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MODERATE RISK MEDTECH JURISDICTION: US VERIFIED AUDIT

HeartFlow (heartflow.com)

Executive Compliance, WCAG 2.2 / European Accessibility Act (EAA), Cyber Hygiene & AI Discoverability Audit

1. Executive Summary & Statutory Fine Exposure Score: 52/100

Comprehensive pre-flight risk evaluation against mandatory EU Directive 2019/882 (European Accessibility Act) and EN 301 549 standards.

WCAG Risk Index
52/100
Security Headers
94/100
AI Discoverability
26/100 (D)
DMARC Policy
REJECT
Statutory Regulatory Exposure: $250,000 FDA 21 CFR Part 11 / EU EAA digital portal accessibility liability + MDR compliance audit risk. Under the EU European Accessibility Act (transposed across EU member states including the German BFSG, French Law 2023-171, and Irish SI 636/2023), private commercial service providers face mandatory compliance enforcement effective June 28, 2025. Non-compliant consumer portals risk formal market surveillance sanctions, public injunctions, and commercial liability.
2. Live WCAG 2.2 & EU EAA EN 301 549 Violations 0 Violations Flagged

Direct DOM inspection findings across keyboard navigation, semantic markup, and mandatory statutory disclosures.

Standard & Criterion Severity Observed Finding & Remediation Requirement
WCAG 2.4.1 (Level A)
Bypass Blocks
Critical Keyboard skip navigation link detected on initial focus.
WCAG 3.1.1 (Level A)
Language of Page
Compliant <html> tag specifies a valid language attribute.
WCAG 1.1.1 (Level A)
Non-text Content
Compliant All sampled storefront images provide alt attributes or decorative role tagging.
WCAG 4.1.2 / 1.3.1 (Level A)
Form Inputs & Labels
Compliant All interactive form inputs correctly define accessible programmatic names.
EU Directive 2019/882
EN 301 549 Clause 9
Compliant Discoverable Accessibility Statement link detected in footer.
3. HTTP Security Headers & Email Authentication Posture Enforced (p=reject)

Transport layer security headers and SPF/DMARC domain anti-spoofing verification.

Control Status Impact & Recommendation
DMARC DNS Policy REJECT
v=DMARC1; p=reject; pct=15; rua=mailto:dmarc-reports@heartflow.com; ruf=mailto:dmarc-reports@heartflow.com; sp=none; fo=1:d:s
Active domain protection enforced across mail servers.
SPF DNS Policy STRICT_FAIL
v=spf1 include:_spf.qemailserver.com include:_spf.google.com include:amazonses.com include:_spf.salesforce.com include:9179125.spf04.hubspotemail.net -all
Missing Security Headers 1 Missing Missing: Content-Security-Policy. Recommended to deploy Content-Security-Policy and Permissions-Policy.
4. AI Agent & LLM Discoverability Audit (/llms.txt) Unindexed (Missing /llms.txt)

Readiness for autonomous AI search agents (ChatGPT Search, Perplexity Pro, Claude Artifacts, and WebMCP shopping agents).

Status: heartflow.com currently lacks a /llms.txt specification. As enterprise buyers and consumers shift query volume to LLM engines, unindexed catalogs face lower citation rates and inaccurate hallucinated summaries.

# Recommended /llms.txt specification for heartflow.com # HeartFlow (heartflow.com) > Official Documentation & Enterprise Service Catalog for AI Agents ## Core Endpoints & Legal - [Home & Catalog](https://heartflow.com/): Primary storefront & capabilities - [Accessibility Statement](https://heartflow.com/accessibility): EU EAA EN 301 549 statement - [Security & Compliance](https://heartflow.com/security): Trust center & data governance
5. Bespoke Remediation Sprint Proposal Turnkey Gating

Rapid, zero-headcount engineering remediation sprint designed specifically for HeartFlow's stack.

$3,150 48-Hour FDA 21 CFR / EU EAA MedTech Portal Remediation Sprint
Turnaround: 48 Hours • Scope: Full DOM, Security & AI Hardening
$3,150
  • Turnkey native HTML/DOM remediation (bypass blocks, form labels, ARIA landmarks)
  • Mandatory EU EAA EN 301 549 Accessibility Statement page and footer integration
  • HTTP Security Header policy injection (HSTS, CSP report-only, X-Frame-Options)
  • DMARC policy hardening roadmap from p=none to p=quarantine/reject with SPF alignment
  • /llms.txt and /.well-known/mcp.json generation for AI search discoverability
Direct Theme / HTML Code Remediation Patch:
<!-- 1. WCAG 2.4.1 Skip-to-Content bypass link (Insert at top of <body>) --> <a href="#MainContent" class="skip-link visually-hidden-focusable">Skip to main content</a> <!-- 2. WCAG 4.1.2 Programmatic Label on Search & Form Fields --> <input type="search" name="q" aria-label="Search HeartFlow catalog" placeholder="Search..." /> <!-- 3. EU EAA EN 301 549 Mandatory Footer Link --> <a href="/pages/accessibility-statement" rel="help">Accessibility Statement (EN 301 549)</a>
Prepared by AccessGuard Pro Executive Advisory • Zero-Call Async Delivery • Contact: ronan.chenlopes@gmail.com
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