HIPAA Compliance for Software – How to Get Compliant Certification

The Health Insurance Portability and Accountability Act (HIPAA) is a US federal law that mandates healthcare organizations, including their vendors, with access to PHI to implement standard best practices to protect patient data (such as medical records) and other personal health information. 

This law extends to cloud-hosted tech firms that use software applications to process electronic Protected Health Information (ePHI), and hence, such companies must ensure their software is HIPAA compliant. 

Any instance of non-compliance can come with severe repercussions ranging from severe financial penalties to legal trouble.

In this article, we dwell on how to make your healthcare application comply with HIPAA and, more importantly, why you need to do so.  We’ll also discuss the best practices of being a HIPAA compliant software.

What is HIPAA-compliant software?

HIPAA compliant software is an application or a service, usually from a healthcare-related organization that follows all the necessary privacy, administrative, and technical safeguards under HIPAA requirements. 

For example, let’s take a HIPAA-compliant chat. It is a common solution used in healthcare companies to enable secure patient messaging to talk and collaborate with medical and nonmedical personnel. 

The main goal it aims to achieve is to talk about sensitive patient health data without the risk of exposing the chats to malicious actors or personnel who are not supposed to have access to the chat. 

Note: However, note that the term HIPAA compliant software is misused. Usually, the meaning behind the term is that software that is well adjusted to make you, your employees, and your company HIPAA compliant (like the example, HIPAA compliant chat). 

Why do you need to be HIPAA compliant?

You need to be HIPAA-compliant because healthcare organizations are legally obligated to comply with HIPAA regulations under federal law. HIPAA imposes heavy fines or penalties and may even take legal action for non-compliance.

It’s a way of ensuring patient privacy and PHI security. The main reason for this is the surge in electronic transactions and the need to safeguard ePHI as it zipped between healthcare providers, health plans, and clearinghouses. 

Also, further standards were published to shield the privacy of individually identifiable health information in any format. These standards are popularly known as the HIPAA Security and Privacy Rules.

What happens to healthcare data if HIPAA does not protect it?

If HIPAA doesn’t protect healthcare data, it could be stolen and used for fraud. This data is valuable because people could use it to get expensive healthcare treatments without paying. Healthcare fraud makes insurance costs go up, and then everyone ends up paying more for insurance.

Anyone who deals with electronic healthcare info has to follow HIPAA rules. But if you’re not involved with that kind of data, like stores or restaurants, you don’t need to worry about it.

If you want a handy checklist for quick reference, download it below:

Certain organizations do not have to follow HIPAA rules, and do you fit into that group?

Many organizations hold data that falls under the category of PHI as defined by HIPAA. However, since they are not classified as covered entities under HIPAA, they are not mandated to comply with its regulations.

If you want to know whether your company falls under the purview of HIPAA, you need to answer the following questions:

• Who is the end user of your software application? Is it a Covered Entity or a Business Associate?
• What data will it handle? Will your software be privy to PHI in any form?

If your software doesn’t interact with PHI in any form, you needn’t worry about HIPAA compliance. But if it does, you must make all efforts to ensure you comply with HIPAA.

In HIPAA parlance, you are a Business Associate if you are a health tech firm that builds and sells software applications that will interact with PHI. 

Aside from the mandatory requirement, following HIPAA compliant software requirements ensure you implement some of the global best practices in information security that dovetail with other compliance frameworks. 

How to make your software HIPAA-compliant?

To make your software HIPAA Compliant, you need to make sure that it meets all the requirements outlined in the HIPAA regulations. 

Here’s a list of 11 things you must do to ensure you are on the right side of HIPAA:

1. Evaluate risks based on the type of data 

You must first understand the type of data your software application will be privy to and list the potential risks against them. Know that risk assessment must be an exhaustive audit of all the risks that can impact the confidentiality, integrity, and availability of ePHI in your environment.

Conduct the risk assessment diligently as it lays the foundation for identifying and implementing security controls and safeguards that comply with the HIPAA Security Rule standards. 

A thorough risk analysis should help you assess whether the controls you have implemented are reasonable and appropriate. Training employees on HIPAA is one security measure you must implement.

Collect data: Identify how the PHI enters your Business Environments (BE), where it is stored, and to whom it is transmitted. Identify and document possible threats that can result in unauthorized access or leakage. 

Assess existing security measures: Assess and document existing security infrastructure. Ensure that those get configured or implemented correctly. 

