As clinical trials have
become increasingly complex,
building systems that can address
privacy and security concerns are
paramount for driving collaboration that
can accelerate therapies to market.
The ability to quickly and cost
effectively deliver new drugs to
market and help ensure safety, is
one of the greatest challenges faced
by the health care ecosystem today.
Real World Data (RWD) has the potential
to increase the efficiency of the
traditional drug development process and
improve future clinical trial design.
At Leidos, we've been looking for
ways to streamline and accelerate the
clinical drug trial and approval process.
A huge challenge we have found is
gathering real-world data from hospitals,
clinics, and medical groups.
This must be accomplished while
preserving patient privacy and complying
with HIPAA and other regulations.
We have partnered, with Intel,
Microsoft and Fortanix to develop a
reference architecture for collecting
and analyzing real-world data securely.
We have integrated medical images
and electronic health records using
a standard common data model form.
We used Intel Software Guard extension
enclaves, also known as Intel SGX.
Orchestrated using Fortanix,
Confidential computing manager.
to create a distributed,
trusted computing infrastructure
that provides a secure service for
conversion management and sharing
of DICOM healthcare image data.
We created a centralized research
portal using Intel SGX to capture,
anonymize, encrypt,
and analyze protected health care data.
These secure enclaves at distributed
real-world data endpoints receive queries,
verify policy approvals,
gather data,
and return requests to the centralized
portal for aggregated analysis.
This network is running on Azure
confidential computing infrastructure
with full auditability using the
Fortanix data security manager as
a centralized key management system
running on Azure confidential
computing with Intel SGX.
Clinical data is tokenized and remains
encrypted at rest in transit and in use,
allowing agencies like the FDA,
CDC,
and NIH to drive better health care outcomes.