The Health Insurance Portability and Accountability Act (HIPAA) is a U.S. federal law that sets strict standards for the privacy, security, and handling of protected health information (PHI).
It governs how medical data is collected, stored, accessed, shared, and disposed of by healthcare providers, insurers, and any third parties that interact with this data. These rules directly influence how HIPAA compliance software must be built, including what security features and processes must be in place.
In 2024, over 276 million individuals’ PHI was exposed or stolen, averaging 758,288 records per day, according to HIPAA Journal. Failure to meet HIPAA compliance requirements can result in significant financial penalties, reputational damage, and legal consequences. For software developers and businesses building healthcare platforms, understanding HIPAA software requirements is essential to ensure data protection and compliance from the ground up.
In Canada, the equivalent regulation is the Personal Information Protection and Electronic Documents Act (PIPEDA). While it shares many principles with HIPAA, it applies more broadly to personal data used in commercial activities and is supplemented by provincial laws like Ontario’s Personal Health Information Protection Act (PHIPA).
HIPAA is a Federal United States legislation that governs the privacy and security of personal health information within the healthcare industry. This includes hospitals, clinics, insurers, and health data exchange organizations.
The law outlines HIPAA compliance requirements that must be followed by any entity handling PHI, helping to protect patient data and ensure ethical, secure use of medical information.
While individual U.S. states may also have their own privacy laws, HIPAA compliance software must adhere to federal standards. However, when health data is transferred outside the U.S., it is no longer protected by HIPAA.
In Canada, the equivalent legislation is the Personal Information Protection and Electronic Documents Act (PIPEDA). Unlike HIPAA, which focuses solely on health data, PIPEDA applies to all personal data collected during commercial activities, including medical records.
Organizations are required to take full responsibility for the collection, use, disclosure, and safeguarding of this information. Individuals also have the right to access their personal information, understand how it’s used, and challenge its accuracy.
Each Canadian province may have its own health privacy laws. For example, in Ontario, the Personal Health Information Protection Act (PHIPA) serves as a healthcare-specific regulation, much like HIPAA. PHIPA outlines how health information custodians – including doctors, hospitals, and clinics – must collect, use, and disclose personal health information.
Understanding these distinctions is critical when developing or selecting HIPAA compliance solutions that also serve Canadian markets or when evaluating cross-border HIPAA software requirements.
In Canada, specifically under Ontario’s Personal Health Information Protection Act (PHIPA), health information custodians are individuals and organizations responsible for the collection, use, and disclosure of personal health information. These custodians include:
The key difference between PHIPA and PIPEDA lies in scope. PIPEDA applies to any organization that collects, uses, or discloses personal information during commercial activities. In contrast, PHIPA specifically governs health custodians, regardless of whether their activities are commercial in nature.
If your organization is developing or managing HIPAA compliance software for the Canadian market, understanding the roles and responsibilities of health custodians under PHIPA is essential to meeting local privacy regulations and aligning with HIPAA compliance requirements.
Under PIPEDA, a commercial activity is defined as any transaction, act, or conduct that has a commercial character. This includes:
This definition is important because PIPEDA compliance is required whenever personal information is collected, used, or disclosed during such activities, even if your business is not in the healthcare sector. If you’re evaluating HIPAA compliance software for use in Canada, understanding how PIPEDA defines commercial activity is critical, especially when handling health-related or personally identifiable information across provinces.
Under HIPAA compliance requirements, the law protects both Protected Health Information (PHI) and Electronic Protected Health Information (ePHI). These data types are considered sensitive and must be safeguarded using appropriate HIPAA compliance software and protocols.
Examples of protected health information under HIPAA include:
These data types are the foundation of many HIPAA compliance checklist items that healthcare providers, insurers, and software vendors must adhere to. Failing to properly manage any of this information can result in significant fines.
In contrast, PIPEDA, Canada’s federal privacy law, applies more broadly. It governs any personal information that, alone or when combined with other data, can identify an individual. This includes, but is not limited to, health-related data.
Examples of personal data protected under PIPEDA include:
This wider scope of coverage means that HIPAA Canada comparisons must be made carefully. For organizations developing or implementing HIPAA compliance software in a Canadian context, understanding both HIPAA and PIPEDA is crucial.
Under HIPAA compliance requirements, a covered entity refers to any healthcare-related professional or organization that has access, either directly or indirectly, to protected health information (PHI). This includes but is not limited to:
These entities are responsible for ensuring HIPAA compliance solutions are in place to protect patient data.
Under PIPEDA, a covered entity is broader and refers to any private organization that collects personal information during the course of commercial activities. This includes not only businesses but also federally regulated organizations involved in:
Additionally, PIPEDA governs organizations involved in interprovincial or international transfers of personal information.
