The IEEE Standards Association (IEEE SA) pre-standards workstream for Clinical Internet of Things (IoT) data validation and interoperability with blockchain was initiated to determine if a viable standards framework could be established to enable the validation of data generated from a clinical-grade IoT device and shared through the interoperability of blockchain technology. Participants in the workstream were gathered from an IEEE SA workshop held at Johns Hopkins University in Rockville, Maryland in April 2018, and grew to include their network of healthcare and Health-IT ecosystem players, as well as participants in prior IEEE SA efforts in related areas. The workstream commenced in August 2018 and completed in February 2019. Participants in this pre-standards workstream who are the authors of this paper are listed in Appendix A. The pre-standards workstream led to the recommendation of the development of an IEEE SA Standards effort on Clinical IoT data and device interoperability with TIPPSS-Trust, Identity, Privacy, Protection, Safety and Security-in connected healthcare to improve data sharing and healthcare outcomes. The pre-standards workstream team decided that blockchain is not necessary for clinical IoT data and device interoperability and validation, nor does it necessarily meet the robust TIPPSS needs in connected healthcare. The workstream recommendation includes a draft TIPPSS Architectural Framework for Clinical IoT data validation & interoperability, which could include digital ledger technology but does not need to do so. The resulting IEEE Standards Association P2733 working group to develop a standard for Clinical IoT Data and Device Interoperability with TIPPSS kick off meeting is scheduled for July 17, 2019, sponsored by the IEEE SA Engineering in Medicine and Biology Society (EMBS).
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