Apple Now Requires Health Apps to Display Medical Device Status on the App Store

Apple is introducing a new transparency requirement for health and medical apps on the App Store in the European Economic Area, United Kingdom, and United States. Starting today, developers must declare whether their software functions as a regulated medical device, with that status displayed directly on the app’s product page.

Apple Now Requires Health Apps to Display Medical Device Status on the App Store

The requirement applies to apps categorized under Health & Fitness or Medical, as well as any app marked as containing frequent references to medical or treatment information in its age rating questionnaire. If an app meets either condition, developers must provide its regulatory status in App Store Connect. Apps that do not provide medical functionality or use health data to support such features can simply select “No.”

For apps that qualify, Apple defines regulated medical device software as those used for diagnosis, prevention, monitoring, and treatment of diseases or physiological conditions. This includes standalone apps as well as those that interface with external medical hardware.

New app submissions that meet these criteria must include the declaration immediately to distribute in the EEA, UK, or US. Existing apps have until early 2027 to provide a status. After that point, developers who have not submitted the required information will no longer be able to release app updates.

When an app is declared as a regulated medical device, developers must provide specific regulatory information. For the US, this includes an FDA Owner/Operator Number, while EU distribution requires an EU Manufacturer SRN aligned with an EUDAMED listing. Apple notes that a corresponding number is not currently required for the UK.

Developers must also provide a URL with the app’s instructions for use, along with an intended use statement and detailed safety information. This includes warnings, precautions, and contraindications taken directly from official labeling. For US apps, this section can also include instructions on how users can report adverse events to the FDA.

Once submitted and verified, this information will appear directly on the app’s App Store listing, giving users clearer visibility into an app’s regulatory status before downloading.

Source link

Visited 1 times, 1 visit(s) today

Related Article

Indonesia starts implementing social media restrictions for children under 16

JAKARTA, Indonesia — Indonesia on Saturday began implementing a new government regulation approved earlier this month that bans children younger than 16 from access to digital platforms that could expose them to pornography, cyberbullying, online scams and addiction. With the move, Indonesia became the first country in Southeast Asia to ban children from having accounts

Sweet 16 Prediction Apps: Get Top Sign-Up Bonus for Kalshi, Novig, More

Photo Credit: Craig Dudek Photo Credit: Craig Dudek This article contains references to products from our advertisers and/or partners, and… Photo Credit: Craig Dudek Photo Credit: Craig Dudek This article contains references to products from our advertisers and/or partners, and we may receive compensation when you click on links to products and services College basketball

Should social media apps be banned for children?

Jimmy Kakanis surprised his Australian classroom with an unusual pop quiz. He posed a single yes-or-no question to his teenage students: Are you still using social media? In December, the Australian Parliament banned popular apps such as TikTok, X, and Instagram from hosting users under the age of 16. It was the first such law

Nio CEO Says China’s EV Market Faces Rebound in Second Half of March

Nio‘s founder and CEO William Li said on Friday that China’s EV market is facing a rebound in the second half of March. According to the local media outlet Securities Times, Li attributed the expected recovery to trade-in subsidies being implemented and new car model launches approaching “intensively.” The penetration rate of new energy vehicles

Google Pixel 10a Review: This is Fine

At a glance Expert’s Rating Pros Great software with long support Excellent screen Attractive, camera bump-free design Good cameras Cons Incremental to say the least Misses out on Qi2 magnetic charging Old processor Our Verdict While the Pixel 10a is a perfectly good mid-range phone, if we remove the blinkers, then the distinct lack of

Wuling launches fifth-gen Hongguang Mini EV to defend market share

The fifth-generation Hongguang Mini EV starts at 42,800 yuan ($6,190) after trade-in subsidies. The Mini EV family sold over 430,000 units in 2025. (Image credit: SAIC-GM-Wuling) SAIC-GM-Wuling has launched its fifth-generation Hongguang Mini EV, marking the company’s latest move to defend its dominance in China’s fiercely competitive entry-level electric vehicle (EV) market. Wuling officially rolled

I fixed my boring Android Auto setup with these 3 utility apps

Android Auto has been a big upgrade in my driving experience. Having just purchased a compatible car after driving a tech-challenged Toyota Camry since 2012, the navigation, connection speed, and general functionality have all made going from point A to point B that much more enjoyable. There was clearly something missing, though, that could have

Electric Vehicle Traction Motor Market to Reach $316.84 Billion

The global electric vehicle traction motor market, valued at $11.3 billion in 2024, is on track to reach $17.12 billion in 2025 and $316.84 billion by 2035, expanding at a compound annual growth rate of 33.88% over the forecast period. This exceptional growth trajectory reflects accelerating EV adoption worldwide, tightening emissions standards across major economies,

