How to check a design agency before you sign: reviews, references and results
Check a design agency like an investor: verified reviews, client calls, who does the work, real results, returning clients and contract basics.
12 Jan 2027
The European Accessibility Act: what it means for your health app
Does the European Accessibility Act apply to your health app? Scope, the microenterprise exemption, EN 301 549, penalties and a practical WCAG checklist.
Short answer
Possibly. The European Accessibility Act (Directive (EU) 2019/882) has applied since 28 June 2025. It doesn’t list health apps as a category, but a consumer health app that sells subscriptions, bookings or products online can count as an e-commerce service. Microenterprises providing services are exempt. Confirm scope with counsel, and design to WCAG 2.1 AA regardless.
Start with a number. In 2025, 94.8% of the top one million home pages had detectable WCAG failures, and 79.1% had low-contrast text (WebAIM Million 2025). Low contrast is the most common failure on the web. It’s also the one that hurts older eyes first. Pale grey text looks very elegant in a design review and very invisible at 7am without your glasses.
Those eyes belong to a lot of people. The WHO estimates that over 1.3 billion people, about 16% of the world’s population, live with disability, including at least 135 million in its European Region (WHO Europe). Health apps serve this group more than almost any other kind of software.
The European Accessibility Act now turns some of that good practice into law. Plenty of health founders assume it’s about banks and online shops. Mostly, it is. That’s exactly how health apps get caught out.
At Dtail Studio, a Barcelona design studio working with HealthTech and renewable energy startups, we design for people with cognitive impairment on Elli Cares (case study). This is a designer’s reading of the Act. It isn’t legal advice, and your counsel should have the final word on scope.
What is the European Accessibility Act?
It’s an EU directive that sets accessibility requirements for a defined list of products and services. It applies to in-scope products placed on the market, and services provided to consumers, after 28 June 2025 (Directive (EU) 2019/882, Chapter I).
The European Commission’s summary lists what’s covered: computers and operating systems, smartphones, ATMs and ticketing machines, telephony services, audiovisual media access, passenger transport services, banking services, e-books and e-commerce. Health isn’t on the list. The last item, though, is a very big tent.
Because it’s a directive, each Member State wrote it into national law. Spain did so through Title I of Ley 11/2023, of 8 May (CMS).
Does the EAA apply to my health app?
Not automatically, but more often than founders expect. Health isn’t one of the listed categories. Bird & Bird’s analysis says medical devices under the MDR “are not a product category explicitly within scope of the EAA”, while noting the Act can still apply when a device or service falls into another category (Bird & Bird).
The category that catches most health apps is e-commerce. The Directive defines e-commerce services as services provided at a distance, through websites and mobile device-based services, by electronic means, at the consumer’s request, with a view to concluding a consumer contract (Article 3). In plain words: if a consumer can pay you through a screen, keep reading. Bird & Bird adds that health app features sold on a subscription or payment basis may be captured this way, and that commercial web or app-based health services that are medical devices provided directly to consumers must be EAA-compliant.
A rough way to think about your own product:
Sold or booked by consumers inside the app or on your website (subscriptions, paid consultations, devices, test kits):
Likely in scope as e-commerce. Check with counsel.Messaging, calls or video between users:
May touch the electronic communications category. This is less settled, so ask.Sold only to hospitals, clinics or insurers, with no consumer contract:
The services list applies to services “provided to consumers”, so a purely B2B tool may sit outside. Confirm this, because the line between patient-facing and consumer-facing can blur.Based outside the EU:
Not an exemption. Foster Garvey’s alert for US companies says the EAA may apply “even if you are based outside the EU” (Foster Garvey).
If you want the wider regulatory picture, including MDR and HIPAA, we covered it in why healthcare UI regulation makes better products.
Are small startups exempt?
Some are. Microenterprises providing services are exempt from the service accessibility requirements (Article 4(5)). A microenterprise employs fewer than 10 people and has an annual turnover, or balance sheet total, not exceeding EUR 2 million (Article 3(23)).
Three catches. The exemption covers services, not products, so a connected device you sell is a separate question. Both conditions apply, so ten people on a small budget is already out. And you’ll outgrow it, often in the same quarter you raise a seed round and hire. An exemption that ends with your next good hire is a deadline in disguise. Retrofitting accessibility into a finished app at Series A usually costs more than designing it in at pre-seed.
What standard should we design to?
In practice, EN 301 549, the harmonised European standard for ICT accessibility, which incorporates WCAG 2.1 Level AA (Level Access). If you design and test to WCAG 2.1 AA, you’re working to the same bar the standard sets for web and app content.
For contrast, that means at least 4.5:1 for normal text and 3:1 for large text (W3C, Understanding SC 1.4.3). Dosage instructions are normal text. They deserve the 4.5.
What happens if we don’t comply?
Each Member State sets its own penalties (Foster Garvey). France, for example, allows fines of up to EUR 7,500 per infraction, which can add up with the number of violations (Norton Rose Fulbright). In Spain, Ley 11/2023 includes an infringement and sanctions regime applied by the Autonomous Communities (CMS). Ask counsel which amounts apply to you before anyone quotes a figure.
