HIPAA-Compliant Application Development (2025 Handbook)

Key Takeaways

• Types of apps that need to be HIPAA compliant are telemedicine, EHRs, remote patient monitoring software applications, and condition-based healthcare apps. Applications that don’t require compliance are fitness apps, diet, and wellness applications.
• If any hospital fails to follow HIPAA compliance, they suffer heavy fines. Hospitals must pay a fine ranging from $100 to $50,000 if it fails to protect patient privacy.
• The average cost of a full-featured HIPAA-compliant software application is around $100,000. It covers the creation and development of the entire system encompassing physical and technical security guidelines.

As security threats and data breaches continue to grow, so does the need to protect confidential patient data with utmost care. For this reason, healthcare providers and businesses are seeking ways to create applications that meet the requirements of HIPAA regulations.

It implements stringent industry standards for information, sensitive patient-doctor data, and billing to protect your healthcare data.

Here we discuss the best practices and tips you need to know in order to develop a HIPAA-compliant app:

A Quick Glance at HIPAA Compliant App Development

In 1996, former U.S. President Bill Clinton signed and introduced the Health Insurance Portability and Accountability Act (HIPAA) as a Federal Law. The act mandated a list of standards for electronic medical records (EHR) across the nation.

Its goal was to help workers in the U.S. ensure privacy, transfer coverage, and extend benefits to their family members. Today, HIPAA security rules help maintain the confidentiality, availability, safety, and integrity of Public Health Information (PHI).

HIPAA-compliant apps can protect ePHI as it implements HIPAA-approved standards, such as:

• Technical Safeguards
• Physical Safeguards
• Administrative Safeguards

What Data Does HIPAA Protect?

HIPAA requires healthcare business providers and workers to implement its guidelines and standards to protect the following information:

• Conversations between a medical professional and nurses or other specialists about a patient’s care or treatment
• Data from a patient’s health insures’ computer
• Information added to a patient’s medical record by doctors, nurses, and other healthcare providers
• Patient billing and payment information
• Other private health information owned and managed by health providers and others who fall under this law

Arkenea has over 14 years of experience as a HIPAA-compliant app development company. Get in touch with us today for a free consultation and quote.

Healthcare Data Breach Statistics

• 721 healthcare data breaches reported to the Office for Civil Rights (OCR) in 2024.
• Over 275 million patient records compromised, representing a significant increase in breach severity.
• The largest healthcare data breach in history occurred during the Change Healthcare ransomware attack, affecting approximately 190 million individuals.
• Kaiser Foundation Health Plan experienced a breach impacting 13.4 million individuals.
• Average cost per healthcare data breach reached $10.93 million in 2024, the highest of any industry.

Main Features of a HIPAA Compliant App

HIPAA compliant app development starts with understanding its main features:

1. User Identification

Allowing users to log into your mobile app via email is not safe and increases the risks of data breaches. HIPAA compliant apps should use a strong password or PIN for user authentication.

Or they can add a smart key or card, biometric identification, or face identification.

2. Access during Emergencies

Easy access to healthcare data is essential and must continue regardless of the circumstances. During times of emergency, healthcare providers need to ensure essential services and utilities don’t experience a disruption.

For this reason, you need to ensure you have a solution for potential disasters like running out of electricity.

3. Data Encryption

Data encryption is critical in healthcare apps to ensure confidential data is safe. In addition, it implements an extra layer of protection against malicious malware and breaches.

Since emails are not encrypted, healthcare providers should refrain from sharing information through emails. Ensure you encrypt all data, whether you store it in SaaS or Cloud Servers.

4. Data Transit Encryption

To ensure maximum safety, you need to implement data encryption during transmission. Use AWS, Google Cloud, or similar tools running Transport Layer Security 1.2.

With these revolutionary tools, you can effectively address all encryption, authentication, and identification specifications outlined by HIPAA.

