Healthcare Mobile App Development: The Ultimate 2025 Guide

As a custom healthcare app development company, we have been developing healthcare apps for over 13 years. This article will provide you with deep insights from our experience and industry experts to get your journey started in healthcare mobile application development.

According to a recent survey, 56 percent of US physicians said that they have discussed an app or a digital program with a patient related to their diagnosis or treatment in the past year. 

While the benefits mobile applications offer in improving patient outcomes and promoting interoperability are multifold, developing an application for the healthcare industry also involves major attention to detail in areas like data privacy and security, making healthcare mobile app development a bit different than conventional app development. 

If you’re looking into taking a deep dive into developing medical or healthcare mobile applications, here are some of the popular healthcare mobile app categories that you can pick from.

Types of Healthcare Mobile Applications

1. Clinical and Provider Focused Healthcare apps

Healthcare mobile applications span a diverse ecosystem, each tailored to meet distinct clinical, operational, and patient‑centric needs. At the foundation are clinical and provider focused apps, which serve as indispensable tools at the point of care.

Imagine a physician flipping through drug interaction checkers, dose calculators, and medical guidelines on a single device: by integrating securely with EHR systems via OAuth and leveraging offline caching, these apps ensure that practitioners have critical information at their fingertips even deep inside an OR or during a house call.

While they reduce chart review time and minimize prescribing errors, developers must navigate HIPAA‑compliant data storage, frequent content updates, and the complexities of interfacing with multiple EHR vendors. A leading academic medical center, for instance, saw a 30% drop in after‑hours callbacks after deploying an iOS companion to their desktop EHR.

2. Telemedicine apps

Telemedicine apps have transformed how care is delivered beyond the brick and mortar clinic. From on demand video consultations and asynchronous e‑visits to high acuity tele‑ICU monitoring and teleradiology reads, these platforms break down geographic barriers.

Key features include end to end encrypted video streaming, virtual waiting rooms, device‑agnostic screen sharing, and seamless scheduling. Health systems deploying these solutions report dramatic increases in appointment adherence and patient satisfaction, yet they grapple with variable network bandwidth, state by state licensure hurdles, and evolving reimbursement models.

During the COVID‑19 surge, one regional system launched a virtual visit program in two weeks, pivoting 80% of their outpatient volume online without compromising care quality.

3. Remote monitoring apps

Beyond live interactions, remote monitoring apps collect and analyze continuous biometric data such as blood glucose, blood pressure, oxygen saturation, and more by pairing with FDA cleared devices over Bluetooth LE. These apps feature trend dashboards, automated threshold alerts to care teams, and patient‑entered symptom checklists, enabling “hospital at home” models that reduce readmissions by up to 25% in heart failure programs.

Yet keeping patients engaged over the long term and ensuring interoperability across diverse devices (IEEE 11073, FHIR) remains a challenge. Arkenea’s MiPHR solution, for example, integrates smart device sync, USDA food‑database calorie tracking, and automated eFax reporting to help users and clinicians monitor diabetes risk seamlessly.

4. Lifestyle healthcare applications

On the wellness front, lifestyle healthcare apps empower consumers to drive preventive care through nutrition, exercise, women’s health, and mindfulness tools. Whether it’s tracking calories with gamified streaks, joining social fitness challenges, logging menstrual cycles, or practicing guided meditations, these apps thrive on engagement loops and content libraries that tap into community support.

However, retention rates often dip below 10% after a month, and the line between “wellness” and “medical claim” can be a regulatory gray area. A Fortune 500 employer branded habit tracker that tied wearable step counts to wellness incentives saw a 15% reduction in sick days over six months, underscoring the impact of well designed behavior change features.

5. Healthcare reminder applications

Healthcare reminder apps tackle one of the simplest yet most critical gaps in care: adherence. Push notification dosing alerts, QR code medication scans, refill reminders, and integrated pharmacy ordering functionalities boost on time medication use by 20–30% and sharply reduce no shows.

Private practices often extend these tools to appointment and post procedure follow ups, equipping caregivers with shared dashboards to monitor family members. Yet, notification fatigue and variable patient tech literacy can blunt their effectiveness. In one neurology clinic’s post stroke pathway, integrating a medication reminder app cut readmissions for thrombotic events by nearly half within 3 months.

6. Medical resources and information apps

Finally, medical resources and information apps act as digital encyclopedias and triage assistants. Interactive symptom checkers guide patients through branching questionnaires, while disease and treatment libraries rich with videos and infographics prepare users for more informed provider discussions.

