Navigating ePHI Compliance Across Borders

Understanding ePHI 

So, what exactly is ePHI? To keep it simple, electronic protected health information (ePHI) refers to individually identifiable protected health information that is sent or stored electronically. This data can be related to the patient’s health condition, payment or treatment plan, lab reports, medical records and email communication that can be linked to a specific individual. 

Under HIPAA, there are 18 types of categories that can be used to identify a patient. Some of these include: 

• Name 

• Dates (date of birth, date of treatment(s), date of admission, date of discharge, date of death) 

• Address 

• Contact information (phone numbers, fax numbers, email addresses, URLs, etc) 

• Identification numbers ( Social Insurance Number, Social Security Number, License, etc) 

• Physical identity information (photo, fingerprints, Voiceprints, etc.) 

• Health plan beneficiary number 

• Account numbers 

• Vehicle identifiers, serial numbers, or license plate numbers 

• Medical record numbers. 

The responsibility of protecting this data is between two entities. These are Covered Entities and Business Associates.  

Covered Entities  

Under HIPAA, are individuals, organizations, or institutions that transmit protected health information electronically. There are a couple categories of covered entities.  

• Healthcare Providers: Doctors, Clinics, Psychologists, Dentists, Chiropractors, Nursing Homes, or Pharmacies 

• Health Plans: Health insurance companies, HMOs (health maintenance organizations), Company health plans or Government programs that pay for healthcare, such as Medicare, Medicaid, and the military and veterans healthcare programs 

• Healthcare Clearinghouse: These are entities that process nonstandard health data they receive from another entity into a standard outlined in the HIPAA administrative simplification regulations.  

Business Associates 

A business associate is a person or entity that performs certain functions or activities that involve the use or disclosure of protected health information on behalf of or provides certain services to covered entities. These could be lawyers, accountants, IT cloud providers, IT personnel, and many more roles associated with the healthcare organization.  

Understanding the Regulatory Landscape  

When healthcare organizations operate across different regions, following privacy regulations for electronic protected health information (ePHI) becomes a challenge. In the United States and Canada, covered entities and business associates must follow their own country’s privacy laws when managing sensitive patient data in electronic format.

In the U.S., HIPAA regulations require strict safeguards for protected health information (PHI). This includes implementing administrative safeguards, technical safeguards, and physical safeguards to maintain confidentiality, integrity, and availability. These security standards apply to healthcare providers, health plans, and any organization that handles PHI through electronic media.

Canada has similar rules under PIPEDA and PHIPA. Both laws aim to protect personal health information by requiring organisations to limit collection, use, and disclosure to legitimate purposes. Businesses must also implement policies that support data integrity and prevent unauthorized disclosure.

As more healthcare operations rely on electronic health records and connected medical devices, the risks of exposure increase. To remain HIPAA compliant, organisations must identify potential vulnerabilities and apply security measures that reduce data breaches and protect sensitive health information.

Navigating ePHI compliance in cross-border healthcare services involves understanding how each regulation defines individually identifiable health information, how it must be stored, and what happens in the event of a breach. Knowing the rules under HIPAA’s Security Rule, Privacy Rule, and Breach Notification Rule is critical to avoiding penalties and protecting public trust.

HIPAA  

Created in 1996 by the U.S. Department of Health and Human Services, HIPAA is an American federal law that sets a national standard to protect medical records and other personal health information. Under HIPAA, there are three main rules that healthcare professionals should be aware of. 

