HIPAA Compliance Software Checklist: Key Features and Legal Requirements

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).

What Is the Difference Between HIPAA & PIPEDA?

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.

Who Are Considered Health Information Custodians in Canada?

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:

• Doctors and nurses
• Hospitals and long-term care homes
• Homes for special care
• Pharmacies and medical laboratories
• Local medical officers of health
• Ambulance and paramedic services
• Community care centres and mental health programs
• The Ministry of Health

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.

What Counts as a Commercial Activity Under PIPEDA?

Under PIPEDA, a commercial activity is defined as any transaction, act, or conduct that has a commercial character. This includes:

• Selling goods or services
• Bartering or trading
• Leasing or renting
• Any regular course of business involving personal data

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.

What Personal Health Information Does HIPAA Protect?

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:

• Full names of patients
• Complete residential addresses
• Dates of birth, hospital admissions and discharges, and death
• Phone numbers and fax numbers
• Email addresses
• Social Security Numbers (SSN)
• Medical records
• Health insurance beneficiary numbers
• Account and billing numbers
• Certificates and license numbers
• Vehicle identifiers (e.g., license plate or VIN)
• Device identifiers and serial numbers
• IP addresses and web URLs
• Biometric data (e.g., fingerprints, voice prints)
• Full-face photos or comparable images
• Any other unique identifying codes or data

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.

What Personal Information Is Covered Under PIPEDA in Canada?

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:

• Name, age, and ID numbers
• Race, nationality, or ethnic origin
• Marital status and social status
• Email addresses, phone numbers, and fax numbers
• Educational and employment history
• Financial and banking information
• DNA and biometric data
• Driver’s license and Social Insurance Number (SIN)
• Health records and all PHI covered under HIPAA
• Employee files, evaluations, and disciplinary actions
• Credit and loan records
• Disputes, comments, intentions, and opinions

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.

Who Are Covered Entities Under HIPAA?

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:

• Doctors
• Nurses
• Hospitals
• Medical officers
• Health insurers
• Healthcare clearinghouses

These entities are responsible for ensuring HIPAA compliance solutions are in place to protect patient data.

Who Does PIPEDA Consider a Covered Entity?

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:

• Aerospace
• Banking and financial services
• Transportation
• Telecommunications
• Offshore drilling
• Radio and television broadcasting

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.

What Is a Business Associate Under HIPAA?

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:

• Lawyers
• IT specialists and service providers
• Billing companies
• Third-party consultants

These associates must also comply with HIPAA compliance software standards and security protocols to ensure the privacy and protection of sensitive health data.

What Are the Key HIPAA Rules and PIPEDA Principles for Compliance?

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.

What Are the Main HIPAA Rules?

1.    HIPAA Privacy Rule

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.

2.    HIPAA Security Rule

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.

3.    HIPAA Omnibus Rule

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.

What Are the 10 Principles Behind PIPEDA?

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.

1. An organization is required to be accountable for personal information under its control. An individual or individuals must be designated to ensure the organization is compliant, including any and all information that is transferred to third-party vendors for processing.
2. Personal information gathering must be identified. When personal information is collected, the organization will identify at the time or before the time of collection.
3. There must be consent given. Individuals must consent and have knowledge of that personal information is being collected, used, or disclosed, except where inappropriate.
4. Personal information collected is limited. The type of personal information that is collected must be limited to only what is necessary for the purposes identified by the organization. It must also be collected through fair and lawful means.
5. There is limited use of disclosure and retention. All personal information cannot be used or disclosed for any purpose other than that for which it was collected for, except with the consent of the individual as required by law. Information that is retained can only be retained for as long as necessary to fulfil the purpose for which it was collected.
6. All personal information must be accurate, complete, and up to date for the purpose of which it is to be used.
7. Personal information must be protected by safeguards that are appropriate to the sensitivity level of the information
8. An organization must be readily available and willing to provide individuals with specific information about its policies and practices that relate to how personal information is managed.
9. An individual has access, upon request, to the existence, use, and disclosure of their personal information and will be given access to that information. An individual can challenge the accuracy and completeness of the information and have it amended.
10. An individual has challenging compliance; where they can address a challenge that concerns compliance with the above principles to the individual(s) accountable for their organization’s compliance.

How Can This Help You Create HIPAA and PIPEDA Compliant Software?

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.

How to Make Your HIPAA Compliance Software: An 8-Point Checklist

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:

1. How Should Access to Health Data Be Controlled?

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.

• Identify all users (doctors, nurses, IT staff, administrators, etc.) who will interact with your software.
• Assign minimum necessary permissions based on their job functions.
• Implement a secure process for requesting additional access when needed.

2. Why Should Session Times Be Limited?

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.

3. What Are Best Practices for Data Encryption?

Though HIPAA doesn’t explicitly require encryption, encrypting stored and transmitted data is a widely accepted HIPAA compliance solution.

• Use strong, reliable encryption protocols.
• Store encryption keys securely and separately from the data.

4. How Can Activity Tracking Improve Security?

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.

5. Why Is Data Backup Important?

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.

6. How Do You Create Secure Authentication?

Strong authentication methods reduce the risk of unauthorized access. Consider combining the following options:

• • Biometric authentication: Fingerprint or facial recognition for device-level access.
  • Multi-factor authentication (MFA): Password plus a one-time code sent via email or an authenticator app.
  • Password expiration policies: Force users to update passwords regularly.
  • Physical tokens or ID cards: Used alongside passwords or MFA.
  • Risk-based authentication: Analyzes login patterns and may require additional verification if anomalies are detected.

7. What Are the HIPAA Software Requirements for Data Transfer and Storage?

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.

8. How Should Correspondence Containing Personal Health Information Be Protected?

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.

Secure, Compliant, and Scalable: Partner with Lets Nurture Today

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.