FISMA for US federal clinical research

When FISMA applies, NIST SP 800-53 requirements, and Trialinx alignment.

FISMA as federal framework

FISMA (2002, modernized 2014) requires US federal agencies to establish information security programs. Implementation relies on NIST Risk Management Framework and NIST SP 800-53 family.

For NIH, VA, or DoD-funded research, systems handling study data typically must align with these controls, often through FedRAMP authorization.

FISMA-relevant scenarios

•NIH, VA, DoD-funded research
•Systems processing federal CUI
•Federal agency contracts

NIST SP 800-53 alignment

✓AC, AU, IA, SC, SI control families at Moderate baseline
✓MFA + NIST 800-63B password compliance
✓AES-256 + TLS 1.2+ encryption (SC-13, SC-28)
✓Detailed auditing (AU-2, AU-3)
✓Continuous dependency scanning (RA-5, SI-2)

FAQ

Does Trialinx have FedRAMP ATO?

Not currently. For FedRAMP-requiring projects contact us — we can explore certified infra subcontracting.

Need specific documentation?

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