PD CEN ISO/TS 14441:2013

1   Scope This Technical Specification examines electronic patient record systems at the clinical point of care that are also interoperable with EHRs. Hardware and process controls are out of the scope. This Technical Specification addresses their security and privacy protections by providing a set of security and privacy requirements, along with guidelines and best practice for conformity assessment .

ISO/IEC 15408 (all parts) defines “targets of evaluation” for security evaluation of IT products . This Technical Specification includes a cross-mapping of 82 security and privacy requirements against the Common Criteria categories in  (all parts). The point-of-service (POS) clinical software is typically part of a larger system, for example, running on top of an operating system, so it must work in concert with other components to provide proper security and privacy. While a Protection Profile (PP) includes requirements for component security functions to support system security services, it does not specify protocols or standards for conformity assessment , and does not address privacy requirements. This Technical Specification focuses on two main topics: