HIPAA Compliance for SAAS: Complete Guide

HIPAA compliance for SaaS providers is no longer a gray area—whether you’re building software for healthcare, or supporting those who do, understanding your responsibilities is essential. The days of assuming data protection is someone else’s problem are over; as a SaaS company handling ePHI (electronic protected health information), you play a pivotal role in safeguarding sensitive health data every step of the way.

From the moment you start processing, storing, or transmitting ePHI, you could be categorized as a business associate under HIPAA. This brings a unique set of legal, technical, and operational requirements, from signing BAAs to managing sub-processors and ensuring robust security controls across your platform. Failing to comply isn’t just a regulatory headache—it risks your reputation and your customers’ trust.

This complete guide is designed to cut through the confusion and help you chart a clear course for HIPAA SaaS compliance. We’ll walk you through identifying your role, mapping ePHI data flows, and understanding how multi-tenancy, RBAC, encryption at rest and in transit, key management, and audit logs all fit into a secure, compliant architecture. You’ll also learn how to address secure SDLC practices, respond to incidents, and build customer trust with evidence and assurance packs—all in line with industry standards like SOC 2.

Let’s get straight to the essentials, so you can turn HIPAA compliance from an obstacle into a competitive advantage for your SaaS business.

Are we a Covered Entity or Business Associate

Determining whether your SaaS company is a Covered Entity or Business Associate under HIPAA is the cornerstone of your compliance journey. This isn’t just legal jargon—it directly impacts your obligations, risk profile, and relationships with clients in healthcare.

Let’s break it down simply: a Covered Entity is typically a healthcare provider, health plan, or healthcare clearinghouse. These are organizations that directly create, receive, maintain, or transmit protected health information (PHI) as part of their core activities. Most SaaS companies, unless they are delivering direct healthcare services or processing claims, will not fall under this category.

On the other hand, the vast majority of SaaS vendors serving the healthcare sector are classified as Business Associates. According to HIPAA, a business associate is any company or individual that performs services for, or on behalf of, a covered entity which involves access to ePHI. This includes a wide range of SaaS models, from cloud-based EHRs to secure messaging, appointment scheduling, and analytics platforms.

To determine your classification, ask yourself:

• Does my SaaS product process, store, or transmit ePHI on behalf of healthcare providers, health plans, or clearinghouses?
• Do my customers require a signed BAA (Business Associate Agreement) before using my platform?
• Am I responsible for implementing security mechanisms—such as multi-tenancy isolation, RBAC (Role-Based Access Control), encryption at rest and in transit, key management, or audit logs—to protect ePHI?
• Will I rely on sub-processors (like cloud infrastructure providers) that might also access ePHI, requiring flow-down BAAs?

If you answered “yes” to any of the above, your SaaS company is almost certainly a Business Associate. This means you must adopt robust HIPAA SaaS controls, including:

• Signing and honoring BAAs with your clients and key sub-processors.
• Implementing technical safeguards such as strong encryption at rest and in transit, secure key management, and detailed audit logs to track access and changes to ePHI.
• Enforcing RBAC and multi-tenancy controls to ensure that users only access the data they’re authorized to see.
• Embedding privacy and security into your secure SDLC (Software Development Life Cycle) and considering third-party attestations like SOC 2 for added trust.

In short: if your SaaS platform touches ePHI for a healthcare client, you are a Business Associate under HIPAA. Embracing this role means taking concrete steps to protect sensitive health data, building trust, and fueling long-term partnerships in healthcare. If you’re still uncertain, consult with a HIPAA specialist or legal counsel—it’s always better to clarify your status than risk non-compliance.

Map data flows that include ePHI

Mapping data flows that include ePHI is a foundational step for any HIPAA SaaS provider serious about compliance and risk management. Understanding how electronic protected health information moves through your application—from intake to storage, processing, and sharing—enables you to proactively identify vulnerabilities, ensure proper safeguards, and demonstrate accountability as a business associate.

