If you’re running a SaaS company, especially one in or even remotely related to healthcare, you’ve probably come across HIPAA compliance by now. And if you’re like most businesses, that word likely triggers one thing: stress.
While HIPAA is a serious regulation with real consequences, it doesn’t have to be overly intimidating. In fact, once you break it down, achieving and maintaining HIPAA compliance is very doable – especially with the right roadmap and support.
In this checklist, we’ll walk you through exactly what HIPAA compliance means for SaaS companies, why it matters, and the exact steps you need to take to simplify the process. This will help clarify HIPAA without watering it down, so you can build lasting trust while staying on the right side of the law.
TL;DR
- HIPAA (Health Insurance Portability and Accountability Act) sets the U.S. national standard for protecting sensitive patient data.
- If your SaaS company handles protected health information (PHI), whether directly or indirectly, HIPAA compliance is non-negotiable.
- Our 8-step HIPAA compliance checklist breaks down the process into clear, actionable steps, helping you prepare for audits and safeguard patient data.
What is HIPAA Compliance?
HIPAA compliance refers to the ongoing process of meeting the regulatory and security requirements set by the Health Insurance Portability and Accountability Act of 1996. This U.S. law was created to streamline the flow of healthcare information, reduce fraud and abuse, and – most importantly for your business – ensure that protected health information (PHI) stays confidential, secure, and accessible when needed.
For SaaS businesses working with healthcare clients or data, HIPAA compliance is more than just a regulatory requirement. It’s a framework that governs how sensitive health data is handled across your organization – from storage and transmission to access control and breach reporting.
The 3 Core HIPAA Rules for Protecting PHI
There are three primary rules that make up the HIPAA framework. Each one plays a crucial role in protecting PHI and together, they form the foundation of every business’s HIPAA GRC program.
| HIPAA Rule | Focus | Key Features |
| Privacy Rule | Regulates the use and disclosure of PHI | Gives patients control over their data, including the right to access, amend, and receive an accounting of disclosures |
| Security Rule | Protects electronic PHI (ePHI) through administrative, physical, and technical safeguards | Requires encryption, access control, audit logs, and policies to prevent unauthorized access or tampering |
| Breach Notification Rule | Requires prompt response and reporting of security incidents | Mandates that affected individuals and the Department of Health and Human Services (HHS) be notified within 60 days of discovering a breach |
⚠️ These rules aren’t only guidelines, but are enforceable federal standards. Failure to comply can result in hefty financial penalties and reputational damage, even for unintentional PHI mishandling.
For SaaS providers, understanding how HIPAA rules apply to your systems, teams, and vendors is essential. Are you transmitting PHI through your application programming interface (API)? Storing it on a cloud service? Allowing clients to access patient data via dashboards? All of these interactions fall under HIPAA, and appropriate safeguards, such as encryption and access controls, must be in place.
Before diving into our HIPAA IT compliance checklist, let’s first take a moment to understand what HIPAA is really all about.
By aligning your security practices with the Privacy, Security, and Breach Notification Rules, you’re not only complying with the law but also building long-term trust with clients, partners, and end users who rely on you to protect their most sensitive data. Ultimately, HIPAA compliance aims to provide patients with peace of mind while supporting technology that advances healthcare.
Who Must Comply with HIPAA Compliance?
HIPAA compliance applies to two types of organizations: covered entities and business associates. Curious if your organization fits the bill? Keep reading to see if HIPAA applies and which category you fall into.
Covered Entities
- Healthcare providers
- Insurance plans
- Healthcare clearinghouses
Covered Entities are individuals and organizations that directly handle PHI. This includes hospitals, private practices, insurance companies, and any organization that falls under the direct domain of the U.S. healthcare system.
Business Associates
- Cloud storage providers
- Analytics tools
- Communications platforms
Business Associates, however, are third-party vendors who handle PHI on behalf of a covered entity. That’s where most SaaS companies come in. If your software collects, stores, processes, or transmits PHI (yes, even if you’re not a healthcare provider yourself), you’re considered a Business Associate under HIPAA.
💡 Still unsure if HIPAA compliance applies to you? Dive into this article to clear up your responsibilities.
Key HIPAA Requirements You Should Know
At its core, HIPAA compliance is about managing risk and protecting patient data. To achieve this, HIPAA outlines several key categories of safeguards and responsibilities that every covered entity and business associate must address.
Here’s a breakdown of the essential HIPAA requirements:
| Requirement Type | Purpose | Key Actions |
| Administrative Safeguards | Set internal policies and processes that govern access and security | 1. Train employees on HIPAA policies 2. Assign a HIPAA Security Officer 3. Conduct regular risk assessments |
| Physical Safeguards | Protect physical systems and data from unauthorized access or theft | 1. Restrict physical access to servers and data centers 2. Implement workstation security protocols 3. Ensure secure disposal of hardware and devices |
| Technical Safeguards | Secure electronic protected health information (ePHI) through IT controls | 1. Implement role-based access controls 2. Encrypt data in transit and at rest 3. Maintain audit logs and monitoring systems 4. Use strong authentication and password policies |
| Organizational Requirements | Manage relationships with vendors and third parties that handle PHI | 1. Establish Business Associate Agreements (BAAs) with all vendors handling PHI 2. Ensure third parties meet HIPAA standards |
| Policies & Procedures | Document all privacy and security practices | 1. Maintain written security policies and protocols 2. Review and update documentation regularly 3. Ensure all policies reflect actual operations and HIPAA rules |
These 5 key HIPAA compliance requirements ensure your organization tackles privacy and security from every angle – people, processes, physical environments, and technology.
