An Entrepreneur’s Guide on How to Develop a HIPAA Compliant Mobile Application

  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. 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. 

As medical providers strive to meet the demands of healthcare consumerization, the digital solutions market for this sector is rapidly expanding.

Consequently, many companies are investing in technologies to meet patient needs and stay competitive. However, it is vital that their software adheres to the latest HIPAA laws.

So, let’s move ahead and first understand what exactly is the HIPAA Act. 

What is the 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 on the path of understanding HIPAA law or compliance, there is still a lot of confusion around why HIPAA rules are important. 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 creating a mobile app with HIPAA compliance 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 checklist for software development. 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

Here are the main steps to create HIPAA Compliant apps for mobile:

• Get help from experts: The whole process of HIPAA compliant app development is complex. So, don’t try to meet all HIPAA requirements without guidance if you don’t have enough experience. It’s better to contact a reputed HIPAA compliant software development company. Taking help from experienced healthcare app developers for HIPAA compliant app development will make the task easy for you and help you prepare better. Understanding HIPAA compliance and adhering to its rules is beneficial for both startups and big healthcare companies. 
• Evaluate patient data: Any healthcare institution will have access to confidential patient data. This data can be stored, shared and maintained via a mobile app. You need  to analyze and identify what comes under the purview of PHI. Once you do that, see what PHI data you can avoid storing or transferring through your mobile app.
• Find HIPAA compliant third-party solutions: Providing HIPAA compliant for an app is very expensive. In such situations, it’s advisable to use infrastructure and solutions that are already HIPAA compliant instead of developing HIPAA compliant phone apps from scratch. This is called IaaS — Infrastructure as a service. For example, Amazon Web Services and TrueVault are compliant with HIPAA and are responsible for data security.

If you are using a third-party solution provider for storing and managing PHI data, you’ll need to sign a business associate agreement with third-party companies and make sure they’re reliable.

• Protect sensitive data: Use best security measures to protect sensitive data of your patients. Use several levels of encryption and make sure there are no security breaches.
• Maintain and test your app for security: Testing your app is really important. Do it after every update. If there is any issue with your app, it can be fixed immediately.

Maintenance is a constant process that you need to follow for safer and secure HIPAA compliance application development.  After you build a HIPAA-compliant app, you’ll need to make sure you update it regularly; otherwise, a security breach can occur.

Generic Features of a HIPAA Compliant Applications

While like other mobile app sectors, no two healthcare applications are the same. There are, however, some features that are common in all HIPAA compliant apps. Our effective Health application development guide will further help you understand the process in detail. 

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.

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 criterias 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. 

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 HIPAA Privacy Rule, there are two types of organizations which are subjected to the 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 which 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 in diagnosing skin diseases by studying the anonymous photos does not interact with any PHI. However, when you mention the patients’ name or address, it would become a PHI and would be termed as 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.

How much does HIPAA compliance application development cost?

To give you a rough idea, the HIPAA compliance application 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: It is the best option to develop a quality product at an optimized rate. Hiring a team in the regions like Asia can help you optimize your development budget while, at the same time, leveraging their exceptional field expertise.
  

[Also Read: How much does it cost to build a HIPAA-Compliant platform for medical supplies delivery]

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

When building HIPAA-compliant software, 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 developing HIPAA-compliant mobile apps, 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.  

Driven by the impact of the coronavirus pandemic on the healthcare sector, we are soon entering the phase where digital healthcare transformation will be the new norm. The digital healthcare transformers who understand the nuances of the compliances and implement them in their medical software today will see the most success. It means there will be a sharp shift to a focus on compliance adherence in the time to come.

Appinventiv is a leading healthcare technology consulting 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 the development of secure eHealth software, compliant with all HIPAA regulations. Our expertise and knowledge in this field make us an ideal partner for any healthcare-related project.

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 creating a HIPAA compliance mobile app. 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. 
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 move forward with improvement and growth. Our team is here to help you devise a plan for future mobile app development and potential scaling up, provide post-launch support for your HIPAA-compliant app, 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.

THE AUTHOR

Dileep Gupta

DIRECTOR & CO-FOUNDER