Let’s break down why this matters. As a SaaS company, especially one leveraging multi-tenancy, you likely handle ePHI across multiple environments, users, and even integrated partners or sub-processors. Without a clear map of data flows, it’s easy to overlook weak points where unauthorized access or data leakage can occur. Regulators—and your covered entity customers—expect you to know exactly where ePHI is at all times, who has access, and how it’s protected.

To map your data flows effectively, we recommend the following steps:

• Identify all touchpoints with ePHI: List every place in your system where ePHI is collected, transmitted, processed, or stored. This includes front-end forms, APIs, integrations, databases, backups, monitoring tools, and any external services acting as sub-processors.
• Document user and system access: Use RBAC (role-based access control) to determine which users and services can view, edit, or transfer ePHI. Mapping who can do what helps limit unnecessary exposure and supports the principle of least privilege.
• Track data movement: Diagram how ePHI flows between application components, storage locations, and networks—both internally and with third parties. Make sure to include flows involving encryption in transit (such as TLS) and encryption at rest in your architecture.
• Pinpoint key management practices: Identify where and how encryption keys are generated, stored, rotated, and destroyed. Proper key management is critical to ensure encryption controls remain effective throughout the entire data lifecycle.
• Incorporate audit logging: Ensure your map includes points where audit logs are generated to record access, changes, and data exports. These logs are vital for incident response and for demonstrating compliance during a SOC 2 audit or BAA negotiation.

By thoroughly mapping your ePHI data flows, you’re not just ticking a compliance box—you’re laying the groundwork for a secure SDLC (software development life cycle), informed risk assessments, and resilient system design. This transparency also streamlines the process when you need to share details with covered entities, sign BAAs, or onboard new sub-processors. In short, a well-documented data flow map empowers your team to protect ePHI intelligently and meet the stringent expectations of HIPAA SaaS customers.

BAA terms and sub-processor flow-downs

Business Associate Agreements (BAAs) form the legal backbone of HIPAA compliance for SaaS providers. These agreements set the expectations for protecting ePHI and outline each party’s responsibilities. However, BAAs do much more than just tick a regulatory checkbox—they define how your SaaS business interacts with the vast web of partners, vendors, and sub-processors that help deliver your services.

Sub-processor flow-downs are a critical, yet often overlooked, aspect of this relationship. If your HIPAA SaaS platform relies on third-party vendors—such as cloud infrastructure providers, analytics tools, or email services—that come into contact with ePHI, these vendors become your sub-processors. Under HIPAA, you don’t just need a BAA between your company and your healthcare clients; you must also ensure that every sub-processor is contractually obligated to meet the same stringent requirements for privacy, security, and breach notification.

Here’s how to approach BAA terms and sub-processor flow-downs in a practical, effective way:

• Map Your Data Flows: Identify every point where ePHI could be accessed by a third party in your stack, including in multi-tenancy scenarios.
• Vet Your Sub-processors: Assess each vendor’s security posture—look for certifications like SOC 2, robust secure SDLC practices, and capabilities such as encryption at rest, encryption in transit, RBAC (role-based access control), key management, and audit logs.
• Negotiate Flow-down BAAs: Your contracts with sub-processors should include BAA terms that mirror your obligations to covered entities. This ensures there are no weak links in the chain of custody for ePHI.
• Monitor Ongoing Compliance: Set up a process to regularly review sub-processor practices. If a vendor changes their security model or fails a compliance audit, you need to know—and respond—immediately.
• Document Everything: Keep thorough records of all BAA agreements and any updates, including dates, contacts, and specific obligations. This is crucial for demonstrating compliance during HIPAA audits.

By handling BAA terms and sub-processor flow-downs rigorously, we can ensure our HIPAA SaaS offerings are not only compliant but also trustworthy and resilient. This proactive approach protects both our business and the sensitive health information entrusted to us.

Tenant isolation and RBAC/least privilege

Tenant isolation and RBAC/least privilege are fundamental to HIPAA compliance for SaaS providers, especially when your platform is built on a multi-tenancy architecture. In a multi-tenant SaaS environment, multiple healthcare clients—each with their own users and data—operate within the same infrastructure. This setup offers efficiency and scalability, but it also introduces the critical responsibility of ensuring that each tenant’s ePHI remains fully segregated and protected from unauthorized access.

