+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 …

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. Overview

,
Summary Regulation

1.1 References

1.2 Identified Requirements

1.3 Related Standards

2. Identified Requirements

Requirements
Source Requirement

3. Related Standards

Standards
Source Requirement