Provider locators filtered by insurance plan and geolocation further streamline access. Maintaining clinical accuracy, liability protections, and content currency requires an ongoing commitment to expert review and agile updates. Isabel Healthcare’s clinician grade symptom checker, deployed in over 100 hospitals, exemplifies how these resources reduce diagnostic oversights by flagging atypical conditions that might otherwise go unnoticed.

Step by step guide to developing a healthcare mobile application

The competition in the mobile app market is extremely fierce. Standing out from the crowd, reaching the target audience and receiving downloads while managing to engage and retain the users is no small feat in these ultra-competitive times.

Starting out right is extremely vital as a task well begun is truly half done.

Here is a 10 step process that healthcare entrepreneurs looking to enter the healthcare mobile app development space need to follow through to maximize the chances of success. 

1. Brainstorm and validate the healthcare app idea

The foundation of any successful healthcare app is a crystal clear problem statement: what specific challenge are you solving, for whom, and why does it matter? Start by conducting market surveys and stakeholder interviews, talk to clinicians, patients, administrators, and payers to surface pain points they experience today. Use online questionnaires or one‑on‑one discovery calls to quantify how often these issues arise and how urgently they need a fix.

Once you’ve gathered real world insights, sketch out a minimum viable product (MVP) that addresses the highest priority need with just enough functionality to test your hypothesis. Run MVP testing with a small cohort of target users, observe them navigating your prototype, note where they stumble, and collect both qualitative feedback and usage metrics. This early validation helps you refine features and weed out unnecessary “nice‑to‑haves” before you invest heavily in development.

Parallel to prototyping, perform a problem–solution fit analysis: map your proposed features against user pain points and existing solutions in the market. Identify gaps where current apps fall short, perhaps they lack seamless EHR interoperability, robust security, or an intuitive interface for non tech savvy users. Highlight what will set your app apart (for example, real time eFax reporting for care teams or orientation‑agnostic AI image recognition) and use that differentiation to build a unique value proposition.

Finally, validate market demand with a competitive landscape review and a willingness to pay survey. If you discover an app already exists with similar functionality, determine whether you can raise the bar, better UX, deeper analytics, or tighter integrations and confirm that users are prepared to switch. By combining surveys, MVP testing, problem–solution mapping, and competitor analysis, you’ll identify genuine unmet needs and focus your team on building an app that healthcare providers and patients truly need.

2. Conduct a competitive analysis

A systematic competitive analysis ensures you understand the landscape and can position your app to outshine existing solutions. Begin by identifying direct and adjacent competitors: search the Apple App Store and Google Play Store using your core keywords, and leverage tools like Sensor Tower or App Annie to uncover top ranked apps and download trends. Compile a shortlist of 5–10 apps that either solve the same problem or serve a complementary need.

• Strengths: Note standout features (e.g., real‑time data sync, AI‑powered insights), UX highlights (clean onboarding, intuitive navigation), and strong monetization models (tiered subscriptions, enterprise licensing).
• Weaknesses: Look for feature gaps (missing offline support, limited device integrations), pain points in user reviews (crashes, confusing menus), and any compliance concerns (weak security, outdated HIPAA disclosures).
• Opportunities: Translate those weaknesses into your app’s unique advantages, perhaps by offering deeper analytics dashboards, seamless EHR interoperability, or a gamified adherence engine.
• Threats: Acknowledge high‑quality incumbents with large marketing budgets or entrenched partnerships that could make user acquisition more challenging.

1. Features & Functionality: Build a comparison matrix that lists every major capability (e.g., secure messaging, calendar sync, device pairing) and highlights where competitors excel or fall short.
2. User Experience (UX): Conduct a heuristic evaluation, assess navigation flow, visual hierarchy, accessibility, and onboarding friction. Tools like Hotjar screen recordings or Appsee heatmaps (if available) can reveal drop off points.
3. Monetization & Go‑to‑Market: Document pricing tiers, free vs. premium feature sets, trial lengths, and customer acquisition channels (app store ads, healthcare partnerships). Identify innovative approaches, enterprise volume licensing, white label offerings, or API based revenue.
4. User Sentiment & Reviews: Scrape app store reviews or use services like Appbot to aggregate sentiment scores and tag recurring feedback themes (e.g., “battery drain,” “excellent support,” “hard to navigate”). Prioritize issues that appear most frequently or carry the strongest emotional weight.

Finally, prioritize your roadmap by impact vs. effort focus first on low effort, high impact fixes (e.g., add offline caching) and key differentiators that make your app unmistakably better.

