State Expansions of the Health Insurance Portability and Accountability Act (HIPAA)
This training covers state expansions of HIPAA, focusing on California’s CMIA and Texas’ TMRPA. It outlines requirements for communications, safeguards, […]
Legal Teams
HITECH Act
This course provides an overview of the HITECH Act, its impact on HIPAA protections, and guidelines for compliance. Topics include
General Data Protection Regulation (GDPR)
This training explains GDPR requirements for handling personal data of EU individuals, including patient health records, clinical trial data, and
Prescription Drug Marketing Act (PDMA)
This training covers PDMA rules for drug sample distribution, including practitioner validation, inventory tracking, and FDA reporting for thefts/losses. Suggested
Pharmacovigilance
This module explains U.S. pharmacovigilance systems, emphasizing adverse event (AE) reporting timelines, serious AE criteria, and FDA’s FAERS database. Participants
Patient Protection and Affordable Care Act Sections 6002 & 6004
Covers the Sunshine Act’s reporting requirements for payments to HCPs (Section 6002) and drug sample disclosures (Section 6004). Suggested For: