MFA was an "addressable" specification under 164.312(a)(2)(i)
Organizations could opt out if they documented why it was "not reasonable and appropriate"
Many organizations relied on password-only authentication
No specific guidance on acceptable MFA methods
MFA is now a "required" specification
All electronic PHI access must use multi-factor authentication
No exceptions or alternative measures allowed
Specific technical standards defined by NIST 800-63B
In 2024, 81% of healthcare breaches involved compromised credentials. Password-only authentication is no longer sufficient to protect patient data. MFA blocks 99.9% of automated credential-based attacks.
Enforcement actions for lack of MFA are expected to increase significantly in 2025.
MFA requires at least two different types of authentication factors
TOTP Authenticator Apps
Recommended - most secure and cost-effective
Hardware Security Keys (FIDO2/WebAuthn)
Excellent - phishing-resistant
Push Notifications to Mobile App
Good - user-friendly but requires internet
Biometric Authentication
Good - when combined with device authentication
SMS Codes
Acceptable only as backup - vulnerable to SIM swapping
Email-based Codes
Not recommended - email may already be compromised
Follow these steps to deploy MFA across your organization
Identify every system, application, and interface where ePHI can be accessed
Choose an appropriate MFA method for your organization's needs
Roll out MFA across all access points in priority order
Educate all users on MFA usage and security best practices
Maintain evidence of compliance and ongoing oversight
Solution: Emphasize security benefits, provide training, use user-friendly authenticator apps, implement gradual rollout
Solution: Implement network-level MFA (VPN), use single sign-on with MFA, isolate systems without MFA capability
Solution: Establish backup authentication methods, maintain secure recovery procedures, provide backup codes during enrollment
Solution: Verify vendor MFA capabilities, use SSO with MFA where possible, require MFA in Business Associate Agreements
Solution: Support multiple MFA methods, provide company-owned authentication devices if needed, enable SMS as fallback