Things To Know When Creating a Medical App in the United States

Why Adalo Works for Building a Medical App

Adalo is a no-code app builder for database-driven web apps and native iOS and Android apps—one version across all three platforms, published to the Apple App Store and Google Play. This unified approach is particularly valuable for medical app developers who need to reach patients and healthcare providers across multiple devices while maintaining consistent security protocols and compliance standards.

Having your medical app available in official app stores builds trust with users who expect healthcare tools to meet rigorous quality standards. Adalo's native push notification capabilities also enable timely medication reminders, appointment alerts, and critical health updates—essential features for patient engagement and care continuity. With paid plans offering unlimited database records and no usage-based charges, you can scale your patient data without worrying about hitting storage caps or unexpected bills.

Why Adalo Works for Building a Medical App

Adalo is an AI-powered app builder for database-driven web apps and native iOS and Android apps—one version across all three platforms, published to the Apple App Store and Google Play. This unified approach is particularly valuable for medical app developers who need to reach patients and healthcare providers across multiple devices while maintaining consistent security protocols and compliance standards.

Having your medical app available in official app stores builds trust with users who expect healthcare tools to meet rigorous quality standards. Adalo's native push notification capabilities also enable timely medication reminders, appointment alerts, and critical health updates—essential features for patient engagement and care continuity. With paid plans offering unlimited database records and no usage-based charges, you can scale your patient data without worrying about hitting storage caps or unexpected bills.

Before diving into development, understanding the regulatory landscape is crucial for creating a compliant medical app.

Developing a medical app in the U.S. means navigating strict regulations to protect sensitive health data and ensure compliance. Key laws like HIPAA, the FTC Act, and the FD&C Act govern how apps handle Protected Health Information (PHI). Non-compliance can lead to severe penalties, with HIPAA fines reaching up to $50,000 per incident.

Here's what you need to know:

• HIPAA Compliance: Apps managing PHI must follow rules for privacy, security, and breach notifications. Encryption, multi-factor authentication, and risk assessments are essential safeguards.
• Additional Regulations: Depending on the app's purpose, laws like the 21st Century Cures Act, COPPA, and state-specific laws like the CCPA may apply.
• FDA Oversight: Apps functioning as medical devices must meet FDA requirements for safety and effectiveness.
• Security Measures: Use encryption, access controls, and regular audits to protect health data.
• Streamlined Development: Platforms like Adalo simplify app creation and deployment across web, iOS, and Android without rebuilding for each platform, while supporting HIPAA compliance through built-in security features.

Compliance is not a one-time task—it requires continuous updates, audits, and adherence to evolving regulations. Tools like the "Mobile Health Apps Interactive Tool" and HHS Security Risk Assessment Tool can help you stay on track.

Given these complex requirements, choosing the right development platform becomes essential—one that simplifies the technical build while giving you full control over data handling and compliance features. Adalo lets you build database-driven web apps and native iOS and Android apps—published to the App Store and Google Play—from a single visual editor, with AI assistance to accelerate the process.

Mastering HIPAA Compliance in Healthcare Apps: Top 5 Developer Questions Answered

Regulatory Requirements for Medical Apps in the U.S.

If you're developing a medical app, the first question to tackle is: does your app deal with Protected Health Information (PHI)? PHI refers to identifiable health data like names, Social Security numbers, or birth dates. When this data is stored or transmitted electronically, it becomes electronic PHI (ePHI), triggering specific regulations you must follow.

But HIPAA isn't the only regulation you need to consider. Depending on your app's purpose, it might also fall under other federal laws, such as the Federal Food, Drug, and Cosmetic Act (FD&C Act) or the FTC Act, as well as state laws like the California Consumer Privacy Act (CCPA). Here's a quick look at key federal regulations that could impact your app:

The stakes are high. Since 2016, HIPAA-related fines have exceeded $40 million, with penalties ranging from $100 to $50,000 per incident, depending on the level of negligence. Medical data is a prime target for cybercriminals, reportedly selling for three times the value of financial data on the black market. With this in mind, understanding these regulations is crucial before diving into HIPAA's specific requirements.

