u63a7\u5236\u8005\u6cd5\u5f8b\u4e49\u52a1\u4e4b\u5fc5\u8981\uff0c\u4f9d\u636e\u4e2a\u522b\u6570\u636e\u8bb8\u53ef\u5411HDAB\u63d0\u4f9b\u6570\u636e\u3002\u53c8\u4f8b\u5982\uff0cGDPR\u7b2c9(2)(j)\u6761\u57fa\u4e8e\u516c\u76ca\u800c\u4f8b\u5916\u5141\u8bb8\u5904\u7406\u7279\u6b8a\u4e2a\u4eba\u8d44\u6599\u65f6\uff0c\u6240\u8981\u6c42\u63d0\u4f9b\u4e4b\u9002\u5f53\u5177\u4f53\u4fdd\u969c\u63aa\u65bd\uff0c\u5373\u4f53\u73b0\u5728EHDSR\u7b2c\u56db\u7ae0\u4e4b\u5141\u8bb8\u7528\u9014\u3001\u6570\u636e\u8bb8\u53ef\u3001\u5b89\u5168\u5904\u7406\u7a0b\u5e8f\u7b49\u89c4\u5b9a\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E4%BB%A5%E9%AB%98%E6%A0%87%E5%87%86%E5%BB%BA%E7%AB%8BEHR%E7%B3%BB%E7%BB%9F\"><\/span><strong>\u4ee5\u9ad8\u6807\u51c6\u5efa\u7acbEHR\u7cfb\u7edf<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>EHDSR\u9488\u5bf9EHR\u7cfb\u7edf\u5efa\u7acb\u4e0a\u5e02\u524d\u53ca\u4e0a\u5e02\u540e\u4e4b\u6cd5\u89c4\u9075\u5faa\u67b6\u6784\uff0c\u5305\u62ec\u5236\u9020\u5546\uff08Art.30\uff09\u3001\u8fdb\u53e3\u5546\uff08Art.32\uff09\u4e0e\u7ecf\u9500\u5546\uff08Art.33\uff09\u4ee5\u53ca\u5e02\u573a\u76d1\u7763\u673a\u6784\uff08Art.43\uff09\u7b49\u4e3b\u4f53\u4e49\u52a1\uff0c\u4ee5\u786e\u4fdd\u5176\u7b26\u5408\u4e25\u683c\u4e4b\u5b89\u5168\u6027\u4e0e\u4e92\u64cd\u4f5c\u6027\u6807\u51c6\u4ee5\u53ca\u9ad8\u8d28\u91cf\u6570\u636e\u8981\u6c42\u3002<\/p>\n<h1><span class=\"ez-toc-section\" id=\"%E5%AE%9E%E6%96%BD%E6%97%B6%E7%A8%8B\"><\/span><span style=\"color: #026292;\">\u5b9e\u65bd\u65f6\u7a0b<\/span><span class=\"ez-toc-section-end\"><\/span><\/h1>\n<p>EHDSR\u5e76\u975e\u81ea2025\u5e743\u670826\u65e5\u8d77\u5373\u5168\u9762\u9002\u7528\uff0c\u800c\u662f\u7ecf\u8fc7\u4e00\u5b9a\u8fc7\u6e21\u671f\u95f4\u540e\uff0c\u624d\u9010\u6b65\u843d\u5b9e\u5404\u7ae0\u8282\u5185\u5bb9<a href=\"#_ftn6\" name=\"_ftnref6\">[6]<\/a>\uff0c\u4ee5\u5229\u5404\u65b9\u5229\u5bb3\u5173\u7cfb\u8005\u505a\u8db3\u51c6\u5907\uff08Art.105\uff09\u3002\u5176\u5b9e\u65bd\u65f6\u7a0b\u5927\u81f4\u5206\u4e3a\u4e09\u9636\u6bb5\uff1a<\/p>\n<ul>\n<li><strong><em>\u7b2c\u4e8c\u7ae0\u4e0e\u7b2c\u4e09\u7ae0\u4e4b\u4e3b\u8981\u89c4\u5b9a<\/em><\/strong>\u7cfb\u81ea2029\u5e743\u670826\u65e5\u8d77\u9002\u7528\u4e8e\u4e2a\u4eba\u5065\u5eb7\u6570\u636e\u4f18\u5148\u7c7b\u522b\u4e4b\u7b2c\u4e00\u7ec4\uff08\u6307\u75c5\u5386\u6458\u8981\u3001\u7535\u5b50\u5904\u65b9\u4e0e\u7535\u5b50\u8c03\u5242\u8bb0\u5f55\uff09\uff1b\u5e76\u81ea2031\u5e743\u670826\u65e5\u8d77\u9002\u7528\u4e8e\u4f18\u5148\u7c7b\u522b\u4e4b\u7b2c\u4e8c\u7ec4\uff08\u6307\u533b\u5b66\u5f71\u50cf\u3001\u533b\u7597\u68c0\u9a8c\u7ed3\u679c\u4e0e\u51fa\u9662\u62a5\u544a\uff09\u3002<\/li>\n<li><strong><em>\u7b2c\u56db\u7ae0<\/em><\/strong>\u7cfb\u81ea2029\u5e743\u670826\u65e5\u8d77\u9002\u7528\u4e8e\u7b2c51\u6761\u5927\u90e8\u5206\u6570\u636e\u7c7b\u522b\uff08\u4f8b\u5982\u6765\u81ea\u7535\u5b50\u5065\u5eb7\u8bb0\u5f55\u4e4b\u6570\u636e\uff09\uff1b\u5e76\u81ea2031\u5e743\u670826\u65e5\u8d77\u9002\u7528\u4e8e\u5176\u4f59\u7c7b\u522b\uff08\u4f8b\u5982\u57fa\u56e0\u4f53\u6570\u636e\uff09\u3002<\/li>\n<li><strong><em>EHDSR\u7b2c75(5)\u6761<\/em><\/strong>\u7cfb\u81ea2035\u5e743\u670826\u65e5\u8d77\u9002\u7528\uff0c\u5141\u8bb8\u7b2c\u4e09\u56fd\u53ca\u56fd\u9645\u7ec4\u7ec7\u7533\u8bf7\u53c2\u4e0eHealthData@EU\u3002<\/li>\n<\/ul>\n<p>\u5728\u6b64\u4e4b\u524d\uff0c\u6267\u59d4\u4f1a\uff08European