Tenant isolation means that no customer or user from one tenant can ever access or even infer the presence of data belonging to another tenant. This is non-negotiable under HIPAA, as data leakage—even accidental—can constitute a reportable breach. Effective isolation can be achieved through careful database schema design, strong application-level controls, and, where needed, network-layer segregation. Automated testing as part of a secure SDLC (Software Development Life Cycle) helps ensure these boundaries are robust and continually validated.

Role-Based Access Control (RBAC) combined with the principle of least privilege is another cornerstone for HIPAA SaaS solutions. RBAC lets you define roles based on job functions and responsibilities, then assign permissions to those roles—rather than directly to individual users. This makes management simpler and reduces the risk of privilege creep. The principle of least privilege means users and even sub-processors should have access only to the minimum data and functions required to perform their tasks, and nothing more. This approach minimizes potential damage in the event credentials are compromised or user accounts are misconfigured.

• Practical tip: Map out every role in your application, and periodically review what each role can access. Remove unnecessary permissions promptly—and don’t forget to audit the access of sub-processors as well.
• Utilize encryption at rest and encryption in transit to further ensure that even if isolation controls are bypassed, ePHI remains unreadable to unauthorized parties. Integrate strong key management practices to keep encryption keys as secure as the data itself.
• Maintain audit logs of access and administrative actions. These logs are essential both for internal monitoring and for compliance reporting—such as during SOC 2 assessments or responding to an incident under your BAA (Business Associate Agreement).

We need to remember that HIPAA compliance isn’t achieved by default in a multi-tenant SaaS model—it’s enforced by design, with tenant isolation and RBAC/least privilege at the heart of your architecture. By proactively addressing these requirements, we not only protect sensitive data, but also build trust with our customers—demonstrating that we take our role as a business associate seriously.

Encryption at rest/in transit and key management

Encryption at rest and in transit is a cornerstone of HIPAA SaaS security, ensuring that ePHI remains protected from unauthorized access or interception—no matter where the data resides or travels. As a business associate, you are expected to implement robust encryption strategies that address both storage and transmission of health information within your platform. These requirements are not just checkboxes, but proactive defenses aligned with the HIPAA Security Rule and best practices for cloud environments.

Let’s break it down simply:

• Encryption at rest means that all ePHI stored within your SaaS infrastructure—whether databases, file systems, or backups—is encoded using strong cryptographic algorithms. If someone gains physical or logical access to your storage, they cannot read the data without the proper decryption keys. For SaaS platforms with multi-tenancy, it’s crucial to segregate tenant data and encrypt each tenant’s information independently to avoid cross-customer exposure.
• Encryption in transit protects data as it moves between users, applications, and internal services. By enforcing secure protocols like TLS 1.2+ for all communications—including API calls and integrations with sub-processors—you ensure that ePHI cannot be intercepted or tampered with during transmission.

However, encryption is only as strong as your key management practices. HIPAA expects SaaS providers to maintain rigorous controls over encryption keys. This means:

• Storing keys in hardware security modules (HSMs) or equally secure environments
• Restricting access to keys using RBAC (role-based access control)
• Regularly rotating keys and retiring old ones to eliminate risk from potential compromise
• Maintaining detailed audit logs of all key access and management activities, tying actions back to individuals for accountability and compliance verifiability

These measures not only help you meet HIPAA requirements, but also demonstrate a culture of security to your customers and partners—critical when signing a BAA or undergoing SOC 2 assessments. By treating encryption and key management as ongoing commitments, integrated into your secure SDLC (Software Development Life Cycle), you create a safer environment for ePHI and build trust in your SaaS solution.

Remember, strong encryption and diligent key management aren't optional; they're essential defenses that keep sensitive health data confidential, even in the event of a breach. Investing in these areas today means fewer headaches—and liabilities—tomorrow.

