Is HIPAA certified on AWS, or just attested?

There is no HIPAA certification — for AWS, for you, or for anyone. HHS OCR enforces HIPAA reactively, usually after a breach is reported. AWS publishes a Business Associate Addendum (BAA) on AWS Artifact and has been audited under HITRUST CSF and SOC 2 Type II for the HIPAA-aligned controls — that is the strongest objective signal available. On the customer side, most platforms layer SOC 2 Type II + HIPAA mapping (or HITRUST r2 if a hospital partner requires it) as the closest thing to a certification an external auditor can give you.

Which AWS services are HIPAA-eligible — and which are not?

AWS publishes a HIPAA Eligible Services list (~150 services). The headline eligible services include S3, EC2, Lambda, RDS, DynamoDB, ECS, EKS, Bedrock (and AgentCore as of Feb 2026), SageMaker, KMS, CloudTrail, CloudWatch, EventBridge, Step Functions, ALB, CloudFront, API Gateway, Cognito, Macie, GuardDuty, Amazon Inspector, and Security Hub. Common services that are NOT HIPAA-eligible: AWS Glue DataBrew, Amazon Q for Business (eligibility varies by feature), and several preview-stage services. Our gap assessment always confirms eligibility for every service in your PHI data flow before remediation begins.

Do we need to encrypt PHI at rest, in transit, or both?

Both — and HIPAA §164.312 makes encryption "addressable" rather than "required," but every modern audit treats encryption as required. At rest: KMS-CMK on every service that touches PHI (S3, EBS, RDS, DynamoDB, EFS, Backup vaults). In transit: TLS 1.2+ on every endpoint, with TLS 1.3 and ML-KEM hybrid where the AWS SDK supports it (KMS, ACM, Secrets Manager since April 2026). Internal AWS-to-AWS PHI flows should use VPC endpoints or PrivateLink to avoid traversing the public internet.

How does the BAA chain actually work?

AWS signs a BAA with you (downloadable on AWS Artifact). You sign downstream BAAs with anyone you share PHI with — third-party SaaS subprocessors, contractors, business associates. Each BAA must specify the permitted uses and disclosures of PHI, the safeguards required, and the breach notification timeline (60 days by default under HIPAA Breach Notification Rule). We help you draft the technical-safeguard sections of downstream BAAs; your covered-entity attorney owns the legal terms and the Notice of Privacy Practices.

How do AI workloads (Bedrock, SageMaker) change HIPAA scope?

Bedrock has been HIPAA-eligible since 2023, and Bedrock AgentCore was added to the HIPAA Eligible Services list in February 2026. The compliance scope changes in three ways: (1) BAA boundaries shift — your BAA must reflect that a foundation model now processes PHI. (2) Audit log retention expands to include prompt and inference logs. (3) Bedrock Guardrails (PII redaction, denied topics, contextual grounding, Automated Reasoning) are HIPAA-eligible and become evidence for §164.312(a) access control and §164.312(b) audit control extensions. Confirm the specific model you call is HIPAA-eligible — most are, but some third-party models on Bedrock have opted out.

What does an HHS OCR investigation actually look like?

OCR investigations begin with a data request — usually triggered by a breach report, a complaint, or a random audit. They will ask for your risk analysis, your policies and procedures, your BAA inventory, your audit logs for the affected period, your training records, and your incident response documentation. The 2024 HIPAA Audit Program closed-out report from OCR found that 89% of audited entities had insufficient risk analysis documentation — that is the single most common finding. Our engagements produce the risk analysis as a continuously-updated document tied to Security Hub findings, so when OCR asks, you have a living artifact rather than a 12-month-old PDF.

A triangular steel padlock beside its key, 1531 — HIPAA §164.312(e)(1) Transmission Security

HIPAA on AWS

From PHI Risk to Audit-Ready in 8 Weeks.

Book a Free HIPAA Gap Assessment

9 controls Audit once FAQ The hub

HIPAA at a glance

HIPAA has no formal certification. It is enforced by HHS OCR — and enforcement is reactive. We build the technical safeguards, BAA boundaries, and evidence trail your covered-entity attorney and downstream auditors need before they ever ask.

