FedRAMP
U.S. government-wide program that standardizes security assessment, authorization, and continuous monitoring for cloud services sold to federal agencies.
Definition
FedRAMP (Federal Risk and Authorization Management Program) is the U.S. federal government's standardized approach for assessing and authorizing cloud services. Cloud Service Providers (CSPs) work with a Third Party Assessment Organization (3PAO) to evaluate a defined set of NIST SP 800-53 controls (tailored to the FedRAMP Low, Moderate, or High baseline) and receive an Authorization to Operate (ATO) from either an individual agency or the Joint Authorization Board. Once authorized, a CSP's package can be reused by other agencies, a 'do once, use many times' model.What this means in practice
For MedTech, FedRAMP becomes relevant when selling cloud-hosted SaMD, AI/ML platforms, RPM services, or clinical trial software to the VA, IHS, DoD/MHS (Military Health System), or any HHS agency. The VA and DoD increasingly require FedRAMP Moderate as a baseline for any cloud service handling veteran or service member health data. Even private-sector hospitals are starting to reference FedRAMP Moderate as a credibility marker for cloud-hosted device backends.Examples
- A company developing a cloud-based Software as a Medical Device (SaMD) for diagnostic imaging analysis pursues FedRAMP Moderate authorization to qualify for contracts with the Department of Veterans Affairs (VA) for its healthcare facilities.
- When a federal agency seeks a new remote patient monitoring (RPM) platform, it mandates that all prospective cloud service providers demonstrate FedRAMP authorization, ensuring the security of patient health data hosted off-premises.
- A private hospital system, evaluating vendors for a new AI/ML platform to optimize clinical workflows, includes FedRAMP Moderate authorization as a key criterion, recognizing its rigorous security standards even if not strictly required.
- •Sponsoring an ATO with a single agency when you actually need a Joint Authorization Board (JAB) Provisional ATO for broad federal reuse.
- •Assuming FedRAMP Low is sufficient for health data, VA and MHS deployments typically require Moderate or High.
- •Underestimating continuous monitoring, monthly POA&Ms, annual assessments, and significant-change reauthorization are non-negotiable.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsU.S. federal law governing the privacy and security of protected health information.
Healthcare-focused certifiable security framework that consolidates HIPAA, NIST, ISO 27001, and other authorities into a unified control set.
International standard for information security management systems (ISMS), often required of MedTech vendors by enterprise customers.
Federal control catalogs (800-53) and CUI-handling requirements (800-171) often referenced in MedTech contracts.
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· Same categoryAICPA attestation report on a service organization's controls over Security, Availability, Processing Integrity, Confidentiality, and Privacy, the standard SaaS trust artifact.
AAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle.
AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management.
AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57.
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Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1FedRAMPTier 2 VerifiedGSAfedramp.gov
- 2FedRAMP MarketplaceTier 2 VerifiedGSAmarketplace.fedramp.gov
- 3CISA - Healthcare and Public Health SectorTier 2 VerifiedCISAcisa.gov
Inline markers like [1] jump to the matching reference above.