Length: 2 Days
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The Ensuring Cybersecurity in Medical Device Applications Training course by Tonex is designed to equip professionals in the healthcare and medical technology sectors with the knowledge and skills necessary to safeguard critical medical devices and applications from cyber threats. This comprehensive training program delves into the intricacies of medical device security, regulatory compliance, and best practices to mitigate vulnerabilities.

Learning Objectives: Upon completion of this course, participants will:

  • Understand the unique cybersecurity challenges within the healthcare and medical device industry.
  • Learn the principles of medical device security, risk assessment, and threat modeling.
  • Gain insight into the regulatory frameworks governing medical device cybersecurity.
  • Acquire hands-on skills for vulnerability assessment, penetration testing, and security assessment.
  • Develop strategies to secure medical device applications and data to protect patient safety and privacy.
  • Learn incident response protocols for handling cyber threats and breaches in a healthcare setting.

Audience: This course is intended for professionals working in the healthcare and medical technology sectors, including but not limited to:

  • Medical Device Engineers
  • Healthcare IT Professionals
  • Regulatory and Compliance Specialists
  • Biomedical Engineers
  • Information Security Officers
  • Healthcare System Administrators

Course Outline:

Introduction to Medical Device Cybersecurity

  • Understanding the importance of medical device cybersecurity
  • The evolving threat landscape in healthcare
  • Key stakeholders and their roles in medical device security
  • Common attack vectors and vulnerabilities in medical devices
  • Overview of relevant regulations and standards
  • Industry case studies on medical device security breaches

Risk Assessment and Threat Modeling

  • Conducting risk assessments for medical devices
  • Threat modeling techniques for identifying vulnerabilities
  • Creating threat models specific to medical device applications
  • Prioritizing security risks and vulnerabilities
  • Mapping threats to vulnerabilities for mitigation

Regulatory Compliance and Standards

  • FDA and international regulations for medical device cybersecurity
  • Compliance frameworks such as HIPAA and GDPR
  • Medical Device Security Standards (e.g., IEC 62304, ISO 27001)
  • Achieving compliance with regulatory requirements
  • Documentation and reporting for regulatory authorities
  • Case studies in regulatory compliance and non-compliance

Vulnerability Assessment and Penetration Testing

  • Conducting vulnerability assessments on medical devices
  • Penetration testing methodologies and tools
  • Identifying and exploiting vulnerabilities in a controlled environment
  • Reporting and mitigating discovered vulnerabilities
  • Ethical hacking in a healthcare context
  • Real-world case studies of penetration testing

Securing Medical Device Applications

  • Security best practices for developing and deploying medical device applications
  • Authentication and authorization mechanisms
  • Data encryption and privacy considerations
  • Secure software development lifecycle (SDLC)
  • Securing wireless communication in medical devices
  • Real-time monitoring and intrusion detection

Incident Response and Cybersecurity Management

  • Creating an incident response plan for healthcare organizations
  • Steps to take during and after a security breach
  • Legal and ethical considerations in healthcare cybersecurity incidents
  • Crisis communication strategies
  • Continual improvement and the role of cybersecurity in healthcare management
  • Preparing for future cyber threats in medical device applications

By the end of this course, participants will be equipped with the knowledge and practical skills to ensure the cybersecurity of medical device applications, ultimately contributing to the safety and privacy of patients in the healthcare sector.

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