Privacy Rule 

The HIPAA Privacy Rule establishes standards for safeguarding individuals’ PHI. Its main focus is giving patients authority over their data. This rule is not designed to affect the treatment process of the patients. However, Patients do have the right to: 

• See or receive a copy of their medical records 

• Request amendment to their records where errors are made 

• Control who is informed about their health information 

• See an accounting of their non-routine disclosures  

• Restrict information  

• File Complaints 

• Receive a Notice of Privacy Practices 

The privacy rule also includes the use or disclosure of only the minimum necessary information. Under HIPAA, disclosure refers to the release, transfer, any form of provision of access to, or divulging of any form of PHI outside of the entity storing it. Furthermore, the minimum necessary standard is that requires covered entities and business associates to evaluate their practices and limit unnecessary or inappropriate access to and disclosure of protected health information. They should also restrict the use, disclosure and request of protected health information to the minimum amount necessary to accomplish the intended purpose.  

Please note, the Privacy Rule does not apply in cases where documents or information lack patient identifiers and therefore cannot be linked to them. However, when in doubt, assume that all information is protected by the Privacy Rule. 

Security Rule  

The security rule outlines protection for electronic protected health information. It mandates physical, technical, and administrative protections for patient ePHI. The rule also requires that covered entities don’t “sit still” – covered entities must continuously review and update their security measures to ensure ePHI is protected at all times. 

• Physical: Locks, alarm systems, security systems, fences, facility access control, device and media control, proper disposal procedures. 

• Technical: Access controls, encryption, audit controls, integrity controls,  

• Administrative: Risk management and analysis, training, documentation, contingency planning 

Breach Rule 

This rule requires covered entities and businesses to associate to notify affected patients, the U.S Department of Health and Human Services and sometimes the media, when their unsecured protected health information is disclosed or “breached”. Under HIPAA, a breach is defined as the acquisition, access, disclosure or use of unsecured protected health information in a matter against regulations. The notification must be sent to affected individuals, the department of health and human services and the media within 60 days of discovery. Delays or failures in timely notification can lead to significant penalties. 

PIPEDA 

Enforced fully on January 1, 2004, PIPEDA is a Canadian federal privacy law that applies to private-sector organizations. PIPEDA was created with Europe’s GDPR in mind, and thus many aspects are similar, and have the same level of protection as the EU. 

It governs how businesses manage personal information for commercial use and activities in all provinces, except those that have their own privacy laws which are deemed substantially similar. Its goal is to find the balance between the privacy of individuals with the needs of businesses to collect and use personal information for legitimate purposes. 

Basically, under PIPEDA, organizations need to obtain an individual’s consent when they collect, use, or disclose said individual’s personal information. It operates using ten principles as a guide. These principles ensure that the collected personal data is handled ethically and securely.  

Principles of PIPEDA: 

• Accountability  

• Identifying Purposes 

• Consent 

• Limited Collection  

• Limited Use, Retention and Disclosure 

• Accuracy  

• Safeguards  

• Openness 

• Individual Access 

• Challenge Compliance   

Under PIPEDA, this personal information being collected refers to any subjective or factual information about an identifiable individual. 

This includes: 

• Age, name, ID numbers, income, ethnic origin, or blood type 

• Personal health information 

• Cookie data 

• Opinions, evaluations, comments, social status, or disciplinary actions 

• Credit records 

• Loan records 

PHIPA 

Established on November 1, 2004, the Personal Health Information Protection Act (PHIPA) is Ontario’s health-specific privacy legislation. It governs how personal health information is collected, used and disclosed within the health sector.  

PHIPA’s definition of  personal health information includes a person’s: 

• physical or mental health, including their family medical history 

• personal care and service plan  

• home and community care 

• payment, or eligibility for healthcare services or coverage 

• health identification number 

• healthcare provider or authorized decision-maker 

Under PHIPA, the organization is obligated to: 

• Obtain consent to collect, use or disclose personal health information (PHI), except in limited cases. 

• Implement strong security measures to protect PHI. 

• Ensure that the collected PHI is accurate. 

• Limit data collection, use and disclosure to what is necessary to carry out tasks. 

• Provide individuals access to their PHI if they request. 

• Edit inaccurate or incomplete PHI, unless the record was created by another custodian or professional that was made in good faith.   

