Healthcare Mobile App Development Best Practices [Compliance Tips]

This is why the mHealth market is growing so fast. By the end of 2025, there will be more than 600k+ medical apps, growing at a CAGR of 11.6%, PRNewswire reports.

With apps today combining different technologies such as AI, cloud, and IoT technology, under the hood, security and privacy have become critical concerns for healthcare app developers. And as companies everywhere keep investing in digital solutions, they're focused on finding the best ways to build apps faster.

But in the push for speed, developers often overlook standard practices, leading to technical debt and maintenance headaches. As a healthcare mobile app development company, we've put together some standard ways to build a healthcare app, such as what we call best practices.

Best Practices for Healthcare Application Development

When you're building a healthcare app, there are so many guidelines that developers need to follow. They help healthcare app developers deliver high-quality applications. Generally, they’re decided by:

• Industry leaders & experts (Google, Microsoft, etc.)

• Communities & organizations (OWASP for security, Clean Code principles)

• Experience & case studies (What works best over time)

As your app grows in size and features, you'll realize the importance of these practices. They play an important role in easier debugging and smooth development. 

Building healthcare apps is a complicated process, mainly because of all the rules around keeping patient data safe and private. You will need to keep in mind a ton of legal and technical and legal requirements. If you are planning to build a medical application, you will have to nail these essentials first. To help you navigate regulatory compliance and

We will start with security as we deal with sensitive data and a highly regulated market. You will need to learn regulations like HIPAA and GDPR that will tell you exactly where and how you're allowed to store this sensitive data. 

1. Data centers (where you are supposed to keep the data) have to be secure to stop anyone unauthorized from getting in.

2. You will need strong technical safeguards, like encryption, to protect data from hackers. 

3. Add access controls to limit who can see it and regular security checks to find any weaknesses.

4. There might be rules about where the data has to be stored geographically.

5. You also have to know how long you're required to keep the data and how to properly delete it when you're done.

Beyond just storage, the rules also cover who can access the data and how they can use it. You have to get the patient's permission to use their information. 

Healthcare apps often need to share data with other systems, like electronic health records. There are standards for this.  Depending on what your app does, you might also need to get certain certifications or approvals from regulatory bodies.

Furthermore, you will need to do lots of testing and have experts on board to review the product. There are some technical challenges, but at the same time, there are legal and ethical ones.

Building these apps isn't just a technical challenge; it's a legal and ethical one. You have to catch on to the ever-evolving regulations. Plus, privacy and security are always a priority throughout the entire development process. If you don't, you could damage your prestige and, most importantly, violate patient trust.

1. Usable & Accessible Design

Whether it's a SaaS product or any other medical solution, it comes with its own set of unique challenges. Even though building healthcare apps takes time, the market is growing quickly. There are hundreds of thousands of medical apps out there, and while there's still demand.

As far as UI/UX development is concerned, you have to be extremely careful with the information you give users. Also, you don’t have to jump and start building; there is a standard approach for healthcare mobile app development. If we talk about our process, then we start figuring out why we’re building this app. 

What problem will the app solve? About end users. It requires a significant amount of time to understand the needs of the end-users. We want to know what they expect, what they like, and what they don't like about other apps they've used. 

Another approach to finding out what’s working and what's not is to check what market leaders are doing. A decent UI/UX design includes an appealing design and popular features. You can learn from them to make our app even better. All of this information you can note down in a canvas. It could be a one-page document (digital or physical) that will have everything important about the app: the problem, the solution, how we'll measure success, and what makes our app special.

After that, you can build a prototype because it will let you test the user experience and detect any problems early on before start building the application. 

2. Regulatory Compliance

Data breaches are rapidly growing in healthcare. As we saw from the 2023 Cost of a Data Breach Report, healthcare data breaches are the most expensive across all industries, averaging a staggering $10.93 million. These numbers show just how important mobile app security is. In addition, with regulations constantly changing, it's another challenge for healthcare organizations to stay compliant. 

These compliances are to protect patient data and privacy. For a healthcare app development company, it is crucial to thoroughly understand the regulations before building digital healthcare solutions.Here are some of the most important regulations to keep on your radar:

2.1. HIPAA (Health Insurance Portability and Accountability Act)

HIPAA is required to build applications for the US market. It covers privacy, security, and breach notification.

2.2. GDPR (General Data Protection Regulation)

This EU regulation has a global impact, setting a high bar for data protection and privacy. If you handle data of EU residents, GDPR applies to you, regardless of where your company is based.

2.3. Other Regulations

Depending on where you operate and what your app does, you might also have to comply with other regulations, such as those related to data security, medical device software (like ISO IEC 62304), or even specific state or regional laws.