3. Decide the healthcare app development platform

When choosing your development approach, weigh the trade offs between user experience, time to market, maintenance overhead, and specific healthcare requirements (security, performance, device access):

1. Native Apps (Swift/Objective‑C for iOS, Kotlin/Java for Android)

• Best Performance & Stability: Direct access to device CPU/GPU for smooth animations and rapid data processing, critical for image heavy or AI driven workflows (e.g., real time radiology viewers, surgical checklists).
• Full Device & OS Integration: Unrestricted use of sensors (camera, Bluetooth LE for medical devices, NFC), background tasks, and platform‑native security APIs (Keychain, BiometricPrompt).
• Optimal UX & Accessibility: Adheres perfectly to each OS’s design language and accessibility features, reducing onboarding friction for clinicians and patients.

• Higher Cost & Time: Separate codebases double the development, QA, and maintenance efforts often impractical for early stage MVPs or tight budgets.
• Longer Release Cycles: Independent app store submission processes and review times can delay updates or critical security patches.

2. Cross‑Platform Frameworks (React Native, Flutter)

• Shared Codebase: One team, one codebase accelerates feature delivery across iOS and Android, ideal for resource constrained startups or when targeting a broad device footprint.
• Near Native Performance: Modern runtimes and JIT/AOT compilation deliver 90–95% of native speed, suitable for most telehealth, patient‑monitoring, or reference style apps.
• Rapid Iteration: Hot reload and unified CI/CD pipelines shrink test and release cycles, helping you respond quickly to clinical feedback or regulatory changes.

• Partial Device Access: May require custom native modules for advanced medical‑device integrations, complex background processing, or specialized security features adding hidden complexity.
• UI Consistency Risks: Slight inconsistencies in look and feel or animation may confuse users accustomed to platform conventions, potentially impacting clinician adoption.

3. Web Apps / Progressive Web Apps (PWAs)

• Universal Reach: Runs in any modern browser, no app store approvals, instant updates, and accessible on desktops, tablets, or low end devices. Excellent for hospital intranets or SaaS dashboards.
• Lower Up Front Cost: One web codebase (HTML, CSS, JavaScript/TypeScript) for all form factors, ideal for proof of concepts, patient portals, or informational/reference tools.

• Limited Device Features: Browser sandboxes restrict access to Bluetooth‑paired monitors, background geolocation, or advanced biometrics, often a non starter for RPM or tele ICU applications.
• Performance Constraints: Web rendered charts and heavy client side logic can lag on older hardware; suboptimal for real‑time video or AI inference tasks.
• Security & Compliance: Must layer on HTTPS, CSP, and strict cookie policies; offline caching and data encryption are possible but less battle tested than native equivalents.

How to Choose the Right Platform:

1. Assess Clinical Workflows: Do you need uninterrupted offline operation (native), broad browser access (PWA), or a hybrid?
2. Prioritize Features vs. Budget: If advanced device integrations or top tier performance are non‑negotiable, go native. If you need speed and broad coverage, start with cross platform.
3. Time to Market & Maintenance: For rapid MVPs or SaaS portals, PWAs and cross platform frameworks can get you live faster; plan for native modules or a future native rewrite as you scale.
4. Regulatory & Security Needs: Native offers the most mature toolchains for HIPAA grade encryption, secure enclave usage, and formal audit trails, consider this for any feature handling PHI.

4. Determine the healthcare app development approach

When developing a mobile application, it is natural to aim for something that is all-encompassing and has the perfect set of features but taking an MVP-first approach is likely to contribute more to the app’s success. 

A minimum viable product (MVP) is the most basic version of your app which has all the core, must-have features and is devoid of all fancy bells and whistles in the form of nice-to-have features which are added on a later date in future iterations of the app.

A number of successful apps of today like Uber, Facebook, Airbnb and Instagram started out as MVPs so following the MVP-first methodology definitely lands you in good company.

It accelerates your time to market, gives you a chance to validate your app idea and incorporates user feedback in the future version of your app bringing you closer to achieving a product-market fit. 

Start with building the simplest version of your healthcare app and align it with your future, feature-packed vision by building incrementally.

