HIPAA, GDPR, PIPEDA & PHIPA

Overlap and Differences for AI Startups

Healthcare AI startups often begin by building for a single market—only to discover that expanding into new regions requires significant privacy and compliance adjustments. While laws like HIPAA (U.S.), GDPR (EU), PIPEDA (Canada), and PHIPA (Ontario) share common goals, their definitions, requirements, and enforcement mechanisms differ in ways that can reshape your data architecture, consent processes, and vendor relationships.

For early-stage teams, understanding these similarities and differences before expansion can save time, reduce legal risk, and avoid costly product rework.

Why This Matters for Startups

Cross-border data challenges – Moving or processing data across jurisdictions triggers different obligations, especially under GDPR’s data transfer rules and PHIPA’s Ontario-specific storage requirements. Non-compliance can block partnerships or customer onboarding in target markets.

Conflicting consent standards – HIPAA’s authorization rules, GDPR’s explicit consent requirements, and PIPEDA/PHIPA’s consent models differ in formality, scope, and revocation rights. A consent form valid in one jurisdiction may be invalid in another.

Varying definitions of personal health data – What counts as protected health information under HIPAA may have a broader or narrower definition under GDPR, PIPEDA, or PHIPA. Startups that assume one standard applies globally risk under-protecting data in stricter jurisdictions.

 

Key Areas of Overlap

While each law has unique features, they share several core principles:

Purpose limitation – Data must be collected for a specific, lawful purpose and not used beyond that scope without new consent or legal basis.

Data minimization – Collect only the data necessary for the intended purpose.

Security safeguards – Implement administrative, technical, and physical measures to protect personal health data.

Individual rights – Patients or data subjects have rights to access, correct, and request deletion of their information (with some differences in scope).

Accountability – Organizations are responsible for demonstrating compliance through policies, training, and documentation.

Privacy Law Comparison Table

Key Differences Startups Should Know

1. Scope of Application

• HIPAA applies to covered entities and business associates in the U.S. healthcare system.

• GDPR applies to any organization processing personal data of EU residents, regardless of where the organization is based.

• PIPEDA applies to most private-sector organizations in Canada, with some provincial exceptions.

• PHIPA applies specifically to Ontario health information custodians and their agents.

2. Consent Requirements

• HIPAA often permits PHI use for treatment, payment, and healthcare operations without explicit consent, but requires authorization for other uses.

• GDPR typically requires explicit consent for processing health data unless another legal basis applies (e.g., public interest, vital interests).

• PIPEDA allows implied or express consent depending on context; sensitive health data typically requires express consent.

• PHIPA generally permits implied consent within the circle of care but requires express consent for other disclosures.

3. Data Residency and Transfer Rules

• GDPR restricts personal data transfers outside the EEA unless adequate safeguards are in place.

• PHIPA has practical implications for where health information can be stored, especially in public health contexts.

• PIPEDA allows cross-border transfers but requires organizations to maintain accountability and comparable protections.

• HIPAA has no explicit residency requirement but still mandates safeguarding PHI wherever stored.

Practical Steps for Startups

1. Map your data flows across jurisdictions
Identify where your data is collected, processed, stored, and transferred. Flag steps that involve multiple jurisdictions to determine applicable laws.

2. Create multi-jurisdiction consent templates
Build consent language that meets or exceeds the strictest applicable standard so it remains valid across all target markets.

3. Align vendor contracts with all applicable laws
Vendors handling health data should meet requirements for every jurisdiction you operate in, not just your home market.

4. Document your legal basis for processing
For each market, record whether you rely on consent, contractual necessity, public interest, or another lawful basis.

 

 

Key Takeaways

• Expanding internationally means layering multiple privacy regimes, not replacing one with another.

• Designing compliance for the strictest applicable standard early can reduce friction when entering new markets.

• Documentation of consent, processing activities, and vendor compliance is critical for both audits and investor due diligence.

Relevant Resources

• HHS HIPAA Privacy Rule Summary ↗ – Overview of HIPAA’s privacy requirements.

• European Data Protection Board – GDPR Guidance ↗ – Official EU interpretations of GDPR obligations.

• Office of the Privacy Commissioner of Canada – PIPEDA Overview ↗ – Summary of Canada’s federal privacy law.

• Information and Privacy Commissioner of Ontario – PHIPA Guide ↗ – PHIPA requirements for Ontario health custodians.