What You Need to Know About HIPAA Compliance

HIPAA (the Health Insurance Portability and Accountability Act of 1996) establishes national standards to protect patient data. It's built around four main rules:

• Privacy Rule: Dictates when PHI can be used or disclosed.
• Security Rule: Requires physical, administrative, and technical safeguards for ePHI.
• Breach Notification Rule: Mandates notifying the Department of Health and Human Services (HHS) and affected individuals in case of a data breach.
• Omnibus Rule: Extends HIPAA compliance to business associates.

If your app creates, receives, maintains, or transmits PHI on behalf of a covered entity (like a hospital or health plan), you're considered a "business associate" under HIPAA. As the Office for Civil Rights (OCR) explains:

"A business associate relationship exists if an entity creates, receives, maintains, or transmits ePHI on behalf of a covered entity (directly or through another business associate) to carry out the covered functions of the covered entity."

Before handling PHI, you must sign a Business Associate Agreement (BAA) with the covered entity. Ignoring this can lead to hefty fines. For instance, in 2017, Presence Health paid $475,000 for failing to report a data breach on time, and Mount Sinai-St. Luke's Hospital faced a $387,000 fine after an HIV clinic improperly disclosed a patient's PHI.

The Security Rule, finalized in 2003, requires you to document your HIPAA policies and assessments for at least six years. Your app should also adhere to the "minimum necessary" standard, ensuring it only accesses or transmits the smallest amount of PHI needed for a given task. While encryption isn't always mandatory, failing to encrypt devices handling PHI is a common cause of HIPAA violations.

When HIPAA Applies to Your App

HIPAA applies if your app processes PHI "on behalf of" a covered entity. For example, if a hospital hires you to build a telemedicine platform for its doctors, your app must comply with HIPAA. However, if a user downloads a fitness tracker for personal use and the app doesn't connect to a healthcare provider, HIPAA typically doesn't apply.

This distinction is critical, as the OCR clarifies:

"Once health information is received from a covered entity, at the individual's direction, by an app that is neither a covered entity nor a business associate under HIPAA, the information is no longer subject to the protections of the HIPAA Rules."

Apps subject to HIPAA often include telemedicine platforms, electronic health record systems, appointment schedulers integrated with hospital systems, and prescription management tools. On the flip side, fitness trackers, nutrition apps, meditation tools, and symptom checkers that don't share data with healthcare providers usually fall outside HIPAA's scope.

For guidance, you can use the Mobile Health Apps Interactive Tool created by the FTC, OCR, ONC, and FDA. This tool helps you determine your compliance obligations based on your app's features and data handling.

Other U.S. Regulations That May Apply

HIPAA isn't the only regulation shaping compliance for medical apps. The FDA oversees software that qualifies as a "medical device" under the FD&C Act, which includes apps designed to diagnose, treat, or prevent diseases. As the FDA notes:

"The FDA's policies are independent of the platform on which they might run, are function-specific, and apply across platforms."

Since March 2026, premarket submissions for cyber devices must include postmarket vulnerability plans and a Software Bill of Materials (SBOM).

The FTC's Health Breach Notification Rule applies to health apps not covered by HIPAA. According to the FTC:

"The FTC's Health Breach Notification Rule applies to most health apps that aren't covered by HIPAA because most developers of health apps are acting as 'health care providers' by furnishing health care services or supplies – in this case, apps – to consumers."

If a data breach occurs, you're required to notify consumers, the FTC, and in some cases, the media. Additionally, misleading practices—like sharing health data with third parties after promising privacy—can result in enforcement actions under the FTC Act.

Other regulations to consider include:

• COPPA: Protects privacy for children under 13.
• 21st Century Cures Act: Prohibits practices that block access to electronic health information.
• Opioid Addiction Recovery Fraud Prevention Act (OARFPA): Penalizes deceptive practices related to substance use disorder treatments.
• State Laws: For example, California's CCPA imposes additional privacy requirements.

