The European Accessibility Act: does it reach a health app?

30 September 2026

Accessibility & health literacy Accessibility & Regulation

Directive (EU) 2019/882 lists the products and services it covers. Health care is not named in that list. What the text does and does not say, how it connects to EN 301 549 and WCAG, and what a health team can do whatever the answer for its own product.

Not legal advice This article describes what one EU law says, for design education. It is not legal advice and not a verdict on whether any product is in scope. Scope for a given product depends on what it does and on national law. Ask a qualified adviser.

The European Accessibility Act, Directive (EU) 2019/882, is an EU law that sets common accessibility requirements for a fixed list of products and services, and member states have applied it in national law from 28 June 2025. Health teams ask the same question about it again and again: does it reach a health app? This article reads the text and reports what it names, what it leaves unnamed, and what a design team can do while the scope question stays with lawyers.

What the Act is for

Article 1 gives the purpose as the proper working of the internal market. Countries had different accessibility rules, and that made it harder to sell products and services across borders. The Act replaces that patchwork with shared requirements. It is a Directive, so each member state writes its own national law. Article 31 told states to adopt those laws by 28 June 2022 and apply them from 28 June 2025. The wording and the enforcement body can differ from one country to the next.

What the text names

Article 2 is the scope article. For products, it lists these:

consumer general purpose computer hardware and their operating systems
payment terminals, and self-service terminals for services the Act covers: cash machines, ticketing machines, check-in machines and interactive information terminals
consumer terminal equipment used for electronic communications services, or for accessing audiovisual media services
e-readers

For services provided to consumers, it lists these:

electronic communications services (with an exception for machine-to-machine transmission)
services giving access to audiovisual media services
parts of air, bus, rail and waterborne passenger transport services: websites, mobile applications, electronic tickets, travel information and self-service terminals
consumer banking services
e-books and dedicated software
e-commerce services

Article 2 also covers answering emergency calls to the European emergency number 112. The European Commission's own summary page gives the same short list of products and services.

What the text does not name

No entry in Article 2 is health care, a health app, a patient portal or telemedicine. A search of the full Directive text for health, patient, hospital and telemedicine finds none of these as a covered service. The only medical mention is in a recital about assistive technologies, which refers to the older medical devices Directive. Two things follow, and both matter. First, the list is closed: the Act applies to what Article 2 names. Second, a health product may still do something that Article 2 names.

The definition of e-commerce shows why. It means services provided at a distance, through websites and mobile apps, at the individual request of a consumer, with a view to concluding a consumer contract. A screen where a person buys something is a different case from a screen where a clinician reads a chart. Whether a given health app, or one feature of it, meets that definition is a legal question. So is the question of who counts as a consumer. One more limit sits in the text. Microenterprises that provide services are exempt from the service requirements (Article 4(5)). The Act defines a microenterprise as fewer than 10 people and turnover or balance sheet of no more than EUR 2 million. Any conclusion for a real product needs a lawyer and the national law where it is sold.

How it connects to EN 301 549 and WCAG

The Act sets requirements in general terms. Article 15 says a product or service that meets a harmonised standard, once its reference is published in the Official Journal of the EU, is presumed to meet the requirements the standard covers. For digital content the standard that matters is EN 301 549. Its 2021 version, 3.2.1, is built on WCAG 2.1, and the European accessibility centre says it remains the legal reference for now. Version 4.1.1 was published in September 2026 and moves to WCAG 2.2. The same page says it does not become the legal reference until the Commission cites it in the Official Journal. It also notes this is the first version written with the Act in mind.

So the version a rule points to today is WCAG 2.1 at Level AA, and the newer one is coming. WCAG 2.2 builds on 2.1, so a screen that meets 2.2 at Level AA also meets 2.1 at Level AA. Design to the newer version and both are covered.

What a health team can do either way

Design and test to WCAG 2.2 Level AA. It is the benchmark the European standard is moving towards, and it covers 2.1 as well. Sign-in and repeated data entry are common trouble spots: see Accessible sign-in and No re-typing the same data.
Keep written accessibility information for each service. Where the Act applies, service providers must prepare information under its Annex V and keep it available for as long as the service runs (Article 13). Writing it early costs little.
Ask which national law applies in each market. Put the question to legal or compliance advisers, along with whether any feature counts as e-commerce or another listed service.
Ask separately whether another rule reaches the organisation. Rules for public bodies and for health funding differ from this Act. The Digital health regulation map lists them by region.
Plan to re-check. The reference standard is changing, and the Act asks providers to keep their services in conformity as standards change (Article 13).

For the wider picture of WCAG versions and how rules in several regions point to them, read Accessibility & Regulation.