5. Design and develop the healthcare app for a superlative user experience

• Accessibility (WCAG 2.1 AA): High contrast, scalable text; clear labels; full screen reader support.
• Diverse Audiences: Surface core actions first; progressively disclose advanced options so seniors and power users both succeed.
• Empathy in Design: Calming palettes; gentle micro animations; personalized prompts (e.g., “How are you feeling today?”) to soothe anxiety.
• Clear Data Visualization: Single metric sparklines or color‑coded bars with tooltips rather than cluttered multi line charts.
• Stress Proof Navigation: Critical workflows in three taps or fewer; familiar icons; alerts surfaced front and center.

6. Pay adequate attention to app testing

Healthcare apps demand a zero error approach to quality assurance. The testing journey begins with unit tests, which verify individual components such as dose calculation routines or authentication logic against known clinical edge cases. Next, integration tests ensure that modules communicate correctly, from UI elements to backend services, HL7/FHIR interfaces, and medical‑device pairings, even under intermittent network conditions. Together, these early tests catch functional gaps before they ripple outward.

Building on that foundation, security and performance testing safeguard patient data and guarantee responsiveness. Penetration tests and both static and dynamic code scans uncover vulnerabilities in encryption, session management, and API endpoints, ensuring HIPAA and GDPR compliant data handling. At the same time, load and stress tests simulating simultaneous chart reviews or teleradiology streams verify that critical screens load in under 200 ms and that the system remains stable under peak demand.

Equally vital are usability tests, where real clinicians and patients interact with prototypes to perform core tasks logging vitals, reviewing labs, or initiating virtual consults. Observing users in simulated environments (for instance, clinicians wearing gloves in a mock OR) and collecting standardized usability scores (SUS) uncovers friction points that could otherwise lead to clinical errors or abandonment.

Finally, User Acceptance Testing (UAT) deploys the near‑complete app in actual care settings, hospital wards, outpatient clinics, or home monitoring scenarios. Multidisciplinary stakeholders (IT, compliance officers, nurses, physicians, and patients) follow scripted clinical workflows to validate safety, fit, and regulatory readiness. By involving healthcare professionals and end users from the first wireframes through UAT sign off, you ensure that the final product is not only technically robust but also truly aligned with real world clinical needs.

7. Do not overlook the app data security

Healthcare apps that handle personal health information must navigate a complex regulatory landscape. In the US, HIPAA’s Privacy Rule restricts use and disclosure of protected health information (PHI), while its Security Rule mandates technical, administrative, and physical safeguards. The HITECH Act bolsters these requirements with breach notification obligations and steeper fines, up to $1.5 million per year. For any app processing data on EU or UK residents, GDPR adds strict consent requirements, data minimization principles, and user rights such as access and erasure.

On the technical side, end to end encryption (AES‑256+ at rest, TLS 1.2+ in transit), role‑based access controls with multi factor authentication, and detailed audit trails are non negotiable. Arkenea builds these into every layer, server, API, and client while deploying intrusion detection systems to flag anomalies in real time.

Administrative safeguards include formalized policies, routine risk assessments, and documented incident response plans. We partner with clients to draft and enforce written procedures, conduct regular HIPAA/GDPR training, and audit staff access to maintain continuous compliance.

Finally, physical protections secure data centers with controlled access, environmental controls, and robust device management policies guard against on site breaches. Failure to comply can trigger fines from $100 to $50,000 per violation under HIPAA (capped at $1.5 million annually) and up to 4% of global turnover under GDPR, not to mention reputational damage and legal liabilities.

Partnering with Arkenea ensures you meet today’s standards and stay ahead of tomorrow’s threats.

8. Have an app monetization plan in place

An effective monetization strategy for healthcare apps aligns revenue models with user needs and your value proposition. A freemium + subscription approach where basic features are free and advanced capabilities (like personalized coaching or AI‑driven analytics) require a $9–15/month fee lowers adoption barriers and generates predictable recurring income, though it demands a clear upgrade path to minimize churn.

Alternatively, per consultation fees work well for telemedicine: patients pay only when they book a virtual visit or specialist review, ensuring transparent pricing but yielding more variable cash flow.

For enterprise grade solutions, annual licensing or volume based SaaS contracts deliver high value, stable revenue, think $100,000/year for hospital wide RPM dashboards, but involve longer sales cycles and heavier integration support. In app purchases can complement these models by selling add on modules (e.g., a standalone ECG analysis feature) without forcing full subscriptions. Finally, carefully vetted advertising or sponsorships such as sponsored wellness content can subsidize free access, provided ads never undermine clinical trust. By blending these models to match your users’ expectations and regulatory landscape, you’ll recover development costs and build sustainable growth.

