Annex II points 1 and 2: harmonised components perform as intended without risk to patient safety, install without degrading performance, uphold the rights in Chapter II and interoperate reliably with other products; a system that stores or intermediates data provides an interface giving access to, and receives, data in the exchange format through the interoperability component; one that provides access receives such data; structured entry is granular enough to produce the exchange format; and no feature may prohibit, restrict or unduly burden authorised access, sharing, permitted use or export for replacing the system.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.