Audit logging monitoring and access reviews

Audit logging, monitoring, and access reviews are not just best practices—they are mandated safeguards for any HIPAA SaaS provider acting as a business associate. When your platform is entrusted with ePHI, you’re expected to maintain a clear, tamper-resistant record of all actions that could impact patient data. Let’s break down how this protects both your business and your customers.

At the core, audit logs capture detailed records of every access, modification, or transmission involving ePHI. This includes user logins, changes to permissions, data exports, and administrative actions. In multi-tenancy SaaS environments, it’s crucial that these logs clearly distinguish between tenants and users, ensuring no overlap or confusion in your records. Combined with strong RBAC (Role-Based Access Control), audit logs demonstrate exactly who did what, and when.

But simply collecting logs isn’t enough. Ongoing monitoring is essential to detect suspicious activities, such as unauthorized access attempts or anomalous data transfers. Automated alerting tools can help your team respond swiftly to potential incidents—reducing risk and supporting HIPAA’s requirement for timely breach detection.

Regular access reviews add another layer of protection. By periodically checking who has access to sensitive data, you’ll spot dormant accounts, unnecessary privileges, or inappropriate permissions that may have crept in as your SaaS platform evolved. This is especially important when working with sub-processors or integrating with other business associates, as access boundaries must remain crystal clear.

• Retention policies: HIPAA requires audit logs to be preserved for a minimum of six years. Make sure your SaaS platform’s logging infrastructure supports secure, long-term storage—preferably encrypted at rest and with robust key management controls.
• Encryption in transit: Transmit audit logs securely between services using strong encryption protocols, protecting them from interception or tampering.
• Immutable logging: Consider log immutability—using write-once storage or cryptographic hashes—to ensure logs cannot be altered retroactively by attackers or even privileged users.
• Integration with SOC 2: If your SaaS is SOC 2 certified, leverage those controls to enhance your HIPAA audit log management. Many requirements overlap, streamlining your compliance efforts.

Finally, make sure your audit logging practices are clearly documented in your secure SDLC (Software Development Life Cycle) and that your BAA (Business Associate Agreement) addresses your approach to monitoring and review. If you use sub-processors, require the same level of logging rigor from them—this closes any gaps and shows covered entities you’re serious about compliance.

In the end, robust audit logging and diligent monitoring aren’t just about checking boxes—they’re about building trust and demonstrating your SaaS company’s unwavering commitment to safeguarding ePHI. By investing in these controls, you set a standard that stands up to both HIPAA and customer scrutiny.

Secure SDLC testing (SAST/DAST/pen tests)

Secure SDLC testing (SAST/DAST/pen tests) is a cornerstone for HIPAA SaaS providers who need to protect ePHI at every stage of the software development lifecycle. As a business associate, your commitment to security is measured not just by the controls you put in production, but also by the rigor you apply from the very beginning of development. This is where integrating secure SDLC practices becomes non-negotiable.

Let’s break down what this means in practice. A secure software development lifecycle (SDLC) incorporates security testing activities—like SAST, DAST, and penetration testing—early and often. These methods serve as proactive defenses against vulnerabilities that could put health data at risk, especially in complex multi-tenancy cloud environments.

• SAST (Static Application Security Testing): This technique scans your application’s source code and configuration for security flaws before the code ever runs. By integrating SAST into your CI/CD pipelines, you can catch issues such as broken authentication or improper RBAC (Role-Based Access Control) early, reducing remediation costs and risk.
• DAST (Dynamic Application Security Testing): With DAST, you’re testing your running application for vulnerabilities like cross-site scripting or broken encryption in transit. This is crucial for SaaS solutions where user input and interactions could expose sensitive data.
• Penetration Testing: Regular pen tests, especially by third parties, simulate real-world attacks against your systems. This not only uncovers flaws that automated tools might miss, but also demonstrates due diligence—something both covered entities and auditors expect from HIPAA SaaS companies.

Consistent secure SDLC testing helps you address HIPAA’s Security Rule by ensuring that the software you deliver has been vetted for weaknesses that could lead to unauthorized access or disclosure of ePHI. It also aligns with SOC 2 requirements and gives you the evidence you need for audit logs, risk assessments, and BAA negotiations.

