1. Scope

Keywords

Rationale

Cannabis-derived and hemp-derived products are increasingly used in medical care and are delivered to patients through electronic vaporizer devices. Unlike traditional pharmaceuticals, cannabinoid therapy requires individualized dose titration, making accurate dose delivery and reliable usage data critical to patient safety and clinical decision-making. In the absence of standardized requirements, medical cannabis and hemp vaporizers may be susceptible to tampering, unauthorized modification, or data manipulation, leading to inaccurate dosing, unreliable usage records, and potential patient harm. If device operation or data integrity cannot be trusted, clinicians cannot distinguish between a failed prescription and a failed device, resulting in inappropriate treatment adjustments and reduced confidence in cannabis- and hemp-based therapies. Inadequate authentication controls may also permit use by unintended or contraindicated users. Insecure devices further place sensitive protected health information (PHI) at risk and limit manufacturers’ ability to assess real-world device performance and improve product design based on clinical use. This proposed standard establishes consistent expectations for security, safety, and data integrity across hardware, software, and data systems used in medical cannabis and hemp vaporizer devices. A unified standard will support patient safety, enable reliable clinical use, protect sensitive data, and facilitate healthcare system adoption through standardized, verifiable device performance.