How to Develop HIPAA-Compliant Mobile Application: Step-by-Step Guide  

The healthcare industry in the United States is grappling with an alarming surge in data breaches, with 8.8 million health records compromised in January 2024 alone. This disturbing trend underscores the importance of adhering to HIPAA regulations. Non-compliance can result in fines of up to $68,928 per incident and an annual cap of $2,067,813.

As if the financial implications weren’t daunting enough, the trends for 2024 point towards even stricter enforcement of HIPAA rules by the Office for Civil Rights (OCR).

Thus, it has become imperative for healthcare providers to develop HIPAA-compliant mobile applications. This blog offers a step-by-step roadmap to ensure your mobile app adheres to the stringent HIPAA standards and safeguards sensitive patient data.

HIPAA, or the Health Insurance Portability and Accountability Act, is a federal law passed by the 104th United States Congress in 1996 to safeguard sensitive medical information. It ensures the confidentiality and security of patient’s medical data and promotes the integrity of the healthcare system.

HIPAA applies to healthcare providers, health plans, and healthcare clearinghouses and mandates strict standards for protecting patients’ privacy.

But, to correctly implement HIPAA compliance in mobile apps, you first need to understand the data your app interacts with:

Protected Health Information (PHI):

PHI includes information identifying an individual’s health status or care, including medical records, billing information, and healthcare conversations.

For instance, if a healthcare app stores a patient’s medical history, lab results, and treatment plans, it must adhere to HIPAA to protect this PHI.

Confidential Health Information (CHI):

CHI includes any health-related data collected by non-traditional entities like wellness apps or fitness trackers. It covers exercise routines, dietary habits, and even heart rate measurements.

When you are clear about the data, recognize HIPAA’s significant role in safeguarding sensitive health information. Ensuring compliance with HIPAA regulations protects individuals’ privacy and security and promotes trust between patients and healthcare providers.

HIPAA balances the need for efficient healthcare delivery with the imperative to protect patient privacy and security. It helps patients, healthcare institutions, and startups.

For patients:

For healthcare organizations:

For startup owners:

As technology advances and healthcare applications become more prevalent, you must carefully consider which apps should adhere to HIPAA regulations. By understanding the scope of HIPAA’s applicability, you can ensure that sensitive health information remains protected across various digital platforms.

Any healthcare app (telemedicine, Electronic Health Records (EHR), patient portal, and medical device app) that uses PHI should comply with HIPAA regulations.

To gauge your application against compliance, you need to assess three significant factors:

• The entities involved,
• The data handled,
• The security measures implemented.

1. Entity

Entities encompass organizations or individuals involved in healthcare transactions and accessing PHI. Their classification dictates their obligations under HIPAA law. Two entities need to comply with HIPAA.

(a.) Covered Entities

Covered entities include healthcare providers (hospitals, clinics, and individual practitioners), health plans (HMOs, government healthcare programs), and clearinghouses that directly handle patient information and must comply with HIPAA’s privacy and security standards.

Example:
A hospital’s mobile app that allows patients to access their medical records and schedule appointments is a covered entity and must adhere to HIPAA standards to ensure the confidentiality and security of patient data.

(b.) Business Associates

Business associates are organizations or individuals who perform services or functions on behalf of covered entities involving the use or disclosure of protected health information (PHI). Examples include third-party billing companies, cloud storage providers, and IT support firms.

Example:
Suppose a telemedicine app owner partners with a medical billing company to process payments for virtual consultations. Although the billing company doesn’t deliver healthcare services, it must adhere to HIPAA as a business associate when handling patient billing information.

2. Data

The type of data managed by healthcare apps significantly impacts their obligation to comply with HIPAA regulations. PHI, comprising individually identifiable health information, is subject to stringent privacy and security standards under HIPAA regulation.

Example:
A mobile app designed for remote monitoring of blood glucose levels that collects and stores users’ health data, including glucose readings and medication schedules, falls within the scope of HIPAA regulations. Suppose the app is designed for users to track their glucose levels and medication schedules for personal use. In that case, it does not involve sharing data with healthcare providers or other covered entities, so it may not be subject to HIPAA.

3. Security

Security measures are fundamental in determining whether healthcare apps should adhere to HIPAA, particularly protecting electronic protected health information (ePHI). ePHI refers to protected health information transmitted, maintained, or stored electronically.

Example:
A mental health counseling app that allows users to communicate with therapists via secure messaging and video sessions. As these interactions involve the transmission of ePHI, such as patient assessments and treatment plans, the app must adhere to HIPAA regulations to safeguard the confidentiality and integrity of sensitive information.

Securing ePHI includes:

• Maintaining data integrity,
• Implementing audit controls, and
• Enforcing access controls.

Once you’ve determined which healthcare apps must comply with HIPAA regulations, it’s essential to understand the critical features required for compliance. These features form the backbone of safeguarding sensitive patient data and ensuring confidentiality.

To develop a HIPAA-compliant app, there are essential rules that you should follow:

As an AWS Healthcare Competency Partner, we have the expertise to ensure your mobile app meets the strictest HIPAA security and compliance requirements.

Here’s how the HIPAA rules apply to your work:

Technical safeguards:

• Encrypt patient data at rest and in transit using encryption algorithms such as AES-256 to protect it from unauthorized access or interception.
• Implement robust authentication mechanisms such as biometric recognition or multi-factor authentication to verify the identity of users accessing the app.
• Use secure coding practices, such as input validation and parameterized queries, to prevent vulnerabilities such as SQL injection or cross-site scripting attacks that could compromise ePHI.
• Regularly update the mobile app and underlying software to patch known security vulnerabilities and protect against emerging threats.
• Implement monitoring and logging mechanisms to track access to patient data, detect unauthorized or suspicious activity, and respond promptly.

Physical safeguards:

• Limit physical access to the devices or servers storing patient data by implementing strict access controls and using secure locations.
• Ensure that your application supports encryption and password protection for mobile devices used to access patient information. This prevents unauthorized access in case of theft or loss.
• Implement comprehensive wiping and disposal policies to secure the disposal of old devices and ensure that data is wiped adequately before disposal.
• Train your employees on the importance of physical security measures and enforce policies regarding the handling and storing mobile devices containing patient data.
• Regularly assess and update physical security measures to address environmental vulnerabilities or changes.

Administrative safeguards:

• Develop and enforce policies and procedures for the secure handling, storing, and transmission of patient data, including guidelines for employees’ use of mobile devices.
• Provide regular training and education to employees on HIPAA rules, security best practices, and the importance of protecting patient privacy.
• Designate a HIPAA compliance officer responsible for overseeing the implementation and enforcement of security measures and conducting regular risk assessments.
• Establish procedures for responding to security incidents, including protocols for notifying affected individuals and regulatory authorities as HIPAA requires.
• Conduct regular audits and risk assessments of HIPAA compliance to identify areas for improvement and ensure ongoing adherence to regulatory requirements.

Steps to create HIPAA-compliant mobile apps

HIPAA-compliant app development demands a comprehensive approach to safeguarding sensitive patient data:

Step 1: Select and implement HIPAA as a backend service

Choose a HIPAA-compliant backend service provider like AWS, Microsoft Azure, or Google Cloud and their relevant services, and data centers. For instance, AWS offers HIPAA-eligible services such as EC2 for computing, S3 for storage, and RDS for databases.

Google Cloud’s Cloud Healthcare API provides a fully managed, HIPAA-compliant platform for storing and analyzing PHI.

Step 2: Separate PHI from other app data

Carefully design your app’s architecture to separate sensitive and non-sensitive data. Create distinct data stores and databases for PHI, isolating it from other app data such as user preferences or analytics. This segregation helps minimize the risk of unauthorized access or exposure of sensitive information.

Tip: You may use the programming best practices to separate PHI. For iOS development using Swift, you can create separate data models and repositories for PHI. In Android development with Java/Kotlin, you can use distinct databases or content providers for sensitive information.

Step 3: Encrypt all sensitive data

Implement robust encryption algorithms and protocols to secure data at rest (stored in databases or files) and in transit (during transmission over networks). Industry-standard encryption methods like AES-256 and TLS/SSL should safeguard PHI throughout its lifecycle.

Step 4: Conduct security testing of the application

Regular security testing helps identify and address vulnerabilities in your app. Conduct comprehensive penetration testing, vulnerability scanning, and code reviews to uncover potential weaknesses in your app’s security defenses.

Engage with reputable third-party security firms or leverage automated security testing tools for HIPAA, such as Nessus, Qualys Cloud Platform, Kali Linux, OWASP ZAP, SQLmap, HIPAATrax, etc., to ensure a thorough evaluation of your app’s security posture.

Also, audit data encryption methods, access controls, and transmission protocols.

Step 5: Implement logging and monitoring

Implement robust logging systems that capture all user activities, system events, and data access attempts.

You may use real-time monitoring tools such as Prometheus, New Relic, Datadog, Nagios, Zabbix, etc., to detect and alert you to suspicious activities or anomalies within your app’s infrastructure.

