Regulations and Compliance in Digital Therapeutics
( 25 Modules )
Module #1 Introduction to Digital Therapeutics Overview of digital therapeutics, industry growth, and the importance of regulations and compliance
Module #2 FDA Regulations and Guidance FDAs approach to digital therapeutics, including guidance on software as a medical device (SaMD) and digital therapeutics
Module #3 FDAs Digital Health Innovation Action Plan Understanding the FDAs Digital Health Innovation Action Plan and its impact on digital therapeutics
Module #4 CE Marking and EU Regulations Overview of CE marking, EUs Medical Device Regulation (MDR), and In Vitro Diagnostic Regulation (IVDR)
Module #5 ISO 13485:Medical Device Quality Management Understanding ISO 13485 and its application to digital therapeutics
Module #6 HIPAA and Data Privacy HIPAA regulations and guidance on protecting patient health information in digital therapeutics
Module #7 GDPR and International Data Protection Overview of GDPR and its impact on digital therapeutics, as well as international data protection regulations
Module #8 Cybersecurity and Risk Management Best practices for cybersecurity and risk management in digital therapeutics
Module #9 Clinical Trial Design and Validation Understanding clinical trial design and validation for digital therapeutics
Module #10 Regulatory pathways for Digital Therapeutics Overview of regulatory pathways for digital therapeutics, including 510(k), PMA, and De Novo
Module #11 Labeling and Instructions for Use Understanding labeling and instructions for use in digital therapeutics
Module #12 Post-Market Surveillance and Vigilance Best practices for post-market surveillance and vigilance in digital therapeutics
Module #13 Compliance and Enforcement Understanding compliance and enforcement in digital therapeutics, including FDA inspections and warning letters
Module #14 Digital Therapeutics and Intellectual Property Overview of intellectual property considerations in digital therapeutics, including patents and trade secrets
Module #15 Reimbursement and Payment Models Understanding reimbursement and payment models for digital therapeutics
Module #16 Ethical Considerations in Digital Therapeutics Exploring ethical considerations in digital therapeutics, including bias, equity, and patient autonomy
Module #17 Global Regulations and Market Access Overview of global regulations and market access strategies for digital therapeutics
Module #18 Digital Therapeutics and Real-World Evidence Understanding the role of real-world evidence in digital therapeutics
Module #19 Digital Therapeutics and Artificial Intelligence Exploring the intersection of digital therapeutics and artificial intelligence
Module #20 Digital Therapeutics and Personalized Medicine Understanding the role of digital therapeutics in personalized medicine
Module #21 Regulatory Strategies for Digital Therapeutics Startups Practical regulatory strategies for digital therapeutics startups
Module #22 Regulatory Affairs and Quality Assurance Best practices for regulatory affairs and quality assurance in digital therapeutics
Module #23 Digital Therapeutics and Patient Engagement Understanding the role of patient engagement in digital therapeutics
Module #24 Digital Therapeutics and Healthcare Provider Adoption Strategies for healthcare provider adoption of digital therapeutics
Module #25 Course Wrap-Up & Conclusion Planning next steps in Regulations and Compliance in Digital Therapeutics career
