论病历封存法律制度的不足与完善——兼论《医疗机构病历管理规定(2013年版)》之缺陷

Shortages and Improvements of Legal System of Sealing Medical Record in China:Discussion on Defects of Regulations of Medical Record Management(2013 Version)

病历封存对于客观、公正处理医疗纠纷与医疗诉讼有着非常重要的意义。《医疗机构病历管理规定(2013年版)》是2002年版的修订,单方封存和分段封存的规定是对原病历封存制度的完善,但其规定只能封存复印件属于违法,关于病历封存的其他规定过于简单。法律应当规定医疗机构对病历封存的告知义务,病历封存的对象应当是全部病历原件,电子病历封存应当附有修改日志,应当规定病历封存和启封程序及制作封存笔录,病历封存期限以2年为限,违反病历封存应当承担法律责任。

Sealing medical record plays a significant role in the objective and justice resolving of medical disputes. ＂Regulations of Medical Record Management （2013 version）＂ is the amendment for the version of 2002. The provisions of unilateral seal and segmented seal are the improvements of the formal medical record sealing regulation. However, the provision of only sealing the copy of medical records violates the law, and the other provisions are too simple. The law should stipulate medical institutions~ obligation to inform patients of the regulation of medical record sealing, and the sealed medical records should be all original medical records. Furthermore, the electronic medical records storage should be attached to the change log. Besides, the procedures of sealed and unsealed records should be established, including keep notes for every step. The sealed records period should be limited to two years and any violation of sealed medical record provisions should be taken legal liability.