Framework

Health Insurance Portability and Accountability Act

Version

Security Rule (45 CFR §164.302–§164.318) · Privacy Rule · Breach Notification Rule

Regulator

US Department of Health and Human Services — Office for Civil Rights (HHS OCR)

Assessor

No formal certification — HHS OCR enforces; clients often request HITRUST CSF or SOC 2 + HIPAA mapping as proxy

Scope

Any covered entity, business associate, or subcontractor that creates, receives, maintains, or transmits Protected Health Information (PHI) on AWS.

Who engages on HIPAA

Telehealth and digital-health platforms storing or transmitting PHI on AWS
EHR/EMR vendors, FHIR APIs, and clinical SaaS handling patient records
Healthcare AI workloads on Bedrock or SageMaker (foundation-model inference on PHI)
Health-tech startups onboarding hospital systems that require BAA + technical safeguard evidence

Where AWS stopsfor HIPAA

What AWS does, what you do, and where the line moves under this framework.

The general split

AWS owns

Signs the AWS Business Associate Addendum (BAA) directly via AWS Artifact — covers AWS as your subprocessor
Operates HIPAA-eligible services to AWS HIPAA program standards (physical security, hypervisor, host OS, managed-service patching)
Publishes the current HIPAA Eligible Services list — Bedrock, Bedrock AgentCore (Feb 2026), S3, KMS, RDS, DynamoDB, ECS/EKS, Lambda, SageMaker, and ~150 others

Joint

Encryption: AWS provides KMS, you choose customer-managed CMKs and rotation policy
Audit logging: AWS provides CloudTrail/CloudWatch, you configure retention to ≥6 years for PHI access events
Backup and disaster recovery: AWS provides Backup, you define RPO/RTO and test restoration

You own

§164.312(a) Access control — IAM Identity Center, MFA, role-based access, automatic logoff
§164.312(b) Audit controls — CloudTrail multi-region, log integrity validation, Athena/Security Lake queries
§164.312(c) Integrity — KMS-CMK at rest, immutable backups (S3 Object Lock), code-signing for clinical apps
§164.312(d) Person-or-entity authentication — Cognito MFA, IAM Identity Center MFA, no shared accounts
§164.312(e) Transmission security — TLS 1.2+ everywhere, ML-KEM hybrid where supported, no PHI in URLs
Workforce training, sanction policies, vendor BAAs, Notice of Privacy Practices — your covered-entity counsel owns these

Controls

9 HIPAA controls in 2 families, each mapped to the AWS services that satisfy it.

Excerpts from the full matrix we deliver. Your audit scope drives the final mapping.

§164.308 Administrative Safeguards4 controls

Administrative safeguards are policy and procedure — but every policy needs a technical signal that proves it is operating. AWS provides those signals.

Control	AWS services	Implementation note
§164.308(a)(1)(ii)(A) Risk Analysis	IAM Access Analyzer, Security Hub Essentials, AWS Config, AWS Trusted Advisor	Continuous risk register populated from Security Hub findings tagged HIPAA — replaces point-in-time risk assessment.
§164.308(a)(1)(ii)(D) Information System Activity Review	CloudTrail, CloudTrail Lake, Security Lake (OCSF), Amazon Detective	CloudTrail Lake queries scheduled monthly per workload; Detective for graph-based incident triage.
§164.308(a)(5)(ii)(B) Protection from Malicious Software	GuardDuty Malware Protection, Amazon Inspector	Agentless EBS-snapshot malware scanning; Amazon Inspector for container images and Lambda code.
§164.308(a)(6) Security Incident Procedures	EventBridge, Step Functions, Security Hub automation rules, AWS Systems Manager Incident Manager	Pre-built runbooks for credential exfiltration, public S3 PHI exposure, and IAM privilege escalation.

§164.312 Technical Safeguards5 controls

The technical safeguards are where AWS-native services do the heaviest lifting. Most controls map 1:1 to a managed service.

