All You Need to Know

We live in an era where data is one of the most valuable commodities. Any industry that involves the collection of data, whether it be sensitive or not, must adhere to specific regulations to ensure the safety and security of the data. These compliances are put in place to protect the industry and its users.

The healthcare sector is also under the ambit of strict compliance to save users’ data from getting misused in this mobile-first era. Although the compliances vary from nation to nation, the one that has become universal on many grounds is the HIPAA – Health Insurance Portability and Accountability Act.

If you have ever interacted with the healthcare industry, there is a high chance that you must have heard of HIPAA-compliant apps and how it is a prerequisite for developing healthcare applications.

As medical providers and software developers strive to navigate these regulations, they confront the ongoing challenge of safeguarding sensitive health information. Despite efforts to fortify data security, the healthcare sector faced significant challenges in 2024. Although there was a slight reduction in the total number of data breaches, with 721 incidents reported to the Office for Civil Rights (OCR), the extent of data compromise was alarming.

Over 275 million records were breached, marking an increase in the severity of incidents. This included the largest-ever healthcare data breach during a ransomware attack on Change Healthcare, affecting approximately 190 million individuals. Another notable breach occurred at the Kaiser Foundation Health Plan, impacting 13.4 million individuals.

As businesses strive to meet the demands of healthcare consumerization, the digital solutions market for this sector is rapidly expanding. Consequently, many technologies are needed to meet patient needs and stay competitive. However, their software must adhere to the latest HIPAA laws.

In this article, we will give you a detailed insight into HIPAA compliant app development with the intent to help kickstart your healthcare digital transformation journey.

Understanding HIPAA Act

The HIPAA Act ensures zero anomalies when handling and storing patient data, especially on a software platform. It also includes sharing information related to billing and healthcare insurance coverage for medical patients.

The idea of developing mobile apps with HIPAA compliance was launched in 1996 to regulate the protection of the patient’s data, lower healthcare costs, and provide health insurance coverage for people who lost or changed jobs. The act was last updated in 2013. However, the portion of the act that we are interested in as developers and you would be as healthcare enterprises is the requirement for ensuring that the app protects users against data fraud.

The first part of understanding and implementing the HIPAA regulation compliance or HIPAA Act is to know the kind of data the healthcare software domain interacts with.

• PHI (Protected Health Information) — This information consists of doctor bills, MRI scans, emails, test results, and other medical information. The geolocation details of someone within a territory are also counted as PHI.

• CHI (consumer health information) — These information consist of data which you can gather from a fitness tracker, example: number of calories burnt, heart rate readings, and number of steps.

When businesses consider developing a healthcare product,  there is still a lot of confusion around why HIPAA compliant app development is the way to go. Let us take a look into that in detail.

What Makes HIPAA Compliance Important?

HIPAA regulation is a comprehensive act that has been enacted for helping both healthcare institutions and patients. Thus, understanding why it is important is necessary for both the stakeholders when building HIPAA compliant software.

For the Patients:

• No entity can forward any patient information without their consent – Under the HIPAA compliances, only the healthcare professionals can share the patients’ information with stakeholders. Also, only those stakeholders who attend the healthcare operations are to be covered under the PHI. This in turn, ensures high confidentiality and privacy levels.
• Billing professionals and prescription vendors cannot send patients’ information forward –  Other stakeholders, as mentioned in the above point, are not allowed to send patients’ information forward.
• Entities should notify patients of a breach – The patients have complete right to their medical details. This allows smooth flow of data sharing among multiple healthcare institutions.

For Hospitals:

For hospitals, the importance of HIPAA compliant app development lies in the understanding of what would happen if they are not followed. In case of non-adherence to the compliance, hospitals are held liable to pay massive fines. An individual data breach case can amount to $1000 to $1 million in fine.

There are many live examples of how costly it can get for hospitals when they breach the HIPAA compliance – on both financial and image grounds. Example, in 2015, a Massachusetts hospital had to pay a $218,000 fine for putting the data of more than 500 patients at risk simply because their file sharing application didn’t meet the HIPAA security requirements.

How to Make HIPAA Compliant Mobile Apps?

Developing HIPAA compliant healthcare apps can at times pose a challenge for the healthcare app developers especially because it asks for a number of modifications on both features and design front.

Our experience of having developed more than 70+ mHealth solutions, have aided us with a dedicated HIPAA compliance application development checklist. Here’s a peek into it –

HIPAA compliant software development requires you to follow the four primary rules:

• Privacy
• Security
• Enforcement
• Breach

As an enterprise, you would have to look into all the four rules. But, as a dedicated mHealth  development company, we primarily work around HIPAA privacy and security rules. They majorly consist of physical and technical safeguards.

Physical safeguards

It includes protection of the backend, network for data transfer, and devices that are on Android or iOS – ensuring that they cannot be compromised, lost, or stolen. To ensure applications’ security, you must enforce authentication while making it impossible to access apps without authentication – something that can be achieved through a multi-factor authentication system.

Technical safeguards

They focus on completely encrypting the data which can be transferred or stored on servers and devices. Some of the technical safeguard practices include:

• Emergency access process
• Unique user identification
• Automatic logoff

Another best practice in this regard can be following the minimum necessity requirements:

• Do not collect more data than you would need nor store data for longer than actually needed for work.
• Avoid transmission of PHI data in push notifications or leak the information in logs and backups.

Steps to Create HIPAA-Compliant Apps

Developing a HIPAA-compliant app is essential for any healthcare application handling sensitive patient data. This process involves several critical steps to ensure the security and privacy of protected health information (PHI). Here are the main steps of the HIPAA compliant app development process:

Step 1: Choose a HIPAA-Compliant Backend Service

Start by selecting a backend service that complies with HIPAA standards. Cloud service providers like AWS, Microsoft Azure, and Google Cloud offer specific services designed to handle PHI securely. For instance, AWS has HIPAA-eligible services such as EC2, S3, and RDS, which provide secure computing, storage, and database solutions. Similarly, Google Cloud offers a Cloud Healthcare API that manages PHI compliantly.

Step 2: Separate Sensitive Data

Design your app to keep PHI separate from other data. This means creating special areas in your app’s storage system for sensitive information, away from other data like user settings or app analytics. This helps prevent sensitive data from being accidentally accessed.

Step 3: Encrypt All Sensitive Data

Encrypt all sensitive information, both stored and sent over the internet. Use strong encryption methods such as AES-256 for data at rest and TLS/SSL to transmit data. This step ensures that PHI is protected from unauthorized access at all times.

Step 4: Conduct Regular Security Checks

Regularly test your app for security weaknesses. This includes penetration testing, vulnerability scans, and code review for security flaws. Consider hiring third-party security experts or using advanced testing tools to check your app’s security thoroughly.

Step 5: Implement Logging and Monitoring

Set up systems to log all user activities and system events, especially those involving access to data. Use real-time monitoring tools to detect and respond to unusual activities or potential breaches quickly.

Step 6: Manage Access Carefully

When you build a HIPAA-compliant app, use strict access controls to ensure only authorized people can access PHI. This involves setting up user roles, requiring multiple authentication factors, and regularly checking who has access to ensure it’s still appropriate.

Step 7: Maintain Data Integrity

Keep PHI accurate and tamper-proof throughout its lifecycle. Use techniques like data validation to prevent unauthorized changes and employ security measures like checksums or digital signatures to detect and block tampering.

Step 8: Safely Dispose of Data

Follow HIPAA integration rules for disposing of PHI when it’s no longer needed. Set policies for how long to keep different data types and use secure methods to delete data when it’s time permanently.

Step 9: Sign a Business Associate Agreement

If you work with third-party vendors, ensure you have a HIPAA-compliant Business Associate Agreement. This contract should outline how the vendor will protect PHI and comply with HIPAA standards.

