Healthcare: Regulatory Framework and Compliance
Description
Comprehensive understanding of healthcare-specific regulations, compliance requirements, legal frameworks, and their impact on technology implementation and data management in healthcare organizations.
Learning Objectives
IT professionals will demonstrate mastery of healthcare regulatory requirements including HIPAA privacy and security rules, understand compliance implementation strategies, evaluate legal and ethical considerations in healthcare technology, and design IT solutions that ensure regulatory compliance while supporting healthcare operations and patient care objectives.
Topics (11)
Detailed study of HIPAA Privacy Rule requirements including Protected Health Information (PHI) definitions, minimum necessary standards, patient rights, and technology controls required for compliance.
Development of compliance monitoring frameworks, audit methodologies, risk assessment processes, and technology tools for ongoing compliance management and reporting.
Introduction to the complex healthcare regulatory framework including federal, state, and international regulations that impact healthcare delivery and technology implementation.
Comprehensive coverage of HIPAA Security Rule requirements, risk assessment processes, security controls implementation, and technology solutions for ePHI protection.
Analysis of Joint Commission standards, CMS quality measures, quality reporting requirements, and technology systems needed to support quality improvement and accreditation.
Study of FDA medical device regulations, software as medical device (SaMD) guidelines, clinical decision support regulations, and compliance requirements for health IT systems.
Detailed analysis of HIPAA business associate requirements, contract terms, vendor due diligence processes, and ongoing compliance monitoring for healthcare IT vendors.
Comprehensive study of healthcare breach notification rules, incident response procedures, forensic investigation requirements, and technology solutions for breach prevention and response.
Analysis of global healthcare data protection regulations, cross-border data transfer requirements, and compliance strategies for multinational healthcare organizations.
Study of healthcare ethics principles, ethical frameworks for technology implementation, AI ethics in healthcare, and patient consent considerations for emerging technologies.
Analysis of healthcare-specific technology risks, risk assessment methodologies, mitigation strategies, and technology solutions for comprehensive risk management in healthcare organizations.