HIPAA Compliant Healthcare App Development: 10 Most Critical Steps to Take

GlobeNewswire reports the global mHealth apps market size to reach $113 billion in 2026, correlating to a compound annual growth rate (CAGR) of 25.3%. That also represents the broader rise of healthcare app development trends. As we look forward, the focus on healthcare security and secure messaging has become the bedrock of modern healthcare operations.

However, even though the mHealth market is rising, it doesn’t mean each software development company can build an mHealth app and get desired profits. To get a piece of the pie, you need to keep healthcare application HIPAA compliance in mind. Further, we explore the phenomenon of HIPAA, investigate its importance in app development, and provide a checklist for HIPAA compliance along with ten critical steps for building a HIPAA-compliant mHealth application.

Ready to build a secure healthcare future? Navigating the complexities of HIPAA regulations requires a partner who understands the intersection of medical necessity and technical excellence. Contact SPsoft to learn how we can help you develop a robust, compliant platform!

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HIPAA in a Nutshell

Health Insurance Portability and Accountability Act (HIPAA) is a piece of legislation developed in 1996. Its fundamental goals are to regulate how patient data is handled, decrease healthcare costs, and offer accessible health insurance for vulnerable populations. While HIPAA provides different aspects of functionality, as digitalization was broadly introduced in healthcare, its main objective has shifted toward privacy and security. What is more, such a shift was propagated by the rapid rise in the number of healthcare organizations facing data breaches.

The evidence above shows that digital transformation in healthcare comes along with various security challenges. Companies working on app development cannot avoid HIPAA and secure communication services. In other words, if you intend to develop a HIPAA-compliant messaging app that will work with protected health information at some point, from the get-go, you need HIPAA compliance and strong healthcare security measures.

Basics and Foundations

HIPAA-compliant healthcare software works with several key aspects of the principle. To understand the HIPAA security landscape, you need to understand its constituents. In such a case, the starting point consists of the HIPAA regulations:

• Privacy Rule
• Security Rule
• Enforcement Rule
• Breach Notification Rule

These are foundational elements of the HIPAA act. The rules are regulated and enforced by the Office for Civil Rights (OCR) in the US Department of Health and Human Services (HHS).

Other foundational aspects that must be included in healthcare applications are: 

• Protected health information (PHI) is linked to any individually identifiable data. That includes any personal health information. There are 18 key PHI identifiers to consider. 
• Covered Entities are people and all associated with the provision of medical services. These can consist of healthcare providers and healthcare plans. 
• Business Associates are subcontractors for a particular Covered Entity that involves admitting PHIs. These are linked to Covered Entities with legally binding commitments and work via a signed BAA to handle patient data.

Respectively, keeping all the principles in mind, you need to know where the HIPAA act should be applied in software development. 

When Should Healthcare App Developers Consider HIPAA Compliance? 

The million dollar question – what software products are subject to HIPAA compliance? And the rule of thumb dictates: as any aspect of PHI appears within an app, it must be HIPAA-compliant. Whether you are building a communication platform designed for healthcare professionals or a patient portal, you must ensure HIPAA compliance.

Plunging further, several types of healthcare apps must adhere to the HIPAA rule. So, you need to plan your HIPAA compliance if your app is in any of these categories. 

Telehealth

Telemedicine development, a category that completely rules HIPAA requirements, is on the rise. 

HIPAA-compliant messaging apps in 2025 are essential for communication across healthcare systems. That is because the critical purpose of HIPAA-compliant telehealth software is protecting patient privacy. Secure messaging prevents data leaks during patient communication.

Electronic Health Records (EHRs)

If you plan to develop an EHR platform, regardless of whether it is a desktop or mobile solution, you must include HIPAA. Such tools help healthcare teams substitute paper-based note-taking with digital healthcare ones. They also make patient data sharing more straightforward, which improves diagnostics and treatment. A clinical communication platform integrated with an EHR ensures that health information is shared securely.

Condition Apps

If a medical app relates to a user’s mental or physical health status, you must stay compliant. Condition apps often involve HIPAA-compliant texting for patient care and symptom tracking. Moreover, condition apps work with any payment linked to the care provision processes.

Scenarios to Illustrate

To get a better grasp of how consideration of HIPAA compliance for health app development works, there are some scenarios to examine. 

• A patient is a user with Type 2 diabetes. An individual constantly checks their glucose levels with a personal glucometer. However, this person wants to store glucose data for a particular period to see how it changes. To do that, they download a respective app from the App Store. All the data from the glucometer is then stored within the app. In this case, HIPAA compliance is not required for the app because no PHI was manipulated at any point, and no covered entity or business associate was involved. 
• A patient is a user of a new AI remote patient monitoring app available online. Some clinics provide such an app. When this person downloaded the app, it required inserting some patient health data. After that, the relevant information is automatically synchronized with the clinic’s EHR system. At this point, HIPAA compliance is a must as there are PHIs created and transferred. Also, there is a covered entity involved – the clinic that introduced the app. 