5. Data Subject to HIPAA Compliance

According to the U.S. HSS, the following patient information constituted the PHI alongside health data:

• Name of the patient
• Geographical subdivisions smaller than a state
• Dates related to the patient, including birth date, discharge date, date of death, admission date, etc.
• Phone numbers
• Fax numbers
• Email addresses
• Medical record numbers
• Social security numbers
• P. addresses
• Biometric identifiers, such as voiceprints and fingers
• Health plan beneficiary numbers
• Web URLs
• Account numbers
• Certificate and license numbers
• Device identifiers
• Vehicle identifiers like license plate numbers
• Full-face photographic images and comparable images
• Any unique identifying characteristic, number, or code

What Types of Healthcare Apps Need HIPAA Compliance?

The following types of healthcare apps need to be HIPAA compliant:

• Telemedicine apps
• Condition-based healthcare apps
• Electronic Health Records apps

A few mHealth apps that do not need to follow HIPAA guidelines include:

• Workout programs apps
• Diet apps
• IoT fitness apps

What Are HIPAA Violation Penalties?

HIPAA is a complex healthcare application that makes sure the healthcare industry follows to safeguard patients’ privacy. Organizations that fail to follow the rules set by HIPAA face heavy fines. The following are four different situations and the amount an organization must pay during a year.

1. When an organization is unaware of a HIPAA violation, can not avoid it realistically, and undergoes utmost care to prevent the violation must pay $100 to $50,000 per violation. Organizations must pay a maximum of $25,000 per year.
2. When an organization should have known about the violation even if they could not avoid it even though they tried their best, it has to pay $1000 to $50,000 per violation, a maximum of $100,000 per year.
3. When an organization violates HIPAA Rules due to willful neglect but takes measures to correct it within thirty days, it has to pay $10,000 to $50,000 per violation, a maximum of $250,000 per year.
4. When an organization violates HIPAA Rules due to willful neglect but does not take measures to correct it within thirty days, it must pay $50,000 per violation, a maximum of $1.5 million annually.

Rules to Develop a HIPAA-Compliant App

Almost all HIPAA compliant healthcare app developers face innumerable challenges while developing the app. These challenges mainly occur due to several modifications required on features and design.

App developers have found solutions to avoid innumerable challenges while designing the application quickly. For HIPAA Compliant App Development, developers follow some primary rules that have proven beneficial for the creation and function of the application.

The following are four primary rules necessary to develop a HIPAA-compliant app.

• Privacy
• Security
• Enforcement
• Breach

App entrepreneurs mostly dive into four rules that help them develop a HIPAA compliant healthcare app for organizations that can later benefit from maintaining the privacy of their patients through its security rules.

Scenario: When to Build a HIPAA Compliant Application?

Suppose healthcare organizations and clinics have approached a medical software development company intending to create a mobile application, only to keep track of their patients. The mobile healthcare application allows healthcare providers to store, transmit, and access ePHI. It also allows tracking real time patient conditions and receiving or sending auto-generated notifications on patient health. Such types of healthcare applications must be HIPAA compliant.

In another case, a healthcare development company is approached to build fitness and wellness apps. These applications require user data like age, name, weight, height, BMI, etc., and this information is from a home based device. To build such types of applications, there is no need to be HIPAA compliant. This is because covered entities aren’t involved and the data is only for user reference.

HIPAA-Compliant App Development Guide

HIPAA compliant app development is a complex task that requires developers to follow strict guidelines. Here’s an easy-to-understand guide on how to make an app HIPAA compliant.

Technical Safeguards

Technical safeguards focus on encryption data that doctors and patients transfer and store on servers and devices. Typically, technical safeguard practices include:

Access Control Requirements

Access control ensures that only authorized individuals can access confidential physical health information. To ensure this, developers need to implement the following things:

• Unique User Identification- Software systems should feature unique identifications to ensure users have different login credentials. Moreover, employees should avoid sharing usernames and password
• Emergency Access Procedures- Users should be able to access necessary e-PHI in case of emergencies
• Automatic Logoff- The system should automatically log you out after you’re using
• Encryption and Decryption- You should encrypt all ePHI data stored on the app or software systems

Transmission Security

Developers need to ensure that encrypted all ePHI is transmitted from one system to the other via communication networks.

You may implement various mechanisms to ensure that hackers cannot alter or breach any transmitted data.

