Healthcare: Industry-Specific Regulations
Description
Thorough exploration of regulatory frameworks, statutes, compliance mandates, and enforcement mechanisms unique to the healthcare industry on both global and national levels.
Learning Objectives
IT professionals will master the healthcare regulatory landscape, identify and interpret the requirements of key statutes and agencies (HIPAA, HITECH, FDA, CMS, GDPR, regional laws), ensure technology compliance, and integrate global and local regulations into IT system design and operational processes.
Topics (11)
Meaningful use, MACRA, value-based purchasing, interoperability, and data submission rules.
Key principles, patient rights, consent, data transfer, compliance challenges for IT and cloud.
Conceptual mapping of healthcare regulation ecosystem: legal hierarchy, agency roles, and regulatory levels (federal, state, international).
Provisions, required controls, penalties, audit examples, technology roles, and enforcement scenarios.
510(k) clearance, pre-market approval, software rules, and cybersecurity/device recalls.
Informed consent, IRB approvals, trial registration/reporting, and audit requirements for clinical systems.
OCR, OIG, CMS investigations, audit findings, penalties, lessons from breaches, IT controls, and reporting.
Key differences, cross-border compliance, and global trends in regulatory modernization.
Consent management systems, dynamic consent, de-identification, and ethics board integration.
Licensing, cross-border practice, virtual care protocols, telemedicine privacy/security, and consumer protection.
RegTech, AI and ML regulation, predictive compliance, sandbox pilots, and trends for IT-led compliance transformation.