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Compliance Frameworks

HIPAA, SOC 2, PCI DSS, ISO 27001, NIST CSF, GDPR, DORA & EU AI Act on AWS

Framework-by-framework guidance — what auditors expect, what AWS provides, and what your team configures.

Most regulated SaaS, healthcare, and fintech teams arrive with overlapping framework scope — HIPAA plus SOC 2, or PCI DSS plus ISO 27001 — and EU operators now stack DORA and the EU AI Act on top. The guides below cover the specific controls each framework expects, where AWS-native services already satisfy the control, and where your engineering team has to configure or attest. Written from inside paid audit engagements, not from auditor handbooks.

Part of the AWS Security & Compliance hub.

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Free AWS Well-Architected Review from FactualMinds. Identify risks, compliance gaps, and optimization opportunities.

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FAQ

Frequently asked questions about compliance frameworks

Which framework should we tackle first?
It depends on contract gating and customer pressure. SaaS companies usually start with SOC 2 Type II because enterprise procurement requires it. Healthcare platforms must satisfy HIPAA before any PHI touches the system. Fintech with card data needs PCI DSS scope reduction before scaling. ISO 27001 is best layered on top of SOC 2 — most controls overlap. EU financial entities and their ICT third-party providers must hit DORA, in force since 17 January 2025, and any organization deploying high-risk AI into the EU has the EU AI Act on its critical path with Annex III obligations enforceable from 2 August 2026.
Can we reuse evidence across frameworks?
Yes — that is the entire reason multi-framework control mapping exists. We map controls once against AWS-native services (Security Hub Essentials, AWS Config conformance packs, Inspector v2, IAM Access Analyzer) and reuse the same evidence pipeline for SOC 2, HIPAA, PCI DSS 4.0.1, NIST 800-53 r5, and ISO 27001:2022. Framework-specific controls — PCI DSS 4.0.1 script integrity (Requirement 6.4.3, enforceable since 31 March 2025), HIPAA-specific BAA boundaries, NIS2 24-hour early-warning timeline, DORA threat-led penetration testing, and EU AI Act risk-management documentation — get added on top without duplicating the foundational work.
Does DORA apply to us, and what does AWS provide?
DORA (Regulation (EU) 2022/2554) applies to banks, payment institutions, e-money institutions, investment firms, crypto-asset service providers, insurance and reinsurance undertakings, pension funds, credit rating agencies, and the ICT third-party service providers (including hyperscalers) that serve them — in force since 17 January 2025 with penalties up to 2% of global annual turnover. AWS provides DORA-aligned attestations through AWS Artifact and signs the DORA-compliant addendum on request. Your side covers the ICT risk management framework, third-party register (Article 28), threat-led penetration testing (TLPT under TIBER-EU), and the major-incident reporting workflow on the ESA timeline.
When does the EU AI Act start enforcing for our deployment?
The EU AI Act has a phased timeline. Prohibited-practice rules and AI literacy obligations applied from 2 February 2025. Governance, notified bodies, and General-Purpose AI (GPAI) model obligations applied from 2 August 2025. High-risk Annex III obligations (the bulk of the framework — risk management, data governance, technical documentation, transparency, human oversight, accuracy/robustness/cybersecurity) become enforceable from 2 August 2026 with penalties up to €35M or 7% of worldwide turnover. The Commission has signalled the Digital Omnibus may delay Annex III to December 2027, but treat 2 August 2026 as binding until that change is law.
Did ISO 27001:2022 change again in 2024?
Yes — ISO/IEC 27001:2022 received Amendment 1:2024 (published February 2024) which added climate-change considerations to clauses 4.1 and 4.2. The amendment is non-substantive in technical terms but auditors will check that your context-of-the-organization assessment includes climate-related risks (data-center power, regional flooding, supply chain). The IAF transition window from ISO 27001:2013 to ISO 27001:2022 closed in October 2025 — every accredited certificate is now on the 2022 (with 2024 amendment) baseline.

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