guide
EAA for healthcare sites in Poland — compliance checklist
Operating a healthcare business in Poland after 28 June 2025 means complying with the country's national EAA transposition (Ustawa o zapewnianiu spełniania wymagań dostępności) layered on top of EN 301 549 — and addressing healthcare-specific failure modes including patient portal logins without screen-reader-accessible mfa and telehealth video without captions or sign-language interpreter integration.
EAA in Poland
Transposition: Ustawa o zapewnianiu spełniania wymagań dostępności. Surveillance: PFRON. Max penalty: PLN 50,000.
Healthcare accessibility — what is in scope
HHS's May 2024 final rule under Section 1557 explicitly requires healthcare entities receiving federal funding to conform to WCAG 2.1 AA for web content, mobile apps, and kiosks. Compounding this, HIPAA places privacy constraints on accessibility solutions (overlays cannot legally re-transmit patient health information).
Common failures in healthcare sites
• Patient portal logins without screen-reader-accessible MFA
• Telehealth video without captions or sign-language interpreter integration
• Symptom checkers built as inaccessible single-page apps
• PDF clinical forms not tagged for accessibility
• Appointment scheduling calendars unusable by keyboard
EAA compliance checklist
1. Confirm in-scope status. 2. Map to EN 301 549. 3. Audit and remediate. 4. Publish a localised accessibility statement (Article 13). 5. Maintain technical documentation for market surveillance.
FAQ
Frequently asked questions
Cited answers. Sourced. Updated as standards and case law change.
Does the EAA apply to non-EU healthcare sites selling into Poland?
Yes. The EAA applies to any product or service placed on the EU market or offered to EU consumers, regardless of vendor headquarters.
What is the maximum penalty in Poland?
PLN 50,000
What does HHS Section 1557 require for accessibility?
The May 2024 final rule requires entities receiving federal financial assistance from HHS — virtually all hospitals, clinics, and insurers — to conform to WCAG 2.1 AA for web content, mobile apps, and kiosks. Compliance deadlines stagger from May 2025 through May 2027 based on entity size.
Can a healthcare site use an accessibility widget?
Widgets are problematic in healthcare for two reasons: (1) WCAG conformance must be at source level, not via overlay; (2) HIPAA-covered information transmitted to a third-party overlay vendor may itself create a breach. Most healthcare CISOs disallow third-party overlay widgets.
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