Control	AWS services	Implementation note
§164.312(a)(1) Access Control	IAM Identity Center, AWS IAM, Cognito, Verified Permissions (Cedar)	Workforce SSO with identity propagation; least-privilege IAM enforced via Access Analyzer; ABAC at scale.
§164.312(a)(2)(iv) Encryption and Decryption	KMS, CloudHSM, AWS Certificate Manager (with ML-KEM hybrid)	KMS-CMK with annual rotation; ACM Private CA for internal mTLS; ML-KEM hybrid TLS for long-lived data flows.
§164.312(b) Audit Controls	CloudTrail, CloudTrail Lake, CloudWatch Logs, AWS Config	Multi-region CloudTrail with log file validation; ≥6-year retention via Lake; immutable log archive in dedicated account.
§164.312(c)(1) Integrity	S3 Object Lock, AWS Backup with Vault Lock, KMS-CMK, AWS Signer	Immutable backups with WORM compliance mode; signed Lambda code packages.
§164.312(e)(1) Transmission Security	ALB/NLB with TLS 1.2+, API Gateway, CloudFront, AWS PrivateLink	No PHI in URL paths or query strings; PrivateLink for AWS-internal PHI flows; VPC endpoints for managed services.

Audit once, evidence four frameworks

Pick the frameworks you are scoped for. The tiles below are the AWS services that produce evidence for each one, with the control IDs they answer. The ones in navy cover every framework you picked: set them up once and the same evidence serves every auditor.

Counts come from the control excerpts on our four framework pages, not from your audit scope. Start from HIPAA, SOC 2, PCI DSS or ISO 27001.

AWS services evidence the 9 HIPAA controls we map.

