Healthcare clinics are increasingly relying on technology to manage patient information and deliver care. Electronic medical records, virtual-care platforms, patient portals, cloud storage, online booking systems and artificial intelligence tools can make healthcare more efficient, but they can also change how personal health information is collected, used, disclosed, stored and protected.
Before introducing a new technology or significantly changing an existing process, an Ontario healthcare clinic should consider whether a Privacy Impact Assessment (PIA) is appropriate. A PIA can help a clinic identify privacy risks early, understand its obligations and put appropriate safeguards in place before a new system or process is implemented.
What is a Privacy Impact Assessment?
A Privacy Impact Assessment, commonly known as a PIA, is a structured process for identifying and addressing privacy risks associated with a new or significantly changed program, technology, service or information-handling practice. For a healthcare clinic, this means looking beyond what a technology is designed to do and asking how it will affect patient information.
A PIA helps a clinic understand what personal health information will be collected, why it is needed, how it will be used and disclosed, where it will be stored and who will have access to it. It can also help identify which third parties will process or host the information, what privacy and security risks may arise and what safeguards should be in place before implementation.
Importantly, a PIA should begin during the planning or procurement stage, rather than after the clinic has already purchased or implemented the technology.
Does PHIPA require every clinic to conduct a PIA?
The Personal Health Information Protection Act, 2004 (PHIPA) does not impose a general requirement that every Ontario clinic complete a formal PIA for every new initiative.
However, PHIPA places important obligations on health information custodians. Clinics must maintain information practices that comply with the legislation and take reasonable steps to protect personal health information against theft, loss and unauthorized use or disclosure. They must also protect records against unauthorized copying, modification or disposal, limit the collection, use and disclosure of personal health information to what is reasonably necessary, and ensure that employees, contractors and other agents handle information appropriately.
Where third-party service providers handle information on a clinic's behalf, the clinic also remains accountable for how that information is handled.
A properly conducted PIA can help a clinic assess and document how it intends to meet these obligations. The Information and Privacy Commissioner of Ontario (IPC) describes PIAs as widely recognized best practices and important tools for anticipating and mitigating privacy risks, including in its Privacy Management Handbook for Small Health Care Organizations.
Certain organizations and specialized health-information arrangements may also be subject to more specific assessment requirements under PHIPA and its regulations. Clinics participating in a health information network or another shared digital-health environment should therefore determine whether additional rules apply to their particular circumstances.
When should an Ontario clinic conduct a PIA?
A clinic should consider conducting or updating a PIA whenever a proposed change could materially affect how personal health information is handled. This can arise in many different situations, including the introduction of a new electronic medical record system, the use of artificial intelligence, the launch of a patient portal, an expansion of virtual care, a move to cloud storage or a change in how information is shared with other organizations.
Introducing a new electronic medical record system
Moving to a new electronic medical record (EMR) system can change where patient records are stored, who can access them, how information is shared and whether data is hosted outside the clinic.
A PIA can help the clinic examine issues such as user access and role-based permissions, audit logging and monitoring, data migration risks, encryption and backup arrangements, record retention and secure disposal, emergency access procedures, and the vendor's ability to respond to access, correction and breach matters. The clinic should also consider what happens to its data when the contract with the vendor ends.
Using an AI scribe or other AI tool
AI scribes and other AI tools can introduce particularly important privacy considerations because they may record or process clinical conversations containing sensitive personal health information.
Before using an AI scribe, a clinic should consider whether patient consent is required and how that consent will be obtained. It should also understand whether audio is recorded or temporarily retained, whether patient information is used to train the vendor's AI model, where the information is processed and stored, and whether subcontractors can access it.
The clinic should also consider how inaccurate or incomplete notes will be identified and corrected, whether the system can produce biased, misleading or clinically unreliable outputs, and how the technology will be monitored after implementation.
The IPC recommends that health information custodians complete appropriate assessments before procuring or using AI systems and has published specific guidance on AI scribes together with an accompanying AI Scribe Checklist. Patient information should not be entered into unauthorized AI tools — staff should be prohibited from using public or unapproved AI applications to process patient information.
Launching a patient portal or mobile application
A patient portal or mobile application may allow patients to view test results, book appointments, communicate with healthcare providers or upload medical information.
Before implementing such a platform, a clinic should consider how patient identity will be verified and whether multi-factor authentication is available. It should also examine what information patients can view or download, whether information could be exposed on shared devices and how proxy access will be managed. The clinic should also understand how messages and uploaded documents will become part of the clinical record, and whether the platform tracks users or collects information for purposes unrelated to the clinic's intended use.
Expanding virtual care
Virtual-care services can introduce privacy considerations involving videoconferencing, patient location, recording, screen visibility and communications conducted from shared environments.
A clinic should assess whether the platform is appropriate for health information and whether sessions are recorded and, if so, why. Patients should receive clear privacy information, while clinicians should use private locations and secure devices. The clinic should also consider how information is transmitted and stored, whether staff have procedures for confirming patient identity and whether the vendor can use or disclose information for its own purposes.
Moving information to the cloud
Cloud services can be used for clinical records, backups, email, document management and appointment scheduling.
Before moving personal health information to the cloud, a clinic should understand where the servers are located, which entities may access the data and whether information is encrypted in transit and at rest. The clinic should also consider how security incidents will be detected and reported, whether information can be retrieved when needed, how records will be returned or securely deleted, whether the provider uses subcontractors and whether the contract permits secondary uses of clinic or patient data.