9. Maintenance and support of your healthcare app

Maintenance and support begin the moment your healthcare app goes live and they never really end. First, stay ahead of OS and dependency updates: schedule regular compatibility testing against new iOS and Android releases, and promptly update libraries to prevent deprecation issues. Simultaneously, roll out security patches as soon as vulnerabilities are discovered, automated CI/CD pipelines can help you push fixes within days rather than weeks.

Equally vital is an ongoing feedback loop with real users. Instrument your app with in app surveys, analytics events, and crash reporting tools to capture usage patterns, performance bottlenecks, and feature requests. Triage that data monthly to prioritize enhancements: if providers ask for a faster lab result view or patients request richer trend graphs, build those into your roadmap. Small, iterative releases keep your app fresh, show users you’re listening, and minimize the risk of large, error prone updates.

Establish 24/7 performance monitoring, track API response times, error rates, and system load to catch slowdowns or downtime before they impact care delivery. Partner with a dedicated healthcare app development company (like Arkenea) that understands clinical workflows and compliance requirements; this ensures you have the technical expertise and domain insight to scale your app securely and efficiently for years to come.

Advanced Technologies in Healthcare App Development

Artificial Intelligence and Machine Learning

AI/ML algorithms power everything from image based diagnostics (e.g., detecting diabetic retinopathy in retinal scans) to personalized treatment recommendations and predictive risk models for sepsis or readmission. In app chatbots like Buoy Health triage symptoms, while deep learning pipelines accelerate drug discovery by screening molecular libraries.

When embedding AI, maintain model explainability (so clinicians can trust recommendations) and ensure continuous retraining on representative clinical data to avoid bias.

Internet of Medical Things (IoMT)

Wearables and smart sensors, think continuous glucose monitors, connected blood pressure cuffs, or fall detection pendants feed real time data into mobile dashboards. Integrating these devices demands robust data ingestion pipelines, adherence to device communication standards (Bluetooth LE, IEEE 11073), and end to end encryption to ward off eavesdropping.

Architect your backend to scale with device volume while enforcing strict device pairing workflows and certificate based authentication for each sensor.

Big Data and Analytics

By aggregating de‑identified patient records, claims data, and remote monitoring feeds, healthcare apps can power population health dashboards that spot care gaps or predict outbreaks. Clinical decision support modules can surface risk scores (e.g., AHRQ’s readmission index) within seconds.

To succeed, build a data lake architecture with role based access controls, maintain an audit log for every query, and apply data governance policies that balance analytic depth with patient privacy.

Blockchain

Distributed ledger technology can underpin secure, auditable sharing of EMR/EHR fragments between providers ensuring data integrity without a central authority. Projects like MedRec have demonstrated blockchain’s potential for consent management and immutable audit trails.

In pharmaceuticals, blockchain can track cold chain shipments end to end, reducing counterfeit risk. When adopting blockchain, be mindful of transaction throughput (on chain vs. off chain hybrid models) and ensure compliance with data retention rules that may conflict with immutability.

Augmented and Virtual Reality

AR overlays (e.g., AccuVein’s vein‑finding app) guide needle placement at the bedside, while VR platforms provide immersive surgical‑training environments or exposure therapy for pain management. These experiences require ultra low latency rendering and precise motion tracking. Optimize for device capabilities, whether tablet based AR or tethered VR headsets and validate your visuals against clinical safety standards to prevent disorientation or misuse.

Voice Technology

Voice assistants embedded in healthcare apps enable hands free workflows, clinicians can dictate notes, retrieve patient vitals, or kick off a teleconsult simply by speaking. For patients, voice driven medication reminders and symptom reporting (e.g., “Alexa, record my morning blood pressure”) boost adherence among low literacy or visually impaired users. Implement voice biometrics for user authentication, and rigorously test your NLP models in noisy clinical settings to ensure high recognition accuracy.

By thoughtfully incorporating these technologies, while rigorously addressing data security, usability, and regulatory requirements, you can create next‑generation healthcare apps that drive better outcomes, streamline workflows, and delight users.

The Cost of Developing a Healthcare Application

How much would it cost to develop a healthcare mobile application?

This question remains on the forefront of all healthcare entrepreneurs looking to develop an app in the healthcare niche. The answer to the question remains subjective. Healthcare application development costs depends on numerous factors such as the type of features and functionalities you choose to include within your app, the design complexity of your app, the platform of development that you select, the location of the mobile app developers that you choose to partner with and the hourly development rates in the region.

