The MD PnP Program has had an ongoing relationship with FDA to pursue a definition of the regulatory pathway for integrated medical device systems.
We worked with the FDA to form a Medical Device Interoperability Coordination Council (MDICC) to synchronize the multitude of efforts currently being pursued by different groups around device interoperability. Dr. Julian Goldman is leading the MDICC group on Clinical Landscape & Clinical Needs, contributing our Quantum scenarios and others collected by our MD PnP program.
The Clinical Needs & Clinical Landscape team, under Dr. Goldman’s guidance, is compiling clinical examples that demonstrate clinical benefits that could be realized from interoperable medical devices. Identifying currently available capabilities as well as future needs (or gaps). Given the nascent state of medical device interoperability, articulation of future (desired) states is especially important to ensure that proposed technical solutions and standards will yield useful clinical capabilities. The future-state clinical scenarios will include interoperability among medical devices, among components of integrated medical device systems, among medical devices and EHRs, among medical devices and hospital IT / CIS systems, and among (personal) medical devices and telehealth data hubs.
The objective statement and more information about MDICC CNCL team can be found here.