Don’t forget: If you rely on a sub-processor—like a third-party API or cloud provider—ensure they also follow secure SDLC standards. This oversight is critical to maintaining your compliance chain and protecting your customers’ trust.

By embedding these security tests into your development routine, you’re not just checking boxes—you’re building a culture of privacy and security that sets your SaaS apart in the healthcare space. If you haven’t made secure SDLC a part of your regular process, start today. It’s a practical and proven way to keep compliance worries at bay while delivering secure, high-quality products.

Incident response and breach notification

Incident response and breach notification are critical components of HIPAA SaaS compliance. When handling ePHI, it’s not just about preventing incidents—it’s about being ready to act decisively if something goes wrong. Under HIPAA, SaaS providers acting as a business associate must have robust, well-documented plans for identifying, managing, and reporting security incidents that could compromise protected health information.

Let’s break down what effective incident response and breach notification look like for HIPAA SaaS companies:

• Incident Detection and Investigation: Modern SaaS platforms use layered defenses—such as encryption at rest and encryption in transit—but vulnerabilities can still exist. Maintain comprehensive audit logs that track all access and activity involving ePHI. Automated monitoring and alerting help detect suspicious activity early so your team can respond rapidly.
• Immediate Containment and Analysis: Once a potential breach is detected, isolate affected systems without delay. Utilize RBAC (role-based access control) to limit exposure, and engage your security team to analyze the incident. Determine whether multi-tenancy or a sub-processor was involved and assess the scope and impact on ePHI.
• Root Cause Remediation: Identify how the breach occurred—was it a failure in key management, a gap in your secure SDLC, or an issue with a sub-processor? Close vulnerabilities, update security controls, and document every action taken. These steps are also essential for SOC 2 and other compliance frameworks.
• Breach Notification to Covered Entities: HIPAA sets strict timelines: notify affected covered entities without unreasonable delay, and always within 60 days of discovering a breach. The content of your breach notification must include the nature of the breach, the types of ePHI involved, steps taken to mitigate further risk, and recommendations for affected users.
• Documentation and Continuous Improvement: Maintain thorough records of the incident, investigation, response, and all communications. Regularly review your incident response plan and test it through tabletop exercises or simulated breaches. Incorporate lessons learned to strengthen your processes and satisfy the requirements of your BAA and HIPAA regulations.

By approaching incident response and breach notification proactively, we not only meet regulatory obligations but also build trust with customers and partners. Staying prepared means we can minimize damage, preserve reputations, and keep ePHI safe—even when the unexpected occurs.

Backup DR and emergency mode operations

Backup, Disaster Recovery (DR), and emergency mode operations are not just technical best practices—they’re mandatory elements for HIPAA SaaS providers entrusted with ePHI. The HIPAA Security Rule specifically calls out the need for plans and controls that guarantee the ongoing availability and integrity of health information, even during unexpected events.

Let’s get practical: Imagine a scenario where a major cloud outage, ransomware attack, or natural disaster suddenly takes your SaaS platform offline. Healthcare workflows can’t wait, and neither can regulatory obligations. As a business associate, you’re required to prove that your systems can recover swiftly and securely, minimizing the risk of data loss or unauthorized exposure.

• Comprehensive Backups: You must implement automated, frequent backups of all ePHI stored or processed within your SaaS environment. These backups should be encrypted at rest and in transit, leveraging robust key management to prevent unauthorized access.
• Disaster Recovery Planning: Develop a documented, regularly-tested DR plan that outlines step-by-step procedures for restoring data and application functionality. This plan should address multi-tenancy complexities, ensuring that the data of each tenant remains isolated and protected during recovery.
• Emergency Mode Operations: Define how your team will maintain critical operations if your usual systems are compromised. This includes designating roles using RBAC (role-based access control) so only authorized staff can access sensitive systems in emergency scenarios.
• Audit Logs and Monitoring: Maintain tamper-evident audit logs that capture access and changes during backup, restoration, and emergency operations. This helps with post-incident investigations and SOC 2 or HIPAA compliance audits.
• Sub-processor Readiness: If you use third-party providers (sub-processors) for backup or DR, ensure they’re covered by a BAA and meet your security standards—especially regarding encryption, access controls, and incident response.
• Secure SDLC Integration: Incorporate backup and DR planning into your secure SDLC (software development lifecycle). Test recovery scenarios as part of your release process to catch issues before they impact real users.