It's also a good idea to use just-in-time notices to inform users about sensitive data collection—like geolocation—both during installation and when data collection begins.

Security and Privacy Features for Medical Apps

To safeguard electronic protected health information (ePHI), it's crucial to implement a combination of technical, administrative, and physical safeguards. These measures align with the HIPAA Security Rule, which outlines the necessary steps for compliance. These include encryption, access controls, risk analyses, workforce training, and managing access to devices and facilities. As the U.S. Department of Health and Human Services explains:

"The Security Rule is designed to be flexible, scalable, and technology neutral, enabling a regulated entity to implement policies, procedures, and technologies that are appropriate for the entity's particular size, organizational structure, and risks to ePHI."

This flexibility allows you to tailor your app's security measures to its unique requirements, but certain baseline features are non-negotiable.

Core Security Features to Include

Start by encrypting data both at rest and in transit using strong protocols like NIST SP 800-52 for TLS and FIPS 140-2 for cryptography. The Federal Trade Commission (FTC) underscores the importance of robust encryption:

"Encryption is a key security protection for the health information your app collects. Select stronger encryption methods over weaker ones."

Other essential features include:

• Multi-factor authentication (MFA): This requires users to confirm their identity using a combination of a password and a secondary code sent via email or text.
• Automatic log-off: To prevent unauthorized access when devices are left unattended.
• Password security: Store passwords in a salted, hashed format to enhance protection.
• Role-based access controls: Limit permissions to only what's necessary for specific roles, adhering to the principle of least privilege. For instance, if your app only requires geolocation data, avoid requesting access to contacts or photos.
• Audit controls: Monitor and document system activity to detect anomalies.
• Integrity controls: Ensure data remains unaltered unless authorized.
• Rate limiting: Protect against brute force attacks by restricting the number of login attempts.

Additionally, enforce strict policies for handling hardware that processes ePHI to prevent unauthorized access or data breaches.

Working with HL7 and FHIR Standards

To ensure secure data sharing, adopt HL7 (Health Level Seven) and FHIR (Fast Healthcare Interoperability Resources) standards. These protocols enable seamless interoperability across systems while adhering to HIPAA's "minimum necessary" requirement. Even when using standardized APIs, you are responsible for securing any data your app processes. Carefully vet third-party SDKs or libraries to avoid vulnerabilities or unnecessary permissions.

Risk Assessments and Vulnerability Testing

Performing regular risk assessments is critical to identifying and addressing potential threats. This process should occur at least annually or whenever new technologies or operations are introduced. The Office for Civil Rights highlights the importance of this practice:

"Risk analysis is the first step in an organization's Security Rule compliance efforts. Risk analysis is an ongoing process that should provide the organization with a detailed understanding of the risks to the confidentiality, integrity, and availability of e-PHI."

Use tools like the HHS Security Risk Assessment (SRA) Tool or follow NIST Special Publication 800-30 for guidance. Your evaluation should cover all ePHI your app interacts with, whether stored on cloud servers, mobile devices, or local databases.

When testing for vulnerabilities, simulate real-world scenarios to uncover potential weaknesses, such as back doors or logic flaws. Focus on addressing the OWASP Top 10 most critical web application security risks and the SANS Top 25 Most Dangerous Software Errors. Stay informed about emerging threats by monitoring resources like the National Vulnerability Database.

Finally, document all security policies and assessments thoroughly. HIPAA requires these records to be retained for at least six years from their creation or last effective date. Under the HITECH Amendment, maintaining "recognized security practices" over the past 12 months may also factor into enforcement or audits by HHS.

With comprehensive risk assessments and testing in place, you can confidently move forward with development. Platforms like Adalo make it easier to deploy your app as a Progressive Web App (PWA) or natively on iOS and Android, streamlining the production process while adhering to these critical security frameworks.

Building Medical Apps with Adalo

When creating medical apps, choosing the right development platform is just as important as ensuring compliance with security standards. Adalo, an AI-powered app builder, simplifies this process with its visual builder and hosted backend, allowing you to develop a single app that works seamlessly across web, iOS, and Android. Let's explore how the platform's features, multi-platform publishing capabilities, and HIPAA compliance support make it a strong choice for medical app development.

