{"id":142752,"date":"2021-03-01T03:25:34","date_gmt":"2021-03-01T03:25:34","guid":{"rendered":"https:\/\/labinsights.com\/acf_article\/%e8%87%a8%e5%ba%8a%e6%a4%9c%e6%9f%bb%e5%ae%a4%e3%81%aeai%e3%81%8c%e3%82%82%e3%81%9f%e3%82%89%e3%81%97%e5%be%97%e3%82%8b%e8%a6%8f%e5%88%b6%e3%81%b8%e3%81%ae%e5%bd%b1%e9%9f%bf\/"},"modified":"2026-01-19T13:26:44","modified_gmt":"2026-01-19T13:26:44","slug":"ai-in-the-clinical-lab-what-are-the-regulatory-implications","status":"publish","type":"acf_article","link":"https:\/\/labinsights.com\/ja\/management\/healthcare-transformation\/ai-in-the-clinical-lab-what-are-the-regulatory-implications\/","title":{"rendered":"\u81e8\u5e8a\u691c\u67fb\u5ba4\u306eAI\u304c\u3082\u305f\u3089\u3057\u5f97\u308b\u898f\u5236\u3078\u306e\u5f71\u97ff"},"content":{"rendered":"

2018\u5e74\u4ee5\u6765\u3001\u4eba\u5de5\u77e5\u80fd\uff08AI\uff09\u3092\u30d9\u30fc\u30b9\u3068\u3057\u305f\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308bFDA\u306e\u627f\u8a8d\u304c\u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u81e8\u5e8a\u691c\u67fb\u5ba4\u3067\u4f7f\u7528\u3057\u305f\u308a\u3001\u81e8\u5e8a\u691c\u67fb\u5ba4\u306e\u30c7\u30fc\u30bf\u3092\u6d3b\u7528\u3057\u305f\u308a\u3067\u304d\u308bAI\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306e\u5897\u52a0\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n

AI\u306f\u3001\u6280\u8853\u306b\u95a2\u9023\u3059\u308b\u900f\u660e\u6027\u3068\u8aac\u660e\u53ef\u80fd\u6027\u306b\u95a2\u3059\u308b\u61f8\u5ff5\u306e\u305f\u3081\u306b\u898f\u5236\u5f53\u5c40\u306e\u7cbe\u67fb\u3092\u96c6\u3081\u3066\u3044\u307e\u3059\u3002\u305f\u3060\u3057\u3001AI\u3092\u4f7f\u7528\u3059\u308b\u533b\u7642\u88fd\u54c1\u306b\u5fc5\u305a\u3057\u3082\u533b\u7642\u76ee\u7684\u304c\u3042\u3063\u305f\u308a\u3001\u60a3\u8005\u306b\u9ad8\u3044\u30ea\u30b9\u30af\u3092\u3082\u305f\u3089\u3057\u305f\u308a\u3059\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u898f\u5236\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001\u4eba\u547d\u3092\u6551\u3044\u3001\u60a3\u8005\u30a2\u30a6\u30c8\u30ab\u30e0\u3092\u6539\u5584\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u3053\u308c\u3089\u306e\u88fd\u54c1\u304c\u3001\u5b89\u5168\u304b\u3064\u9069\u5207\u306b\u4f7f\u7528\u3055\u308c\u308b\u3088\u3046\u306b\u3059\u308b\u305f\u3081\u306b\u3082\u5fc5\u8981\u3067\u3059\u3002<\/p>\n

3\u30bf\u30a4\u30d7\u306eAI<\/h3>\n

AI\u30d9\u30fc\u30b9\u306e\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306f\u3001\u30d8\u30eb\u30b9\u30b1\u30a2\u306e\u6c7a\u5b9a\u306b\u304a\u3051\u308b\u4eba\u9593\u306e\u95a2\u4e0e\u306e\u30ec\u30d9\u30eb\u306b\u57fa\u3065\u3044\u3066\u3001\u652f\u63f4\u3001\u81ea\u52d5\u5316\u3001\u304a\u3088\u3073\u81ea\u5f8b\u6027\u306e3\u3064\u306e\u30ab\u30c6\u30b4\u30ea\u306b\u5e83\u304f\u5206\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n

