Summary
The President’s Precision Medicine Initiative (PMI) is “enabling a new era of clinical care
through research, technology, and policies that empower patients, researchers, and
providers to work together toward the development of individualized care”.
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Its
commitment to privacy and security in the setting of responsible data sharing and
transparency is articulated in the “Privacy and Trust Principles”
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and the “Data Security
Policy Principles and Framework”
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, developed by an interagency working groups including
the Office of the National Coordinator for Health Information Technology in conjunction
with multiple stakeholders.
In this paper, we review the threats to the security, confidentiality, integrity, and availability
of PMI data. PMI organizations can mitigate these challenges through a new system
architecture in development at MIT -- the OPAL/Enigma project
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-- which creates a peer-to-
peer network that enables parties to jointly store and analyze data with complete privacy,
based on highly optimized version of multi-party computation with a secret-sharing. An
auditable, tamper-proof distributed ledger (a permissioned blockchain) records and controls
access through smart contracts and digital identities. We conclude with an initial use case
of OPAL/Enigma that could empower precision medicine clinical trials and research.
MIT’s OPAL/Enigma challenges traditional data security paradigms. Centralized databases
cannot assure security and data integrity, regardless de-identification and controlled access
requirements. Safe, vetted queries that are distributed to private, encrypted databases
assure that organizations and participants can share health care data with cryptographic
guarantees of privacy with various stakeholders, assuring momentum for a new era of
medical research and practice.