Similar to HIPAA, PHIPA employs the use of health information custodians (HIC) to regulate healthcare information. They are healthcare practitioners; hospitals, psychiatric facilities, pharmacies, laboratories, nursing homes and long-term care facilities, homes for the aged and homes for special care, community care access corporations, ambulance services, etc. 

Under PHIPA, an HIC is a healthcare practitioner or person who: 

• Manages any organizations that deliver healthcare services to an individual  

• Has custody over the individual’s personal health information  

In summary, all three laws aim to: 

• Protect individuals’ health-related personal data 

• Regulate how organizations collect, use, store, and disclose such information 

• Ensure individuals have the right to access and correct their information where necessary 

• Impose penalties for misuse or unauthorized disclosure. 

However, they differ in 3 main ways, specifically: 

• Scope: HIPAA applies to healthcare entities in the U.S., while PIPEDA and PHIPA apply to Canadian businesses and health organizations respectively. 

• Terminology: HIPAA refers to ePHI and “covered entities”, while PIPEDA talks about “personal information” and PHIPA about “health information custodians (HICs)”. 

• Legal Structure: HIPAA is a federal law; PHIPA is provincial; and PIPEDA is federal but includes exemptions for provinces with “substantially similar” laws.
   

Cross-border Compliance  

Cross-border compliance refers to ensuring organizations adhere to laws, regulations and policies when operating business internationally. For example, companies based in Canada and doing business with U.S. companies or vice versa would need to comply with multiple privacy laws simultaneously.  

Specifically  HIPAA, PIPEDA and PHIPA contain implications for international data sharing: 

• HIPAA allows data transfers, but these vendors must be thoroughly vetted and have strong security practices in place. For example, anonymizing and encrypting data in transit and at rest. 

• PIPEDA allows cross-border data flows but mandates that organizations provide strong protection and transparency, including disclosing third-party storage or access in their privacy policies. 

• PHIPA allows data transfers to third parties, including outside Ontario or Canada, only if safeguards are in place and HICs ensure the foreign party provides equivalent protection. 
  
  
  

Challenges in Protecting Individuals’ Private Health Information 

What are the most common risks? 

• Insider threat – healthcare faces insider threat challenges, whether acting negligently or maliciously, disclosing ePHI to individuals granting unauthorized access to patient data.  

• Ransomware Attacks – Malicious software deployed by hackers to encrypt the patient data until a ransom is paid.  

• Phishing scams – Phishing is the main cause of healthcare breaches and attacks. Cybercriminals use deceptive emails and phone messages to steal credentials allowing them to access accounts containing sensitive data.  

• Unsecured Networks and Devices – Many healthcare workers often share patient updates and information through unsecured devices and networks. Furthermore, many medical devices connected to hospitals and other healthcare facility networks often have weak security measures implemented and thus have easily exploitable critical vulnerabilities. Cyberattacks on these systems can lead to compromised patient data, disrupted medical services, and even direct threats to patient safety.  
  
  
  

Best Practices for ePHI Protection Across HIPAA, PIPEDA, and PHIPA 

For a comprehensive interconnected healthcare ecosystem, it is essential to adopt a regulation-aligned approach to best practices, to ensure they cover all their bases, remaining in compliance, and thus maintaining patient and client trust.  

Having given an overview of each, we will give a breakdown of the best practices for data protection across HIPAA, PIPEDA, and PHIPA. 

Implement Strong Administrative, Technical, and Physical Controls  

All three regulations require organizations to carry out strong controls to protect health data.  

Some are listed below; 

Administrative Implementations:  

• Developing and enforcing security policies and procedures 

• Designating a Privacy Officer and a Security Officer or team to be responsible for overseeing security protection responsibilities 

• Fostering a culture of security-first practices and training employees on security awareness and their roles in safeguarding information 

• Implementing access controls and user management processes. 

