+1. General requirements
---+1.1. The harmonised software components of an EHR system shall achieve the performance intended by …
---+1.2. The harmonised software components of the EHR system shall be designed and developed in such a …
---+1.3. An EHR system shall be designed and developed in such a way that its interoperability, safety …
---+1.4. The harmonised software components of an EHR system that is intended to be operated together …

1. General requirements

1.   General requirements

1. Overview

,
1.1. The harmonised software components of an EHR system shall achieve the performance intended by …

1.1.

 The harmonised software components of an EHR system shall achieve the performance intended by its manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose and their use does not put at risk patient safety.
1.2. The harmonised software components of the EHR system shall be designed and developed in such a …

1.2.

 The harmonised software components of the EHR system shall be designed and developed in such a way that the EHR system can be supplied and installed, taking into account the instructions and information provided by the manufacturer, without adversely affecting its characteristics and performance during its intended use.
1.3. An EHR system shall be designed and developed in such a way that its interoperability, safety …

1.3.

 An EHR system shall be designed and developed in such a way that its interoperability, safety and security features uphold the rights of natural persons, in line with the intended purpose of the EHR system, as set out in Chapter II.
1.4. The harmonised software components of an EHR system that is intended to be operated together …

1.4.

 The harmonised software components of an EHR system that is intended to be operated together with other products, including medical devices, shall be designed and manufactured in such a way that interoperability and compatibility are reliable and secure, and personal electronic health data can be shared between the device and the EHR system in relation to those harmonised software components of an EHR system.

1.1 References

1.2 Identified Requirements

1.3 Related Standards

2. Identified Requirements

Requirements

3. Related Standards

Standards