Step 6: Enforce identity and access management

Implement robust identity and access management (IAM) policies to ensure only authorized individuals can access PHI. Implement role-based access controls, multi-factor authentication, and regular user access reviews to maintain tight control over who can view, modify, or delete sensitive medical data.

You may also use solutions like Auth0 or Okta to set up your app’s IAM by HIPAA standards.

Step 7: Ensure data integrity

Implement measures to ensure the integrity and accuracy of PHI throughout its lifecycle. Data validation techniques, such as input and sanitization, should be used to prevent unauthorized data modifications.

Employ checksums or digital signatures to detect and prevent tampering with PHI during transmission or storage. Maintain an immutable audit trail to track changes to PHI, including recording who made the changes, when they occurred, and the nature of the modifications.

Step 8: Carry out the disposal of data

Securely dispose of PHI following HIPAA when it is no longer needed. Implement data retention policies that define the appropriate retention periods for different types of PHI.

When the retention period expires, use secure data destruction methods, such as cryptographic erasure or physical destruction of storage media, to permanently remove PHI from your systems.

Step 9: Sign a HIPAA-compliant Business Associate Agreement (BAA)

Sign a HIPAA-compliant Business Associate Agreement (BAA) with third-party vendors when working with them.

Ensure that the BAA includes provisions for data security, breach notification, and adherence to HIPAA standards.

Use this quick HIPAA compliance checklist to ensure you have covered all the necessary steps before launching your mobile app:

Standard data formats and secure communication are the features that are often not considered during HIPAA-compliant app development. However, they are crucial, as are the other features mentioned below:

Creating a HIPAA-compliant app requires a robust tech stack that ensures security, privacy, and regulatory compliance. Here is a breakdown of the tech stack components, description, features, and relevant technologies:

Developing a HIPAA-compliant software can be a significant investment. Follow these tips to ensure your app adheres to HIPAA standards and safeguards sensitive consumer health information, which helps avoid costly penalties.

#1. Reach out to experts

HIPAA standards can be complex and ever-changing. Consult with legal experts specializing in healthcare privacy laws to ensure you thoroughly understand the latest requirements. Work with HIPAA-certified compliance officers who can guide you in implementing appropriate administrative, physical, and technical safeguards.

Consider partnering with healthcare IT consultants or cybersecurity firms specializing in HIPAA compliance. These firms can conduct comprehensive risk assessments, develop customized compliance strategies, and provide ongoing support and training for your team.

#2. Evaluate patient data

Conduct a thorough data mapping exercise to identify all the types of patient data your app collects, processes, or stores. Determine which data elements in your app qualify as PHI and require HIPAA compliance. Implement procedures to classify and handle PHI appropriately, such as implementing access controls and encryption measures.

#3. Find HIPAA-compliant third-party solutions

If your app integrates with third-party services or vendors for functions like cloud storage, data analytics, or payment processing, ensure they are HIPAA-compliant. Thoroughly vet their security measures, data handling practices, and compliance certifications.

Review their policies and procedures for safeguarding PHI, including encryption protocols, access controls, and breach notification processes. Consider signing Business Associate Agreements (BAAs) with these entities to outline their responsibilities in safeguarding PHI.

#4. Protect sensitive data

Implement robust security measures to protect PHI throughout its lifecycle. Encrypt data at rest (stored on servers or devices) and in transit (transmitted over networks) using industry-standard encryption algorithms, such as AES-256 or higher.

Enforce strong access controls, such as multi-factor authentication, role-based permissions, and regular password changes, to limit access to sensitive data. Implement secure communication protocols, like HTTPS and TLS, for transmitting PHI over the internet.

#5. Implement an audit mechanism

Establish an audit mechanism to track and log all activities related to PHI within your app. It includes recording when PHI is accessed, modified, or transmitted, as well as the individuals’ identities and the specific actions taken.

Implement centralized logging and monitoring solutions to collect and analyze audit logs from various sources, such as applications, databases, and network devices. Regular audits can help detect potential breaches and enable prompt investigation and response.

#6. Remove PHI from notifications and emails

Avoid including PHI in notifications, emails, or other communications unless necessary and secure. If it’s essential to incorporate PHI, ensure the communication channel is encrypted and complies with HIPAA standards.

Implement secure messaging solutions that use end-to-end encryption and provide secure communication channels for sharing PHI. Train your users on properly handling PHI in communications and the risks associated with unsecured channels.

Here are the common myths and misconceptions you should be aware of:

We’ve debunked some of the most common myths surrounding HIPAA compliance in mobile app development. But what happens if you unintentionally miss the mark? The following section will explore the real-world implications of failing to meet HIPAA standards.