Kenya’s Communications Authority Clarifies Mobile Device Standards, Denies Low-Cost Phone Ban

Overall, the Authority reaffirmed its commitment to ensuring consumer protection while promoting technological advancement, sustainability, and compliance with international standards in Kenya’s ICT sector. The Communications Authority of Kenya (CA)  has issued a clarification regarding recent public discussions and media reports about its “Technical Specifications for Mobile Cellular Devices 2026,” which was published on 24

What if these apps and things existed? A parent’s wish list

As I write this, the Globe is about to host our second-annual Working Mothers Summit, with a sold-out crowd at the Omni Boston Hotel. Our panels will explore everything from maternal mental health to kids and tech to proper workplace support for parents. The breadth and scope is vast, and it underscores the gravity of

XPENG launches 3-year strategy targeting Latin America market

Gasgoo Munich- XPENG has outlined an ambitious push into Latin America, unveiling a three-year regional strategy alongside its official entry into Mexico. Announced on March 25 local time, the plan positions the company to achieve full market coverage across Latin America by 2028, marking a significant step in its broader global expansion. Image source: XPENG

Lawmakers advance Pritzker’s cell phone ban, social media regulations

Article Summary Several prongs of Gov. JB Pritzker’s legislative agenda began to move this week. Those include youth social media protections, a ban on cell phones in classrooms and allowing some community colleges to offer four-year degrees. Many of the measures are expected to be amended and negotiated further in the coming weeks. This summary

App Store now requires medical device disclosure for some apps

Starting today, some App Store apps must declare whether they are regulated medical devices in the US, UK, and Europe. Here are the details. Developers have until early 2027 to comply According to a new blog post on Apple’s Developer blog, “the App Store will now display whether an app is a regulated medical device

Google 發佈 Lyria 3 Pro 音樂模型 支援最長 3 分鐘音樂生成

Gemini Live 迎來重大升級 Google 推出 3.1 Flash Live 版本 Google 今天宣佈推出 Gemini 3.1 Flash Live,稱其為目前最高品質的音訊與語音模型,為 Gemini Live 帶來了迄今為止最大的升級。此新模型在處理音訊細微差別方面更加有效,例如音高和語速,並大幅降低延遲,同時能夠更佳地辨別環境噪音中的相關語音。 支援超過 90 種語言 Gemini 3.1 Flash Live 的降噪能力更佳,能有效過濾背景噪音,例如交通或電視聲音。相較於 2.5 Flash Native Audio 模型,其延遲更低,且能更有效地識別音高與語速等聲音細微差異。此外,此模型支援超過 90 種語言,實現即時多模態對話。 Your browser does not support the video tag. 強化工具整合與指令遵循 Google 大幅提升了模型在即時對話中觸發外部工具和傳遞資訊的能力。同時,其指令遵循能力也顯著增強,確保智能代理即使在對話偏離預期方向時,也能遵守操作規範,大幅提升對話的連貫性。在 Android 和 iOS 版的 Gemini Live 中,3.1 Flash Live 提供更快的反應速度,減少不自然的停頓, New Mobile

Moscow’s mobile internet restored as Saint Petersburg goes offline

Moscovites woke up on March 6 to an inconvenient new reality: the city centre no longer had a mobile internet connection.     Residents with smartphones were suddenly cut off from browsing online, using messenger apps or completing everyday tasks like ordering taxis, using contactless payment systems and even accessing public toilets. Even stranger was the lack of communication

Even Realities’ glasses are finally getting third-party app support

The Even Hub is finally a reality, as the company announces its third-party app platform and a new “Prep Notes” tool to complement conversation tools. Even Realities teased the Even Hub during the release of the Even G2 smart glasses. With the improvements made to the glasses themselves, the company promised that a platform for

How to use Apple’s Playlist Playground to make AI-generated mixes

With the release of iOS 26.4, Apple Music’s Playlist Playground can now generate playlists with the help of AI. Best of all, you don’t need an Apple Intelligence-capable iPhone to take advantage of the new feature. As long as you’re a US Apple Music subscriber with your language set to English, you can start using

Restoring Market Confidence, Li Auto Announces $1 Billion Share Repurchase

Gasgoo Munich- On March 24, Li Auto announced its board approved a share repurchase plan of up to $1 billion, valid through March 31, 2027. The news sent its U.S. shares surging in pre-market trading, with gains topping 5% at one point after the open. The next day, Li Auto’s Hong Kong stock followed suit,

0
Would love your thoughts, please comment.x
()
x