    \n
  1. Assistive AI \u2013 \u533b\u7642\u5f93\u4e8b\u8005\uff08HCP\uff09\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3001\u81e8\u5e8a\u7ba1\u7406\u306e\u60c5\u5831\u3092\u63d0\u4f9b\u307e\u305f\u306f\u63a8\u9032\u3059\u308b<\/li>\n
  2. \u81ea\u52d5\u5316AI \u2013 HCP\u304cAI\u306e\u6c7a\u5b9a\u3092\u627f\u8a8d\u307e\u305f\u306f\u30aa\u30fc\u30d0\u30fc\u30e9\u30a4\u30c9\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u60a3\u8005\u3092\u6cbb\u7642\u307e\u305f\u306f\u8a3a\u65ad\u3059\u308b<\/li>\n
  3. \u81ea\u5f8b\u578bAI \u2013 HCP\u306e\u30ec\u30d3\u30e5\u30fc\u306a\u3057\u3067\u60a3\u8005\u3092\u6cbb\u7642\u307e\u305f\u306f\u8a3a\u65ad\u3059\u308b\u305f\u3081\u306b\u5b8c\u5168\u306b\u72ec\u7acb\u3057\u3066\u884c\u52d5\u3059\u308b<\/li>\n<\/ol>\n

    International Medical Device Regulators Forum\uff08IMDRF\uff09\u306b\u3088\u308b\u3068\u3001AI\u30d9\u30fc\u30b9\u306e\u88fd\u54c1\u306e\u81ea\u5f8b\u6027\u304c\u9ad8\u307e\u308a\u3001\u3088\u308a\u6df1\u523b\u306a\u5065\u5eb7\u72b6\u614b\u306b\u5fdc\u7528\u3055\u308c\u308b\u306b\u3064\u308c\u3066\u3001\u60a3\u8005\u306e\u5b89\u5168\u6027\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u304c\u9ad8\u307e\u308a\u3001\u3088\u308a\u9ad8\u3044\u30ec\u30d9\u30eb\u306e\u4fe1\u983c\u304c\u5fc5\u8981\u306b\u306a\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u5b9a\u7fa9\u3092\u6e80\u305f\u3059\u88fd\u54c1\u306f\u30ea\u30b9\u30af\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u5206\u985e\u304c\u9ad8\u3044\u305f\u3081\u3001\u3088\u308a\u591a\u304f\u306e\u76e3\u8996\u304a\u3088\u3073\u898f\u5236\u304c\u5fc5\u8981\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

    IMDRF\u306b\u3088\u308bAI\u30d9\u30fc\u30b9\u306e\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u88fd\u54c1\u306e<\/strong><\/em><\/p>\n

    \u00a0<\/p>\n

    \u30ea\u30b9\u30af\u5206\u985e \u533b\u7642\u76ee\u7684\u306eAI\u30d9\u30fc\u30b9\u88fd\u54c1\u306e\u30ea\u30b9\u30af\u5206\u985e\u3068\u8a8d\u5b9a\u306f\u3001\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u898f\u5236\u306b\u304a\u3051\u308b\u91cd\u8981\u306a\u653f\u7b56\u5206\u91ce\u3067\u3059\u3002<\/a>\u305d\u306e\u305f\u3081\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3084\u6163\u884c\u306f\u7d76\u3048\u305a\u5909\u5316\u3057\u3066\u304a\u308a\u3001\u6ce8\u610f\u6df1\u304f\u8ffd\u8de1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

    \u81e8\u5e8a\u691c\u67fb\u5ba4\u304b\u3089\u306e3\u3064\u306e\u4f8b<\/h3>\n

    \u73fe\u5728\u306e\u81e8\u5e8a\u691c\u67fb\u5ba4\u3067AI\u3092\u4f7f\u7528\u3057\u3066\u3044\u308b\u88fd\u54c1\u306e\u591a\u304f\u306f\u3001\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u306e\u8cc7\u683c\u3092\u6709\u3057\u3066\u3044\u306a\u3044\u305f\u3081\u3001\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u898f\u5236\u3055\u308c\u308b\u3079\u304d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u308c\u306b\u306f\u3001\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306e\u6700\u9069\u5316\u3068\u54c1\u8cea\u7ba1\u7406\u306e\u305f\u3081\u306e\u30c4\u30fc\u30eb\u3001\u4f4e\u30ea\u30b9\u30af\u306e\u81e8\u5e8a\u610f\u601d\u6c7a\u5b9a\u652f\u63f4(CDS)\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n

