Building on the architecture and interoperability of the Introductory level, this Advanced course develops the privacy, certification and regulatory frameworks that govern health-IT systems and clinical software.

This 32-hour Professional Certificate Course covers the HIPAA Privacy, Security and Breach Notification Rules; the ONC Health IT Certification Program (45 CFR Part 170) with USCDI; the FDA regulation of clinical decision support under the 21st Century Cures Act §3060 and the September 2022 CDS guidance and SaMD framework; and emerging trends in telehealth, mHealth and wearable integration.

By the end, participants can draft a HIPAA assessment, build an element of a health-IT implementation plan and anticipate the FDA regulatory expectations for CDS software.

The Advanced course connects health-IT systems to HIPAA, ONC certification and FDA CDS regulation, preparing participants for privacy, compliance and regulatory roles across clinical software and health systems.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.