Commission, EC\uff09\u5c1a\u987b\u5236\u5b9a\u82e5\u5e72\u65bd\u884c\u7ec6\u5219\uff08implementing acts\uff09\uff1a\u5176\u9884\u8ba1\u5728\u751f\u6548\u65e5\uff082025\u5e743\u670826\u65e5\uff09\u540e\u4e24\u5e74\u5185<a href=\"#_ftn7\" name=\"_ftnref7\">[7]<\/a>\uff0c\u62df\u5b9a\u76f8\u5173\u89c4\u8303\u4e4b\u8be6\u7ec6\u84dd\u56fe\u3002\u5c14\u540e\u4e24\u5e74<a href=\"#_ftn8\" name=\"_ftnref8\">[8]<\/a>\u5219\u7528\u4ee5\u5efa\u7f6e\u3001\u6d4b\u8bd5\u53ca\u90e8\u7f72\u5df2\u786e\u5b9a\u4e4b\u6280\u672f\u7ec6\u8282 \u2014 \u6362\u8a00\u4e4b\uff0cEC\u5fc5\u987b\u4e8e2027\u5e743\u670826\u65e5\u524d\u901a\u8fc7\u6b64\u7b49\u89c4\u8303\u3002\u9002\u7528\u6b64\u4e00\u671f\u9650\u4e4b\u65bd\u884c\u7ec6\u5219\u51719\u9879\uff0c\u4e3b\u9898\u5305\u62ec\uff1a<\/p>\n<ul>\n<li>\u539f\u59cb\u5229\u7528\u4e0b\u4e4b\u6570\u636e\u8d28\u91cf\u8981\u6c42\uff0813(4)\uff09<\/li>\n<li>\u6b27\u6d32\u7535\u5b50\u5065\u5eb7\u8bb0\u5f55\u4ea4\u6362\u683c\u5f0f\uff08European Electronic Health Record exchange Format, EEHRxF\uff09\u4e4b\u6280\u672f\u89c4\u683c\uff0815(1)\uff09<\/li>\n<li>\u6570\u5b57\u5065\u5eb7\u6570\u636e\u5e73\u53f0\u300cMyHealth@EU\u300d\uff0823(4)\uff09<\/li>\n<li>EHR\u7cfb\u7edf\u534f\u8c03\u7ec4\u4ef6\u4e4b\u5171\u901a\u89c4\u683c\uff0836(1)\uff09<\/li>\n<li>\u6570\u636e\u5b58\u53d6\u7533\u8bf7\u3001\u8bb8\u53ef\u4e0e\u8bf7\u6c42\u4e4b\u6a21\u677f\uff0870(1)\uff09<\/li>\n<li>\u5b89\u5168\u5904\u7406\u73af\u5883\u4e4b\u8981\u6c42\uff0873(5)\uff09<\/li>\n<li>\u4e8c\u6b21\u5229\u7528\u4e4b\u8de8\u5883\u6570\u636e\u5e73\u53f0\u300cHealthData@EU\u300d\uff0875(12)\uff09<\/li>\n<li>\u6570\u636e\u96c6\u63cf\u8ff0\u4e4b\u8981\u6c42\uff0877(4)\uff09<\/li>\n<li>\u6570\u636e\u8d28\u91cf\u4e0e\u6548\u7528\u6807\u7b7e\uff08utility label\uff09\uff0878(6)\uff09<\/li>\n<\/ul>\n<p>\u7efc\u5408\u524d\u8ff0\uff0cEHDSR\u5b9e\u65bd\u65f6\u7a0b\u4e4b\u5404\u91cc\u7a0b\u7891\u5927\u81f4\u5982\u4e0b\u56fe\u6240\u793a\uff1a<\/p>\n<figure id=\"attachment_31784\" aria-describedby=\"caption-attachment-31784\" style=\"width: 917px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-31784\" src=\"https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2024\/10\/2.jpg\" alt=\"\" width=\"917\" height=\"273\" srcset=\"https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2024\/10\/2.jpg 917w, https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2024\/10\/2-768x229.jpg 768w\" sizes=\"auto, (max-width: 917px) 100vw, 917px\" \/><figcaption id=\"caption-attachment-31784\" class=\"wp-caption-text\">\u56fe2. EHDSR\u5b9e\u65bd\u65f6\u7a0b\u6574\u7406\uff1b\u6570\u636e\u6e90\uff1a<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/frequently-asked-questions-european-health-data-space-2025-03-05_en\" target=\"_blank\" rel=\"noopener\">Frequently