Skill UI

Provides FDA regulatory guidance for medical device manufacturers encompassing pathway strategy for 510(k)/PMA/De Novo submissions, QSR compliance, HIPAA assessments, and cybersecurity planning to support premarket filings.

Automates compliance and security audit reporting for standards such as PCI DSS, HIPAA, SOC 2, and ISO 27001 by using the compliance-report-generator plugin to collect details, format documentation, and streamline regulatory proof.

This system implements Role-Based Access Control (RBAC) for OpenEvidence, an AI-powered clinical decision support platform. It strictly manages access to sensitive data, including PHI-adjacent datasets and medical literature, ensuring compliance with regulations like HIPAA. The system defines distinct roles—Admin, Clinician, Researcher, Student, and Auditor—with granular permissions for querying, data export, and institutional configuration, maintaining a secure and auditable data environment.

This skill acts as a specialized domain intelligence strategist, capable of analyzing specific industry niches (e.g., Fintech, HealthTech). It goes beyond general functionality to inject crucial domain-specific knowledge, mandatory regulatory compliance (like HIPAA or GDPR), and industry-leading UX/UI patterns. Essential for ensuring the product is optimized for its vertical market.

Guides growth-stage companies through CISO-level security programs by quantifying risks in dollars, sequencing compliance (SOC 2/ISO 27001/HIPAA/GDPR), architecting zero-trust defenses, leading incident response, and translating budgets for boards or sales conversations.