After looking into the steps to build a HIPAA compliant app, let’s examine the essential features of developing such an app.

Generic Features of a HIPAA Compliant Applications

While like other mobile app sectors, no two healthcare applications are the same. There are, however, some common features businesses need to integrate while developing a HIPAA-compliant app. Let’s look at them in detail below:

User Identification: For the authentication of users, the best thing can be to ask them for a PIN or password while using HIPAA compliance mobile app. You can also take the feature up a notch by implementing biometric identification and smart cards.

Access at time of emergency: In case of natural emergencies, the network conditions and essential services might face a disruption. While it is not a direct requirement to arrange for these instances, it would be a good decision, consciously, to have a provision that addresses these issues.

Encryption: The data stored or transmitted must be encrypted for security purposes. Services such as Google Cloud and AWS, which utilize Transport Layer Security 1.2, provide end-to-end encryption. While TLS may be sufficient, it is advisable to further strengthen it with Advanced Encryption Standard (AES) encryption.

Shareable Data: A HIPAA-compliant app must comply with HL7/FHIR data standards to facilitate a shareable data format and ensure seamless interoperability between different healthcare systems. This feature enables healthcare providers to exchange patient information while easily maintaining data integrity and security.

Data anonymization: Data anonymization is crucial in HIPAA compliance software development to protect patient privacy. This process involves removing or encrypting personal identifiers from medical records, making it impossible to trace the information back to individual patients. By anonymizing data, healthcare organizations can safely use patient information for research, analysis, and other purposes without compromising privacy or violating HIPAA regulations.

Audit Trails: This feature tracks all access and actions taken within the app, recording who did what and when. Audit trails help ensure that all interactions with the app’s data can be traced, which is critical for detecting unauthorized access and ensuring compliance with HIPAA regulations.

Automatic Logoff: To prevent unauthorized access, HIPAA-compliant apps should automatically log users off after a period of inactivity. This feature reduces the risk of sensitive data being accessed by unintended users, especially on shared or unsecured devices.

Data Backup: Regular, automated backups of all PHI stored within the app ensure that data can be recovered during a hardware failure, cyberattack, or other data loss scenarios. Backups should be encrypted and stored securely in compliance with HIPAA requirements.

Remote Wipe Capability: If a device containing PHI is lost or stolen, remotely wiping the device is crucial to prevent unauthorized access. This feature allows administrators to remove sensitive data from devices remotely, safeguarding patient information.

Limited Data Retention: Implement policies within the app to limit the retention of PHI to only as long as necessary for legal, regulatory, and business purposes. This feature helps comply with the minimum required standard of HIPAA, reducing the risk of data breaches.

Consent Management: Provide mechanisms for users to give, manage, and revoke consent for data use and sharing within the app. This feature supports compliance with patient rights under HIPAA, ensuring that PHI is not used or disclosed without proper authorization.

Security Incident Response: Equip your app with tools to detect, respond to, and recover from security incidents promptly. This includes setting up alerts for suspicious activity and having a clear plan to address potential data breaches.

Tech Stack to Develop a HIPAA Compliant Mobile App

Selecting the right technology stack is crucial for ensuring security, compliance, and performance during the HIPAA compliant app development process. Here’s a breakdown of the essential tech components that go into creating a robust, secure healthcare application.

Which Healthcare Apps Should Comply With HIPAA Rules?

When we gauge an application against the need to comply with the HIPAA privacy rule, we majorly consider three criteria to define which of them are HIPAA compliance mobile apps:

Entity

When an application is used by some covered entity like a hospital, physician, or a healthcare insurance provider, they will most likely comply with the HIPAA compliant software development requirements.

For example, in case you plan to design an application which facilitates patient-doctor interaction, it would have to comply with the HIPAA rules because both hospitals and doctors are covered entities. On the other hand, an application which solely helps a person in following a medication schedule, it won’t necessarily have to follow the HIPAA privacy rules since there are no covered entities involved.