Asked Questions on the European Health Data Space<\/a>. Posted on 5 March 2025, EC\uff1b\u7531\u5317\u7f8e\u667a\u6743\u62a5\uff0f\u8bb8\u6148\u771f\u6574\u7406\u53ca\u7ed8\u5236<\/figcaption><\/figure>\n<p>\u4e0b\u8868\u4ece\u5229\u5bb3\u5173\u7cfb\u8005\u89d2\u5ea6\u51fa\u53d1\uff0c\u66f4\u80fd\u6e05\u695a\u5448\u73b0EHDSR\u5404\u5b9e\u65bd\u9636\u6bb5\u5177\u5907\u4f55\u79cd\u5b9e\u52a1\u610f\u4e49\uff1a<\/p>\n<figure id=\"attachment_31787\" aria-describedby=\"caption-attachment-31787\" style=\"width: 1340px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-31787\" src=\"https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2024\/10\/3.jpg\" alt=\"\" width=\"1340\" height=\"416\" srcset=\"https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2024\/10\/3.jpg 1340w, https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2024\/10\/3-768x238.jpg 768w, https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2024\/10\/3-1068x332.jpg 1068w\" sizes=\"auto, (max-width: 1340px) 100vw, 1340px\" \/><figcaption id=\"caption-attachment-31787\" class=\"wp-caption-text\">\u88681. \u4ece\u5229\u5bb3\u5173\u7cfb\u8005\u770bEHDSR\u5404\u5b9e\u65bd\u9636\u6bb5\u7684\u5f71\u54cd\uff1b\u6570\u636e\u6e90\uff1a<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/frequently-asked-questions-european-health-data-space-2025-03-05_en\" target=\"_blank\" rel=\"noopener\">Frequently Asked Questions on the European Health Data Space<\/a>. Posted on 5 March 2025, EC\uff1b\u7531\u5317\u7f8e\u667a\u6743\u62a5\uff0f\u8bb8\u6148\u771f\u6574\u7406\u53ca\u5236\u8868<\/figcaption><\/figure>\n<h1><span class=\"ez-toc-section\" id=\"%E7%BB%93%E8%AF%AD\"><\/span><span style=\"color: #026292;\">\u7ed3\u8bed<\/span><span class=\"ez-toc-section-end\"><\/span><\/h1>\n<p>EHDSR\u5f71\u54cd\u5e7f\u6cdb\u4e14\u6df1\u8fdc\uff0c\u5c3d\u7ba1\u7acb\u6cd5\u67b6\u6784\u4e0e\u5b9e\u65bd\u65f6\u7a0b\u9887\u4e3a\u7e41\u590d\uff0c\u4f46\u5728\u53ef\u9884\u671f\u4e4b\u672a\u6765\uff0c\u5c06\u80fd\u5927\u5e45\u63d0\u5347\u6b27\u6d32\u7535\u5b50\u5065\u5eb7\u6570\u636e\u4e4b\u8d28\u91cf\u4e0e\u5229\u7528\u5b89\u5168\u6027\u3002\u81f3\u4e8eEHDSR\u4e0e\u5176\u4ed6\u6570\u636e\u89c4\u8303\u3001\u4e43\u81f3\u4e8e\u300a\u4eba\u5de5\u667a\u80fd\u6cd5\u300b\uff08Artificial Intelligence Act, AI Act\uff09\u4e4b\u5173\u7cfb\uff0c\u4ea6\u5c06\u662f\u5f80\u540e\u5b9e\u8df5\u4e0a\u7684\u91cd\u8981\u95ee\u9898\uff0c\u6b64\u70b9\u5c1a\u8bf7\u8bfb\u8005\u591a\u52a0\u7559\u610f\u3002<\/p>\n<p>\u5907\u6ce8\uff1a<\/p>\n<ol>\n<li><a href=\"#_ftnref1\" name=\"_ftn1\">[1]<\/a> \u6570\u636e\u6e90\uff1a<a href=\"https:\/\/health.ec.europa.eu\/ehealth-digital-health-and-care\/digital-health-and-care_en\" target=\"_blank\" rel=\"noopener\">Digital health and care<\/a>. EC.