Healthcare IT compliance applies to software and service providers that handle patient data or records for regulated health organizations. In the US the core is HIPAA, which binds vendors directly as business associates. HITRUST is a certifiable framework many hospital buyers ask for, and 21 CFR Part 11 governs electronic records at FDA-regulated companies.
3 items in this category
Oct 30, 2026 statuses last checked
At a glance
Healthcare IT compliance compared
How the items in this category differ on the question that matters first: do you have to, or do you choose to?
Health Insurance Portability and Accountability Act, with the Privacy, Security and Breach Notification Rules
HIPAA sets national rules for protecting protected health information (PHI). The Privacy Rule limits uses and disclosures, the Security Rule requires administrative, physical and technical safeguards for electronic PHI, and the Breach Notification Rule requires notice to individuals, HHS and sometimes the media. Software and IT vendors that handle PHI for healthcare clients are business associates: they must sign a business associate agreement and comply with the Security Rule directly.
What it covers, who needs it and why
What it covers
PHI held by covered entities (health plans, clearinghouses, most providers) and their business associates, in any form, with the Security Rule focused on electronic PHI.
Who needs it
Healthcare providers, health plans, and every SaaS, cloud, IT and software vendor that creates, receives, stores or transmits PHI for them.
Why it matters
OCR enforces it with tiered civil penalties, and hospitals will not buy from a vendor that cannot sign a BAA.
Key objectives
Protect the privacy of health information
Secure electronic PHI
Notify people when their data is breached
Mandatory or voluntary
Mandatory by law for organizations in scope.
Owner
US Department of Health and Human Services (HHS), Office for Civil Rights (OCR)
Current version
Security Rule amendments proposed in January 2025 are listed on HHS's regulatory agenda for a final rule in July 2027. The current rule still applies.
Certifiable standard United States, used internationally
HITRUST CSF
HITRUST Common Security Framework and assessment program
The HITRUST CSF is a certifiable framework that combines requirements from HIPAA, NIST, ISO, PCI DSS and other sources into one control set, scaled by risk factors. HITRUST offers three assessment levels: e1 (essential, 1 year), i1 (implemented, 1 year) and r2 (risk-based, 2 years). Assessments are done by authorized external assessors and quality-checked by HITRUST before certification. Many US health systems and payers ask vendors for HITRUST certification.
What it covers, who needs it and why
What it covers
Information security and privacy controls across 14 control categories, tailored to the organization's size, systems and regulatory factors.
Who needs it
Health tech, SaaS and IT vendors selling to US hospitals, health plans and pharmacy benefit managers.
Why it matters
One certification can satisfy many healthcare customers' security reviews and maps to HIPAA requirements.
Key objectives
Harmonize multiple frameworks
Scale controls to risk
Give a reliable, centrally reviewed certification
Mandatory or voluntary
Voluntary, with independent certification.
Owner
HITRUST Alliance
Current version
HITRUST CSF v11.x, updated several times a year; the current release is re-checked at every review.
Regulation United States (FDA-regulated activities)
21 CFR Part 11
FDA regulation on electronic records and electronic signatures, Title 21 Code of Federal Regulations Part 11
Part 11 sets the conditions under which the FDA treats electronic records and signatures as equivalent to paper. It applies to records that FDA predicate rules require pharmaceutical, biotech, medical device and food companies to keep. Systems must be validated, keep secure, computer-generated audit trails, limit access, and link electronic signatures to their records. FDA's 2003 guidance narrowed enforcement focus, so the first job is deciding which records are actually Part 11 records.
What it covers, who needs it and why
What it covers
Electronic records required by FDA rules and the systems that create, modify, store and sign them, including training, quality and clinical systems.
Who needs it
FDA-regulated life sciences companies and the software vendors whose systems hold their regulated records.
Why it matters
FDA inspectors cite Part 11 gaps in warning letters, and life sciences buyers validate vendors against it.
Key objectives
Trustworthy and reliable electronic records
Secure audit trails
Legally binding electronic signatures
Mandatory or voluntary
Mandatory for regulated organizations in scope.
Owner
US Food and Drug Administration (FDA)
Current version
The 1997 rule, read with FDA's 2003 guidance on scope and application.
Most of these frameworks expect trained staff and records to prove it. LMS Advisor assigns the right courses by role, sends reminders, renews certificates on schedule and keeps an audit trail you can export.
Due dates, reminders and overdue reports for mandatory courses
Certificates that expire and renew on your retraining cycle
CSV, Excel and PDF exports of who completed what, and when
LMS Advisor is our product. It runs your training and keeps the records. It does not certify you against any standard.
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