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<p>Digital mental health technologies (DMHTs) increasingly behave as continuously updated services, yet most oversight mechanisms still evaluate them as comparatively static products. This creates a governance gap where software change, deployment context, and mental health risk interact. This perspective presents SECA (Safety Envelope and Continuous Assurance) as a governance framework for regulated software as a medical device (SaMD) DMHTs, with extension to the wider “adjacent app” market through procurement and accreditation levers. Rather than treating oversight as review of a fixed version, SECA combines a bounded Safety Envelope, which pre-specifies change classes and evidence expectations, with Continuous Assurance, which monitors real-world performance and supports escalation, pause, or rollback when needed. The framework is mapped to the EU/UK, US, and India by aligning with existing post-market and vigilance structures while highlighting context triggers especially relevant in mental health, including population vulnerability, language and cultural setting, and interaction design changes that may alter help-seeking or crisis behavior.</p>

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Safety Envelopes and Continuous Assurance for Updates and Postmarket Surveillance in Digital Mental Health Technologies

  • 期刊论文

  • 发表日期：

    2026年4月21日

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  • Siddharth Nandagopal

摘要

Digital mental health technologies (DMHTs) increasingly behave as continuously updated services, yet most oversight mechanisms still evaluate them as comparatively static products. This creates a governance gap where software change, deployment context, and mental health risk interact. This perspective presents SECA (Safety Envelope and Continuous Assurance) as a governance framework for regulated software as a medical device (SaMD) DMHTs, with extension to the wider “adjacent app” market through procurement and accreditation levers. Rather than treating oversight as review of a fixed version, SECA combines a bounded Safety Envelope, which pre-specifies change classes and evidence expectations, with Continuous Assurance, which monitors real-world performance and supports escalation, pause, or rollback when needed. The framework is mapped to the EU/UK, US, and India by aligning with existing post-market and vigilance structures while highlighting context triggers especially relevant in mental health, including population vulnerability, language and cultural setting, and interaction design changes that may alter help-seeking or crisis behavior.