Determine the impact of threat: Analyze how critical the risks are to the PHI in your HIPAA compliant software. Using qualitative or quantitative methods, measure the potential impact on your business in case of a data breach.

Determine the risk level: Assign a level of risk for each security gap. You can do this by assigning a number based on how damaging the impact could be. 

Finalize document: Document the result of your risk assessment. No specific format is defined for this. The idea is to compare historical data and create a log of the same.

Evaluate continuously: Risk assessment is a continuous process. HIPAA Security Rule doesn’t specify how frequently you should do it, as this depends on the covered entity. For instance, the type of risk your solution faces could change when you deploy a new technology to develop the application, face a security incident, or replace key individuals responsible for maintaining compliance.

Did you know that Business Associates must conduct risk assessments periodically (typically once a year)? Failure to do so can attract fines from the Office for Civil Rights (OCR) for noncompliance, and penalties can range from $100 to $50,000 per violation up to a maximum of $1.5 million per year for each violation.

The Sprinto way

Sprinto introduces a fully integrated risk assessment feature within its platform. It intelligently identifies and maps out your organization’s risks, allowing you to select the appropriate risk assessment measures. 

Your identified risks are seamlessly integrated into the system, requiring only minor adjustments to align with your organization’s specifics. Also, Sprinto provides industry-specific risk parameters to guide your risk assessment process in HIPAA further.

Related: A Comprehensive HIPAA Compliance Checklist 

2. Secure ePHI data on servers

The server (on-prem or cloud) you store your ePHI must also be HIPAA compliant. You must sign a Business Associate Agreement (BAA) with them to ensure that. Typically, large cloud storage servers such as AWS, Google Cloud Platform, or Microsoft Azure offer HIPAA-compliant servers for data storage. 

HIPAA encourages data minimization as a security best practice. So, ensure you only collect data that are an absolute must for the smooth running of your application and nothing more.

2. Encrypt data to avoid data breaches

While the HIPAA Security Rule doesn’t mandate encryption, it’s good security practice to implement one when dealing with ePHI. Even so, your risk assessment should help you determine whether you need one. 

That said, even if the risk assessment doesn’t conclude using encryption as an appropriate risk mitigation measure, here’s some food for thought. If there is a potential breach, the onus of explaining your decision to the OCR of why you didn’t use encryption falls on you.

When you use encryption, remember to do so for data-at-rest as well as in transit. Store your decryption tools at a separate location per NIST standards. You can also consider Advanced Encryption Standard (AES) to protect online data transfer and Transport Layer Security (TLS) to transfer data via HTTPS safely.

4. Backup data and implement disaster recovery 

The HIPAA Security Rule lays out guidelines on data backup and disaster recovery. You must institute a policy for the same. The policy should account for when, where, and how often to back up the PHI your software interacts with.

Your data backup policy must also dwell on how to retrieve and maintain ePHI in its original form if an incident occurs (breach, theft, neglect, and more). You must also have a disaster recovery plan outlining what needs to be done during an incident. 

To stay compliant, here are some measures you can implement.

Back up data as frequently as needed: You can automate this task or enable privileged access to handle it manually. 

Create multiple backup copies in encrypted form: Use robust encryption systems like AES-256 and enable two-factor authentication for additional security. 

Facilitate real-time auditing solution: Implement real-time monitoring of backed-up data, continuously test the restoration processes, and track changes made to PHI to identify unauthorized access and audit event logs based on user roles.

Create a disaster management feature: To limit the business risks in case of a mishap, create a recovery process for business continuity in case of a disaster, and determine which systems to restore first.

5. Dispose of old data

You must have procedures to dispose of ePHI permanently such that it isn’t recoverable or accessible to the public. Your software must include the feature to dispose of old data when needed safely. 

• Encrypt the data before deleting it to prevent its decryption
• Overwrite sensitive data with non-sensitive ones
• Exposes the data to strong magnetic fields to destroy the recorded data

Ensure data deletion happens across all devices and in all forms (physical, electronic, and backup).

6. Provide authorized access only 

Your software must implement access management to limit the access of PHI to only those authorized to see or use it. Maintain activity logs to identify unauthorized access or attempts.

Some of the best practices that you should incorporate into your application are

Sprinto advantage:

Traditional access management methods are inefficient, expensive, and prone to human error. While prioritizing convenience over compliance may seem tempting to maintain productivity, you’ll definitely face the brunt later on in the form of increased risks, security vulnerabilities, and potential audit failures.

Sprinto offers access