Professional Certificate in mHealth Compliance: A Global Perspective
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• mHealth Compliance Fundamentals: Understanding the regulatory landscape, compliance challenges, and best practices in mobile health (mHealth)
• Data Privacy and Security in mHealth: Exploring global data protection laws, patient data management, and cybersecurity measures
• Mobile Medical Applications (SaMD): Examining the regulatory framework for software as a medical device (SaMD), including FDA guidance and EU MDR
• Clinical Evaluation and Validation: Learning about clinical evidence requirements, validation processes, and post-market surveillance for mHealth solutions
• Quality Management Systems (QMS): Implementing and maintaining QMS for mHealth, aligning with ISO 13485 and FDA Quality System Regulation
• Digital Health Regulations Worldwide: Comparing mHealth regulations in the US, Europe, Asia, and other regions
• Interoperability and Standards: Adopting global interoperability frameworks, such as FHIR and IEEE 11073, to ensure seamless data exchange
• Risk Management in mHealth: Implementing risk management strategies, complying with ISO 14971, and mitigating potential risks in mHealth applications
• Legal and Ethical Considerations: Addressing intellectual property, liability, and ethical concerns in the global mHealth landscape
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- BasicUnderstandingSubject
- ProficiencyEnglish
- ComputerInternetAccess
- BasicComputerSkills
- DedicationCompleteCourse
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- ThreeFourHoursPerWeek
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