As in any industry, the healthcare sector is eager to embrace any new technology solution that increases productivity, enhances operational efficiency, and cuts costs. However, the rate at which healthcare companies – and their patients and customers – have had to adopt new software and digital tools has skyrocketed since the pandemic. And while a lot of this software is beneficial, a key question arises: is it HIPAA compliant? While an application may serve an organization’s needs – and may be eagerly embraced by patients – it also needs to have the right measures in place to safeguard protected health information (PHI) to determine if it is indeed HIPAA compliant.

Whether you’re a healthcare provider, software vendor, product team, or IT professional, understanding what makes software HIPAA compliant is essential for safeguarding patient data and insulating your organization from the consequences of falling afoul of HIPAA regulations. 

With this in mind, this post breaks down the key indicators of HIPAA compliant software, the technical requirements you should look for, and best practices for ensuring your software is HIPAA compliant.

What Does It Mean for Software to Be HIPAA-Compliant?

The Health Insurance Portability and Accountability Act (HIPAA)  sets national standards for safeguarding PHI, which includes any data related to a patient’s health, treatment, or payment details. In light of this, any applications and systems used to process, transmit, or store PHI must comply with the stringent privacy, security, and breach notification requirements set forth by HIPAA.

Subsequently, while healthcare organizations use a wide variety of software, most of it is likely to be HIPAA-compliant. Alarmingly, many companies aren’t aware of which applications are HIPAA-compliant and, more importantly, if there’s a need for compliance in the first place.   

However, it’s important to note that HIPAA itself does not certify software. Instead, it’s up to software vendors to implement the necessary security and privacy measures to ensure HIPAA compliance. Subsequently, it’s up to healthcare providers, payers, and suppliers to do their due diligence and source HIPAA compliant software. 

How to Determine If Software Is HIPAA Compliant

So, now that we’ve covered why it’s vital that the applications and systems through which sensitive patient data flows must be HIPAA compliant, how do you determine if your software meets HIPAA requirements? To assess whether software is HIPAA compliant, look for these key indicators:

1. Business Associate Agreement (BAA)

A HIPAA compliant software provider must sign a Business Associate Agreement (BAA) with covered entities, i.e., the healthcare company. A BAA is a legal contract that outlines the vendor’s responsibility for safeguarding PHI. If a software provider doesn’t offer a BAA, their software is NOT HIPAA compliant.

Now, if a vendor offers a BAA, it should be presented front and center in their benefits, terms or conditions, if not on their website homepage as part of their key features. If a vendor has taken the time and effort to make their infrastructure robust enough to meet HIPAA regulations, they’ll want to make it known to reassure healthcare organizations of their suitability to their particular needs.  

2. End-to-End Encryption

A key requirement of the HIPAA Security Rule is that sensitive patient data is encrypted end to end during its transmission. This means being encrypted during transit, i.e., when sent in an email or entered into a form, and at rest, i.e., within the data store in which it resides.

In light of this, any software that handles PHI should use strong encryption standards, such as:

• Transport Layer Security (TLS – 1.2 or above): for secure transmission of PHI in email and text communications. 
• AES (Advanced Encryption Standard) 256: the preferred encryption method for data storage as per HIPAA security standards, due to its strength.

3. Access Controls and User Authentication

One of the key threats to the privacy of patient data is access by unauthorized parties. This could be from employees within the organization who aren’t supposed to have access to PHI. In some, or even many, cases, this may come down to lax and overly generous access policies. However, this can result in the accidental compromise of PHI, affecting both a patient’s right to privacy and, in the event patient data is unavailable, operational capability. 

Alternatively, the exposure of PHI can be intentional. One on hand, it may be from employees working on behalf of other organizations, i.e., disgruntled employees about to jump ship to a competitor. More commonly, unauthorized access to patient data is perpetrated by malicious actors impersonating healthcare personnel. To prevent the unintended exposure of PHI, HIPAA compliant infrastructure, software and applications must support access control policies, such as:

• Role-based access control (RBAC): the restriction of access to PHI based on their job responsibility in handling PHI, i.e.., an employee in billing or patient outreach. A healthcare organization’s security teams can configure access rights based on an employee’s need to handle patient data in line with their role in the company. 
• Multi-factor authentication (MFA): this adds an extra layer of security beyond user names and passwords. This could include a one-time password (OTP) sent via email, text, or a physical security token. MFA is very diverse and can be scaled up to reflect a healthcare organization’s security posture. This could include also biometrics, such as retina and fingerprint scans, as well as voice verification.
• Zero-trust security: a rapidly emerging security paradigm in which users are consistently verified, as per the resources they attempt to access. This prevents session hijacking, in which a user’s identity is trusted upon an initial login and verification. Instead, zero trust continually verifies a user’s identity.  
• Robust password policies: another simple, but no less fundamental, component of user authentication is a company’s password policy. While conventional password policies emphasize complexity, i.e., different cases, numbers, and special characters, newer password policies, in contrast, emphasize password length. 

4. Audit Logs & Monitoring

A key HIPAA requirement is that healthcare organizations consistently track and monitor employee access to patient data. It’s not enough that access to PHI is restricted. Healthcare organizations must maintain visibility over how patient data is being accessed, transferred, and acted upon (copied, altered, deleted). This is especially important in the event of a security event when it’s imperative to pinpoint the source of a breach and contain its spread.

