--- title: "HITRUST, HITRUST CSF | MedTech Terms" description: "Healthcare-focused certifiable security framework that consolidates HIPAA, NIST, ISO 27001, and other authorities into a unified control set." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/hitrust#term", "name": "HITRUST CSF", "alternateName": [ "HITRUST", "HITRUST Common Security Framework" ], "description": "HITRUST CSF (Common Security Framework) is a certifiable, risk-based information security framework specifically designed for healthcare. It harmonizes more than 40 authoritative sources, HIPAA, HITECH, NIST SP 800-53, ISO/IEC 27001/27002, PCI DSS, COBIT, GDPR, state privacy laws, into a single control catalog with five maturity levels per control. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Cybersecurity](/terms?cat=Cybersecurity) 6. / 7. HITRUST CSF [All terms](/terms) Cybersecurity [Connected & Cyber-Physical Devices](/ecosystems/connected-devices)HITRUST # HITRUST CSF Healthcare-focused certifiable security framework that consolidates HIPAA, NIST, ISO 27001, and other authorities into a unified control set. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition HITRUST CSF (Common Security Framework) is a certifiable, risk-based information security framework specifically designed for healthcare. It harmonizes more than 40 authoritative sources, [HIPAA](/terms/hipaa), [HITECH](/terms/hitech-act), NIST SP 800-53, [ISO/IEC 27001](/terms/iso-27001)/27002, PCI DSS, COBIT, GDPR, state privacy laws, into a single control catalog with five maturity levels per control. HITRUST offers three assessment tiers: e1 (entry-level, 44 controls), i1 (implemented, ~180 controls), and r2 (the full risk-based certification, scoped per organization, typically 200-700+ controls). What the regulation says Not a regulatory requirement. HHS OCR doesn't certify or endorse HITRUST. HITRUST publishes mapping documentation showing how its controls correspond to [HIPAA](/terms/hipaa) Security Rule citations. ## What this means in practice HITRUST r2 certification is among the most demanding healthcare security attestations available and is increasingly required by large health systems of their SaaS vendors and connected device manufacturers. The harmonization is the value: a single HITRUST report can satisfy hospital procurement requirements that would otherwise involve separate [HIPAA](/terms/hipaa), NIST 800-53, and [SOC 2](/terms/soc-2) evidence requests. Common pitfalls - • Pursuing HITRUST e1 or i1 and marketing it as 'HITRUST certified', the rigor difference vs r2 is material and procurement teams know it. - • Underestimating the cost and timeline, a first-time r2 certification commonly takes 12-18 months and meaningful internal resources. - • Letting the certification lapse, annual interim assessments and biennial recertification are required to maintain validated status. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Cybersecurity FedRAMP(FedRAMP) U.S. government-wide program that standardizes security assessment, authorization, and continuous monitoring for cloud services sold to federal agencies. ](/terms/fedramp)[ Cybersecurity Health Industry Cybersecurity Practices(HICP) Consensus cybersecurity practices for healthcare published under HHS Section 405(d), the recognized 'reasonable practices' safe-harbor reference. ](/terms/hicp)[ Cybersecurity HIPAA(HIPAA) U.S. federal law governing the privacy and security of protected health information. ](/terms/hipaa)[ Cybersecurity ISO/IEC 27001(ISO 27001) International standard for information security management systems (ISMS), often required of MedTech vendors by enterprise customers. ](/terms/iso-27001) ### More in Cybersecurity · Same category [ Cybersecurity NIST SP 800-53 / 800-171(NIST 800-53/171) Federal control catalogs (800-53) and CUI-handling requirements (800-171) often referenced in MedTech contracts. ](/terms/nist-800-53)[ Cybersecurity SOC 2 AICPA attestation report on a service organization's controls over Security, Availability, Processing Integrity, Confidentiality, and Privacy, the standard SaaS trust artifact. ](/terms/soc-2)[ Cybersecurity AAMI SW96 AAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle. ](/terms/aami-sw96)[ Cybersecurity AAMI TIR57 AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management. ](/terms/aami-tir57) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 HITRUST· 1 CISA· 1 FDA· 1 1. [1 HITRUST CSF Verified HITRUST · hitrustalliance.net ](https://hitrustalliance.net/hitrust-csf) 2. [2 CISA - Healthcare and Public Health Sector Verified CISA · cisa.gov ](https://www.cisa.gov/topics/critical-infrastructure-security-and-resilience/critical-infrastructure-sectors/healthcare-and-public-health-sector) 3. [3 FDA - Cybersecurity for Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Working on medical device cybersecurity? Blue Goat Cyber specializes in MedTech cybersecurity - threat modeling, SBOMs, penetration testing, and FDA premarket submissions. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Cybersecurity Acronym HITRUST Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=hitrust) Learn in 60 seconds Card Lesson Quiz Healthcare-focused certifiable security framework that consolidates HIPAA, NIST, ISO 27001, and other authorities into a unified control set. - · The harmonization is the value: a single HITRUST report can satisfy hospital procurement requirements that would otherwise involve separate HIPAA, NIST 800-53, and SOC 2 evidence requests. - · HITRUST offers three assessment tiers: e1 (entry-level, 44 controls), i1 (implemented, ~180 controls), and r2 (the full risk-based certification, scoped per organization, typically 200-700+ controls). Remember this Watch out: Pursuing HITRUST e1 or i1 and marketing it as 'HITRUST certified', the rigor difference vs r2 is material and procurement teams know it. Related terms - [HIPAA(HIPAA) ](/terms/hipaa) - [SOC 2 ](/terms/soc-2) - [FedRAMP(FedRAMP) ](/terms/fedramp) - [ISO/IEC 27001(ISO 27001) ](/terms/iso-27001) - [NIST SP 800-53 / 800-171(NIST 800-53/171) ](/terms/nist-800-53) - [Health Industry Cybersecurity Practices(HICP) ](/terms/hicp) You may also need Auto-suggested from Cybersecurity and shared keywords. - [NIST Cybersecurity Framework(NIST CSF) ](/terms/nist-csf) - [NIST IR 8473, Cybersecurity Framework Profile for HPH(NIST IR 8473) ](/terms/nist-cswp-35) - [CISA Known Exploited Vulnerabilities Catalog(KEV) ](/terms/kev) - [LINDDUN ](/terms/linddun) - [MITRE ATT&CK(ATT&CK) ](/terms/mitre-attack) - [Supply-chain Levels for Software Artifacts(SLSA) ](/terms/slsa) [All Cybersecurity terms](/terms?cat=Cybersecurity) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cyber Tips Practical, organized tips for medical device cybersecurity teams. ](https://medtechcybertips.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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