3. Interoperability 

Mobile apps communicate with different services (external and internal) to exchange information. For example, you are building a super app for a healthcare organization that has different systems like health records (EHRs), lab systems, mobile apps, and pharmacy systems. If each provider has their own separate records, it can be really hard to get a complete picture of a patient's health. Interoperability is a solution to this problem. 

With an interoperable system, these departments can exchange patients’ data within an organization. As a result, professional professionals can access the latest test results, see what medications a patient is taking, check their medical history, etc. 

Why is this so important? 

Interoperability leads to much better coordinated care. Doctors have the most up-to-date information at their fingertips. It also reduces the risk of errors, like duplicate tests or conflicting medications. When everyone is on the same page, patients get better, safer, and more efficient care. Interoperability is a crucial building block for a modern, connected, and effective healthcare system.

4. Strong Authentication

It's not just a nice-to-have; it's the most important thing. You cannot build a secure application without implementing a strong authentication mechanism. Authentication ensures that only the right people can access the data. For this, go beyond simple usernames and passwords here. Patient data is incredibly valuable and incredibly private. It's information people trust you to protect. You wouldn't want just anyone waltzing in and taking a look, right?  So, how do we build a truly secure system? Here's the inside scoop:

5. Encryption & Data Minimization

Encryption is a well-known feature that makes the information unreadable to anyone who doesn't have the "key" to decode it. The benefit of data encryption is that if someone manages to get the data, it wouldn't make any sense to them.

When it comes to handling sensitive patient data in healthcare apps, two key principles are data minimization and encryption. They work hand-in-hand to protect patient privacy and security.

Data minimization is collecting only the absolute minimum amount of data necessary for the app's intended purpose. Suppose you're building an app to track a patient's blood pressure. You don't need to collect their social security number or their entire medical history.

Collecting only what's essential reduces the risk of a data breach and limits the potential damage if a breach does occur. For example, if a fitness tracker app only needs to track steps and heart rate, it shouldn't also collect location data unless absolutely necessary for a specific, clearly explained feature.

Here's why both data minimization and encryption are so important:

1. By limiting the amount of data collected and encrypting it, you significantly reduce the risk of exposing sensitive patient information.

2. Even if a data breach occurs, encryption makes it much harder for attackers to access and use the stolen data.

3. Regulations like HIPAA and GDPR often require data minimization and encryption as part of a comprehensive security strategy.

4. Patients are more likely to trust healthcare apps that demonstrate a commitment to data privacy and security.

For developers, implementing data minimization requires careful planning and design. It's crucial to identify the essential data elements for each feature and avoid collecting anything unnecessary. Encryption requires the use of strong encryption algorithms and secure key management practices.

Using established libraries and frameworks for encryption is highly recommended. Regular security audits and penetration testing are also essential to ensure that the encryption mechanisms are working effectively and are resistant to attack.

6. Audit Trails & Breach Plans

An audit trail is like a detailed, time-stamped log of everything that happens with electronic patient health information. It records who accessed the data, what changes they made (adding, deleting, or editing information), what they searched for, and what parts of the record they viewed.

Essentially, it has a record of all interactions with the data, showing who did what, when, and to what information. An audit trail is one of the crucial features in healthcare apps for maintaining security and ensuring HIPAA compliance.

Healthcare relies heavily on accurate data. With detailed logging and data-related activity monitoring, audit trails are essential for adhering to HIPAA regulations. However, it is not only for HIPAA compliance; there are plenty of benefits to an audit trail for healthcare professionals.

1. They act as a deterrent to breaches and unauthorized access attempts.

2. They establish a clear chain of responsibility for ePHI access.

3. They aid in identifying the source and impact of unauthorized access.

4. They contribute to maintaining the quality and accuracy of patient data.

5. They reinforce patient confidence in the organization's commitment to data protection.

6. They serve as evidence of due diligence and adherence to regulations.

7. They can be invaluable in legal proceedings related to data breaches or disputes.

8. They facilitate the early identification of potential security incidents.

How are healthcare audit trails implemented and used?

Healthcare organizations leverage audit trails for various purposes, including:

• Monitoring ePHI security and protection.

• Demonstrating HIPAA compliance.

• Investigating data breaches to pinpoint the cause and responsible parties.

Let's talk about how you can implement this feature. Audit trails are generally integrated with EHR systems. Plus, the EHR system you are supposed to implement should meet the HIPAA requirements.

An audit trail is used across different industries, including financial institutions and healthcare.

7. Workflow Integration

It's estimated that, on average, 40% of healthcare professionals' time is consumed in paperwork and manual processes such as patient information, onboarding new patients, and managing billing. With digital solutions, these tasks have become much easier and faster.

On the other hand, digital health records have improved patient care and reduced administrative burdens significantly. There are automation tools available to improve the workflow that drain valuable time and energy from healthcare staff. Workflow automation in healthcare is becoming increasingly recognized. For 68% of patients, easy online access for booking, changing, or canceling appointments is an important factor in their choice of provider.