Key Adalo Features for Medical App Development

Adalo's visual interface—described by users as "as easy as PowerPoint"—makes it possible to build apps without writing code, while still meeting the strict safeguards required by HIPAA. It offers built-in user authentication, role-based access controls, and audit logging—key features for protecting electronic protected health information (ePHI). Its hosted database ensures secure data storage with no record limits on paid plans, meaning your patient data can scale without hitting arbitrary caps.

The platform's integration with DreamFactory enables connections to legacy systems like MS SQL Server or PostgreSQL. This makes it easier to access patient data from electronic health record systems or other sources that don't have RESTful APIs.

Ada, Adalo's AI builder, lets you describe what you want and generates your app. Magic Start creates complete app foundations from a description, while Magic Add adds features through natural language.

Magic Start generates complete app foundations from a simple description. Tell it you need a patient intake app for a dermatology clinic, and it creates your database structure, screens, and user flows automatically—what used to take days of planning happens in minutes. Magic Add lets you add features by describing what you want in natural language, such as "add a secure messaging feature between patients and doctors."

From there, you can use the drag-and-drop editor to refine features like appointment scheduling, telemedicine video calls, or medication tracking. The platform also includes X-Ray, which identifies performance issues before they affect users—critical for healthcare apps where reliability directly impacts patient care.

Publishing to Multiple Platforms from One Build

Adalo not only simplifies app development but also makes deployment across platforms effortless. With its single-codebase approach, you can build your app once and publish it on the web, iOS App Store, and Google Play Store. This eliminates the need to maintain separate native codebases for each platform, saving significant time and effort.

Any updates you make in Adalo's visual builder—whether they're security patches, new features, or compliance adjustments—are applied across all platforms instantly, ensuring consistency and reliability. With unlimited app store updates on paid plans, you can push security patches and compliance updates as frequently as needed without worrying about republishing limits.

This is particularly valuable for medical apps, where regulatory requirements evolve and security vulnerabilities must be addressed promptly. Unlike platforms that charge per update or limit republishing, Adalo's approach ensures your healthcare app stays current across all deployment channels.

How Adalo Supports HIPAA Compliance

If your app handles protected health information (PHI) for a hospital, clinic, or health plan, Adalo qualifies as a Business Associate under HIPAA regulations. Before launching, you'll need to establish a Business Associate Agreement (BAA) with Adalo. The platform's infrastructure is designed to meet the technical safeguards outlined in the HIPAA Security Rule, including encryption for data transmission, access controls, integrity checks, and audit capabilities.

Adalo's hosted backend ensures these safeguards are in place across all deployment platforms, easing the technical burden on your team. The Adalo 3.0 infrastructure overhaul, launched in late 2025, made the platform 3-4x faster with modular infrastructure that scales to serve apps with millions of monthly active users. This performance improvement is critical for healthcare apps handling real-time patient data, appointment scheduling, and telemedicine features.

With no usage-based charges on any plan, you won't face unexpected bills as your patient base grows—a common concern with platforms that charge based on database operations or "workload units."

Adalo vs. Other Platforms for Medical Apps

When evaluating platforms for medical app development, understanding the trade-offs matters. Here's how Adalo compares to alternatives:

Bubble offers more customization options, but that flexibility often results in slower applications that struggle under increased load. Their mobile solution is a wrapper for the web app, which can introduce performance challenges at scale and means updates don't automatically sync across web, Android, and iOS deployments. Claims of millions of MAU on Bubble typically require hiring experts to optimize performance.

FlutterFlow is a low-code platform designed for technical users. You'll need to set up and manage your own external database, which requires significant learning complexity—especially when optimizing for scale. This ecosystem is rich with consultants because so many users need help, often spending significant sums chasing scalability.