According to a survey by mobihealthnews, the average cost of developing a healthcare mobile app comes around $425,000 in the US. High-end apps which have more complex features would likely cost more while the simpler apps which have only basic functionalities would be cheaper to develop.

Here are the features that impact the healthcare application development costs.

• App design
• Feature complexity
• Development platform targeted (iOS/Android/cross-platform)
• Expertise and size of development team
• Development time frame

Healthcare Mobile App’s Must Have Features

The features to include in your healthcare app will depend on the type of app that you choose to develop. However, the here are a list of features that can add to the overall user experience of the users of the medical app that you develop.

1. Login and user registration

Login and user registration are the first steps that the users need to take after downloading the app so this feature needs to make the process as seamless as possible. The less number of steps required, the better will be the user experience. Social signups can also be facilitated so that the user does not have to fill in their details in long, elaborate steps. However, the data collection policy with 3rd party integrations needs to be clarified to avoid any concerns regarding data collection.

2. Appointment scheduling features

The healthcare mobile app you develop can be utilized to streamline appointment scheduling for your healthcare organization. In addition to choosing their preferred medical practitioner, the appointment booking feature should make it possible to select their preferred date and time for appointments. Once the appointment is booked, the same can be confirmed through the admin panel and message can be sent out to the patients for the same.

3. Profile look up

The healthcare mobile app that you develop needs to make it easy for the users to select their preferred practitioners. A Smart filter that enables users to search and filter the doctors based on their area of specialization, years of experience, reviews, ratings, educational qualifications, location, etc is a much needed value-add.

4. Reminders and push notifications

The healthcare app can have reminders sent out for upcoming appointments, prescription refills required and medication reminders. Push notifications is a feature that really works well for mobile devices. The doctors can send out the prescriptions through the ePrescription feature and patients would get automated reminders for the medications, ensuring better patient compliance and enhanced outcomes.

5. Software Integrations

Integration with other medical software such as EHR software can bring in an aspect of interoperability to your healthcare workflows. Additionally, cloud integration of data can make the app accessible by patients while on-the-go. The patients can view the previous history, medical reports and other healthcare data through secure and authorized in-app access. Storing data on the cloud also ensures that cross device accessibility remains possible. In case the users change their phones, the data is not lost.

6. HIPAA secure database

If you choose to integrate health and fitness wearables and remote patient monitoring devices with your healthcare app, a HIPAA secure database can collate all the patient data securely, which can then be accessed when through the app dashboard. Since healthcare data is sensitive in nature and needs to be compliant with the guidelines outlined under HIPAA security and privacy rules, secure data integration is a must-have feature for healthcare app development.

7. In-can app messaging

In addition to real-time video and audio consultations, in-app messaging feature is a great value add for situations which do not require an audio/video consultation. The doctors can respond to the patient messages in their own time, which further enhances resource utilization.

You can also choose to integrate advanced technology such as artificial intelligence and machine learning to leverage AI-chatbots which can help patients resolve their routine queries while the more urgent and complicated cases can be referred to the doctors.

8. Generative AI in healthcare app development

Generative AI is rapidly transforming healthcare app development by enabling more intelligent, personalized, and efficient solutions. From automating clinical documentation to generating tailored patient education content, generative AI enhances both provider workflows and patient engagement.

Developers can leverage this technology to build smarter chatbots, predictive tools, and decision-support systems that continuously learn and adapt. By integrating generative AI into healthcare apps, organizations can reduce manual workload, improve diagnostic accuracy, and deliver more meaningful user experiences—accelerating innovation while maintaining compliance with healthcare standards.

Would Your Healthcare Mobile Application Require FDA Approval?

FDA applies a risk-based approach for determining which applications require an approval. The ones those pose minimal risk do not require an approval while the ones that pose serious risk need an approval from FDA. If an app is used to automate processes, help in self management of diseases or complete a non-medical task, an approval from the FDA is not needed.

While determining whether your app requires an FDA approval or not may seem tricky, FDA has a listed out the examples of device software functions that it regulates on its website. General medical mobile apps aimed at streamlining the practice workflows will not require approval. However, if the healthcare app that you are developing is intended to function as a medical device. You would require approval from FDA.

Our Experience in Developing Healthcare Apps

With over a decade of experience, Arkenea consistently ranks among the top healthcare software development companies and is featured in DesignRush as well.

From developing telemedicine platforms and cloud-based EHRs to surgical workflow programs and doctor engagement applications, our team of experts has helped healthcare companies achieve success at the app stores while raising millions in venture capital.

Get in touch with us today for a free project estimate.