ArticleJournal of medical systems2026
Safety Envelopes and Continuous Assurance for Updates and Postmarket Surveillance in Digital Mental Health Technologies.
Article in Journal of medical systems, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.