Storing information outside Canada is not automatically prohibited by PHIPA. However, the clinic remains responsible for protecting the information and should assess the legal, contractual and practical risks associated with where the data is stored.
Connecting with other organizations
A PIA may also be appropriate when a clinic begins sharing information electronically with a laboratory, hospital, pharmacy, insurer, referral partner or health information network. The assessment should clarify the authority for the disclosure, whether consent is required, which information will be exchanged and the responsibilities of each organization. It should also consider how errors and privacy breaches will be managed, whether access and disclosure activities can be audited and how individuals can exercise their access and correction rights.
Changing internal workflows
A PIA is not limited to new technology. It may also be useful when a clinic centralizes records across multiple locations, introduces remote work, outsources billing, transcription or administrative services, uses personal devices for clinic work, adds video surveillance, digitizes paper records, introduces new research or quality-improvement activities or changes how long information is retained. The key question is whether the proposed change could materially affect how personal health information is handled.
What should a clinic PIA include?
The scope of a PIA should reflect the size, complexity and level of risk associated with the initiative. There is no one-size-fits-all assessment.
A practical clinic PIA should begin by describing the proposed initiative, the problem it is intended to solve and how it will operate. The clinic should then map the flow of information, identifying what information will be collected and how it will move between patients, staff, systems, vendors and other organizations.
The assessment should also examine legal authority and consent — determining the legal authority for each collection, use and disclosure, and identifying when express consent is required and how consent will be documented or withdrawn.
Data minimization should form another part of the assessment. The clinic should consider whether each category of information is reasonably necessary and avoid collecting information simply because the technology makes it possible.
Vendor due diligence is also important. A clinic should review the vendor's privacy practices, security controls, data locations, subcontractors, breach history and ability to meet the clinic's legal and operational requirements. Marketing assurances or a general statement that a product is “PHIPA compliant” are not enough — PHIPA does not provide a government certification for commercial products.
Security and contractual protections matter too
A PIA should also consider the safeguards protecting the information. Depending on the initiative, this may include access controls, multi-factor authentication, encryption, audit logs, backups, device security, incident detection and business-continuity measures.
The contractual relationship with a vendor should also be examined. The agreement should address permitted uses of information, confidentiality and security requirements, restrictions on secondary use and AI training, subcontractor controls, breach reporting timelines, audit and compliance rights, data ownership, record access and export, secure deletion, termination assistance and the allocation of responsibility between the parties.
A privacy-risk register can help turn the assessment into an actionable process. It should document each identified risk, its likelihood and potential effect, the required mitigation, the person responsible and the implementation deadline. The PIA should then be reviewed by the clinic's privacy contact and appropriate decision-makers. Significant risks should be addressed before launch, and the assessment should be updated when the technology or information practices materially change.
PIA, security assessment or threat risk assessment?
A PIA, security assessment and Threat Risk Assessment (TRA) may overlap, but they are not interchangeable. A PIA primarily considers legal authority, consent, data minimization, transparency, individual rights, accountability and privacy risks. A security assessment focuses on the technical and organizational controls used to protect confidentiality, integrity and availability. A TRA focuses on threats, vulnerabilities, likelihood, potential harm and the security treatments required.
Where artificial intelligence or automated systems are involved, an AI or algorithmic assessment may also consider accuracy, bias, explainability, human oversight and the broader effects of the system. A clinic implementing a high-risk system may therefore need more than one type of assessment — for example, an AI scribe may require a PIA, security or threat risk assessment, vendor review and an AI-specific assessment.
Common PIA mistakes
A PIA is less effective when it is treated as an administrative exercise rather than a genuine risk assessment. Problems can arise when a clinic begins the assessment only after signing the vendor contract, relies exclusively on the vendor's representations, or treats the PIA as a checklist without properly analyzing the risks.
Other common issues include failing to map where information actually travels, ignoring subcontractors and data-storage locations, assuming encryption resolves every privacy concern, failing to assign responsibility for implementing recommendations, completing the assessment once and never reviewing it again, or allowing a project to launch with unresolved high-risk findings. The goal is not simply to produce a report — it is to identify and address privacy risks before they affect patients.
A PIA supports trust and better decision-making
A PIA can help a clinic identify potential problems before committing to a technology or process that may not meet its legal or operational requirements. It also creates a documented record showing that privacy was considered during planning, procurement and implementation.
For patients, this can support trust. For clinics, it can improve vendor selection, contract negotiation, staff training, incident preparedness and regulatory readiness. Privacy should therefore be considered as part of the decision-making process, rather than as an issue to address after implementation.
How Ewan Legal Solutions can help
Privacy compliance can become complicated when a clinic is introducing new technology, working with third-party vendors or changing how patient information is handled. Ewan Legal Solutions assists Ontario healthcare providers with Privacy Impact Assessments, AI scribe and digital-health privacy reviews, vendor privacy due diligence, privacy and security contract clauses, PHIPA policies and procedures, consent and patient-notice documentation, privacy breach-response planning, privacy training and ongoing privacy compliance support.
If your clinic is introducing a new EMR, AI scribe, patient portal, cloud service or virtual-care platform, a privacy review should form part of the process before implementation.
This article provides general legal information and does not constitute legal advice. Privacy requirements depend on the nature of the organization, technology and information-handling arrangement.