Scrybe: A Secure Audit Trail for Clinical Trial Data Fusion
This addresses regulatory compliance and security issues for clinical trial researchers, but it is incremental as it builds on existing blockchain concepts for a specific domain.
The paper tackles the challenge of securing clinical trial data from wearable IoT devices by proposing Scrybe, a permissioned blockchain system for audit trails, and demonstrates tamper resistance through a proof-of-concept integration with REDCap.
Clinical trials are a multi-billion dollar industry. One of the biggest challenges facing the clinical trial research community is satisfying Part 11 of Title 21 of the Code of Federal Regulations and ISO 27789. These controls provide audit requirements that guarantee the reliability of the data contained in the electronic records. Context-aware smart devices and wearable IoT devices have become increasingly common in clinical trials. Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS) do not currently address the new challenges introduced using these devices. The healthcare digital threat landscape is continually evolving, and the prevalence of sensor fusion and wearable devices compounds the growing attack surface. We propose Scrybe, a permissioned blockchain, to store proof of clinical trial data provenance. We illustrate how Scrybe addresses each control and the limitations of the Ethereum-based blockchains. Finally, we provide a proof-of-concept integration with REDCap to show tamper resistance.