オープンシステムについて
1997年にFDAが施行した21 CFR Part 11 「電子記録・電子署名」では、クローズドシステムとオープンシステムが区別されている。
クローズドシステムとは、企業が管理できる範囲のネットワークの内側に存在するシステムのことである。LANやイントラネットといったものが相当するだろう。
一方で、オープンシステムとは、インターネットのような企業が管理できない範囲のネットワークに電子記録を委ねるものである。
オープンシステムというシステムは恒久的には存在していない。クローズドシステムとクローズドシステムをインターネットで接続した際などにオープンシステムが構築されるのである。
例えば、ネットで航空券や新幹線チケットを予約・購入したり、AMAZONや楽天などでショッピングするなどはその例である。
その際に、多くの場合、クレジットカード番号などの重要な情報をインターネットに流すことになる。
しかしながら、インターネットの世界には盗聴・改ざん・なりすましといった3つのリスクが存在する。
例えば、クレジットカード番号や暗証番号を盗み取られてしまうリスクがある訳だ。
そこでPart11では、オープンシステム(インターネット)を介して電子記録を送受信する場合は、暗号化やデジタル署名の利用を要求している。
暗号化やデジタル署名の利用といっても難しいことではない。Part11発行当時から存在したSSL(Secure Socket Layer)という技術を使えば良い。
SSLでは、ユーザが気付かないまでも、暗号化やデジタル署名といった技術を使用しているのである。
現在となっては、SSLの使用は常識である。
なお、デジタル署名と電子署名は異なるので注意が必要だ。 Part11は未来を予測して作成されたものであったが、25年が経った今ではそのほとんどが常識となっている訳である。
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