When we talk about entities, it is important to look into the Privacy Rule. The rule addresses what is Protected Health Data while defining who is responsible for ensuring that the PI detail is not disclosed.

To cater to HIPAA compliance software development, you must make sure that HIPAA regulations are applicable for each entity that accesses, processes or stores any Protected Health Information (PHI).

According to the HIPAA Privacy Rule, there are two types of organizations which are subjected to HIPAA law compliance:

Covered Entities

They are defined as any healthcare organization, provider,  or private practice that is involved in the transmission of health information. This includes, but is not limited to, pharmacies, nursing homes, and insurers. All of these entities are subject to the regulations set forth by the Health Insurance Portability and Accountability Act (HIPAA). It is important for these entities to ensure that they are compliant with HIPAA regulations in order to protect the privacy and security of individuals’ health information.

Business Associates

Business associates are entities that provide services to covered entities and are entrusted with the handling of Protected Health Information (PHI). These organizations are responsible for collecting, storing, and managing PHI on behalf of the covered entities. Examples of business associates include software and cloud service providers, lawyers, and accountants. It is important for covered entities to ensure that business associates are compliant with the Health Insurance Portability and Accountability Act (HIPAA) in order to protect the confidentiality, integrity, and availability of PHI.

Data

Mobile apps with HIPAA compliance are mainly concentrated on protected health information – any medical information that can be used to identify an individual along with the data that has been created, utilized, or disclosed in the time when healthcare organizations managed services like diagnosis or treatment was offered.

PHI consists of two sections: personally identifiable information and medical data. An important thing to note here is that only when a personally identifiable information is linked with the medical data, the information becomes PHI.

For example, an application that helps physicians diagnose skin diseases by studying anonymous photos does not interact with any PHI. However, when you mention the patient’s name or address, it becomes a PHI and is termed a HIPAA secure app.

To summarize, when the information shared or stored in an application can be identifiable individually, it must comply with the HIPAA law compliances. The same rule applies when the sensitive data is stored on some third-party server.

Software security

The last factor which helps identify whether or not healthcare app development falls in the HIPAA rules is related to the employed technology and consists of multiple standards applied for protection and control access of the electronic protected health information (ePHI).

These standards mainly consist of integrity, audit, and access controls.

Example of a HIPAA-Compliant Application for Businesses

Creating a HIPAA compliant app involves more than just understanding the regulations. Businesses must follow a meticulous approach to protect all aspects of patient data. Such applications must adhere to specific HIPAA compliant app guidelines to secure sensitive healthcare information effectively.

For example, consider a telehealth platform to connect patients with physicians via video consultations. The first step in developing this app would be to ensure that all data transmitted between patients and doctors is encrypted in transit using protocols like TLS or SSL. This encryption protects the data from unauthorized access as it moves across the internet.

Next, the app would need to incorporate robust authentication measures to verify the identity of users. This could include multifactor authentication mechanisms that require a combination of passwords, biometric data, and security tokens. Ensuring that only authorized users can access the app is crucial for maintaining privacy and complying with HIPAA regulations.

Lastly, the app should include detailed logging and monitoring of all data access and activities within the platform to provide an audit trail for compliance. This would involve implementing systems that track who accessed patient data, when it was accessed, and what changes were made.

This level of detail helps detect and respond to potential data breaches more effectively, ensuring ongoing compliance with HIPAA requirements. By addressing these key areas, the app can provide secure and private telehealth services that comply with HIPAA standards, making it a trustworthy tool for patients and healthcare providers.

After looking into the HIPAA compliant app development example above, let’s move ahead and understand the overall cost of developing a HIPAA compliant app.

How Much Does HIPAA Compliant Application Development Cost?

To give you a rough idea, the HIPAA compliant app development can cost anywhere between $45,000 to $300,000. Several factors further affect the budget of HIPAA compliance mobile apps, and those include:

• The overall complexity of the app
• Location of the app development agency
• Hired team size for developing the app
• The number of user roles for whom the app is to be made (user, admin, staff, etc.)