To sum up, robust backup, DR, and emergency operations are your safety net—and your clients’ peace of mind. By treating these as core features (not afterthoughts) of your HIPAA SaaS product, you prove your reliability as a business associate and pave the way for secure, resilient healthcare innovation.

Evidence library and customer assurance pack

Evidence library and customer assurance pack are essential tools for SaaS companies operating in the healthcare sector. As a business associate entrusted with ePHI, providing clear, documented proof of your security, privacy, and compliance controls is not just a best practice—it’s a critical requirement for building trust with healthcare customers.

Let’s face it: covered entities and their security teams want transparency. They need to quickly verify that your SaaS solution aligns with HIPAA and industry standards like SOC 2. This is where an evidence library shines. By proactively organizing and sharing your compliance documentation, you make the evaluation process smoother for everyone involved.

Your evidence library should include:

• Signed BAA templates and versions, demonstrating your commitment to contractual compliance as a business associate.
• SOC 2 audit reports, which validate your security controls and operational effectiveness. These reports give customers confidence that your environment is regularly evaluated by independent auditors.
• Security policy documents covering key areas such as multi-tenancy isolation, RBAC (role-based access control), encryption at rest and encryption in transit, key management procedures, and audit logs retention.
• Secure SDLC evidence, like code review checklists, threat modeling reports, and penetration test summaries, showing your commitment to security throughout the software development lifecycle.
• Sub-processor risk assessments and due diligence summaries, so customers know you’re vetting third parties who may have access to their ePHI.
• Incident response plans and examples of tabletop exercises, proving you’re prepared for security incidents.
• Access review logs and change management records, which provide transparency into how sensitive data is managed and protected over time.

A customer assurance pack takes this a step further. It’s a curated, customer-friendly bundle of the most important documents from your evidence library, tailored to answer the most common due diligence questions. Think of it as your “compliance resume”—something you can share with potential and current customers to streamline security reviews and foster trust from day one.

To make your evidence library and assurance pack as effective as possible:

• Keep documents up to date—outdated evidence can undermine your credibility.
• Redact sensitive information as needed, especially in audit reports, while still providing enough detail for customer assurance.
• Organize by control area so customers can easily find what matters most: RBAC configurations, encryption settings, audit logs policies, etc.
• Respond quickly to requests for additional information, signaling your transparency and readiness to collaborate.

By investing in a thorough evidence library and a polished customer assurance pack, we not only meet regulatory expectations but also give our customers the peace of mind they deserve. After all, trust is built on transparency—and in the world of HIPAA SaaS, that’s everything.

HIPAA compliance for SaaS providers isn’t just a box to check—it's a responsibility that extends to every aspect of your platform, from how you handle ePHI to the way you build and maintain your software. As a business associate, you must prioritize best practices like multi-tenancy isolation, strict RBAC (role-based access control), robust encryption at rest and in transit, and effective key management. These technical safeguards work together to keep sensitive data secure and accessible only to those who need it.

It’s equally important to ensure every sub-processor meets your standards and that audit logs are detailed and tamper-resistant. Your commitment should extend beyond compliance paperwork—signing a BAA is just the start. By embracing a secure SDLC (software development life cycle) and aiming for third-party attestations like SOC 2, you show partners and clients that you take security seriously at every level.

Remember, HIPAA SaaS success is about building trust through transparency, vigilance, and continuous improvement. By staying proactive about security and compliance, we can deliver innovative solutions while protecting the privacy and well-being of everyone who depends on us. Let’s make HIPAA compliance a core strength, not just a requirement.

FAQs

Do SaaS vendors need a BAA?