    \u4f8b\u3048\u3070\u3001IVD\u6a5f\u5668\u306e\u3088\u308a\u7a4d\u6975\u7684\u306a\u76e3\u8996\u304a\u3088\u3073\u30b5\u30dd\u30fc\u30c8\u3092\u53ef\u80fd\u306b\u3059\u308b\u305f\u3081\u306b\u3001\u305d\u306e\u30d9\u30f3\u30c0\u30fc\u3068\u5171\u306b\u9060\u9694\u30b5\u30fc\u30d3\u30b9\u30e2\u30c7\u30eb<\/a>\u3092\u63a1\u7528\u3059\u308b\u81e8\u5e8a\u691c\u67fb\u5ba4\u304c\u5897\u3048\u3066\u3044\u307e\u3059\u3002\u904b\u7528\u30c7\u30fc\u30bf\u306f\u30aa\u30f3\u30e9\u30a4\u30f3\u63a5\u7d9a\u3092\u901a\u3058\u3066\u5171\u6709\u3055\u308c\u3001AI\u3092\u4f7f\u7528\u3057\u3066\u3053\u308c\u3089\u306e\u30d7\u30ed\u30bb\u30b9\u306e\u3044\u304f\u3064\u304b\u3092\u3055\u3089\u306b\u81ea\u52d5\u5316\u3057\u3001\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u8981\u4ef6\u3092\u3088\u308a\u826f\u304f\u4e88\u6e2c\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u4e00\u65b9\u3001\u3053\u308c\u3089\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306eAI\u306f\u898f\u5236\u5bfe\u8c61\u306e\u533b\u7642\u6a5f\u5668\u306b\u306f\u8a72\u5f53\u3057\u307e\u305b\u3093\u3002<\/p>\n

    \u5225\u306e\u4f8b\u3068\u3057\u3066\u3001\u30a2\u30b8\u30a2\u592a\u5e73\u6d0b\u5730\u57df\u306e\u4e00\u90e8\u306e\u533b\u7642\u7d44\u7e54\u306f\u3001AI\u30d9\u30fc\u30b9\u306e\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u3092\u6d3b\u7528\u3059\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u4f7f\u7528\u3057\u3066\u3001\u5b66\u969b\u7684\u30c1\u30fc\u30e0\u306e\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u6700\u9069\u5316\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u3046\u3057\u305f\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306f\u901a\u5e38\u3001\u672c\u8cea\u7684\u306b\u88dc\u52a9\u7684\u3067\u3042\u308b\u305f\u3081\u3001\u6bd4\u8f03\u7684\u4f4e\u30ea\u30b9\u30af\u3067\u3042\u308b\u306e\u3067\u3001\u91cd\u5927\u306a\u898f\u5236\u4e0a\u306e\u76e3\u8996\u3092\u8ab2\u3059\u53ef\u80fd\u6027\u306f\u9ad8\u304f\u3042\u308a\u307e\u305b\u3093\uff08\u6ce8\uff1a\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u8a8d\u3081\u3089\u308c\u3001\u60a3\u8005\u306e\u5b89\u5168\u6027\u306b\u5bfe\u3059\u308b\u9ad8\u3044\u30ea\u30b9\u30af\u3092\u3082\u305f\u3089\u3059\u30e2\u30b8\u30e5\u30fc\u30eb\u306f\u3001\u72ec\u7acb\u3057\u3066\u8a55\u4fa1\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\uff09\u3002<\/p>\n

    \u81e8\u5e8a\u691c\u67fb\u5ba4\u306b\u304a\u3051\u308bAI\u306e\u898f\u5236\u8981\u4ef6 \u81e8\u5e8a\u691c\u67fb\u00a0<\/strong><\/em><\/p>\n

    \u00a0<\/p>\n

    \u5ba4\u306b\u304a\u3051\u308bAI\u306e\u898f\u5236\u8981\u4ef6 \u30ea\u30b9\u30af\u7bc4\u56f2\u306e\u9ad8\u3044\u4f8b\u3067\u306f\u3001\u60a3\u8005\u30b1\u30a2\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u3001\u81e8\u5e8a\u691c\u67fb\u5ba4\u30c7\u30fc\u30bf\u3068\u30a4\u30e1\u30fc\u30b8\u30f3\u30b0\u3084\u81e8\u5e8a\u60c5\u5831\u306a\u3069\u306e\u4ed6\u306e\u8981\u56e0\u3092\u7d44\u307f\u5408\u308f\u305b\u305fAI\u30d9\u30fc\u30b9\u306e\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u3092\u958b\u767a\u3059\u308b\u533b\u7642\u6280\u8853\u4f01\u696d\u304c\u5897\u3048\u3066\u3044\u307e\u3059\uff08\u4f8b\u3048\u3070\u3001\u4e2d\u56fd\u306b\u304a\u3051\u308b\u8840\u6e05\u816b\u760d\u30de\u30fc\u30ab\u30fc\u306e\u81e8\u5e8a\u7684\u6709\u7528\u6027\u3092\u62e1\u5927\u3059\u308b\u305f\u3081\u306eAI\u4f7f\u7528\u306b\u95a2\u3059\u308b\u6700\u8fd1\u306e\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3<\/a>\uff09\u3002\u305d\u306e\u3088\u3046\u306a\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306f\u3001\u60a3\u8005\u3092\u76f4\u63a5\u8a3a\u65ad\u53ca\u3073\u30c8\u30ea\u30a2\u30fc\u30b8\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u3001\u3057\u305f\u304c\u3063\u3066\u3001\u3088\u308a\u5927\u304d\u306a\u76e3\u8996\u53ca\u3073\u898f\u5236\u3092\u53d7\u3051\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

