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    基于信息安全技術的電子病案管理

    時間:2013-07-23 15:43:39  來源:  作者:韓立煬
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    基于信息安全技術的電子病案管理
    前言
    病案是記錄醫院門診和住院病人的就診記錄、治療全過程的重要資料,是醫院固有醫療活動的主要信息載體,是臨床醫療、教學和科研最基礎的原始資料,是重要的法律文件, 同時也是社會醫療保險支付的依據。病案在醫院信息中占有極為重要的地位,將成為醫學領域的重要部分。長期以來,紙張是病案信息的惟一載體,隨著病案的逐年增多,紙張病案給病案管理工作帶來諸多問題,因此,只有加速病案管理的現代化進程,才能使病案信息真正為醫院的發展提供有效服務。
    應用現狀及分析
    目前各醫院基本都已建立了病案管理系統,其設計目標是立足于對紙質病案的檔案管理,主要功能包括病人主索引、病案追蹤、首頁管理、質量控制四個部分。 其主要特點有:建立、修改、查詢病人主索引,為各部門提供最基本的病人基本信息;建 立病案借閱檔案,完成批借閱、個別借閱、在借病案、病案歸還等信息的登記、查詢、打印;期內首頁錄入、過期首頁錄入;病案首頁數據的查詢檢索、分類統計、打印輸出各種病案信息登記表;質控指標錄入、單病案質量評價、分類質量評價、綜合查詢打印等功能。
    病案電子化的一種方式是微縮照相,這也是紙質病案的一種電子化存儲方式。縮微技術是通過光學影像拍攝技術,把需要保存的文獻拍攝到較小的膠片上,以便保存。其一般工作流程為:病案整理→拍照→膠片沖洗→按每份病案分裝封套→保存→閱讀(在閱讀機上)。縮微膠片的保管:必須有合適的溫度,濕度,懸浮顆粒度,光線照射度等條件。縮微資料的法律地位:根據我國的檔案法,縮微膠片及其復印件與原件具同等的法律效力。
    隨著電子病歷系統在醫院的應用和普及,越來越多的信息在其產生源頭就已經電子化普及,例如醫院信息系統(HIS)、電子病歷系統(EMR)、影像傳輸系統(PACS)、檢驗系統(LIS)、手術麻醉系統(OIS)等,這些系統產生了大量的數據,不僅包括了紙張病案的所有內容,而且還包括圖像、視頻、音頻、設備數據等大量信息,其內容已經遠遠超越了紙質病案的內容。因此,電子病案的管理與應用具有廣闊的發展前景,數字化的病人全信息集合必將成為醫院臨床診療、臨床科研和信息共享的核心。
    電子病案管理
    按照現行法律,只有紙質病案具有法律效力,在醫療糾紛中仍然承擔著主要的法律證據,在未來的一段時間內,還將采取紙質病案和電子病案并存的方式。但是原來紙質病案的管理方法已不適用于新的電子病案的管理方法,在此呼吁國家衛生管理部門和信息安全部門應盡快出臺相關的管理規定。筆者對電子病案管理的想法和見解如下:
    技術層面
    由于電子病案牽涉到個人隱私,其法律作用日益重要。隨著人們對法制和自我保護意識的增強,病案作為法律依據文件還被社會廣泛應用,不僅對醫療糾紛取證、公檢法立案調查取證、交通事故取證、社會醫療保險取證等起著舉足輕重的法律憑證作用,還在健康保險、傷殘鑒定、遺產繼承等民事、刑事案件的訴訟中具有重要的法律效力作用。因此電子病案應采取嚴格的信息安全技術。
    電子病案系統中的電子簽名技術,以電子形式代表與電子病案有聯系的簽名者,并鑒別和表明此人認可該電子病案所含信息。時間戳服務器是一款基于PKI(公鑰密碼基礎設施)技術的時間戳權威系統,對外提供精確可信的時間戳服務。它采用精確的時間源、高強度高標準的安全機制,以確認系統處理數據在某一時間的存在性和相關操作的相對時間順序,為信息系統中的時間防抵賴提供基礎服務。在電子病歷系統中,提供有效的時間認證,可以確保電子病歷中關鍵信息(如:醫囑等)的時間合法性。
    電子病案中的簽字一般發生在以下幾種情形:一是病案簽收,即醫務人員書寫電子病案后,使用電子簽字對內容進行確認;二是醫療機構合法執業的醫務人員對實習醫務人員、試用期醫務人員書寫的電子病案,經審閱、修改后以電子簽字方式審核。三是修改簽字,電子病案修改后經修改者電子簽字并保留修改痕跡方可生效。電子簽名可以確認簽名者的身份,表明簽名者對電子數據內容的認可,確保原始文件的完整性和真實性。電子簽名和時間戳技術在電子病案中的綜合應用,既可以保證電子病案內容的機密性及一致性,又可以保證電子病案至最終形成時的完整性,防止簽名者對其電子簽名的抵賴。安全的電子簽名與時間戳服務可以達到與手寫簽名同等的法律效力。
    在我國當前的醫院信息化應用中,電子病案的數據大部分保存在電子病歷系統數據庫中,而非全部數據。病案數據分為兩大類,一類是文件,一類是數據。不管是文件還是數據,都應該集中、統一存儲在一個物理數據庫中。建立完整的數據安全備份機制,配之以完善的加密、審計機制,確保數據安全。對訪問者應設定嚴格的權限,一旦患者出院歸檔,該患者的所有電子病案都不允許修改,調閱、打印的權限需要定義到每個訪問者和每個文件,任何一次的訪問及調閱記錄都應被日志記錄下來。
    電子病案應作成永久保存處理。患者出院要求打印的病歷內容需做嚴格規定,可以打印的有,入院記錄、體溫單、醫囑單、各類報告單、各類同意書、手術及麻醉單記錄、護理記錄、出院記錄,除此之外其它項目不予打印,打印后應有電子記錄。電子病案歸檔后,調閱或復制的病案需要保留操作痕跡。電子病案需定義對外開放的內容,用于患者瀏覽及區域醫療共享。病歷文檔質控部分的功能由電子病歷應用系統完成,同時,需要對臨床數據應用、臨床科研應用和病案統計分析設計專用的數據庫系統,與電子病案系統物理分離。
     
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