In light of this, HIPAA compliant software must:

• Maintain detailed audit logs of all employee interactions with PHI.
• Provide real-time monitoring and alerts for suspicious activity.
• Support log retention for at least six years, as per HIPAA’s compliance requirements.

5. Automatic Data Backup & Disaster Recovery

Data loss protection (DLP) is an essential HIPAA requirement that requires organizations to protect PHI from loss, corruption, or disasters. With this in mind, a HIPAA-compliant software solution should provide:

• Automated encrypted backups: real-time data backups, to ensure the most up-to-date PHI is retained in the event of a security breach.
• Comprehensive disaster recovery plans: to rapidly restore data in case of cyber attack, power outage, or similar event that compromises data access.  
• Geographically redundant storage: a physical safeguard that sees PHI. stored on separate servers in different locations, far apart from each other. So, if one server goes down or is physically compromised (fire, flood, power outage, etc.,) patient data can still be accessed. 

6. Secure Messaging and Communication Controls

For software that involves email, messaging, or telehealth, i.e., phone or video-based interactions, in particular, HIPAA regulations require:

• End-to-end encryption: for all communications, as detailed above.
• Access restrictions: policies that only enable those with the appropriate privileges to view communications containing patient data.
• Controls for message expiration: automatically deleting messages after a prescribed time to mitigate the risk of unauthorized access.
• Audit logs: to monitor the inclusion or use of patient data.

7. HIPAA Training & Policies

Even the most secure software can be compromised if its users aren’t sufficiently trained on how to use it. More specifically, the risk of a security breach is amplified if employees don’t know how to identify suspicious behavior and who to report it to if an event occurs. With this in mind, it’s prudent to look for software vendors that:

• Offer HIPAA compliance and cyber safety awareness training for users.
• Implement administrative safeguards, such as usage policy enforcement and monitoring.
• Support customizable security policies to align with your organization’s compliance needs.

Shadow IT and HIPAA Compliance

Shadow IT is an instance of an application or system being installed and used within a healthcare organization’s network without an IT team’s approval. Despite its name, shadow IT is not as insidious as it sounds: it’s simply a case of employees unwittingly installing applications they feel will help them with their work. The implications, however, are that:

1. IT teams are unaware of said application, and how data flows through it, so they can’t secure any PHI entered into it.
2. The application may have known vulnerabilities that are exploitable by malicious actors. This is all the more prevalent with free and/or open-source software.

While discussing the issue of shadow IT in general, it’s wise to discuss the concept of “shadow AI” – the unauthorized use of artificial intelligence (AI) solutions within an organization without its IT department’s knowledge or approval. 

It’s easily done: AI applications are all the rage and employees are keen to reap the productivity and efficiency gains offered by the rapidly growing numbers of AI tools. Unfortunately, they fail to stop and consider the data security risks present in AI applications. Worse, with AI technology still in its relative infancy, researchers, vendors, and other industry stakeholders have yet to develop a unified framework for securing AI systems, especially in healthcare. 

Consequently, the risks of entering patient data into an AI system – particularly one that’s not been approved by IT – are considerable. The privacy policies of many widely-used AI applications, such as ChatGPT, state the data entered into the application, during the course of engaging with the platform, can be used in the training of future AI models. In other words, there’s no telling where patient data could end up – and how and where it could be exposed. 

The key takeaway here is that entering PHI into shadow IT and AI applications can pose significant risks to the security of patient data, and employees should only use solutions vetted, deployed, and monitored by their IT department. 

Best Practices for Choosing HIPAA Compliant Software

Now that you have a better understanding of how to evaluate software regarding HIPAA compliance, here are some best practices to keep in mind when selecting applications to facilitate your patient engagement efforts:

✔ Look for a BAA: quite simply, having a BAA in place is an essential requirement of HIPAA-compliant software. So, if the vendor doesn’t offer one, move on.

✔ Verify encryption standards: ensure the software encrypts PHI both at rest and in transit.

✔ Test access controls: choose HIPAA-compliant software that allows you to restrict access to PHI based on an employee’s role within the organization. 

✔ Review audit logging capabilities: HIPAA compliant software should track every PHI interaction. This also greatly assists in incident detection and reporting (IDR), as it enables security teams to pinpoint and contain cyber threats should they arise.

✔ Ensure compliance support: knowing the complexities of navigating HIPAA regulations, a reputable software vendor should provide comprehensive documentation on configuring their solution to match the client’s security needs. Better yet, they should provide the option of cyber threat awareness and HIPAA compliance training services. 

✔ Create a List of Software Vendors: combining the above factors, it’s prudent for healthcare organizations to compile a list of HIPAA compliant software vendors that possess the features and capabilities to adequately safeguard PHI.

Choosing HIPAA Compliant Software

Matching the right software to a company’s distinctive workflows and evolving needs is challenging enough. However, for healthcare companies, ensuring the infrastructure and applications within their IT ecosystem also meet HIPAA compliance standards requires another layer of, often complicated, due diligence. 

Failure to deploy a digital solution that satisfies the technical, administrative, and physical security measures required in a HIPAA compliant solution exposes your organization to the risk of suffering the repercussions of non-compliance. 

If select and deploy the appropriate HIPAA compliant software, in contrast, your options for patient and customer engagement are increased, and you’ll be able to include PHI in your communications to improve patient engagement and drive better health outcomes. Schedule a consultation with one of our experts at LuxSci to discuss whether the software in your IT ecosystem meets HIPAA regulations. and how we can assist you in ensuring your organization is communicating with patient and customers in a HIPAA compliant way.