There is a transition period to 28 June 2030, but Norton Rose Fulbright notes it only applies to services that rely on physical products already in use, such as self-service terminals. Your app’s interface doesn’t get extra time.
The practical checklist
Start here. It isn’t a full audit, but it covers the most common failures in the WebAIM data plus the ones that matter most in health products, mapped to WCAG 2.1.
Text contrast.
WCAG 2.1 reference: 1.4.3 Contrast (Minimum).
What it looks like in a health app: 4.5:1 for body text, including medication names, doses and times.Text resize.
WCAG 2.1 reference: 1.4.4 Resize text.
What it looks like in a health app: screens still work at 200% text size and respect the phone’s text setting.Colour isn’t the only signal.
WCAG 2.1 reference: 1.4.1 Use of colour.
What it looks like in a health app: a high reading says “High” in words, not just red.Alternatives for charts and images.
WCAG 2.1 reference: 1.1.1 Non-text content.
What it looks like in a health app: mood or symptom charts have a text summary a screen reader can read.Labels on every field.
WCAG 2.1 reference: 3.3.2 Labels or instructions.
What it looks like in a health app: symptom and intake forms say what goes where, outside the placeholder.Clear errors.
WCAG 2.1 reference: 3.3.1 Error identification.
What it looks like in a health app: “Date of birth is missing” instead of a red outline.Screen reader names.
WCAG 2.1 reference: 4.1.2 Name, role, value.
What it looks like in a health app: VoiceOver and TalkBack announce “Book appointment, button”, not “Button”.Enough time.
WCAG 2.1 reference: 2.2.1 Timing adjustable.
What it looks like in a health app: session timeouts warn people and let them extend.Keyboard and focus.
WCAG 2.1 reference: 2.1.1 Keyboard, 2.4.7 Focus visible.
What it looks like in a health app: web booking and checkout work without a mouse, with a visible focus ring.Captions.
WCAG 2.1 reference: 1.2.2 Captions (Prerecorded).
What it looks like in a health app: education and onboarding videos have captions.Accessible checkout.
WCAG 2.1 reference: all of the above.
What it looks like in a health app: subscription, payment and booking flows pass every row, since they’re what makes you “e-commerce”.
What we learned on Elli Cares
Elli Cares is an app for people living with cognitive impairment and their families. When we started, the problem was high cognitive load, low contrast and an unclear hierarchy. Our work was simpler flows, a high-contrast UI and a calm visual language across reminders, mood tracking, scheduling, location and caregiver communication.
That’s where WCAG and real users meet, and also where they part ways. WCAG 2.1 AA is a floor. Contrast ratios and labels help everyone, but someone living with dementia also needs fewer choices per screen and language that doesn’t make them feel tested. No checklist row covers that.
The Elli App is used in 19 countries, was joint winner of the 2024 Future of Ageing Award (Technology Consumer) and is a 2026 SilverEco and Ageing Well Awards nominee. Those are their team’s achievements. Angela Edwards, CEO of Elli Cares: “Working with Dtail felt like having a senior team that truly cared about results and users.”
More on designing for this audience in designing tech for older adults and designing apps for dementia. Accessibility and consent overlap, too: our post on HealthTech onboarding, consent and permissions in the first 60 seconds (coming soon) covers the privacy side. If you’re choosing a team for this work, read how to choose a HealthTech design agency.
FAQ
When did the European Accessibility Act start applying?
On 28 June 2025, for in-scope products placed on the market and services provided to consumers after that date.
Is my medical device app exempt because it’s regulated under the MDR?
Not automatically. Medical devices aren’t a listed category, but a device or app can still fall in scope through another category, such as e-commerce. Check with counsel.
We have eight people. Are we exempt?
Only if you provide services, have fewer than 10 staff and your turnover or balance sheet is EUR 2 million or less. Products aren’t covered by that exemption.
Is WCAG 2.1 AA enough?
It’s the bar built into EN 301 549, so it’s the right target for compliance. For users with cognitive impairment, treat it as the minimum and test with real users.
Does it apply if we’re based outside the EU?
It may. If you provide in-scope services to consumers in the EU, being based elsewhere doesn’t take you out of scope.
Try this today
Set your phone’s text size to the largest setting and turn on VoiceOver or TalkBack. Now try to sign up and pay for your own product. If you can’t finish, neither can a good share of your users, and in the EU that may now be a legal problem as well as a design one.
If you want a second pair of eyes on your app before a regulator’s, let’s talk.
About the author: Slavena Vasileva is a partner and Brand Strategist at Dtail Studio, a senior brand and product design studio in Barcelona with 16+ years and 300+ projects behind it.
Sources: Directive (EU) 2019/882, Chapter I (legislation.gov.uk) · Directive (EU) 2019/882, Article 4 · European Commission, European Accessibility Act · Bird & Bird, Understanding the impact of the European Accessibility Act on medical devices · Norton Rose Fulbright, European Accessibility Act: not a nice-to-have anymore · Foster Garvey, US businesses must prepare for EU Accessibility Act compliance · CMS, La trasposición de la Directiva (UE) 2019/882 · Level Access, EU accessibility requirements and EAA compliance · W3C, Understanding SC 1.4.3 Contrast (Minimum) · WebAIM Million 2025 · WHO Europe, Disability fact sheet · Elli Cares case study
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