Here are some areas where you can integrate these automation tools to improve productivity and enhance user experience.

7.1. Appointment Scheduling

Online booking, chatbots, and patient portals empower patients and reduce administrative workload.

7.2. Patient Admission & Discharge

E-signatures and digital records streamline processes and minimize wait times.

7.3. Health Record Management

Electronic systems reduce errors and ensure quick access to vital information.

7.4. Patient Communication

Automated emails, texts, and reminders improve patient engagement and adherence.

7.5. Staff & Doctor Onboarding

Online portals and digital document management accelerate onboarding.

7.6. Staff Scheduling & Task Distribution

Automation ensures smooth operations and efficient resource allocation.

7.7. Insurance Claim Processing

Automation minimizes errors and speeds up reimbursement.

8. Thorough Testing & Feedback

Users are unlikely to use the app if it doesn't work properly. Therefore, testing is non-negotiable for app developers. It is a multi-faced approach that helps in analyzing the usability, visual appeal, and consistency of any application using different kinds of mobile app testing tools. If the mobile apps are not tested well, there is a high chance of users having trouble with using the app. 

The Ultimate Checklist for Health App Testing

1. Unit Tests

Isolate and test individual components/functions (e.g., data processing algorithms, API calls). Use frameworks like JUnit and XCTest.

2. Integration Tests

Verify interactions between different components (e.g., database integration, communication with external APIs).

3. End-to-End (E2E) Tests

Simulate real-world user scenarios, testing the entire app flow from start to finish. Use tools like Selenium and Appium.

4. User Acceptance Testing (UAT)

Real users (healthcare professionals, patients) test the app in a realistic environment.

5. A/B Testing

Compare different UI designs or features to determine which performs best.

6. Penetration Testing

Simulate attacks to identify vulnerabilities. Vulnerability Scanning: Automated tools to detect known security flaws.

7. Data Encryption Testing

Verify that sensitive data is encrypted both in transit and at rest.

8. Load Testing

Simulate high user traffic to assess app performance under stress.

9. Stress Testing

Push the app beyond its limits to identify breaking points.

10. Performance Profiling

Identify performance bottlenecks in the code.

11. Cross-Platform Testing

Ensure the app works seamlessly on different operating systems (iOS, Android, web).

12. Device Testing

Test on a range of devices (screen sizes, resolutions, hardware capabilities).

13. HIPAA Compliance Testing (US)

Verify adherence to HIPAA privacy and security rules.

14. GDPR Compliance Testing (EU)

Ensure compliance with GDPR data protection regulations.

9. Prioritize User Consent and Transparency

When we talk about using people's information responsibly, two key ideas are consent and transparency. Consent means getting clear permission from people before you use their data. It's not enough to assume they're okay with it just because they use your website or app. They need to know exactly what information you're collecting, why you're collecting it, and how you're going to use it. The explanation of privacy policy needs to be simple and easy to understand, not full of complicated legal words.  

People should be able to say yes or no, and it should be easy for them to change their minds later. They should also be able to choose what kind of information they share and what it's used for. You should be more open and honest about what you do with people's data.

You should have a clear and easy-to-find privacy policy that explains everything. People should know what information you collect, why you collect it, and who you share it with. You should also tell them how you keep their information safe. And, importantly, they should know what rights they have over their own information, like being able to see it, change it, or delete it.  

10. Regular Updates and Patch Management

Let's talk about another important practice that every healthcare developer should follow: regular updates and patch management. Attackers are constantly looking for weaknesses, and updates and patches are the shields that protect sensitive patient information. They plug security holes and keep your app safe from cyberattacks. This is especially critical for healthcare apps handling personal health records.

Regular updates are not only for security patches, but they help eliminate annoying errors that can cause crashes or malfunctions. Technology never stands still. Updates allow you to add new features, improve existing ones, and keep your app modern and competitive.

What is HIPAA?

HIPAA, the Health Insurance Portability and Accountability Act, is a US law designed to protect the privacy and security of sensitive patient health information. It is a framework that outlines rules on how to use patient data, who can see it, and how it's stored and transmitted. HIPAA violations can be expensive. 

Here are the steps you need to take to make your software HIPAA-compliant:

• Know the rules inside and out.

• Figure out what information in your app is considered Protected Health Information (PHI).

• Use strong security measures like encryption and access controls.

• Limit access to PHI to only authorized personnel.

• Check your systems regularly for vulnerabilities.

• Have a plan for dealing with potential data breaches.

• Get certified by a third-party auditor to demonstrate compliance.

• Train your staff on HIPAA regulations.

• Stay up-to-date with changes in regulations and update your systems as needed.