41 AWS services in total, mapped across 36 controls.

Amazon CloudWatch

HIPAA §164.312(b)
SOC 2 CC7.1, CC7.2
PCI DSS 11.6.1
ISO 27001 A.8.16

Amazon Inspector

HIPAA §164.308(a)(5)(ii)(B)
SOC 2 CC6.8
PCI DSS 6.2, 6.3.3, 11.3.1
ISO 27001 A.5.7, A.8.28

AWS Backup

HIPAA §164.312(c)(1)
SOC 2 CC7.5
PCI DSS 6.3.3
ISO 27001 A.5.30, A.8.10

Amazon Detective

HIPAA §164.308(a)(1)(ii)(D)
SOC 2 CC7.4
ISO 27001 A.8.16

Amazon GuardDuty

HIPAA §164.308(a)(5)(ii)(B)
SOC 2 CC6.8, CC7.1, CC7.2
ISO 27001 A.5.7, A.8.16

AWS CloudTrail

HIPAA §164.308(a)(1)(ii)(D), §164.312(b)
SOC 2 CC6.2, CC7.4
ISO 27001 A.8.2

AWS Config

HIPAA §164.308(a)(1)(ii)(A), §164.312(b)
SOC 2 CC7.1
ISO 27001 A.5.23

AWS PrivateLink and VPC endpoints

HIPAA §164.312(e)(1)
SOC 2 CC6.7
PCI DSS 1.3, 1.4

AWS Security Hub

HIPAA §164.308(a)(1)(ii)(A), §164.308(a)(6)
SOC 2 CC7.1, CC7.3
ISO 27001 A.5.23, A.8.16

AWS Signer

HIPAA §164.312(c)(1)
SOC 2 CC6.8
ISO 27001 A.8.24

AWS Systems Manager

HIPAA §164.308(a)(6)
SOC 2 CC7.3
PCI DSS 6.3.3

IAM Access Analyzer

HIPAA §164.308(a)(1)(ii)(A)
SOC 2 CC6.1
ISO 27001 A.5.15

IAM Identity Center

HIPAA §164.312(a)(1)
SOC 2 CC6.1, CC6.2, CC6.6
ISO 27001 A.5.15, A.8.2

Amazon CloudFront

HIPAA §164.312(e)(1)
PCI DSS 6.4.3, 11.6.1

Amazon Cognito

HIPAA §164.312(a)(1)
SOC 2 CC6.6

Amazon S3

HIPAA §164.312(c)(1)
ISO 27001 A.8.10

Amazon Security Lake

HIPAA §164.308(a)(1)(ii)(D)
SOC 2 CC7.4

AWS Certificate Manager

HIPAA §164.312(a)(2)(iv)
ISO 27001 A.8.24

AWS CloudHSM

HIPAA §164.312(a)(2)(iv)
ISO 27001 A.8.24

AWS IAM

HIPAA §164.312(a)(1)
SOC 2 CC6.1, CC6.6

AWS KMS

HIPAA §164.312(a)(2)(iv), §164.312(c)(1)
ISO 27001 A.8.10, A.8.24

EventBridge

HIPAA §164.308(a)(6)
SOC 2 CC7.3

Step Functions

HIPAA §164.308(a)(6)
SOC 2 CC7.3

Amazon Verified Permissions

HIPAA §164.312(a)(1)

API Gateway

HIPAA §164.312(e)(1)

AWS Trusted Advisor

HIPAA §164.308(a)(1)(ii)(A)

Elastic Load Balancing

HIPAA §164.312(e)(1)

Amazon CodeGuru Reviewer

PCI DSS 6.2
ISO 27001 A.8.28

AWS Elastic Disaster Recovery

SOC 2 CC7.5
ISO 27001 A.5.30

AWS Network Firewall

SOC 2 CC6.7
PCI DSS 1.2, 1.3

AWS Organizations and SCPs

SOC 2 CC6.1, CC6.2
ISO 27001 A.5.15, A.8.2

Amazon Q Developer

PCI DSS 6.2

Amazon VPC

PCI DSS 1.2

AWS CodePipeline

ISO 27001 A.8.28

AWS Control Tower

ISO 27001 A.5.23

AWS Firewall Manager

PCI DSS 1.2

AWS Lambda

PCI DSS 11.6.1

AWS Shield

ISO 27001 A.5.7

AWS Site-to-Site VPN

PCI DSS 1.4

AWS Transit Gateway

PCI DSS 1.3

AWS WAF

PCI DSS 6.4.3

How the evidence keeps flowing

AWS Audit Manager closed to new customers on 30 April 2026. This pipeline is what we ship now, and it runs after we leave.

AWS-published conformance pack maps Config rules to HIPAA controls. Deploy via CloudFormation StackSets across your Organization.

Continuous standards checks (AWS FSBP, CIS, NIST 800-53 r5) feeding HIPAA-tagged findings into your GRC tool.

PHI access events queryable in SQL; tamper-evident; meets HHS OCR audit log retention expectations.

Read-only AWS integration so your GRC dashboard reflects live AWS state — not point-in-time screenshots.

What you get, week by week

A date-bound engagement, not an open-ended retainer. Every deliverable is itemised in the statement of work.

Week 1 — Discovery

Week 1

PHI data flow inventory (where it enters, where it lives, where it leaves)
AWS HIPAA-eligible services audit — flag any non-eligible service touching PHI
BAA inventory — AWS BAA on Artifact, downstream subprocessor BAAs reviewed

Weeks 2–3 — Gap Assessment

Weeks 2–3

HIPAA Security Rule control gap report (§164.308 / §164.310 / §164.312 / §164.314 / §164.316)
IAM blast-radius analysis for PHI-handling roles
Encryption posture review — KMS-CMK coverage, key rotation, in-transit TLS versions

Weeks 4–7 — Remediation

Weeks 4–7

IaC-driven hardening (Terraform or CDK) — IAM, encryption, network segmentation
Security Hub Essentials + Config HIPAA conformance pack deployed Org-wide
CloudTrail Lake event store provisioned with 6-year retention

Week 8 — Evidence Handoff

Week 8

Control narratives mapped to HIPAA Security Rule references
Policy library (Information Security, Access Control, Incident Response, Vendor Management)
Risk-assessment workbook (HHS OCR Audit Protocol mapped)
GRC tool integration live — Vanta/Drata/Secureframe reflecting AWS state

Deeper reading on HIPAA, and the frameworks (in navy) most teams certify alongside it.

