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Found 45 Skills
Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development.
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
Technical safeguards and architectural patterns for building HIPAA-compliant software on AWS. Use when building healthcare SaaS, handling PHI (Protected Health Information), designing patient data systems, implementing healthcare APIs, setting up HIPAA-eligible AWS infrastructure, reviewing code for PHI exposure, designing audit logging, or when the user mentions patients, medical records, EHR/EMR, health data, HL7, FHIR, or covered entities. Essential for founders and developers building in healthcare or digital health space.
Plan healthcare privacy, research, and regulatory compliance for a digital health product, including HIPAA, IRB, FDA, GDPR, governance, and operational controls.
Generate legally-sound terms of service, privacy policies, and medical disclaimers for recovery and wellness applications. Expert in HIPAA, GDPR, CCPA compliance. Activate on 'terms of service', 'privacy policy', 'legal terms', 'medical disclaimer', 'HIPAA', 'user agreement'. NOT for contract negotiation (use attorney), app development (use domain skills), or moderation (use recovery-community-moderator).
Use when handling authentication, authorization, encryption, HIPAA compliance, SOC 2, privacy policies, penetration testing, or any security and compliance concerns
TranscribeMe platform help — human+AI hybrid transcription service with 99% accuracy guarantee on human-reviewed tiers, HIPAA compliance, and REST API. Use when uploading audio for human-edited transcription, choosing between Machine Express and human-reviewed tiers, integrating TranscribeMe API into a transcript pipeline, comparing TranscribeMe vs Rev vs GoTranscript vs Sonix for accuracy-critical transcription, troubleshooting slow turnaround or inconsistent punctuation, setting up HIPAA-compliant medical or legal transcription, or debugging chunked upload or OAuth token issues. Do NOT use for live meeting recording or real-time transcription (TranscribeMe is upload-only — use /sales-note-taker for live meeting tools).
Strategic advisory for digital health and healthtech founders covering HIPAA scope, FDA SaMD vs non-SaMD classification, EHR integration patterns, payor/provider/employer GTM, and value-based care models. Complements the RA/QM compliance domain with software-side strategic guidance. Use when scoping a healthtech idea, classifying PHI, picking a GTM, or when the user mentions HIPAA, PHI, FDA SaMD, EHR integration, telehealth, or digital therapeutics.
Hipaa Audit Helper - Auto-activating skill for Security Advanced. Triggers on: hipaa audit helper, hipaa audit helper Part of the Security Advanced skill category.
This skill should be used when the user asks to "scan for PHI", "detect PII", "HIPAA compliance check", "audit for protected health information", "find sensitive healthcare data", "generate HIPAA audit report", "check code for PHI leakage", "scan logs for PHI", "check authentication on PHI endpoints", "scan FHIR resources", "check HL7 messages", or mentions PHI detection, HIPAA compliance, healthcare data privacy, medical record security, logging PHI violations, authentication checks for health data, or healthcare data formats (FHIR, HL7, CDA).
Draft and fill data privacy agreement templates — DPA, data processing agreement, GDPR, HIPAA BAA, business associate agreement, AI addendum. Produces signable DOCX files from Common Paper standard forms.
Produce a report-only HIPAA, PHI, and PII audit for healthcare codebases and delivery systems. Inspects code, configs, data flows, integrations, logging, and deployment boundaries for privacy and security gaps without modifying code.