Glide excels at spreadsheet-based apps but creates generic, template-restricted applications with limited creative freedom. It doesn't support Apple App Store or Google Play Store publishing—a significant limitation for medical apps that need official store presence to build patient trust.

For medical apps specifically, Adalo's combination of true native compilation, unlimited data storage, and predictable pricing makes it well-suited for healthcare use cases where reliability, compliance, and scalability matter.

Maintaining Compliance After Launch

Getting your medical app off the ground is just the beginning. Staying compliant is an ongoing process that requires adapting to evolving regulations and addressing new security challenges.

Staying Current with Regulatory Changes

Your medical app may fall under several federal laws, including HIPAA, the FTC Act, the FD&C Act, and the 21st Century Cures Act. To help navigate these, the HHS Office for Civil Rights (OCR) publishes a quarterly Cybersecurity Newsletter, which offers insights into emerging threats and practical advice, such as system hardening and countering social engineering attacks. Subscribing to OCR updates can provide you with timely FAQs, guidance, and technical assistance.

It's also worth noting that OCR, by statute, considers whether a regulated entity has followed "recognized security practices" over the previous 12 months when conducting audits or enforcing the Security Rule. Incorporating these updates into your risk analysis procedures can help ensure your app stays compliant.

Regular Audits and Security Updates

HIPAA requires regular security audits to assess whether your policies and procedures align with Security Rule standards. These audits and updates should continue throughout your app's lifecycle, even after launch. The Federal Trade Commission emphasizes the importance of this:

"New vulnerabilities arise regularly, so it's important that you have a plan for how you'll provide updates for products and how you'll communicate with consumers – even after you release your app."

To stay ahead, frequently check the National Vulnerability Database for known software issues, and establish a monitored channel where security researchers and users can report vulnerabilities. Pay close attention to third-party libraries or code integrated into your app, as these can introduce risks. Additionally, maintain all HIPAA-related documentation—including audit records and corrective actions—for at least six years to support compliance during reviews.

Adalo's X-Ray feature helps identify performance issues before they affect users, which is particularly valuable for maintaining the reliability healthcare apps require. Combined with unlimited app store updates on paid plans, you can push security patches and compliance updates as frequently as needed without worrying about republishing limits or additional charges.

Tools for Compliance Management

Once your security measures are updated, specific tools can help manage compliance more efficiently. The Mobile Health Apps Interactive Tool, created by the FTC, OCR, ONC, and FDA, can guide you in identifying which federal laws apply based on your app's functionality and data practices. For conducting routine risk analyses, the HHS Security Risk Assessment Tool and the NIST HIPAA Security Rule Toolkit are invaluable resources. Additionally, the FDA's Digital Health Policy Navigator can clarify whether your app's software functions fall under FDA regulation.

Platforms like Adalo simplify compliance maintenance by offering integrated deployment options. You can launch your app as a Progressive Web App (PWA) or as native apps on iOS and Android without needing to rebuild—ensuring a smooth, production-ready rollout. With modular infrastructure that scales to serve millions of monthly active users, your compliance-focused medical app can grow alongside your patient base without hitting technical ceilings.

Conclusion

Developing a medical app in the U.S. comes with its fair share of challenges, especially when it comes to compliance and security. Navigating regulations like HIPAA, FTC guidelines, and sometimes FDA requirements depends on how your app handles Protected Health Information (PHI). As the Office for Civil Rights puts it:

"Building privacy and security protections into technology products enhances their value by providing some assurance to users that the information is secure and will be used and disclosed only as approved or expected."

Compliance isn't a one-and-done task—it's an ongoing process. From day one, you'll need to implement administrative, physical, and technical safeguards, and keep them up to date through regular risk assessments, audits, and updates. Make sure to retain HIPAA documentation for at least six years and stay ahead of evolving security threats.

To streamline the compliance process, tools like the Mobile Health Apps Interactive Tool and the HHS Security Risk Assessment and NIST HIPAA Security Rule Toolkits can be invaluable. With nearly 79% of Americans expressing concerns about how companies handle their health data, focusing on security and transparency isn't just a regulatory necessity—it's key to building trust with your users.

