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Amended Medical Records Administration Measures Strengthens Protection for Patients’ Personal Information

2013.12.30 DONG, Xiao (Marissa)、Yuan, Qiong

The amended Medical Records Administration Measures of Medical Institutions (the “New Measures”) was issued by the National Health and Family Planning Commission (“NHFPC”) and the State Administration of Traditional Chinese Medicine on December 17, 2013, and will become effective from January 1, 2014.


The following points in the New Measures are notable:-:

  • It has included electronic medical records as a new type of medical records, in addition to paper-based medical records, and set forth the requirements for keeping electronic medical records;

  • It strictly prohibits the leakage of patients’ medical records information for purposes of teaching or research, or which are not related to medical treatment;

  • It has included more specific and stricter requirements and procedures for reviewing, borrowing or copying medical records.


These changes are consistent with the Measures for Administration of Personal Health Information issued this November by NHFPC for public comments, which has included electronic medical records as a type of personal health information and requires data subject’s consent for collection, and prohibit duplication, amendment or deletion of such information by any person without proper authorization.


The New Measures includes more practical and specific requirements on protection of patients’ privacy rights compared with the 2002 version.  However, there is no specific administrative penalty being provided thereunder, and it is still to be tested in practice.

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