Sixgill Provides Blockchain-Enabled Data Integrity for Litmus Health Clinical Trial Analytics and Data Streams
Sixgill, LLC, the leader in sensor data services for governing Internet of Everything (IoE) assets, today announced Litmus Health will adopt Sixgill Integrity to provide blockchain data accuracy and consistency for its clinical data science platform. The combination of Sixgill’s data integrity innovation and Litmus’ data science expertise will provide a powerful solution for secure clinical trials data processing and analytics.
The power and flexibility of the Sixgill-Litmus solution will enable sensor data collection, storage, and real-time and historical analysis grounded by absolute confidence of the authenticity of the clinical data chain. With Sixgill Integrity, data authenticity is ensured, trial accuracy is maintained, and clinical truth is secured. Integrated with the Litmus clinical data science platform, Sixgill Integrity will enable:
- Safeguarded data veracity
- Validated device authenticity
- Continuous regulatory-grade audit trails for clinicians
- Automated, near real-time alerts of any data compromise
A device- and ledger-agnostic solution, Sixgill Integrity is designed from the ground up to solve the fundamental need for an end-to-end, real-time sensor data authenticity system. With Integrity, the Litmus platform will provide clinicians with assurance that emitted data, transmitted data, ingested data and acted-upon data are the same.
“Sixgill Integrity protects against the demonstrated reality that digital systems security is an illusion. Data, however, is defensible,” says Phil Ressler, CEO of Sixgill, LLC. “Healthcare industry data is especially personal, vulnerable and regulated. The goal of our exciting work with Litmus Health is to deliver unparalleled security, transparency and immutability necessary to validate, secure and defend painstakingly gathered and rigorously audited clinical data.”
Through the Sixgill-Litmus partnership, clinicians will reliably comply with Title 21 CFR Part 11 regulations when conducting clinical trials.
Part 11 of Title 21 of the Code of Federal Regulations establishes the United States Food and Drug Administration regulations on electronic records. Part 11 defines the criteria for electronic records and electronic signatures to be considered trustworthy, reliable and equivalent to paper records. Litmus customers using electronic Patient Reported Outcome (ePRO) data and data from wearables, smart devices and home sensors will benefit from new ways to save time and lower costs, such as:
- Efficiency of having one, consistent source of data quality and assurance
- Permanent, regulatory-grade auditability, traceability and certainty
- Streamlined quality and process automation
- A breakthrough hybrid on-chain/off-chain approach to blockchain-enabled integrity that protects privacy and enables real-time performance at scale
- Improved data security with tamper-proof, auditable logs of time-series data and near-real-time notification of changes
“We know how pressing concerns of data accuracy and consistency are to our customers, which is why the Litmus platform has always offered a stack that emphasizes traceability and transparency within clinical trial data streams. With the implementation of Sixgill Integrity, we’re pleased to offer clinicians and researchers continuous auditability of their clinical data chain,” says Daphne Kis, CEO of Litmus Health. “This collaboration with Sixgill will accelerate the adoption and integration of novel endpoints by researchers while strengthening the integrity of data captured during clinical trials and observational studies.”
Through this new collaboration, Sixgill seeks to prove that live, trustless audit immutability is feasible for any data system, and Litmus seeks to prove that federally regulated healthcare data projects can meet or exceed data authenticity mandates.
The combined data aggregation, analysis and integrity solution for clinical trials will be fully tested and generally available in Q1 2019.
Sixgill builds universal sensor data automation services that enable organizations to govern IoE assets. Sixgill Sense™ offers developers the ability to easily acquire, analyze and act on any sensor-generated data, at any velocity or scale. Sense offers customers a single powerful platform to unify sensor data management, process automation and analytics for all sensor-informed applications. Other Sixgill products provide blockchain-based sensor data integrity and extend the power of sensor data automation to the edge of a network. To learn more, visit Sixgill.com.
About Litmus Health
Litmus Health is research-ready infrastructure for real life data. We help our customers understand patient behavior and environment in multiple dimensions. We use real life data collected at the point of experience from wearables, smart devices, and home sensors to guide management and to inform both new and traditional endpoints. We help our customers describe the full value of their work in observational studies, therapeutical trials, and post-market research. From small observational studies to large scale registries, we help researchers unlock fundamentally new insights from remote and telemetric patient data. To learn more, please visit: litmushealth.com.
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