Professional Certificate in mHealth Compliance: A Global Perspective
-- ViewingNowThe Professional Certificate in mHealth Compliance: A Global Perspective is a comprehensive course designed to meet the growing industry demand for experts who can navigate the complex regulatory landscape of mobile health (mHealth). This certificate course emphasizes the importance of compliance in mHealth, a field that uses mobile devices for medical purposes, and is poised for exponential growth.
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โข mHealth Compliance Fundamentals: Understanding the regulatory landscape, compliance challenges, and best practices in mobile health (mHealth)
โข Data Privacy and Security in mHealth: Exploring global data protection laws, patient data management, and cybersecurity measures
โข Mobile Medical Applications (SaMD): Examining the regulatory framework for software as a medical device (SaMD), including FDA guidance and EU MDR
โข Clinical Evaluation and Validation: Learning about clinical evidence requirements, validation processes, and post-market surveillance for mHealth solutions
โข Quality Management Systems (QMS): Implementing and maintaining QMS for mHealth, aligning with ISO 13485 and FDA Quality System Regulation
โข Digital Health Regulations Worldwide: Comparing mHealth regulations in the US, Europe, Asia, and other regions
โข Interoperability and Standards: Adopting global interoperability frameworks, such as FHIR and IEEE 11073, to ensure seamless data exchange
โข Risk Management in mHealth: Implementing risk management strategies, complying with ISO 14971, and mitigating potential risks in mHealth applications
โข Legal and Ethical Considerations: Addressing intellectual property, liability, and ethical concerns in the global mHealth landscape
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