<\/li>\n<li><a href=\"#_ftnref2\" name=\"_ftn2\">[2]<\/a> \u6570\u636e\u6e90\uff1a<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/frequently-asked-questions-european-health-data-space-2025-03-05_en\" target=\"_blank\" rel=\"noopener\">European Commission, Frequently Asked Questions on the European Health Data Space<\/a> , p6. Posted on 5 March 2025, EC.<\/li>\n<li><a href=\"#_ftnref3\" name=\"_ftn3\">[3]<\/a> \u5305\u62ec\u300a\u4e00\u822c\u6570\u636e\u4fdd\u62a4\u89c4\u5219\u300b\uff08General Data Protection Regulation, GDPR\uff09\u3001\u300a\u6570\u636e\u6cbb\u7406\u6cd5\u300b\uff08Data Governance Act\uff09\u3001\u300a\u6570\u636e\u6cd5\u300b\uff08Data Act\uff09\u3001\u300a\u7f51\u7edc\u66c1\u4fe1\u606f\u7cfb\u7edf\u6307\u4ee4\u300b\uff08Network and Information Systems Directive\uff09\u7b49\u3002<\/li>\n<li><a href=\"#_ftnref4\" name=\"_ftn4\">[4]<\/a> \u6570\u636e\u6e90\uff1a<a href=\"https:\/\/health.ec.europa.eu\/ehealth-digital-health-and-care\/european-health-data-space-regulation-ehds_en#what-is-the-ehds-regulation-about\" target=\"_blank\" rel=\"noopener\">European Health Data Space Regulation (EHDS)<\/a>. EC.<\/li>\n<li>European Commission, Frequently Asked Questions on the European Health Data Space, p40. Posted on 5 March 2025, EC.<\/li>\n<li><a href=\"#_ftnref5\" name=\"_ftn5\">[5]<\/a> \u4ee5\u5706\u62ec\u53f7\u8868\u793a\u8005\u7cfb\u4e3aEHDSR\u6761\u53f7\u3002<\/li>\n<li><a href=\"#_ftnref6\" name=\"_ftn6\">[6]<\/a> \u6570\u636e\u6e90\uff1aEuropean Commission, Frequently Asked Questions on the European Health Data Space, p7-8. . Posted on 5 March 2025, EC.<\/li>\n<li><a href=\"#_ftnref7\" name=\"_ftn7\">[7]<\/a> \u63a8\u4f30\u4e0a\u5927\u7ea6\u4e3a2025\u5e743\u670826\u65e5\u81f32027\u5e743\u670826\u65e5\uff0c\u60df\u4ecd\u89c6EC\u5b9e\u9645\u6267\u884c\u60c5\u5f62\u800c\u5b9a\u3002<\/li>\n<li><a href=\"#_ftnref8\" name=\"_ftn8\">[8]<\/a> \u63a8\u4f30\u4e0a\u5927\u7ea6\u4e3a2027\u5e743\u670826\u65e5\u81f32029\u5e743\u670826\u65e5\uff0c\u60df\u4ecd\u89c6EC\u5b9e\u9645\u6267\u884c\u60c5\u5f62\u800c\u5b9a\u3002<\/li>\n<\/ol>\n<div>\n<div>\n<p><strong>\u8d23\u4efb\u7f16\u8f91\uff1a\u5362\u9880<br \/>\n<\/strong><\/p>\n<p class=\"Article_content_15px\"><strong>\u3010\u672c\u6587\u4ec5\u53cd\u6620\u4e13\u5bb6\u4f5c\u8005\u610f\u89c1\uff0c\u4e0d\u4ee3\u8868\u672c\u62a5\u7acb\u573a\u3002\u3011<\/strong><\/p>\n<table border=\"0\" width=\"89%\" cellspacing=\"1\" cellpadding=\"8\">\n<tbody>\n<tr>\n<td bgcolor=\"#EFEFF8\">\n<table border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td valign=\"top\">\n<table border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"3\">\n<tbody>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\" width=\"13%\"><strong>\u4f5c\u8005\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" bgcolor=\"#DBDBEE\" width=\"87%\">\u8bb8\u6148\u771f<\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#EFEFF8\"><strong>\u73b0\u4efb\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" bgcolor=\"#EFEFF8\">\u53f0\u6e7e \u53f0\u5317\u5927\u5b66\u571f\u5730\u4e0e\u73af\u5883\u89c4\u5212\u7814\u7a76\u4e2d\u5fc3\u7814\u7a76\u5458<\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\"><strong>\u5b66\u5386\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" bgcolor=\"#DBDBEE\">\u53f0\u6e7e \u8f85\u4ec1\u5927\u5b66\u6cd5\u5f8b\u5b66\u7cfb\u535a\u58eb<br \/>\n\u53f0\u6e7e \u8f85\u4ec1\u5927\u5b66\u5916\u8bed\u5b66\u9662\u8d22\u7ecf\u6cd5\u5f8b\u7ffb\u8bd1\u7855\u58eb\u5b66\u7a0b<br \/>\n\u53f0\u6e7e \u8f85\u4ec1\u5927\u5b66\u8d22\u7ecf\u6cd5\u5f8b\u5b66\u7cfb\u7855\u58eb<br \/>\n\u53f0\u6e7e \u8f85\u4ec1\u5927\u5b66\u6cd5\u5f8b\u5b66\u7cfb\u5b66\u58eb<\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#EFEFF8\"><strong>\u4e13\u957f\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" bgcolor=\"#EFEFF8\">\u77e5\u8bc6\u4ea7\u6743\u3001\u6cd5\u5f8b\u7ffb\u8bd1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<div class=\"td-a-rec td-a-rec-id-content_bottom tdi_1 td_block_template_10\"><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>2025\u5e743\u670826\u65e5\u751f\u6548\u4e4b\u300a\u6b27\u6d32\u5065\u5eb7\u6570\u636e\u7a7a\u95f4\u89c4\u5219\u300b\uff08European Health Data Space Re [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":2658,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[254,261,277,255],"tags":[2107,2108,2109,1928,2110,2111,2112,2096,2113,598,2114,2115,2116,2117,2097,2098,2099,2118,2100,2101,2102,882,2103,2106,2105,615,2104],"author_name1":[324],"class_list":{"0":"post-31780","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-254","8":"category--zh-hans","9":"category-277","10":"category-255","11":"tag-ai-act-zh-hans","12":"tag-common-european-data-spaces-zh-hans","13":"tag-cross-border-healthcare-directive-zh-hans","14":"tag-ec-zh-hans","15":"tag-ehds-zh-hans","16":"tag-ehds-board-zh-hans","17":"tag-ehdsr-zh-hans","18":"tag-ehds","19":"tag-electronic-health-record-ehr-systems-zh-hans","20":"tag-eu-zh-hans","21":"tag-hdab-zh-hans","22":"tag-primary-use-zh-hans","23":"tag-secondary-use-zh-hans","24":"tag--zh-hans","25":"tag-2097","26":"tag-2098","27":"tag-2099","29":"tag-2100","30":"tag-2101","31":"tag-2102","32":"tag-882","33":"tag-2103","34":"tag-2106","35":"tag-2105","37":"tag-2104","38":"author_name1--zh-hans"},"_links":{"self":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/31780","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/comments?post=31780"}],"version-history":[{"count":1,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/31780\/revisions"}],"predecessor-version":[{"id":31790,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/31780\/revisions\/31790"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/media\/2658"}],"wp:attachment":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=31780"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/categories?post=31780"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/tags?post=31780"},{"taxonomy":"author_name1","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/author_name1?post=31780"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}