A Developer’s Guide to Build HIPAA Compliant Software in 2022 (+with checklist)

Shantanu Deshmukh

While developing software solutions for the healthcare industry, one of the most crucial things that developers have to take care of is that it is Health Insurance Portability and Accountability Act (HIPAA) compliant. The US government, in 1996, enacted the HIPAA to handle the PHI (Protected Health Information) of patients that are held or transmitted during the services provided by healthcare organizations. 

Despite the Act, in 2020, there were 616 data breaches containing 500 or more records, reported to the HHS Office for Civil Rights. Also, there were 28,756,445 healthcare records exposed, compromised, or impermissibly disclosed. Because of this, healthcare organizations were subject to millions of dollars of fines. note

Want to avoid such disastrous data breaches? In this article, you will learn how to make your software solution HIPAA-compliant. Read on.

Two Scenarios When Software Needs To Be HIPAA Compliant

Health IT companies that offer services of ensuring HIPAA compliance generally have two types of healthcare software development clients:

1.A client already owns healthcare software and wants to adapt it to the US healthcare market:

There could be various situations under this scenario. A client having their own healthcare software may want to expand its market in the United States as part of its expansion strategy. For this, they will have to follow the HIPAA guidelines and change the software application accordingly. For instance, a telemedicine healthcare application created and employed effectively in Europe would need HIPAA IT compliance for the software to be used in the US.

Alternatively, a client may not have software related to healthcare such as ERP solutions, video conferencing apps, etc. but may want to extend its functionality to cover the medical industry. In these cases also, organizations have to ensure that they are compliant with all HIPAA rules and regulations.

2. A client has an idea or a startup or MVP of an application for the healthcare software market

In this case, the client creates an MVP (minimum viable product) or fully completed application related to the medical services keeping in mind the HIPAA compliance. Significant fines for intentional or unintentional data breaches are excellent proof and a reminder of the importance of HIPAA.

Apart from the above two general scenarios, here are other entities in the US that have to treat patient-related information in compliance with HIPAA regulation:

  • Healthcare Providers – Organizations providing direct medical services to the patient. Like hospitals, pharmacies, labs etc.
  • Healthcare Plans – Ancillary health service providers like health insurance, health maintenance companies
  • Healthcare Clearinghouses – Companies that are not directly involved in healthcare services but work with patient’s information (PHI or EPHI), such as medical data transmitting services
  • Business Associates – Employees of healthcare IT services providers that process protected health information

Key Identifiers Covered Under HIPAA Rule

Knowing what PHI (Protected Health Information) is and how to protect it is a key part of HIPAA compliance. PHI is any individually identifying health information that can reveal a patient’s identity, and under HIPAA requirements these specific patient identifiers must be protected:

Name Health plan beneficiary number 
Address (full address including city, sub-divisions, pin codes, etc.)Account number 
All relevant dates associated with a patient (birth date, admission date, discharge date, etc.)License number 
Contact number Internet Protocol (IP) Address
Email address/Fax number Web address 
Medical record number Finger or voice print 
Photographic image (not limited to images of the face)Device/Vehicle identifiers 
Social security number Any other unique identifying information 

Challenges of Developing (And Staying) a HIPAA Compliant Software

Before publishing their solutions or products, the majority of healthcare developers check their solutions for all of the necessary security tools to ensure HIPAA compliance. However, there are some challenges they face while aiming for developing a perfect HIPAA-compliant software application. These challenges are:

1.Large amounts of data to protect – Developers need to have a clear understanding of the amount, nature, and presentation of sensitive information before implementing any form of data protection. This can be particularly difficult in healthcare organizations, where the data is stored at a variety of locations: EHR (electronic health record) systems, data centers, physical storage spaces, mobile devices, supply chains, vendor environments, etc.

2. Lack of resources and time – Creating HIPAA-compliant software requires a lot of time, knowledge, and attention from various field experts such as lawyers, cybersecurity experts, DevOps engineers, and medical experts. It is essential that the solution passes through all the security checks. Creating a product in a haste or without proper guidance (due to budget constraints or otherwise) can hamper the data security of the product.

3. Many development platforms – There are many development platforms used in a healthcare organization that have to be protected with the same security measures in order to be HIPAA compliant. Hospital infrastructure includes real and virtual user endpoints, servers, data centers, mobile devices, cloud services, and more. A skilled and experienced healthcare IT team is needed to develop MDMs for all these platforms, in order to protect sensitive information.

4. No regular audits or risk assessments – Even after a healthcare solution is deployed, work on it should never stop. HIPAA regulations, cybersecurity threats, and the IT environment of healthcare organizations change constantly. Therefore, developers must conduct regular audits, conduct periodic risk assessments, and keep updating documentation and security policies to ensure their software remains HIPAA-compliant.

How To Develop HIPAA Compliant Software Solution

The tools to make your medical software or mobile app HIPAA-compliant or design one from scratch depends a lot on how you store and transmit sensitive healthcare data. Here are six key ways to meet these requirements for HIPAA compliance as you build your application:

1. Encryption is Important

Any ePHI (electronic protected health information) or patient’s data should be encrypted before being transmitted. HIPAA compliant software encrypts sensitive medical information during transmissions, and the first step is to make it safe with SSL (Secure Sockets Layer) and HTTPS protocols. Your public or private cloud provider should configure your SSL so that it can use strong encryption methods. The SSL protects both login pages and sites collecting or showing health information.

