Author: Michael Hathaway, Co-Founder, CEO
The management of data from clinical trials of medical devices and treatments presents several challenges. These include ensuring that data is accurate and not tampered with, maintaining the privacy of trial participants, and managing access to trial data across a diverse group of stakeholders, which include contracted research and manufacturing organizations (CROs & CMOs), clinicians, pharmaceutical or medical device manufacturers and regulators.
Weak links in these systems include data and access security, identity management, and data integrity management. The incorporation of IoT medical devices further complicates matters due to inconsistent and inadequate security of these devices.
The suite of identity management solutions offered by the Cognida Platform establishes a single digital identity for all stakeholders and participants which can be used across all systems utilized in clinical trials. These identities, associated with a public/private key, are stored on a blockchain ledger to prevent identity tampering and enforce identity authorization across all databases, IoT devices and systems used in clinical trials. Identities are stored as digital addresses on the system, enabling anonymity to be maintained as required to protect the privacy of trial participants.
Cognida partnerships with private key management solution providers offering a range of private key security solutions to insure identities remain secure.
Sources of data, including databases and IoT devices also have digital identities. The Cognida Platform integrates solutions enabling digital signatures for all data sourced from these devices and systems. These measures further enhance data integrity through the validation of the sources of data.
Cognida utilizes blockchain technology to further enhance data integrity by storing hashes of data and data access logs onto an immutable blockchain ledger. This provides tools to detect any tampering of stored data or data access logs.
The Cognida Platform provides blockchain secured document data and messaging services which can be flexibly hosted in the cloud or enterprise. Security policies and access to data records, logs and messaging systems are enforced using Cognida security offload technology, which utilize blockchain as the back end database for identity management and access controls.
For the CROs & CMOs, clinicians, pharmaceutical or medical device manufacturers and regulators this means:
The suite of solutions provided by the Congida Platform leverages blockchain technology to significantly enhance identity security and privacy, enforce data access policies across all Cognida connected systems, validate data at its source, and detect any tampering or alteration of data and data access logs. This results in significantly reduced costs for identity and data management.