Failure to comply with HIPAA standards for a healthcare application can result in substantial financial penalties, criminal charges, and reputational damage.

The OCR, part of the US Department of Health and Human Services (HHS), charges penalties for HIPAA violations. The fines get imposed on a tier-based structure, depending on the level of negligence or willful disregard for the HIPAA rules.

Here are some examples of penalties imposed due to HIPAA violations:

• Essex Residential Care, LLC failed to provide a son with timely access to his mother’s medical records. It took 161 days from the initial request for the records to be provided.OCR investigated the case and imposed a civil monetary penalty of $100,000.
• Green Ridge Behavioral Health is a provider of psychiatric evaluations that experienced a ransomware attack that exposed the PHI of 14,000 individuals. OCR investigated, identified potential privacy violations, and imposed a fine of $40,000.

Moreover, HIPAA breaches can severely damage an organization’s reputation and erode public trust. Patients may seek healthcare services elsewhere, and the organization may face lawsuits, loss of business, and increased scrutiny from regulatory bodies.

While non-compliance with HIPAA regulations can have severe consequences, one way to mitigate them is to invest in developing a HIPAA-compliant mobile app. However, cost is the primary factor.

The approximate cost of developing a HIPAA-compliant mobile application ranges from $65,000 to $650,000, depending on the project’s complexity and scope.

Here are the factors that affect the cost calculations:

1. Complexity of the app

Simple apps with basic functionalities and limited user interactions will be less expensive to develop. Complex apps with advanced features like secure messaging, data encryption, and integrations with electronic health records (EHR) systems will cost more.

Approximate range: $10,000 – $100,000

2. Location of developers

Costs can vary depending on the development team’s location. Developers in regions with higher living expenses typically charge more. Offshore development teams may offer lower rates than those based in countries with higher labor costs.

Approximate range: $20,000 – $150,000

3. Type of development team

Hiring freelancers or small development agencies might be more cost-effective, but they may lack the expertise for complex HIPAA compliance. Established software development companies specializing in healthcare applications may charge higher rates but offer comprehensive solutions and compliance expertise.

Approximate range: $15,000 – $150,000

4. Number of features

Each feature added to the application increases development time and costs. Features such as appointment scheduling, telemedicine capabilities, and secure file sharing contribute to the complexity. Prioritize essential features to manage costs while ensuring user needs.

Approximate range: $5,000 – $50,000 per feature

5. Number of user roles

Apps involving multiple user roles, such as patients, healthcare providers, and administrators, require more intricate user interfaces and backend systems. Each additional user role adds complexity to the app’s functionality and may increase development costs.

Approximate range: $5,000 – $30,000 per user role

6. Security requirements

HIPAA compliance necessitates robust security measures to protect sensitive patient data. Implementing encryption, secure authentication mechanisms, and regular security audits adds to development costs.

Approximate range: $10,000 – $50,000

7. Compliance consulting and legal fees

Engaging compliance consultants and legal experts to ensure adherence to HIPAA rules is crucial. These professionals help with risk assessments, policy development, and documentation required for compliance.

Approximate range: $5,000 – $30,000

8. Testing and quality assurance

Rigorous testing is essential to identify and rectify security vulnerabilities or usability issues.
Testing procedures include functionality testing, security testing, and compliance validation.

Approximate range: $10,000 – $50,000

So, the total cost of developing a HIPAA-compliant mobile application would be approximately:

However, to get a clearer picture of the investment needed for a HIPAA-compliant app, you should partner with the right HIPAA-compliant mobile app development company, like Simform. Here’s why:

Developing HIPAA-compliant apps demands more than just standard mobile app development know-how. It entails a deep understanding of HIPAA and a meticulous approach to ensure compliance throughout development.

As a seasoned technology partner, Simform boasts a track record of successfully delivering HIPAA-compliant healthcare applications for numerous clients. We offer a comprehensive HIPAA compliance approach, including:

• Thorough risk assessments
• Robust data encryption techniques
• Secure user authentication and authorization mechanisms
• Stringent access controls
• Strict audit trails and logging mechanisms
• Regular security updates and patches
• Comprehensive employee training on HIPAA compliance protocols
• Ongoing support and maintenance to uphold compliance standards

Plus, as an AWS Healthcare Competency Partner and an AWS Premier partner, we specialize in streamlining workflows, automating tasks, and prioritizing patient care first.

Partner with Simform today to take the first step towards a secure and compliant HIPAA-approved mobile app.