Common questions

Is HIPAA certified on AWS, or just attested?: There is no HIPAA certification — for AWS, for you, or for anyone. HHS OCR enforces HIPAA reactively, usually after a breach is reported. AWS publishes a Business Associate Addendum (BAA) on AWS Artifact and has been audited under HITRUST CSF and SOC 2 Type II for the HIPAA-aligned controls — that is the strongest objective signal available. On the customer side, most platforms layer SOC 2 Type II + HIPAA mapping (or HITRUST r2 if a hospital partner requires it) as the closest thing to a certification an external auditor can give you.
Which AWS services are HIPAA-eligible — and which are not?: AWS publishes a HIPAA Eligible Services list (~150 services). The headline eligible services include S3, EC2, Lambda, RDS, DynamoDB, ECS, EKS, Bedrock (and AgentCore as of Feb 2026), SageMaker, KMS, CloudTrail, CloudWatch, EventBridge, Step Functions, ALB, CloudFront, API Gateway, Cognito, Macie, GuardDuty, Amazon Inspector, and Security Hub. Common services that are NOT HIPAA-eligible: AWS Glue DataBrew, Amazon Q for Business (eligibility varies by feature), and several preview-stage services. Our gap assessment always confirms eligibility for every service in your PHI data flow before remediation begins.
Do we need to encrypt PHI at rest, in transit, or both?: Both — and HIPAA §164.312 makes encryption "addressable" rather than "required," but every modern audit treats encryption as required. At rest: KMS-CMK on every service that touches PHI (S3, EBS, RDS, DynamoDB, EFS, Backup vaults). In transit: TLS 1.2+ on every endpoint, with TLS 1.3 and ML-KEM hybrid where the AWS SDK supports it (KMS, ACM, Secrets Manager since April 2026). Internal AWS-to-AWS PHI flows should use VPC endpoints or PrivateLink to avoid traversing the public internet.
How does the BAA chain actually work?: AWS signs a BAA with you (downloadable on AWS Artifact). You sign downstream BAAs with anyone you share PHI with — third-party SaaS subprocessors, contractors, business associates. Each BAA must specify the permitted uses and disclosures of PHI, the safeguards required, and the breach notification timeline (60 days by default under HIPAA Breach Notification Rule). We help you draft the technical-safeguard sections of downstream BAAs; your covered-entity attorney owns the legal terms and the Notice of Privacy Practices.
How do AI workloads (Bedrock, SageMaker) change HIPAA scope?: Bedrock has been HIPAA-eligible since 2023, and Bedrock AgentCore was added to the HIPAA Eligible Services list in February 2026. The compliance scope changes in three ways: (1) BAA boundaries shift — your BAA must reflect that a foundation model now processes PHI. (2) Audit log retention expands to include prompt and inference logs. (3) Bedrock Guardrails (PII redaction, denied topics, contextual grounding, Automated Reasoning) are HIPAA-eligible and become evidence for §164.312(a) access control and §164.312(b) audit control extensions. Confirm the specific model you call is HIPAA-eligible — most are, but some third-party models on Bedrock have opted out.
What does an HHS OCR investigation actually look like?: OCR investigations begin with a data request — usually triggered by a breach report, a complaint, or a random audit. They will ask for your risk analysis, your policies and procedures, your BAA inventory, your audit logs for the affected period, your training records, and your incident response documentation. The 2024 HIPAA Audit Program closed-out report from OCR found that 89% of audited entities had insufficient risk analysis documentation — that is the single most common finding. Our engagements produce the risk analysis as a continuously-updated document tied to Security Hub findings, so when OCR asks, you have a living artifact rather than a 12-month-old PDF.

The open round door of the Cleveland Trust Company safe-deposit vault, 1908

Ready for HIPAA?

2-week read-only assessment. We map your AWS environment to HIPAA Security Rule controls, flag the gaps, and show you the remediation path. No retainer commitment.