AWS Security Blog
HIPAA Security Rule on AWS – Technical Safeguards Implementation and Readiness Guidance
Today, we’re releasing the HIPAA Security Rule on AWS: Technical Safeguards Implementation and Readiness Guidance. This helps covered entities and business associates configure, implement, and evidence compliance with the HIPAA Security Rule Technical Safeguard requirements (45 CFR §164.312) when building healthcare workloads on AWS.
The HIPAA Security Rule’s Technical Safeguards (§164.312) define five standards and nine implementation specifications covering access control, audit controls, integrity, authentication, and transmission security.
The guidance also covers the 2025 NPRM proposed changes, including encryption at rest and in transit becoming required, multi-factor authentication (MFA) becoming mandatory for all electronic Personal Health Information (ePHI) access, and new specifications for network segmentation, configuration management, anti-malware protection, patch management, software removal, incident response and breach notification.
Key topics included
- Shared responsibility for HIPAA on AWS – A responsibility matrix mapping each §164.312 specification to what AWS manages nd what the customer must configure and operate.
- ePHI boundary architecture – Guidance on establishing a defined ePHI boundary
- ePHI data flow and encryption – A reference architecture tracing ePHI with the applicable §164.312 specification
- Foundation checklist – Prerequisite recommendation before configuring individual Technical Safeguard controls.
This guidance is written for cloud architects, security engineers, CISOs, and compliance teams at covered entities and business associates building or operating AWS healthcare workloads. It assumes familiarity with AWS services and is intended as a practical implementation reference, not a legal or regulatory interpretation. This guidance focuses exclusively on Technical Safeguards.
HHS published a Notice of Proposed Rulemaking in January 2025, proposing significant updates to the HIPAA Security Rule—including eliminating the Addressable designation, making encryption, MFA, and asset inventory mandatory, and introducing new technical requirements not present in the current rule. As of June 2026, the final rule has not been published. This guidance covers both the current rule and the proposed changes and recommends treating all specifications as Required for new workloads.
Download HIPAA Security Rule on AWS: Technical Safeguards Implementation and Readiness Guidance.
For questions about HIPAA readiness on AWS, including Administrative Safeguards, Physical Safeguards, risk analysis, and assessment preparation, contact the AWS Security Assurance Services team or your AWS account representative.
This guidance is provided by AWS Security Assurance Services, LLC, a HITRUST External Assessor Firm and PCI-QSAC along with contribution from AWS HCLS, AWS Compliance teams. It is for informational and guidance purposes only and does not constitute legal, regulatory, or compliance advice. Recipients are solely responsible for determining applicability to their specific environments and legal obligations.
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