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

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Regulations and Compliance in Digital Therapeutics ( 25 Modules )

Regulations and Compliance in Digital Therapeutics
( 25 Modules )