Remember, even if your infrastructure is rock solid, you could still be non-compliant if your workforce isn’t trained or your policies are outdated. Likewise, failing to sign a Business Associate Agreement (BAA) with a vendor handling PHI could put your company at risk, even if that vendor is otherwise secure.
GET HIPAA COMPLIANT 90% FASTER
In short, HIPAA compliance is a holistic effort. Getting a handle on these requirements and putting them into action creates a solid foundation for a resilient, sustainable GRC program that will protect your business and drive its success in today’s competitive market.
8-Step HIPAA Compliance Checklist
While HIPAA compliance can seem like a massive undertaking, it becomes much more manageable when broken down into steps. Here’s a simple HIPAA compliance checklist to guide your business in getting and staying compliant:
1. Conduct a Thorough Risk Assessment
The first step is to identify where protected health information (PHI) lives within your organization and understand how it moves through your systems. This means taking a close look at every process, application, and integration that may handle health data. A comprehensive risk assessment helps uncover technical and operational vulnerabilities that could lead to unauthorized access, data loss, or misuse.
Documenting these findings is essential, not only for guiding remediation efforts, but also for proving due diligence during an audit.
2. Implement Security Safeguards
Based on the results of your risk assessment, implement security controls that align with HIPAA’s Security Rule. This means covering administrative, technical, and physical safeguards. Think role-based access controls, encrypting data both in transit and at rest, setting up secure logins, and limiting physical access to servers and devices.
You should also have a clear process for handling requests to access health data. Finally, don’t forget to run regular system audits to catch any small issues before they turn into bigger problems.
3. Establish Privacy Policies and Procedures
With your technical and administrative safeguards in place, the next step is to document your privacy practices. Your policies should clearly define how your business collects, stores, uses, and shares PHI. They should also detail how you support patients‘ rights under HIPAA, including their ability to access their own data or request corrections.
Ensure these documents are thorough and reflect how your specific SaaS business operates, focusing on what’s most relevant to your organization’s day-to-day activities.
4. Sign Business Associate Agreements (BAAs)
Any vendor, consultant, or third-party tool that may come into contact with PHI on your behalf must sign a Business Associate Agreement (BAA). These agreements legally bind them to HIPAA-level standards and define their responsibilities when handling PHI. Think cloud storage providers, analytics tools, communication platforms, or anyone else supporting your infrastructure.
Even if your own systems are secure, a missing BAA could lead to serious compliance violations.
5. Train Your Team
HIPAA compliance is just as much about the people behind it as it is about the technology that supports it. Every employee, contractor, or partner with access to PHI must be properly trained on your HIPAA policies. HIPAA training should cover what PHI is, how to identify potential breaches, and how to report security concerns.
Security awareness training should happen regularly – ideally annually – and every session must be well-documented to maintain compliance.
6. Develop an Incident Response Plan
Despite all precautions, data breaches can still occur. A strong incident response plan helps you act quickly and effectively when they do. Your plan should outline how you identify a HIPAA breach, how you contain it, whom you notify, and how you report it.
HIPAA requires that affected individuals and the Department of Health and Human Services (HHS) be notified within 60 days of discovery. Simply put, the more prepared you are, the faster and more confidently you can respond.
7. Keep Compliance Documentation Organized and Up-to-Date
Good documentation is your safety net. It shows you’re not only committed to compliance but actively managing it. Keep thorough records of your risk assessments, training sessions, policies, BAAs, and incident reports.
Documentation adds structure and transparency to your compliance efforts and is often the first thing reviewed during an audit. Keeping everything organized can save you time, resources, and a major admin headache.
8. Continuously Monitor and Improve
HIPAA compliance isn’t something you do once and forget. It requires ongoing effort. Regularly review and update your policies, conduct internal audits, and re-assess risks as your infrastructure, team, or product evolves.
Continuous monitoring helps you maintain a rock-solid security posture around the clock and quickly adapt to new threats and regulatory updates.
💡For more helpful tips on achieving HIPAA compliance, check out our 10 Go-To Tips for HIPAA Compliance.
GET COMPLIANT 90% FASTER
Streamline HIPAA Compliance with Scytale
Managing HIPAA compliance manually is a drain on time and resources, especially as your business grows. But with Scytale, you can trade the stress of compliance for the ease of automation.
Scytale’s HIPAA compliance software simplifies the entire process, from achieving compliance to maintaining it. And the best part? It does this 90% faster. Our AI-powered platform centralizes everything you need in one AI-powered security and compliance hub – automating key processes like evidence collection, continuous control monitoring (CCM), custom policy templates, risk assessments, vendor risk management, multi-framework cross-mapping, and more.
These smart features cover everything on the HIPAA compliance software checklist and beyond, allowing you to focus on what truly matters: delivering high-quality patient care. Plus, with a dedicated team of GRC experts by your side, you’re never alone in your compliance journey.
In a world where a single security incident can cost you everything, the peace of mind that comes with automated HIPAA compliance is priceless. With Scytale, your organization can protect PHI, reduce risk, and stay ahead of the curve – effortlessly.
FAQs
What is HIPAA compliance?
HIPAA compliance means following U.S. national standards to protect health data. If your business stores, processes, or shares protected health information (PHI), HIPAA guides you on how to do it securely and legally.
What is needed for HIPAA compliance?
To be HIPAA compliant, you need documented policies, risk assessments, security safeguards, Business Associate Agreements (BAAs), employee training, and an incident response plan. All of this must be regularly reviewed and updated.
Why do you need a HIPAA compliance checklist?
A HIPAA compliance checklist helps your organization break down complex regulatory requirements into manageable steps. It ensures nothing important slips through the cracks and ensures your business remains protected and audit-ready all year round.
