Module #1 Introduction to Digital Health Regulations Overview of the importance of regulations in digital health, key stakeholders, and the impact on innovation
Module #2 History of Digital Health Regulations Evolution of regulations in digital health, key milestones, and lessons learned
Module #3 International Digital Health Regulations Overview of regulations and standards in key regions:EU, US, Asia, and Latin America
Module #4 US FDA Regulations for Digital Health In-depth review of FDA regulations, guidance, and enforcement for digital health products
Module #5 EU Regulations for Digital Health In-depth review of EU regulations, GDPR, and MDR for digital health products
Module #6 HIPAA and Data Privacy in Digital Health Overview of HIPAA, GDPR, and other data privacy regulations impacting digital health
Module #7 Cybersecurity Regulations for Digital Health Review of cybersecurity regulations, standards, and best practices for digital health
Module #8 Standards for Digital Health Overview of key standards for digital health, including IEC, ISO, and ASTM
Module #9 ISO 13485 for Digital Health In-depth review of ISO 13485, a standard for medical device quality management
Module #10 IEC 62304 for Digital Health In-depth review of IEC 62304, a standard for medical device software
Module #11 ASTM Standards for Digital Health Review of ASTM standards for digital health, including E2845 and E3141
Module #12 Clinical Evaluation and Clinical Trials for Digital Health Overview of clinical evaluation and clinical trial requirements for digital health products
Module #13 Regulatory Strategies for Digital Health Strategies for regulatory compliance, including pre-submission, IDE, and 510(k) pathways
Module #14 Global Regulatory Submission Strategies Strategies for submitting digital health products to regulatory authorities worldwide
Module #15 Post-Market Surveillance and Vigilance Overview of post-market surveillance and vigilance requirements for digital health products
Module #16 Compliance and Enforcement in Digital Health Review of compliance and enforcement mechanisms, including audits and inspections
Module #17 Digital Health Regulations in Emerging Markets Overview of regulations and standards in emerging markets, including Brazil, Russia, India, and China
Module #18 Artificial Intelligence and Machine Learning Regulations Review of regulations and standards for AI and ML in digital health
Module #19 Blockchain and Distributed Ledger Regulations Review of regulations and standards for blockchain and distributed ledger in digital health
Module #20 Telemedicine and Remote Patient Monitoring Regulations Overview of regulations and standards for telemedicine and remote patient monitoring
Module #21 Wearable Devices and Mobile Health Regulations Review of regulations and standards for wearable devices and mobile health
Module #22 Digital Therapeutics Regulations Review of regulations and standards for digital therapeutics
Module #23 Regulatory Considerations for Digital Health Startups Practical advice for digital health startups on navigating regulations and standards
Module #24 Case Studies in Digital Health Regulations Real-world examples of digital health products navigating regulations and standards
Module #25 Course Wrap-Up & Conclusion Planning next steps in Regulations and Standards for Digital Health career