Yes, SaaS vendors that handle electronic protected health information (ePHI) for healthcare organizations are considered business associates under HIPAA. This means they are legally required to sign a Business Associate Agreement (BAA) with any covered entity they serve. The BAA outlines each party’s responsibilities for protecting ePHI, ensuring that proper safeguards like encryption at rest and encryption in transit, robust key management, and strong role-based access controls (RBAC) are in place.

Without a signed BAA, both the SaaS vendor and the healthcare provider can be held liable in the event of a data breach. This is why covered entities should always require a BAA before sharing any ePHI with a SaaS provider—regardless of whether the platform uses multi-tenancy, leverages sub-processors, or claims SOC 2 compliance. The BAA also requires SaaS vendors to maintain comprehensive audit logs and follow a secure software development lifecycle (secure SDLC) to prevent unauthorized access or disclosure of sensitive health information.

In summary, if your SaaS solution interacts with ePHI on behalf of healthcare clients, a BAA isn’t just a best practice—it’s a HIPAA requirement. This contract is foundational for trust and compliance in the health tech ecosystem, protecting both your business and your customers.

How do we isolate tenants with ePHI?

Isolating tenants with ePHI is a critical aspect of HIPAA SaaS security, especially when operating in a multi-tenancy environment. To achieve this, we use strong logical separation between customer data at every layer of the stack. This means each tenant’s electronic protected health information (ePHI) is strictly segregated by design, preventing any unauthorized cross-tenant access.

Role-Based Access Control (RBAC) is implemented to ensure that only authorized users within a specific tenant can access their own ePHI. This adds an extra layer of control, making sure even internal staff or sub-processors cannot access data unless it’s absolutely necessary for their role and covered under a valid BAA.

Encryption at rest and in transit is always used to protect ePHI wherever it exists. Each tenant’s data is encrypted with unique keys, managed securely through robust key management systems. This ensures that, even if storage or network layers are compromised, ePHI remains safe and unreadable to unauthorized parties.

Comprehensive audit logs and regular reviews are essential. We keep detailed records of all access and changes to ePHI, making it easy to detect and respond to suspicious activities. Pairing these controls with a secure SDLC and meeting SOC 2 requirements ensures our platform is built and maintained to the highest security standards.

Which logs are required under HIPAA?

HIPAA requires that audit logs are maintained to track access and activity related to electronic protected health information (ePHI). As a HIPAA SaaS provider or business associate, you must record who accessed ePHI, what actions were performed, and when these activities took place. These logs help detect unauthorized access, support incident investigations, and demonstrate compliance during audits.

The key audit logs required under HIPAA include: logs recording user authentication events (logins and logouts), access to ePHI, changes to permissions or roles (RBAC), data modifications or deletions, and transmission of sensitive data. If your SaaS platform uses multi-tenancy, make sure audit logs distinguish actions across tenants to maintain proper boundaries. Sub-processors handling ePHI must also generate and retain similar audit logs.

HIPAA also expects logs to be protected through encryption at rest and in transit, with proper key management practices in place. Audit logs themselves contain sensitive data, so guard them with the same rigor as ePHI. Regular reviews of logs and integrating them into a secure SDLC process are considered best practice, and aligning with standards like SOC 2 can further strengthen your compliance posture.

Can we use public cloud services safely?

Yes, you can safely use public cloud services for HIPAA SaaS—if you take the right steps. Security and compliance go hand-in-hand, especially when handling sensitive ePHI. Public cloud providers often offer robust security controls, but as a business associate, it’s on us to ensure our applications are configured and managed for HIPAA compliance.

Key safeguards must be in place. We need to implement strong access controls like RBAC, use encryption at rest and in transit, manage encryption keys securely, and maintain detailed audit logs. Multi-tenancy requires careful isolation of customer data, and any sub-processor must also sign a BAA and follow secure SDLC practices. Choosing cloud providers with SOC 2 certification adds another layer of trust.

Remember—shared responsibility matters. While public cloud platforms offer powerful tools, it’s our job to set up and monitor them properly. With the right configurations and agreements, public cloud can be a safe, scalable choice for HIPAA SaaS solutions.