Levels of conceptual interoperability model for healthcare framework for safe medical device interoperability

The Medical Device and Healthcare Information Technology (HIT) industries have not achieved safe PNP cross-manufacturer (heterogeneous) interoperability although it has been achieved decades ago in other safety critical industries. We believe that the Levels of Conceptual Interoperability Model (LCIM) [1] offers an essential account of the disparity and thereby offers insight for how to achieve safe PNP cross-manufacturer interoperability in HIT. The LCIM is a conceptual framework for interoperability first developed for military simulation and modeling. We have expanded its scope and detail while applying it to medical devices. Our results show that safe interoperability minimally requires system components that are aligned about a conceptual model (i.e. manufacturers are operating at level 6). Furthermore, such devices can be assured to be safely interoperable cross-manufacturer only if different manufacturers share the conceptual model embodied by the communicating devices. We identify some root causes preventing this realization.