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National Health Act, 2003 (Act No. 61 of 2003)


Norms and Standards Regulations Applicable to Different Categories of Health Establishments, 2017

Clinical Governance and Clinical Care

6. User health records and management


(1) The health establishment must ensure that health records of health care users are protected, managed and kept confidential in line with section 14, 15 and 17 of the Act.


(2) For the purposes of sub-regulation (1), the health establishment, must—
(a) have a health record filing, archiving, disposing, storage and retrieval system which complies with the law;
(b) ensure confidentiality of health records; and
(c) secure health records with appropriate security control measures in the records storage area and in the clinical service area in accordance with the Protection of Personal Information Act, 2013 (Act No. 4 of 2013).


(3) The health establishment must create and maintain a system of health records of users in accordance with the requirements of section 13 of the Act.


(4) For the purposes of sub-regulation (3), a health establishment must—
(a) record the biographical data of the user and the identification and contact information of the user and his or her next of kin; and
(b) record information relating to the examination and health care interventions of users.


(5) The health establishment must have a formal process to be followed when obtaining informed consent from the user.


(6) The health establishment must issue a discharge report to users in accordance with section 10 of the Act.