Audit and Integrity

HIPAA compliant software needs to implement hardware, procedural, and software tools that can effectively track the activity in various systems.

In addition, healthcare providers and businesses need to ensure that confidential patient data within the HIPAA compliant app does not corrupt unintentionally. To protect the integrity of ePHI data, they may place revolutionary mechanisms.

Physical Safeguards

Physical safeguards encompass network protection for data transfer, backend, and devices on Android/iOS. They prevent the loss and theft of data by requiring developers to enforce authentication.

To ensure the security of doctor-patient data, you need to implement a multi-factor authentication system:

Device Controls

Ensure you wipe all sensitive data if you’re disposing of software that previously contained confidential data.

HIPAA requires compliant apps to delete relevant healthcare data from old and unused devices.

Workstation Safety

Healthcare businesses should guarantee maximum workstation safety by ensuring no one other than the employees can view computer monitors.

In addition, all systems should have strong passwords on their screensavers.

Workstation Use

Ensure that all devices used on a workstation, such as computers, mobile phones, etc., are appropriately logged off and secured when not in use.

In addition, antivirus software should always be up-to-date.

Facility Access Control

Facility access control means limiting access to facilities where you store ePHI.

Implementing facility access control practices and policies can help prevent unauthorized users and malicious malware from breaching your hardware.

Administrate Safeguards

Administrating safeguards means managing the implementation, working, and maintenance of security measures crucial to protect ePHI.

• HIPAA compliant app development must include Information Access Management to ensure that employees have access to relevant ePHI
• Only particular people should have access to ePHI and only if it is relevant to their job function
• Employees must undergo regular training to learn and familiarize themselves with new security policies relevant to ePHI
• In the case of a security breach, users should implement a contingency plan to notify all affected parties

Cloud Platform Specific Implementation

Amazon Web Services (AWS) HIPAA Compliance

AWS offers a comprehensive suite of HIPAA-eligible services that healthcare organizations can leverage for compliant application development. The key services include Amazon EC2 for secure computing instances, Amazon S3 for encrypted data storage, Amazon RDS for database management with encryption at rest and in transit, and AWS CloudTrail for comprehensive audit logging. Organizations must sign a Business Associate Agreement (BAA) with AWS and ensure that all data processing occurs within HIPAA eligible services configured with appropriate security controls.

Microsoft Azure Healthcare Solutions

Microsoft Azure provides specialized healthcare cloud services including Azure Health Data Services, which offers FHIR-compliant APIs for healthcare data exchange, and Azure Confidential Computing for processing sensitive health information in encrypted environments. Azure’s compliance framework includes built in HIPAA controls, automated compliance monitoring, and comprehensive audit capabilities that simplify the compliance process for healthcare developers.

Google Cloud Healthcare API

Google Cloud’s Healthcare API provides managed services specifically designed for healthcare data, including FHIR, HL7v2, and DICOM data stores with built in HIPAA compliance features. The platform offers advanced security features such as customer managed encryption keys (CMEK), VPC Service Controls for network isolation, and Cloud Security Command Center for continuous security monitoring.

HIPAA Compliant App Development: Key Steps

To help you create a HIPAA compliant app, we have a step-by-step guide to follow. Read the procedure to understand the process thoroughly.

Step 1: Hire an expert

To make an app HIPAA compliant, you need to have experience. If you do not have enough experience, you must hire a third-party expert to help you with essential guidance and support. You can also outsource HIPAA compliant app development from a skilled team.

Whether you are an entrepreneur or a well-known healthcare brand, you must look for an expert’s services to perfectly design the application. You may find many experienced and skilled experts in the market to help develop your HIPAA compliant app.

Step 2: Data evaluation and differentiating PHI from other applications

Evaluate the patient’s data to separate PHI data. Once done, evaluate what PHI data you cannot transfer or store.

Step 3: Come up with 3rd-Party Solutions

Designing a HIPAA compliant app is a costly investment. To start creating the application, you need to have enough resources to support the overall expenses.

The total cost of HIPAA compliant app development consists of designing the entire system that meets the technical and physical security requirement. In addition, you will need time to audit the system and get all the required certifications.