Thus, coursing through various scenarios offers a greater perspective on when HIPAA is a must.

Why All the Fuss Around HIPAA Compliant Healthcare App?

Some sources like The Verge argue that, sometimes, HIPAA might be as helpful as it looks. Yet, in most cases, there is a consensus that HIPAA is important. Thus, you should know how HIPAA compliance aids people and organizations to get a clearer view of the issue. 

Importance for Patients

Any regulation is directed to protect people. It does not matter whether you use innovative techs like data automation and cloud computing or rely on some older methods. Users must be sure the health information they share will not be breached. HIPAA-compliant patient tools:

• Ensure secure messaging and data transfer
• Protect from identity theft
• Prioritize privacy and security in medical app requirements

HIPAA ensures healthcare app developers do not put profits above patient care. On the patient side, the principle takes away the bread and butter of cybersecurity crimes – sensitive data. 

Significance for Hospitals

In turn, healthcare organizations look for ways to reduce expenditures. HIPAA compliance helps healthcare providers avoid hefty fines.

Moreover, a HIPAA-compliant messaging platform is effective for hospitals because it:

• Prevents any litigation linked to patient data breaches
• It makes it easier to manage and store health data
• Builds trust in a particular healthcare vendor

Large healthcare entities and mid-sized healthcare practices alike rely on these communication tools to streamline communication.

Examples of Healthcare Application HIPAA Non-Compliance

Some healthcare organizations thought they could get away from HIPAA compliance. A large health insurer, Anthem, lost a staggering 78 million patient records due to phishing techniques used by cybercriminals and was fined $16 million. As a result of investigation, OCR identified severe HIPAA violations, the key being an inadequate system of access control to PHIs. 

Another example is about HIPAA non-compliance linked to the usage of unencrypted devices. The OCR investigated a Texas-based cancer research center, MD Anderson, after a breach of 34,000 records. The investigation revealed the center had unreasonable encryption standards, leading to three mobile devices being stolen with thousands of unprotected patient records. This non-compliance led to MD Anderson paying $4.3 million in fines and highlighted the importance of audit logging and encryption in the healthcare environment. 

How to Ensure HIPAA mHealth App Compliance?

HIPAA-compliant healthcare apps stem from following several principles.

Safeguarding Healthcare Mobile Applications

All aspects of appropriate data protection revolve around physical and technical safeguards. HIPAA-compliant healthcare software must have a protected backend and secure messaging channels. These are critical physical safeguards to consider. In turn, technical safeguards entertain unique access control and audit logging procedures. Keeping both physical and technical safeguards establishes a core of HIPAA compliance. 

HIPAA mHealth App Compliance Checklist

When it comes to taking HIPAA compliance further, keep in mind the following checklist:

1. Information access. Limit access to PHIs in the app. Only authorized parties should have access to patient data. Use two-factor authentication and bio authentication for access control. 
2. Patient data encryption. Encrypt all PHIs using AES 256-bit encryption and S/MIME. 
3. Auditing. Have an audit mechanism intact. Track down how to access and use the app.
4. Data integrity. No unauthorized party should be able to manipulate the PHIs your app works with. To ensure data integrity, consider blockchain technology. 
5. Safe transferring. Use only secure data transfer connections and protocols. These include SSL/TLS. 
6. Notifications. Never use PHIs in push notifications and emails. Moreover, remorse all PHIs from outside-the-app messaging. 
7. Backup. Ensure data protection through backups and removals. When storing data in the cloud, you should always back it up. Besides, users should have an option to remove their PHIs, especially when a person loses their mobile device. 
8. Privacy policy. HIPAA is all about following particular rules. Have a transparent privacy policy to show users how you follow HIPAA and how patients’ data is protected.

This checklist grants you a starter pack for healthcare app HIPAA compliance. You can use it for mHealth, telemedicine, and condition-based apps alike. 

How Much Does It Cost to Develop a HIPAA mHealth App?

When developing any new app, one of the critical concerns is the budget. The same is true for mHealth apps – you must be ready to spend a hefty sum on building such an app. On average, it costs about $425,000 for the entire medical app development cycle. 

Yet, keep in mind that the number mentioned above is an average one. It is hard to put a specific price tag on mHealth app development because each project is unique. 

Besides, when putting the factor of HIPAA into the equation, additional expenditures should be considered. While robust data protection measures can be costly, you also need to be ready to pay about $2,000 per month for HIPAA adherence. Moreover, you may need to pay for a signed BAA with a phone system or cloud provider. However, using a HIPAA-compliant messaging app infrastructure can reduce these development costs.

