Regulations and Standards for Digital Health
( 25 Modules )

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

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Regulations and Standards for Digital Health ( 25 Modules )

Regulations and Standards for Digital Health
( 25 Modules )