Patient Consent & AI: What You Should Know

When a clinic begins using AI tools, patient consent becomes central to compliance and trust. Regulations across jurisdictions (HIPAA in the U.S., PHIPA in Ontario, PIPEDA in Canada, GDPR in Europe) place strong emphasis on patients’ rights to know how their personal health information is collected, stored, and used.

Unlike traditional tools, AI introduces unique considerations: it may analyze data, make predictions, or store sensitive information in systems outside the clinic’s direct control. This means clinics need to approach consent in a more structured way.

Updated: September 20, 2025

What Counts as “Consent” in AI Use?

Consent in healthcare AI goes beyond a signed form. It should be:

Informed: Patients must understand what the AI tool does and how their data will be used.
Specific: Consent should apply to clearly described purposes, not blanket permissions.
Ongoing: Patients should be able to revoke or update their consent if circumstances change.
Documented: Clinics need proof that consent was obtained properly.

Regulatory Contexts

HIPAA (United States)

HIPAA permits use of PHI for treatment, payment, and operations without additional consent.
If an AI tool processes PHI for purposes beyond treatment, payment, or healthcare operations (for example, secondary analysis or vendor training), patient authorization may be required depending on the context.
Clinics must also ensure a Business Associate Agreement (BAA) is signed if a vendor handles PHI.

PHIPA (Ontario)

PHIPA requires knowledge and consent for collecting, using, and disclosing PHI.
Consent can be implied in certain circumstances (e.g., direct care), but clinics should be cautious with AI systems that involve third parties or cloud processing.
Clinics should ensure patients understand when their PHI is handled by external AI systems, especially where third-party vendors or cloud services are involved.

PIPEDA (Canada, outside Ontario health-specific laws)

PIPEDA requires meaningful consent, meaning patients understand the nature, purpose, and consequences of how their information will be used.
For AI, this often means explaining both immediate use (clinical assistance) and secondary risks (cloud storage, third-party access).

GDPR (European Union)

Under GDPR, processing health data generally requires a valid legal basis, with explicit consent as one option. Additional safeguards apply because health data is a sensitive category.
Consent must be freely given, specific, informed, and unambiguous.
Under the GDPR, patients must also be informed of their rights to access, rectification, and erasure.

Practical Steps for Clinics

Here are common steps clinics can take to strengthen AI-related consent practices (educational only):

1. Update Consent Forms

Add clear sections about AI tools, describing their function and data use.

Include vendor names if data is transmitted externally.

2. Use Plain-Language Explanations

Replace technical jargon with accessible terms.

Example: “This system helps your provider summarize your medical notes” instead of “This NLP engine ingests structured PHI.”

3. Describe Risks and Limitations

Inform patients that AI outputs support but do not replace clinical judgment.

If the AI may make errors or biases are possible, disclose this openly.

4. Offer Choices

Where possible, allow patients to opt out of AI-based processing.

If opt-out is not possible, make that explicit in the consent documentation.

5. Maintain Consent Records

Store timestamps, patient signatures (digital or paper), and version history of consent forms.

Keep a record of any withdrawals of consent.

6. Review Vendor Terms

Ensure vendor contracts respect patient rights and comply with regional laws.

Confirm that patients can request deletion or correction of their data even when stored with vendors.

Ethical Best Practices Beyond Legal Requirements

Transparency: Inform patients whenever an AI system contributes to their care.
Explainability: Ensure staff can explain AI recommendations or outputs to patients in understandable terms.
Avoid Implied Consent: Do not assume that a general treatment consent form covers AI use.
Continuous Communication: If an AI tool evolves or a new vendor is introduced, revisit consent with patients.

Consent Scenarios in Practice

Scenario	Consent Implication	Example of Good Practice
Clinic uses AI transcription tool that stores audio on vendor servers	Consent should explicitly mention storage and processing by third party	Update consent form and BAA/DPA; inform patients where data is stored
AI decision support tool used in diagnosis, outputs presented to doctor	Consent must explain AI role and limits	Inform patients that “AI assists your doctor by analyzing data; final decisions are made by your physician”
Vendor requests to use patient data for improving its AI model	Requires explicit, opt-in consent	Provide a separate consent form allowing patients to agree or refuse data reuse
Patient withdraws consent after initial approval	Clinic must stop further AI processing of that patient’s data (where feasible), while noting that uses already made under valid consent or authorization may remain valid.	Document withdrawal, update vendor access, confirm deletion

Key Takeaways

Consent in AI contexts is not a one-time checkbox — it must be informed, specific, and ongoing.
Different jurisdictions (HIPAA, PHIPA, PIPEDA, GDPR) set different thresholds, but all emphasize patient knowledge and choice.
Clinics should combine clear communication, updated forms, and transparent vendor contracts to meet both legal and ethical expectations.

Official Resources

IPAA for Professionals – HHS.gov: https://www.hhs.gov/hipaa/for-professionals/index.html

PHIPA Guidance – IPC Ontario: https://www.ipc.on.ca/privacy/health-privacy/

PIPEDA Overview – Office of the Privacy Commissioner of Canada: https://www.priv.gc.ca/en/privacy-topics/privacy-laws-in-canada/the-personal-information-protection-and-electronic-documents-act-pipeda/

General Data Protection Regulation (GDPR): https://gdpr-info.eu/