International Privacy Regulations
Last updated June 16, 2025
At Smile Digital Health, privacy and compliance aren’t just features—they are foundational. Our platform is designed to give organizations and individuals more control over their health data, supporting patient and organization access to the right data, data exchange and interoperability, as well as ethical considerations.
Whether data is being accessed across borders or used to power clinical insights, Smile enables lawful, secure, and ethical handling of personal health information. Our privacy-by-design approach helps organizations meet their privacy requirements—while empowering patients with transparency, consent, and control.
Supporting Compliance with International Privacy Regulations
Smile’s solutions help support compliance for a wide range of regional and national frameworks, including (but not limited to):
- Health Insurance Portability and Accountability Act (HIPAA)
- Health Information Technology for Economic and Clinical Health Act (HITECH)
- 21st Century Cures Act – Centers for Medicare & Medicaid Services (CMS)
- U.S. Food and Drug Administration Quality System Regulations (FDA QSR)
- Personal Information Protection and Electronic Documents Act (PIPEDA)
- Health Canada Quality Management System Regulations
- Alberta : Personal Information Protection Act (PIPA)
- British Columbia : Personal Information Protection Act (PIPA)
- Québec : Act Respecting the Protection of Personal Information in the Private Sector
- New Brunswick : Personal Health Information Privacy and Access Act
- Newfoundland and Labrador: Personal Health Information Act
- Nova Scotia: Personal Health Information Act
- Ontario : Personal Health Information Protection Act (PHIPA)
- General Data Protection Regulation (GDPR)
- European Health Data Space (EHDS)
- European Union Medical Device Regulation (EU MDR and CE Marking)
- Privacy Act of 1988 and the Privacy Act Amendment Act
- Privacy and Personal Information Protection Act 1998 (PPIP Act)
- Australian Capital Territory: Information Privacy Act 2014
- Northern Territory : Information Act 2002
- New South Wales : Privacy and Personal Information Protection Act 1998
- New South Wales : Health Records and Information Privacy Act 2002
- Queensland: Information Privacy Act 2009
- Tasmania : Personal Information Protection Act 2004
- Victoria : Privacy and Data Protection Act 2014
- Malaysia’s Personal Data Protection Act (PDPA) 2010 and 2024 Amending Act
- Malaysia’s Data Sharing Bill 2024
- Indonesia’s Health Law and Personal Data Protection (PDP) Law
- Indonesia’s Ministry of Health (MOH) Regulation No.24 of 2022
- Saudi Arabia’s Personal Data Protection Law (PDPL)
- Egypt’s Data Protection Law (DPL)
Built-in Capabilities for Trusted Health Data Exchange
Smile’s capabilities are designed to help organizations operate in compliance with today’s privacy expectations and tomorrow’s emerging standards:
Data Standardization
HL7® FHIR® ensures consistent formats that are standardized and harmonized across systems so that data is available for machine-readable analytics and AI-augmentation.
Ethics
Our platform supports ethical use by ensuring transparency, informed consent, data minimization, and ensuring data is used for agreed-upon purposes.
Interoperability
Smile’s FHIR-native architecture enables seamless, standards-based exchange across jurisdictions, and supports open APIs.
Privacy Regulations
Our privacy-by-design architecture includes consent models, encryption, and audit controls that help meet regulatory requirements.
Device Quality Management
Smile is certified under ISO 13485:2016 to support regulatory-grade quality and safety of medical devices.
Cross-Border Data Sharing
Federated exchange and localization options that support the navigation of international data transfer laws.
Patient Access
Patients gain secure digital access to their own records—aligned with global mandates for transparency, timely accurate access and control.