Adalo's AI-powered platform can simplify the technical side of app development, letting you create production-ready medical apps that work as Progressive Web Apps or native apps for iOS and Android, all from a single build—with unlimited database records and no usage-based charges to worry about as your patient base grows.

FAQ

Why choose Adalo over other app building solutions?

Adalo is an AI-powered app builder that creates true native iOS and Android apps. Unlike web wrappers, it compiles to native code and publishes directly to both the Apple App Store and Google Play Store from a single codebase—the hardest part of launching an app handled automatically. With unlimited database records on paid plans and no usage-based charges, you can scale your medical app without worrying about data caps or unexpected bills.

What's the fastest way to build and publish an app to the App Store?

Adalo's drag-and-drop interface and AI-assisted building let you go from idea to published app in days rather than months. Magic Start generates complete app foundations from descriptions, while Magic Add lets you add features using natural language. Adalo handles the complex App Store submission process, so you can focus on your app's features and user experience instead of wrestling with certificates, provisioning profiles, and store guidelines.

Can I easily build a HIPAA-compliant medical app?

Yes, with Adalo you can build a HIPAA-compliant medical app. The platform offers built-in user authentication, role-based access controls, audit logging, and secure data storage that align with HIPAA Security Rule requirements. You can also establish a Business Associate Agreement (BAA) with Adalo to ensure your app meets regulatory standards when handling protected health information.

What regulations apply to medical apps in the United States?

Medical apps in the U.S. may need to comply with multiple regulations including HIPAA for protected health information, the FTC Act for privacy practices, and the FDA's FD&C Act if the app functions as a medical device. Additional laws like COPPA for children's data, the 21st Century Cures Act for interoperability, and state laws like California's CCPA may also apply depending on your app's functionality.

What security features are essential for a medical app?

Essential security features include encryption for data at rest and in transit, multi-factor authentication, automatic log-off, role-based access controls, and audit logging. You should also implement the minimum necessary standard for data access, conduct regular risk assessments, and maintain documentation of your security policies for at least six years as required by HIPAA.

How do I maintain compliance after launching my medical app?

Compliance is an ongoing process that requires regular security audits, staying current with regulatory updates from HHS and the OCR, and addressing new vulnerabilities as they emerge. Use tools like the HHS Security Risk Assessment Tool and monitor the National Vulnerability Database for known issues. Keep all HIPAA documentation for at least six years and establish channels for security researchers to report vulnerabilities.

Does my medical app need to comply with HIPAA?

HIPAA applies if your app processes protected health information on behalf of a covered entity like a hospital or health plan. If a healthcare provider hires you to build a telemedicine platform, your app must comply. However, if users download a personal health tracker that doesn't connect to healthcare providers, HIPAA typically doesn't apply—though other regulations like the FTC's Health Breach Notification Rule may still govern your app.

How much does it cost to build a medical app with Adalo?

Adalo's paid plans start at $36/month, which includes native iOS and Android app publishing, unlimited database records, and no usage-based charges. This is more affordable than alternatives like Bubble ($59/month with Workload Unit limits) or FlutterFlow ($70/month per user plus external database costs). The predictable pricing is particularly valuable for healthcare apps where patient data can grow significantly over time.

Which is better for medical apps, Adalo or Bubble?

For medical apps, Adalo offers several advantages: true native iOS and Android compilation (vs. Bubble's web wrapper), unlimited database records on paid plans (vs. Workload Unit limits), and predictable pricing without usage-based charges. Bubble offers more customization, but that flexibility often requires hiring experts to optimize performance at scale. Adalo's 3.0 infrastructure, launched in late 2025, delivers 3-4x faster performance with modular scaling.

Can I publish my medical app to both the App Store and Google Play?

Yes, Adalo lets you build once and publish to the web, iOS App Store, and Google Play Store from a single codebase. Updates made in the visual builder are applied across all platforms instantly, ensuring consistency for security patches and compliance adjustments. With unlimited app store updates on paid plans, you can push changes as frequently as needed without additional charges.