Also, you should check if the HTTPS protocol is properly configured and there are no expired or insecure TLS (Transport Layer Security) versions. Hash values should be used to transmit and store passwords, which, in combination with secure, and complex passwords, can help prevent compromising events.

2. Backup Data Must Be Inaccessible to Unauthorized Users

Most healthcare software development companies offer backup services so that data is not lost in case of an accident. If in any case, the server is attacked or compromised, the data should be encrypted and inaccessible. Use AES and RSA algorithms with strong keys (preferably 256 bits for AES, and at least 4096 bits for RSA). Alternatively, a PostgreSQL manager with a built-in data encryption feature could also be used to keep the data secure.

Moreover, database administrators have more options than ever when deploying and managing databases in the cloud. For example, you can use Amazon Relational Database Service (RDS) for AWS or Cloud SQL in the Google Cloud Platform. These managed services provide a high degree of security and automation, making it easy to get your database up and running quickly.

3. Having a Robust Identity and Access Management System Is a Must

To ensure HIPAA compliance, it is essential to have a robust identity and access management system in place. This means that passwords and user IDs must be kept as secure as possible, and never shared among employees. The HIPAA regulations stipulate a high level of security that must be maintained to protect user data privacy.

A HIPAA compliant software should keep track of all access to protected health information (PHI) through writing access logs and event logs. Two-factor authentication (2FA) should be used to ensure that only authorized users are able to access sensitive health data and information. This can be done by using multiple forms of authentication to verify an individual’s identity.

There could be instances when someone demands access to a patient’s data fast. There are new technologies rising in the healthcare industry that aim to keep data secure while providing it on demand. These technologies include biometrics and single sign-on (SSO). With single-sign-on, healthcare professionals can sign in once and access all the applications and websites they need during a single session. This is useful because it enables professionals to quickly and easily gain access to user data across an ecosystem of apps and sites while still maintaining the privacy of institutional data.

Biometrics can also be used while building HIPAA-compliant software. Biometric authentication solutions are becoming more popular because of the uniqueness of human fingerprints, faces, and voices. However, these technologies require advanced anti-spoofing techniques to prevent people from pretending to be someone else. For instance, liveness detection can be used to prevent hackers from imitating the biometrics of another person.

Another way of ensuring HIPAA compliance for healthcare applications is through attribute-based access control (ABAC). Attribute-based access control (ABAC) is a way of managing user permissions that is more flexible than role-based access control (RBAC). With ABAC, permissions are granted based on the attributes of the user, rather than on predetermined roles. This allows for more dynamic and contextual access to resources, applications, and other locations. Individual attributes can be much more easily modified than predefined roles, making ABAC a more efficient system for managing user permissions over time.

4. Immediate Detection of Unauthorized Data Tampering

To ensure your patient’s health information is safe, have a system that immediately detects and reports any unauthorized data tampering. For example, suppose you are developing a healthcare software solution, use digital signatures, and verify all data stored or transmitted in the system.

Here blockchain can provide significant advantages for healthcare information security. Blockchain is a distributed database system that allows for secure, transparent, and tamper-proof transactions. It can be used to track the movements of data and ensure that it is not tampered with. Blockchain can also help to ensure that patients have control over their own data.

5. Data Disposal

To ensure healthcare data security and HIPAA compliance all backed up and archived data must expire and be permanently disposed of. This also applies to all the decryption keys used. Don’t forget that every location where the data is transmitted or stored might also be creating a backup file. Ensure that if the data is marked expired, or whenever the server is no longer in use, the health data must be disposed of as well.

6. Business Associate Agreement Must Be Signed

The last step to ensuring HIPAA-compliant software is that ePHI is hosted on servers of a company that has entered into a Business Associate Agreement with you. If this is not possible, then ePHI should be hosted on secure in-house servers or partner with HIPAA compliant hosting service providers like Google Cloud, AWS, and Microsoft Azure as you build your healthcare software solution.

Checklist For Software Development

One way to ensure HIPAA compliance when developing software is by using a checklist. This helps health IT developers to keep track of which requirements have been met and which still need to be addressed:

Requirement Steps To Ensure Status
Data Access Control Data encrypted with a reliable cipher 
Two-factor authentication 
Ensure all users have unique identifiers 
Automatic session termination or logoff methods 
Single sign-on or biometrics system for quick access to data 
Attribute-based access control
Means to deny access to/form devices using non-protected communication methods 
Deactivate inactive user profiles 
Hash values for transmitting passwords 
Backup data access control Data encryption
AES and RSA algorithms with strong keys (preferably 256 bits for AES, and at least 4096 bits for RSA) 
PostgreSQL manager with a built-in data encryption feature 
Amazon Relational Database Service (RDS) or Cloud SQL, if data is in a cloud platform.
Login/Logoff Monitoring  Record all login attempts – successful and failed
Show history of changes 
Log activity only available to system admins 
Anti-tampering mechanism Immediate notification of an unauthorized activity
Digital signatures 
Blockchain technology 
A document explaining action against unauthorized use or disclosure of protected health information & ePHI
Hosting on servers Health information is transmitted through only encrypted connections
In-house secure servers 
Business Associate Agreement signed if third-party servers 

Build HIPAA Compliant Software and mHealth App with BTC

The cybersecurity mechanisms required by HIPAA regulation can be time-consuming and challenging to implement, but they are necessary to protect healthcare companies from unexpected data breaches. These protections can help companies avoid severe penalties if a breach does occur.

At BTC, we have substantial experience and expertise in developing and testing HIPAA-compliant software. To know more about how BTC can help you, check out our HIPAA-compliant healthcare applications services page.

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