It is essential to clearly understand the main values that will be provided when creating an MVP and building a HIPAA compliance application. To ensure a cost-effective outcome, it is important to focus on the app’s core features and create a project plan that is mindful of the budget.

One of the major challenges enterprises face while deciding on the app development budget is finding a dedicated team with a thorough knowledge of building a HIPAA-compliant mobile app.

Here are a few options that you can try out while finalizing your development team:

•  Hiring an in-house team: Hiring in-house developers is an effective strategy only if you have an unlimited budget and can spend hundreds of hours interviewing potential employees. However, there are many risks associated with building a team from scratch. These risks include the lack of business analysis, project management, and development expertise. Without these skills, it can be difficult to effectively manage the project and ensure that it is completed promptly and efficiently. Additionally, it may be difficult to identify and address any potential issues during the project’s development. As such, it is important to ensure that the team is adequately equipped with the necessary skills and expertise to successfully complete the project.
• Hiring freelancers: Even though hiring freelancers is the cheapest option available, their lack of expertise and inability to manage resources can hamper the overall app’s quality and productivity.
• Outsourcing a dedicated app development agency: The best option is to develop a quality product at an optimized rate. Outsourcing your project to a dedicated healthcare app development team can help you maximize the cost of developing a HIPAA compliant mobile app while, at the same time, leveraging their exceptional field expertise.

Steps Followed by Appinventiv For Making HIPAA Compliant Application

At Appinventiv, our focus is always on a safety-first mobile app development approach. Whether we are developing an MHealth app or On-demand software, the priority always lies in ensuring that the users’ data are safeguarded under every condition.

When we make HIPAA-compliant mobile apps, there are several requirements that we abide by in our role as a custom healthcare software development company. Let’s take a look at them.

1. Transport Encryption

During the HIPAA-compliant mobile app development process, it is mandatory to keep the health data encrypted in transmissions. The first step that we follow to achieve that is using HTTP protocols and SSL. In the case of client-server data transfer, when the data has to be transmitted in the body of the POST requests, we first encrypt them on the sender’s front and then decrypt them on the receiver’s side. This helps with the prevention of man-in-the-middle attacks. Additionally, we transmit and store passwords in hash values to safeguard the compromising of data.

2. Backup

The hosting providers we partner with offer recovery and backup services; this ensures that the data is not lost in an emergency or accident. For example, if the web software sends the data elsewhere, the messages get backed up, securely stored, and made accessible to the authorized staff.

3. Authorization

We are a healthcare app development company that builds and upgrades your medical app to protect authorization. Some ways we do that is: by auditing the access control and securing the logins, which ensure that the data can only be accessed by authorized personnel.

4. Integrity

When initiating the HIPAA compliant app development process, infrastructure must be set up to ensure that the collection, storage, and transfer of information is safe and cannot be altered in any way, whether intentionally or by mistake.

The first step, in this regard, is to make sure the system can detect and report unauthorized data tampering, even when the tiniest bit of information is changed. Measures like encryption, regular backup, access authorization, adequately defined users’ roles and privileges, and restricting physical access to infrastructure become must-have elements when making HIPAA-compliant applications.

5. Storage Encryption

The rule of dealing with PHI is that it should only be available to authorized personnel. We cover all the data stored in the software system – backups, databases, and logs – in this rule. Our experts apply industry-backed encryption with the help of RSA and AES algorithms with strong keys. We even use encrypted databases like SQLCipher to store the data on the backend safely.

6. Disposal

It is of prime importance that the archived and expired backup data would be disposed of permanently. We take measures to dispose of all unused data safely and in a non-retrievable manner.

How Do We Manage PHI Collection, Transmission, and Storage?

