Results for “healthcare-compliance”

Expert HIPAA compliance assistant for healthcare and software contexts. Use this skill whenever the user mentions HIPAA, PHI (Protected Health Information), ePHI, covered entities, business associates, healthcare data privacy, medical records, health information security, BAA (Business Associate Agreements), or any compliance review involving patient data. Also trigger for requests to draft privacy notices, HIPAA policies, consent forms, security risk assessments, or breach notification letters. Use for developers building healthcare software who need technical safeguard guidance (encryption, access controls, audit logs), compliance officers reviewing documents or procedures, and anyone asking "is this HIPAA compliant?" or "what does HIPAA require for X?". When in doubt about whether a healthcare or data privacy question falls under this skill — use it.

Implements telehealth privacy compliance covering HIPAA requirements for virtual care, state licensing and recording consent laws, platform security with BAA requirements for telehealth vendors, cross-state prescribing rules, and OCR enforcement discretion during public health emergencies. Keywords: telehealth privacy, virtual care, HIPAA, recording consent, platform BAA, cross-state licensing, OCR enforcement.

针对医疗隐私和安全工作的HIPAA特定入口点。当任务明确围绕HIPAA、PHI处理、受保实体、BAA、违规态势或美国医疗合规要求时使用。

Orchestrates multi-framework compliance programs by selecting applicable frameworks, mapping control overlaps, simulating audits, and consolidating evidence checklists.

Ensure HIPAA compliance when handling PHI (Protected Health Information). Use when writing code that accesses user health data, check-ins, journal entries, or any sensitive information. Activates for audit logging, data access, security events, and compliance questions.

Applies the HIPAA framework to identify, assess, and mitigate security risks in systems, processes, and data handling.

Implements HITECH Act privacy and security requirements including breach notification expansion, four-tier penalty structure, state attorney general enforcement authority, EHR meaningful use privacy conditions, and business associate direct liability. Keywords: HITECH Act, breach notification, penalty tiers, state AG enforcement, meaningful use, EHR privacy.

Addresses HIPAA compliance for mobile health (mHealth) applications, wearable devices, and remote patient monitoring. Covers OCR guidance on mobile device PHI, FDA-regulated mobile medical applications, FTC Health Breach Notification Rule for non-HIPAA apps, BYOD policies, and encryption requirements for ePHI on mobile platforms. Keywords: mHealth, mobile health, HIPAA mobile, wearable, remote monitoring, BYOD, mobile device management, app privacy.

Routes compliance requests to the appropriate regulatory and quality-management skill among 15 bundled options, covering ISO 13485, EU MDR, FDA submissions, ISO 14971, CAPA, document control, ISO 27001, ISO 42001, EU AI Act, GDPR, SOC 2, and auditing.

Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2 for HealthTech and MedTech companies.

Guides implementation of data protection and privacy controls for regulatory frameworks such as GDPR, HIPAA, SOC 2, and PCI-DSS, including audits, retention policies, and data subject requests.

Implements Children's Online Privacy Protection Act (COPPA) compliance under 16 CFR Part 312. Covers verifiable parental consent methods including signed forms, credit card verification, government ID, knowledge-based authentication, and video call. Includes FTC safe harbor programs and enforcement actions. Keywords: COPPA, FTC, children, parental consent, safe harbor, verifiable consent.

Guides implementation of the GDPR accountability principle under Articles 5(2) and 24, including documentation requirements for policies, DPIAs, RoPA, training records, and breach logs. Activate when establishing or reviewing accountability measures, preparing evidence portfolios, or demonstrating compliance to supervisory authorities. Keywords: accountability, Article 5(2), Article 24, documentation, compliance evidence, governance.

Validates the integrity of a project's .planning/ directory, reporting missing files, invalid configurations, and inconsistent state, with optional auto-repair of safe issues.

Create patient intake forms with history and screening. TRIGGERS - Use when user needs help with intake-form related tasks.

Navigates regulatory compliance, government relations, and administrative law across financial services, healthcare, environmental, FDA, privacy, energy, government contracts, trade, and securities domains. Use when handling agency interactions, compliance programs, enforcement defense, rulemaking comments, or administrative proceedings.

Enforce CLAUDE.md framework compliance. Re-reads rules, displays applicable rules, processes request with full compliance.

Conduct HIPAA Security Rule risk analysis, implement administrative, physical, and technical safeguards, manage Business Associate Agreements, and establish breach-notification readiness for covered entities and business associates.

Maps the US federal privacy landscape including sectoral laws (HIPAA, GLBA, FERPA, COPPA, FCRA, ECPA, VPPA), FTC Section 5 enforcement, proposed federal comprehensive legislation, and the interaction between federal and state privacy regimes. Keywords: federal privacy, HIPAA, GLBA, FERPA, COPPA, FCRA, FTC, sectoral, preemption.

Create medical coding guides for billing accuracy. TRIGGERS - Use when user needs help with coding-guide related tasks.

Drafts formal responses to governmental Notices of Violation, covering acknowledgment, factual timeline, legal defenses, mitigation, and proposed corrective action. Use when responding to environmental enforcement actions, regulatory citations, compliance violations, or governmental NOVs from agencies including EPA, OSHA, state environmental departments, or local code enforcement.

Virginia Consumer Data Protection Act (VCDPA) compliance implementation. Covers 5 consumer rights, controller obligations, processor requirements, opt-in for sensitive data, data protection impact assessments, AG enforcement, and cure period provisions. Effective January 1, 2023.

Implements HIPAA breach notification requirements under 45 CFR §164.400-414. Covers individual notification within 60 days, HHS reporting thresholds (500+ immediate, under 500 annual), state attorney general notification, media notification for 500+ in a state, and breach risk assessment. Keywords: HIPAA breach notification, HHS reporting, OCR breach portal, individual notice, state attorney general.

Reference for SOC 2, PCI-DSS, HIPAA, and GDPR compliance requirements, including control checklists, evidence collection, and audit preparation guidance.

Write HIPAA privacy notices and acknowledgments. TRIGGERS - Use when user needs help with hipaa-notice related tasks.

Expert technical compliance auditor specializing in SOC 2, ISO 27001, HIPAA, and PCI-DSS audits — from readiness assessment through evidence collection to certification.

Implements HIPAA Privacy Rule requirements under 45 CFR §164.500-534 for covered entities and business associates. Covers minimum necessary standard, treatment-payment-operations exceptions, directory opt-out, personal representative rules, and authorization requirements. Keywords: HIPAA Privacy Rule, PHI, minimum necessary, TPO, authorization, covered entity.

Regulatory compliance and audit agent. Maps business regulatory requirements (SOC2/PCI-DSS/HIPAA/ISO 27001), checks control implementations, designs audit trails, and implements Policy as Code. Use when compliance auditing is needed.

Write HIPAA privacy notices and acknowledgments. TRIGGERS - Use when user needs help with hipaa-notice related tasks.

Track compliance requirements and generate audit trail reports. Use when auditing controls, checking policies, generating audit trails.

Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.

The annual compliance scramble exists because controls are tested once, by

Verifies that blockchain code implements exactly what documentation specifies, identifying gaps between specs and implementation for audit engagements.

Prepare ISO 13485:2016 certification documentation for medical device Quality Management Systems, including gap analysis, template-based document creation, and compliance checklists.