10 Steps for Developing a HIPAA-Compliant mHealth App

With all the bases covered, it is time to proceed to the critical steps needed for developing a HIPAA-compliant mHealth app. The following ones can be used for all mHealth solutions. 

Step 1. Expert Opinion

Dealing with HIPAA compliance guidelines and keeping in mind all the rules, entities, and variables is hard. The golden rule dictates that attempting HIPAA on your own is challenging. The best solution is to start with an expert opinion. Thus, hire a third-party expert to audit your workflow. You can outsource the HIPAA-compliant app build to provide the best results.

Step 2. Categorizing PHIs

The next step is to categorize the information you receive from patients. Double-check whether you need all the data users provide you with. Next, you must identify which health information is PHI.This ensures the most valuable data is HIPAA-compliant. Finally, figure out which PHIs can be stored and transferred and which ones better stay without access by any third parties. In healthcare apps, HIPAA starts from ensuring the most valuable PHIs are best protected. 

Step 3. Separating PHIs

After you detect the PHIs, it is time to separate them from all the rest of the data. When building a HIPAA-compliant mHealth app, always keep PHI in a separate database from non-sensitive data. Keeping them apart shows what information should be protected and encrypted first. This helps improve the workflow and app performance.

Step 4. Limiting Access to PHIs

In the same manner, most valuable PHIs should be kept away. You need to limit the amount of data to the minimum an app’s functionality requires. Work only with data useful for users, as well as the one that directly impacts the app’s performance. Besides, enforce strict access control and avoid caching patient data on mobile devices.

Step 5. Top-grade Encryption

Use secure healthcare communication standards available. If you do not know which ones to choose, you can always look for an expert option. In addition, many texting apps offer robust cybersecurity services. They ensure all the relevant information coursing through your app has bank-grade encryption for a reasonable price. For instance, Paubox provides HIPAA-compliant email and messaging integrations.

Step 6. Testing

Testing is one of the key steps in HIPAA-compliant mHealth app development. No wonder application security and the testing market is soaring.

Test your mHealth app after every update. Engage in both static and dynamic testing, and check whether all the relevant documentation is up-to-date. If a HIPAA-compliance officer wants to investigate your product for compliance, you will have all the needed information in one place. 

Step 7. Third-Party Solutions

Building a HIPAA-compliant app from scratch can be costly. Meeting physical and technical safeguards means integrating various security measures that all dip into your budget. Besides, you will pay for auditing and certification in the development process. 

As a solution, don’t build everything from scratch. You can utilize messaging platforms designed for healthcare. Ensure you have a Business Associate Agreement in place and use a pre-made infrastructure with all HIPAA requirements met. Generally, hiring a third-party vendor means the third party becomes responsible for storing and managing your app’s PHI data. 

Step 8. Integrations

If your app connects to Google Meet or AWS, ensure they are HIPAA-compliant. Otherwise, your organization can find itself in a position when PHIs are stolen from cloud databases without you even being aware of that. Luckily, there are several reliable cloud-based solutions with HIPAA-compliant backends included. Besides, mobile communication must be scalable.

Step 9. Audit, Audit, and Audit

Each healthcare HIPAA software development step should be audited from a broad perspective. There are a lot of testing methods involved, including:

• Usability testing
• Functional testing
• Compatibility testing
• Performance testing
• Security testing
• Installation testing
• Manual testing
• Localization testing

Your audit logging should be thorough because PHIs can be used during various aspects of an app’s performance. Internal communication and staff communication should be also subject to a regular audit. If you do not want to overbear yourself with all the auditing and testing, you can always outsource it to vendors with expertise and experience. 

Step 10. Long-Term Thinking

You need to think long-term when working with HIPAA compliance in app development. It entails setting up various procedures to help monitor all the potential HIPAA issues. Thus, your clinical messaging tool must evolve with every new update and iteration. The same should be applied to the app’s security. Think about how you would face potential risks that can compromise PHIs and ePHIs. Maintaining HIPAA means you must stay compliant as HIPAA regulations change.

Conclusion

All in all, you can tell that HIPAA compliance is multi staged and complicated. There are many running elements included. By using the right HIPAA-compliant messaging app and following these 10 steps, you can provide the best patient messaging experience. When all healthcare application HIPAA compliance requirements are met, you get the product users will use and feel that their data is appropriately protected. So, let’s harness the power of a clinical communication platform to streamline communication and improve patient care.

Are you considering elevating your healthcare communication? Message SPsoft’s experts to discuss how our HIPAA-compliant app development services can safeguard your reputation and empower care teams!

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