Can this skill handle both DTC and HCP marketing?

Yes, the framework includes specific regulatory checklists for both Direct-to-Consumer (DTC) and Healthcare Professional (HCP) communication standards.

How does it help with HIPAA compliance?

It guides users through a Data & Consent Map, ensuring that data sources, identifiers, and retention policies are clearly documented for every campaign.

Does this skill automate the legal approval process?

While it doesn't replace legal counsel, it automates the creation of 'Reviewer Packets' that contain all necessary evidence and data maps, making the human review process much faster and more accurate.

What is the Compliance Briefing Kit for Claude Code?

It is a specialized skill that provides templates and frameworks to ensure healthcare marketing materials meet HIPAA, FDA, and FTC regulatory standards before they are published.

Healthcare Compliance Briefing Kit

Name: Healthcare Compliance Briefing Kit
Author: gtmagents

bygtmagents

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마케팅 자동화

Standardizes the intake, review, and approval process for HIPAA and FDA-compliant healthcare marketing campaigns.

소개

The Healthcare Compliance Briefing Kit is a specialized skill designed to streamline the complex regulatory review process in healthcare marketing. It provides Claude with a structured framework to generate comprehensive briefing kits that cover HIPAA data privacy, FDA/FTC regulatory checklists, and clinical claim evidence. By formalizing the documentation of data consent, risk statements, and approval workflows, this skill helps marketing teams prepare audit-ready materials and reduces friction during medical, legal, and regulatory (MLR) reviews.

주요 기능

29 GitHub stars
Integrated regulatory checklists covering FDA (DTC/HCP), FTC, and accessibility.
Standardized campaign intake templates for HIPAA and FDA compliance.
Structured claim-evidence tracking to validate clinical and value propositions.
Defined approval workflows with reviewer SLAs and escalation paths.
Comprehensive data and consent mapping for privacy regulation adherence.

사용 사례

Kicking off a new FDA-compliant pharmaceutical marketing campaign review.
Auditing historical campaign documentation for regulatory and data retention compliance.
Preparing structured reviewer packets for medical, legal, and regulatory teams.

소개

주요 기능

29 GitHub stars
Integrated regulatory checklists covering FDA (DTC/HCP), FTC, and accessibility.
Standardized campaign intake templates for HIPAA and FDA compliance.
Structured claim-evidence tracking to validate clinical and value propositions.
Defined approval workflows with reviewer SLAs and escalation paths.
Comprehensive data and consent mapping for privacy regulation adherence.

사용 사례

Kicking off a new FDA-compliant pharmaceutical marketing campaign review.
Auditing historical campaign documentation for regulatory and data retention compliance.
Preparing structured reviewer packets for medical, legal, and regulatory teams.