• Conducting regular audits and reviews of security controls 

• Monitoring and managing third-party vendors and business associates 

Technical Implementations: 

• Employing role-based access control, using unique identifiers, to grant or deny access to data based on the user roles 

• Implementing systems that automatically log off users after a period of inactivity to prevent unauthorized access.  

• Maintaining detailed audit trails that can be used to track access to and changes made to ePHI. 

• Implementing procedures to validate the integrity of ePHI, ensuring that it is accurate and complete. 

• Using secure transmission channels, such as encryption or secure email, to transmit ePHI.  

• Implementing secure storage solutions, such as cloud storage or secure file servers, to store ePHI. 

Physical Implementations: 

• Utilizing video surveillance and other monitoring technologies to deter and detect unauthorized access and potential threats 

• Managing and tracking the removal and disposal of sensitive equipment  

• Restricting unauthorized access to server rooms and network infrastructure using locks, security cards, badges, etc 

• Implementing procedures for managing visitors and unauthorized individuals. 

• Developing plans for accessing patient data during emergencies or system outages, ensuring continued operation and data availability 
  
  
  

Use Data Minimization and Purpose Limitation 

Data minimization involves collecting and storing the bare minimum of personal information needed and retaining it for the shortest duration possible. It is a fundamental principle in data privacy and protection. Further, once this data is collected. They should ensure that secondary uses of data are disclosed and justified. Data minimization specifically aligns with HIPAA’s minimum necessary standards and both PIPEDA and PHIPA emphasize purpose-limited collection and use of personal health information. 

Educate and Train Staff Regularly 

Human error is the major course of data breaches in healthcare. Therefore, providing training and education to members of staff related to privacy and security should be conducted. This training should be done continuously and updated as cyber threats evolve. It should be tailored to the specific roles and responsibilities of each employee. Lastly, it should include topics around best practices, data privacy, and the importance of ethics in handling private data. All three regulations require training.  

Breach Notification Plan 

Security breaches are not a matter of it, it’s a matter of when; It therefore matters how swiftly and transparently action is taken. It’s the portion that answers the question: “If something goes wrong, who do we tell, when, and how?”  It begins with defining what constitutes a breach under relevant laws like HIPAA, PIPEDA, and PHIPA, followed by assigning responsibility for detection and triage. Once identified, the incident undergoes a risk assessment to determine whether it meets the threshold for regulatory or individual notification.  

Regulatory timelines vary—HIPAA requires reporting within 60 days, PIPEDA mandates notification as soon as feasible when there’s a real risk of significant harm, and PHIPA requires prompt disclosure of any unauthorized use or disclosure. Organizations must prepare communications for affected individuals using clear, accessible language and coordinate with third parties or vendors when applicable. A media and public relations strategy is also essential, especially in large-scale breaches.

Internally, escalation protocols and governance structures should be well-defined, and all actions and decisions meticulously documented and retained for legal compliance. To maintain effectiveness, the plan should be regularly tested, updated, and supported with breach templates, current contact lists, and employee training, ultimately helping mitigate legal risk and protect stakeholder trust in the face of inevitable security incidents. 

Final Thoughts 

Whether it is HIPAA, PIPEDA, or PHIPA the responsibility of protecting personal healthcare data remains a responsibility of healthcare providers and associate specialists. As the healthcare industry continues to adapt to the use of digital solutions and connected systems, protecting the ePHI evolves far beyond checking boxes and avoiding penalties. If shortcuts are taken, patients’ livelihood, privacy and trust could be destroyed. 

Each regulation, policy, and response plan exists to ensure that trust isn’t broken by carelessness, oversight, or evolving threats. While there are slight differences between them, they ultimately share the same goal of keeping health information private, secure, and safe. If your organization conducts business in this field and assistance navigating the complexities of ePHI security and compliance, our team of experts is here to help! 

At Oppos, our specialists are ready to help guide healthcare providers through each step, whether it be assessments, training, system updates, or policy development. Let us help you turn privacy protection into a strength your patients can count on.