Essential Compliance Tips for Health App Development

Non-compliance can have profound consequences. The breach of regulatory standards also opens the door to legal consequences and reputational damage. Therefore, regulatory compliance is a crucial aspect of healthcare mobile app development.

Here is a short guide on how to navigate regulatory compliance in healthcare apps.

If your app handles Protected Health Information (PHI), HIPAA compliance is mandatory. PHI includes any information that can identify a patient, such as medical records, diagnoses, treatment details, and even billing information. HIPAA requires specific safeguards:

1. Administrative Safeguards

These are your written policies and procedures. They dictate how employees access PHI, how you train them on HIPAA, and the steps to take in case of a data breach. A crucial part of this is conducting regular risk assessments to pinpoint potential vulnerabilities in your system.

2. Physical Safeguards

These are the measures you take to protect the physical locations where PHI is stored. This might involve secure servers, locked rooms, and access controls to limit who can physically access these areas.

3. Technical Safeguards

These are the technical measures used to protect PHI. Encryption (scrambling data so it's unreadable without the key) is vital, both when data is stored (at rest) and when it's being transmitted (in transit). Strong passwords, access controls (who can see what data), and audit trails (a record of who accessed what data and when) are also essential.

4. Business Associate Agreements (BAAs)

If you work with any third-party vendors (like cloud storage providers or analytics companies) who handle PHI, they must sign a BAA. This legally obligates them to comply with HIPAA regulations. If your app is used by individuals in the European Union, GDPR applies. It's a comprehensive regulation focused on giving individuals control over their personal data. Key principles include:

5. Data Minimization

Collect only the data that is absolutely necessary for your app's functionality. Avoid collecting data "just in case."

6. Purpose Limitation

Use the data only for the specific purpose for which you collected it. You can't suddenly start using health data for marketing without explicit consent.

7. Data Security

Implement robust technical and organizational measures to protect data from unauthorized access, loss, or alteration.

8. Data Subject Rights

GDPR gives individuals many rights, including the right to access their data, correct inaccuracies, erase their data ("right to be forgotten") and receive a copy of their data (data portability).

9. Consent

You must obtain clear and explicit consent from users before collecting or processing their personal data. 

If your app functions as a medical device (SaMD - Software as a Medical Device), it's subject to regulations by the Food and Drug Administration (FDA) in the US and similar agencies in other countries. These regulations are designed to ensure the safety and effectiveness of medical devices.

10. Device Classification

The FDA classifies medical devices based on risk (Class I, II, and III). The class determines the level of regulatory scrutiny.

11. Premarket Submission

Depending on the classification, you'll likely need to submit your app to the FDA for review. This could involve a 510(k) premarket notification or a more rigorous Premarket Approval (PMA).

12. SaMD Guidance

The FDA has specific guidance documents for SaMD, which you must follow. These guidelines cover areas like software validation, risk management, and post-market surveillance.

13. State Privacy Laws

Many US states have their own privacy laws, some of which are even stricter than HIPAA. California's Consumer Privacy Act (CCPA) is a prime example. Stay informed about the laws in the states where your users are located.

14. Accessibility

Your app should be usable by everyone, including people with disabilities. Follow accessibility guidelines like the Web Content Accessibility Guidelines (WCAG).

15. Cybersecurity

Protecting your app from cyberattacks is essential. Implement strong security measures, conduct regular vulnerability assessments, and have an incident response plan in place.

Practical Tips for Healthcare App Developers

1. Integrate security and privacy considerations into every stage of the app development process, from planning to testing and deployment.

2. Regulations are constantly changing. Stay informed about updates and adjust your app accordingly. Subscribe to industry newsletters and follow regulatory agencies.

3. Conduct regular security testing, including penetration testing and vulnerability scanning, to identify and fix weaknesses.

4. Keep thorough records of your app's functionality, security measures, and compliance processes.

5. Don't hesitate to consult with legal experts specializing in healthcare and data privacy, as well as cybersecurity professionals. Navigating this regulatory landscape can be complex, and expert guidance is invaluable.

6. Compliance is an ongoing process, not a one-time task. By prioritizing data privacy and security and adhering to regulations, you can build a successful and responsible healthcare app that earns the trust of your users and contributes to better patient care.

How Can Brilworks Help You Build a Secure Healthcare App?

As a leading healthcare application development company, we provide expert healthcare development and dedicated professionals to help enterprises build solutions to improve their operations and solve their business hurdles.

Our experienced healthcare developers built HIPPA and GDPR-compliant apps. We house over 50+ software architects who provide end-to-end services, from planning to deployment. Over 100+ companies across the globe have leveraged our expertise to build cutting-edge digital solutions.

Types of services we provide;

• Patient-centric apps

• Medical apps

• Apps for healthcare providers

• Healthcare apps for startups

• Appointment management applications

• EHR software

• Clinical task management apps

• Billing applications