Understanding the scope of covered entities under both HIPAA Canada and HIPAA U.S. laws is critical for organizations managing personal and health data across borders.
A Business Associate under HIPAA compliance requirements is any non-medical individual or organization that works with covered entities and may have access to protected health information (PHI) or electronic protected health information (ePHI). Examples include:
These associates must also comply with HIPAA compliance software standards and security protocols to ensure the privacy and protection of sensitive health data.
Understanding the foundational rules and principles behind HIPAA compliance software and Canadian data protection laws like PIPEDA is essential for developing secure healthcare software that meets legal requirements.
This rule gives individuals full control over their personal health information. It establishes legal requirements for the use and disclosure of electronic personal health information (ePHI), setting a national standard to protect a wide range of medical and healthcare data.
Added in 2005, this rule sets standardized security requirements for how covered entities must handle ePHI during its receipt, transmission, storage, or creation, focusing specifically on electronic data protection.
This expanded the definition of a business associate to include third-party contractors, requiring them to comply with HIPAA privacy and security rules. It also enforces breach notification requirements to ensure prompt reporting when ePHI is compromised.
Beyond these, HIPAA includes additional provisions related to workflow processes, physical security of workplaces, internal network protections, and enforcement policies, although these are less directly related to HIPAA software requirements.
PIPEDA, Canada’s comprehensive data protection law, outlines 10 core principles that guide how organizations must manage personal information, including health data.
A comparable list to HIPAA’s 3 main rules, is PIPEDA’s 10 main principles. This is just an overview look at these so that you can see what the compliance guidelines are when creating software in Canada.
With these key HIPAA compliance requirements and PIPEDA principles in mind, you can build a HIPAA compliance checklist and software solutions that safeguard sensitive health data, whether you operate in the U.S. or Canada.
If you’re developing HIPAA compliance software or healthcare applications in the United States, it’s essential to understand that HIPAA does not mandate specific technologies. Instead, it requires that your software meets the latest HIPAA compliance requirements to securely protect personal health information. This gives you flexibility to choose tools and technologies that remain effective and up-to-date.
But what exactly must your software do to comply? Here is a practical HIPAA compliance checklist outlining eight critical features your software should have:
Access to electronic personal health information (ePHI) must be tightly restricted. Your healthcare software is going to process a large volume of sensitive data in the form of electronic personal health information, and while it may seem like you need a lot of employees to handle the data, you shouldn’t assign all employees. Use role-based access control (RBAC) to ensure only authorized personnel can view or edit data relevant to their role, minimizing human error and insider threats.
Automatic session timeouts help prevent unauthorized access from unattended devices. Configure your software to log users out after a defined period of inactivity, adjustable per user role for optimal security.
Though HIPAA doesn’t explicitly require encryption, encrypting stored and transmitted data is a widely accepted HIPAA compliance solution.
Implement activity logging and monitoring to detect unusual behavior patterns. Alerts for suspicious activity can help identify potential breaches early and trace unauthorized access back to a user.
Regularly back up all healthcare data to a secure, HIPAA-compliant third-party server separate from your primary data storage. This safeguards against data loss due to system failures or cyberattacks.
Strong authentication methods reduce the risk of unauthorized access. Consider combining the following options:
Cloud storage is recommended for scalability and security. Choose a cloud provider that is HIPAA compliant by default and supports secure data transfer protocols to protect ePHI during transmission.
While HIPAA doesn’t require email encryption, it is strongly advised when transmitting sensitive data externally. Use encryption protocols like S/MIME, OpenPGP, or AES to secure emails. For internal communication, consider integrating secure messaging features within your software to avoid the risks of email altogether.
Ensuring full HIPAA or PIPEDA compliance may seem complex, but with the right development partner and a clear roadmap, it becomes a manageable and strategic advantage. Secure, compliant healthcare software not only protects sensitive patient data but also strengthens user trust, supports regulatory transparency, and reduces the risk of costly legal penalties.
Whether you’re developing a new telehealth platform, upgrading your EHR system, or launching a smart diagnostic tool, integrating the proper safeguards and adhering to compliance checklists from day one is essential.
At Let’s Nurture, we specialize in building HIPAA and PIPEDA-compliant software for clients across North America. Our experienced developers and compliance specialists stay up to date with the latest health data regulations and security best practices, ensuring your project meets all applicable privacy and security standards.
From role-based access control and encrypted communications to cloud-based storage and secure authentication workflows, we build customized solutions that are secure, scalable, and tailored to your users’ needs.
Don’t leave HIPAA compliance software to chance. Partner with Let’s Nurture to build reliable, future-ready healthcare applications that meet all HIPAA compliance software requirements or Canadian privacy laws like PIPEDA and PHIPA.
Contact Lets Nurture today to discuss your project and learn how we can help bring your healthcare vision to life safely and securely.
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