When planning our PHI management process, we look into three situations:

• When the information is in transit – between the device and server – We use modern cipher suites and TLS to manage data on the move. In cases where the devices operate in untrusted networks such as public wi-fi, we use the certificate pinning process.
• When the information is on the server side – once the data has entered the server storage, we make provisions around the key rotation, key management, encrypted backup, audit logging, etc.
• When the information is at rest on the device – iOS and Android generally store that data on disks when the network is offline. This, in turn, can attract heavy penalties and fines. Thus, it is vital that the data is well encrypted.

Appinventiv is a leading healthcare app development services firm, boasting a wealth of experience and an in-depth understanding of the industry. With our cutting-edge technological capabilities, we are well-equipped to assist in developing secure eHealth software that is compliant with all HIPAA regulations. Our expertise and knowledge in this field make us an ideal partner for any healthcare-related project.

Our experts can help you with HIPAA integration, ensuring that your app is compliant and equipped with the latest security features to protect sensitive patient data. We focus on providing robust encryption, secure data storage solutions, and comprehensive risk management strategies tailored to the unique needs of healthcare applications.

Get in touch with our mHealth experts to kickstart your HIPAA compliant app development journey!

FAQs

Q. Is there any certification required to build a HIPAA secure app?

A. Adhering to the guidelines set out by the concerned authorities is essential for the HIPAA compliance application development process. These guidelines cover the proper administration and technical safeguards and the installation of robust physical infrastructure and security. It is important to note that there is no such thing as a HIPAA Certificate; instead, one must take the necessary steps to ensure their app complies with the standards the authorities set out.

Q. How to make an app HIPAA compliant?

A. Here are a few necessary steps to carry out for HIPAA compliance application development:

1. Start with a solid business idea: Before beginning the development of a HIPAA-compliant mobile app, it is important to consider the creative and definite idea that will make it stand out in the marketplace. It is essential to consider the target audience and how the solution will benefit them. To create a comprehensive business plan, questions such as who the user is, what makes the app unique, and how the app will generate revenue should be explored.
2. Choose a dedicated mHealth development company: Choosing the right development company is of utmost importance. An experienced and competent team can provide invaluable assistance in ensuring that your app complies with HIPAA regulations, conducting data privacy analysis, and helping you reach your desired outcomes. Before choosing a firm, always make sure that they have a proven track record in HIPAA compliance technology and can showcase examples of past projects that demonstrate their expertise in building secure healthcare applications.
3. Develop an MVP: MVP, or Minimum Viable Product, is an invaluable tool for enterprises or startups. It provides a way to test an idea with real-world customers without creating a full-fledged product. It should not be confused with a prototype or a draft, as an MVP is a fully-functioning product with a limited set of features. These features are sufficient for users to complete their journey and provide feedback. This feedback can be used to improve the product and make it more desirable to customers.
4. Launch your product to the app store: Once customer feedback has been received and data has been analyzed, it is time to improve and grow. Our team is here to help you plan for future improvement and potential scaling up, and provide post-launch support for your HIPAA-compliant mobile app development process. In addition, we will help release updates and rectify any issues that may arise. We are committed to helping you reach your goals and ensure the success of your mobile app.

Q. Why is HIPAA compliance important for businesses investing in healthcare app development?

A. HIPAA compliance is crucial for businesses investing in healthcare app development primarily because it protects sensitive patient information. HIPAA, or the Health Insurance Portability and Accountability Act, sets the standard for safeguarding personal health information. By complying with HIPAA, businesses adhere to legal requirements and build trust with their users. This trust is essential in the healthcare industry, where privacy concerns are significant.

Additionally, HIPAA compliant app development helps prevent potentially costly legal issues and fines associated with data breaches. For a business, adhering to these standards means enhancing its credibility and securing its reputation, which is vital for maintaining and growing a customer base in the health sector.

These HIPAA compliance application development benefits also include innovating within a framework that values data security. By developing apps that are HIPAA compliant, businesses can leverage the latest technology in a way that is both secure and effective. This compliance mitigates risks and opens the door to partnerships with larger healthcare organizations that require strict adherence to privacy laws.