    \u533b\u7642AI\u306e\u898f\u5236\u306f\u307e\u3060\u521d\u671f\u6bb5\u968e\u306b\u3042\u308b\u304c\u3001\u900f\u660e\u6027\u3068\u8aac\u660e\u53ef\u80fd\u6027\u306f\u3001\u30a2\u30b8\u30a2\u592a\u5e73\u6d0b\u3001\u6b27\u5dde\u3001\u7c73\u56fd\u306b\u304a\u3051\u308b\u73fe\u5728\u306e\u67a0\u7d44\u307f\u306e\u4e2d\u3067\u7e70\u308a\u8fd4\u3057\u898b\u3089\u308c\u308b2\u3064\u306e\u539f\u5247\u3067\u3059\u3002\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u304c\u81ea\u5206\u3067\u6c7a\u5b9a\u3092\u4e0b\u3059\u3053\u3068\u304c\u3067\u304d\u308b\u5834\u5408\u3001AI\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u304c\u7279\u5b9a\u306e\u6c7a\u5b9a\u306b\u3069\u306e\u3088\u3046\u306b\u5230\u9054\u3057\u305f\u304b\u3092\u4eba\u9593\u304c\u660e\u78ba\u306b\u7406\u89e3\u3067\u304d\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u4fe1\u983c\u3092\u69cb\u7bc9\u3059\u308b\u3053\u3068\u306b\u52a0\u3048\u3066\u3001\u305d\u306e\u52d5\u4f5c\u306b\u304a\u3044\u3066\u900f\u660e\u306aAI\u306f\u3001\u30e6\u30fc\u30b6\u304c\u30e2\u30c7\u30eb\u306e\u554f\u984c\u3092\u4fee\u6b63\u3057\u3001\u305d\u306e\u80fd\u529b\u3092\u7d99\u7d9a\u7684\u306b\u6539\u5584\u3059\u308b\u3053\u3068\u3092\u53ef\u80fd\u306b\u3057\u307e\u3059\u3002<\/p>\n

    \u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8<\/h3>\n
      \n
    • AI\u306e\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u306b\u304a\u3051\u308b\u898f\u5236\u306f\u3001\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u306e\u9069\u683c\u6027\u3068\u60a3\u8005\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u306e\u30ec\u30d9\u30eb\u306b\u3088\u3063\u3066\u6c7a\u5b9a\u3055\u308c\u308b<\/li>\n
    • \u30c7\u30fc\u30bf\u96c6\u7d04\u30c4\u30fc\u30eb\u304a\u3088\u3073\u9060\u9694\u6a5f\u5668\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u306f\u3001\u898f\u5236\u3092\u5fc5\u8981\u3068\u3057\u306a\u3044\u81e8\u5e8a\u691c\u67fb\u5ba4\u306b\u304a\u3051\u308b\u4f4e\u30ea\u30b9\u30afAI\u30d9\u30fc\u30b9\u88fd\u54c1\u306e\u4f8b\u3067\u3042\u308b<\/li>\n
    • \u30d8\u30eb\u30b9\u30b1\u30a2\u306b\u304a\u3051\u308bAI\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u304b\u3089\u306e\u4fe1\u983c\u3092\u5f97\u308b\u305f\u3081\u306b\u3001\u8aac\u660e\u53ef\u80fd\u3067\u900f\u660e\u6027\u304c\u5fc5\u8981\u3067\u3042\u308b<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

      2018\u5e74\u4ee5\u6765\u3001\u4eba\u5de5\u77e5\u80fd\uff08AI\uff09\u3092\u30d9\u30fc\u30b9\u3068\u3057\u305f\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308bFDA\u306e\u627f\u8a8d\u304c\u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u81e8\u5e8a\u691c\u67fb\u5ba4\u3067\u4f7f\u7528\u3057\u305f\u308a\u3001\u81e8\u5e8a\u691c\u67fb\u5ba4\u306e\u30c7\u30fc\u30bf\u3092\u6d3b\u7528\u3057\u305f\u308a\u3067\u304d\u308bAI\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306e\u5897\u52a0\u304c\u542b\u307e\u308c\u307e\u3059\u3002 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