Regulations and Compliance in Digital Health
( 30 Modules )

Module #1
Introduction to Digital Health and Regulations
Overview of the digital health landscape and the importance of regulations and compliance

Module #2
HIPAA Fundamentals
Understanding the Health Insurance Portability and Accountability Act (HIPAA) and its impact on digital health

Module #3
HIPAA Privacy Rule
In-depth review of the HIPAA Privacy Rule, including patient rights and protected health information (PHI)

Module #4
HIPAA Security Rule
In-depth review of the HIPAA Security Rule, including safeguards for electronic protected health information (ePHI)

Module #5
HIPAA Breach Notification Rule
Understanding the requirements for breach notification under HIPAA

Module #6
FDA Regulations for Digital Health
Overview of FDA regulations for medical devices, software, and mobile apps in digital health

Module #7
FDA Clearance and Approval Process
In-depth review of the FDA clearance and approval process for digital health products

Module #8
FDA Guidelines for Mobile Medical Apps
Understanding FDA guidelines for mobile medical apps and their classification as medical devices

Module #9
CMS Regulations for Digital Health
Overview of Centers for Medicare and Medicaid Services (CMS) regulations for digital health

Module #10
ONC Regulations for Health IT
Understanding Office of the National Coordinator for Health Information Technology (ONC) regulations for health IT

Module #11
Meaningful Use and EHR Incentives
Understanding the Meaningful Use program and electronic health record (EHR) incentives

Module #12
State-Specific Regulations for Digital Health
Overview of state-specific regulations for digital health, including telemedicine and online prescribing

Module #13
International Regulations for Digital Health
Overview of international regulations for digital health, including EUs GDPR and MHRAs guidelines

Module #14
Risk Management and Compliance Strategies
Developing risk management and compliance strategies for digital health organizations

Module #15
Audit and Compliance Readiness
Preparing for audits and ensuring compliance readiness in digital health organizations

Module #16
Cybersecurity in Digital Health
Understanding cybersecurity threats and best practices for digital health organizations

Module #17
Incident Response and Breach Notification
Developing incident response plans and breach notification procedures for digital health organizations

Module #18
Compliance Training and Awareness
Developing compliance training programs and promoting awareness in digital health organizations

Module #19
Vendor Management and Third-Party Risk
Managing vendor relationships and mitigating third-party risk in digital health organizations

Module #20
Digital Health Policy and Advocacy
Understanding digital health policy and advocacy efforts to shape regulations and compliance

Module #21
Regulatory Updates and Trends
Staying current with regulatory updates and trends in digital health

Module #22
Case Studies in Digital Health Compliance
Real-world case studies of digital health compliance challenges and solutions

Module #23
Compliance in Emerging Digital Health Technologies
Understanding compliance implications for emerging digital health technologies, such as AI and blockchain

Module #24
Global Digital Health Compliance
Understanding global digital health compliance requirements and regulations

Module #25
Digital Health Compliance in Research and Development
Understanding compliance implications for digital health research and development

Module #26
Compliance in Digital Therapeutics
Understanding compliance implications for digital therapeutics and software as a medical device

Module #27
Compliance in Telemedicine and Virtual Care
Understanding compliance implications for telemedicine and virtual care

Module #28
Compliance in Health Information Exchange (HIE)
Understanding compliance implications for health information exchange (HIE)

Module #29
Compliance in Personal Health Records (PHRs)
Understanding compliance implications for personal health records (PHRs)

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Regulations and Compliance in Digital Health career

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Regulations and Compliance in Digital Health ( 30 Modules )

Regulations and Compliance in Digital Health
( 30 Modules )