FISMA Alignment

Trialinx aligned with FISMA and NIST RMF

Security controls aligned with NIST SP 800-53 and the Risk Management Framework. Relevant for US federally-funded research.

Federal Information Security Management Act · Estados Unidos (gobierno federal)

What is FISMA

FISMA (Federal Information Security Management Act, 2002) requires US federal agencies to establish information security programs. Implementation relies on the NIST Risk Management Framework and the NIST SP 800-53 control family.

For researchers funded by federal agencies (NIH, VA, DoD), systems handling study data typically must align with these controls, often through FedRAMP authorization.

Key NIST SP 800-53 controls

System categorization (FIPS 199)

Classify data as low, moderate, or high impact on availability, integrity, and confidentiality.

Control selection and tailoring

Select baseline controls based on categorization and tailor them to the organization.

Access control (AC family)

Account control, least privilege, separation of duties, remote access, mobile devices.

Audit and accountability (AU family)

Audit trail with specific events, automated generation, protection, retention, and periodic review.

Incident response & continuity (IR, CP families)

Incident response plan, contingency plan, operational continuity.

Continuous monitoring

Monitoring program with metrics, periodic vulnerability scans, reporting to authorities.

How Trialinx meets it

✓Detailed audit trail by user/entity/action (AU-2, AU-3)
✓RBAC with least privilege (AC-6)
✓MFA on privileged accounts (IA-2)
✓Encryption at rest and in transit (SC-13, SC-28)
✓NIST 800-63B compliant password policies (IA-5)
✓Continuous dependency scanning with weekly patch cycle (RA-5, SI-2)
✓Documented incident response process (IR-4, IR-8)
✓Architecture documentation available under NDA for federal sponsors

Shared responsibility

FISMA is a framework for federal agencies and contractors. Trialinx is not currently FedRAMP-authorized, but our technical controls align with most NIST SP 800-53 Moderate-baseline requirements.

For research requiring a formally FedRAMP-authorized system, the path is a project-specific ATO (Authority to Operate) via our infrastructure provider and documentation supplements from the investigator.

•Trialinx provides base technical controls
•The federal project selects and tailors controls
•The federal project supplies categorization documents and POA&M
•Share specific federal needs on Institutional for a plan

Frequently asked questions

Is Trialinx FedRAMP-authorized?

Not currently. If your project requires a FedRAMP-certified system, contact us — we can explore paths like subcontracted certified infrastructure for specific cases.

Which NIST 800-53 baseline does Trialinx cover?

Our technical controls cover most of the Moderate baseline in AC, AU, IA, SC, and SI families. Complete mapping docs are delivered under NDA on Institutional.

What's the difference between FISMA and HIPAA?

HIPAA protects medical information (PHI). FISMA protects federal information systems. For clinical research funded by NIH/VA/DoD, both typically apply.

Official resources

Need the package for your ethics committee or DPO?

Request documentation