Certification standards

Standards are developed by dividing the areas of EMR system certification into three: functionality, interoperability and safety & security.

• Functionality (62 items)

  Definition

  Performance of EMR system required for generating and managing medical information

  Major content

  Review on whether to apply essential functions of EMR system such as generation, storage and management of medical record and selective functions linked with advanced medical service such as clinical decision making.

• Interoperability (10 items)

  Definition

  Function to exchange information among more than two EMR systems or EMR system components and utilize exchanged information

  Major content

  Examine whether the function required by Health Information Exchange Standard of the Ministry of Health and Welfare can be applied to enable exchange of medical information between medical institutions

• Safety & security (14 items)

  Definition

  Function of EMR system to provide administrative, physical and technical security and personal information protection

  Major content

  Review whether technical security is provided to EMR system, whether technical, administrative and physical security is provided to products stored outside and compliance with applicable laws including Personal Information Protection Act

Certification type

It is divided at the type and size of medical institutions where EMR system is applied. Dental clinics, oriental medicine clinics and nursing hospitals are excluded from review temporarily.

• Type 1

  Grade applicable to systems mainly used by clinic level medical institutions

• Type 2

  Grade applicable to systems used in hospitals and general hospitals with less than 300 beds

• Type 3

  Grade applicable to system used in general hospitals with more than 300 beds * Type 2 hospitals can apply for certification for type 3

Classification of functionality certification criteria by certification type

• The functionality certification criteria have been developed based on domestic and overseas certification system and criteria. As there are differences in functionalities exist depending on the type and roles of medical institutions, certification review is conducted case by case where some criteria are either selected as mandatory or selective depending on the type of certification application.