Such applications minimize the chances of misinformation and errors.

Step 4: Encrypt stored and transferred data

The primary benefit of using a HIPAA compliant app is the surety of safeguarding patients’ data. To ensure safety, healthcare organizations must use applications to protect one’s identity and personal data.

While designing HIPAA compliant mobile apps, encrypting patients’ data is essential. Ensure that there are no privacy invasions. It is vital to encrypt stored and transferred data to avoid any misuse of the data from the device.

Step 5: Test Your App for Security

Testing your application once the designing part is complete is necessary. Testing the application after every update is also important. Make sure you test the application statistically and dynamically. Moreover, take expert consultation to ensure that your documents are up to date.

Step 6: Maintain your application

Maintaining your application is a constant process. It helps to keep your application safe from unwanted invasions. To secure your app, you need to update the security checks to ensure the highest levels of privacy. Once you have created a HIPAA compliant software application, maintaining the application regularly is necessary; otherwise, anyone can access sensitive information.

All About Signing A Business Associate Agreement

A Business Associate Agreement (BAA) is a legal contract between a covered entity and a business associate that ensures the business associate will appropriately safeguard protected health information (PHI).

Critical BAA Components

Every BAA must include specific provisions that define the permitted uses and disclosures of PHI, require the business associate to implement appropriate safeguards, mandate reporting of security incidents and breaches, and establish procedures for returning or destroying PHI when the relationship ends. The agreement must also include provisions for subcontractors who may have access to PHI, ensuring that the same level of protection extends throughout the entire service delivery chain.

Technology Vendor BAA Requirements

When selecting technology vendors for HIPAA-compliant application development, organizations must ensure that all vendors who may have access to PHI are willing and able to sign comprehensive BAAs. This includes cloud hosting providers, software development partners (if they handle PHI), data analytics companies, and any third-party service providers involved in the application lifecycle. The absence of a properly executed BAA with any vendor who handles PHI constitutes a HIPAA violation regardless of other security measures in place.

How Much Does A HIPAA Compliant App Development Cost?

The average cost of a fully featured HIPAA compliant software application ranges from $100,000-$250,000, depending on the complexity. It covers the creation and development of the entire system encompassing physical and technical security guidelines.

Typically, the cost of a HIPAA compliant mobile app depends on the following features:

• Type of organization
• Size of the business
• Organization’s culture
• Geographic location
• Total number of business associates

Future Proofing and Emerging Technologies

Artificial Intelligence and Machine Learning Compliance

As healthcare organizations increasingly adopt AI and ML technologies for clinical decision support, predictive analytics, and automated diagnosis, new compliance challenges emerge. AI systems that process PHI must implement explainable AI principles to ensure that automated decisions can be audited and validated. Training data must be properly de-identified or used under appropriate authorization, and AI models must be regularly tested for bias and accuracy.

Internet of Things (IoT) and Wearable Device Integration

The proliferation of IoT devices and wearable health monitors creates new data collection and transmission pathways that must be secured under HIPAA requirements. Organizations must implement device authentication, secure communication protocols, and comprehensive data governance policies that address the unique challenges of distributed, always connected health monitoring systems.

Blockchain and Distributed Ledger Technologies

Blockchain technology offers potential benefits for healthcare data integrity and interoperability, but implementation must carefully consider HIPAA requirements for data modification and deletion. The immutable nature of blockchain records conflicts with HIPAA’s requirement for data correction and deletion, requiring innovative technical solutions and careful legal analysis.

The Bottom Line

Medical data is sensitive; thus, any breach or discrepancy can have significantly costly and inconvenient repercussions for patients, software suppliers, and medical institutions.

HIPAA compliant application development ensures that developers do not violate any industry rules leading to data privacy concerns. While developing the healthcare software at Arkenea, My Breast Cancer Journey, we assisted in building the app’s in-messaging feature, the feature to share documents and images.

Most importantly, we ensured that all features were HIPAA compliant to warranty the safety of PHI. Get started building your app today with the help of our professionals!

Disclaimer: To fully understand HIPAA compliance for your app, consult a healthcare attorney.