HIPAA and Medical Device Cybersecurity Compliance Fundamentals Training by Tonex
This comprehensive training equips professionals with the critical knowledge needed to navigate the intersection of HIPAA regulations and cybersecurity in the context of medical devices. The course provides a detailed understanding of how to ensure compliance while addressing threats in embedded medical systems. Participants will explore secure development practices, AI/ML model protection in devices, and embedded hardware design security. The rising number of cyberattacks targeting healthcare infrastructure makes it vital to secure implantable and wearable medical technologies. This training enhances preparedness, enabling professionals to safeguard patient data and uphold integrity in connected medical ecosystems.
Audience:
- Cybersecurity Professionals
- Medical Device Engineers
- Healthcare IT Security Teams
- Compliance Officers
- Embedded Systems Developers
- Regulatory Affairs Specialists
Learning Objectives:
- Understand HIPAA mandates related to device security
- Identify unique risks in wearable and implantable devices
- Learn secure coding in VHDL and Verilog for embedded systems
- Apply AI/ML model protection strategies in healthcare devices
- Assess vulnerabilities in medical device ecosystems
- Align device security with industry compliance standards
Course Modules:
Module 1: HIPAA Compliance Essentials
- Overview of HIPAA Security and Privacy Rules
- Protected Health Information (PHI) safeguards
- Risk assessments and documentation
- Role of covered entities and business associates
- Security incident response procedures
- Regulatory enforcement and penalties
Module 2: Medical Device Cybersecurity Overview
- Device classification and FDA cybersecurity guidance
- Threat landscape in connected medical devices
- Importance of software bill of materials (SBOM)
- Lifecycle security for medical firmware and software
- Risk mitigation in device design
- Postmarket cybersecurity management
Module 3: Secure Wearable Device Architecture
- Security design for wearable sensors and processors
- Communication protocols and encryption standards
- Privacy issues in data transmission
- Authentication mechanisms in wearables
- Power and performance trade-offs in secure designs
- Integration with patient monitoring platforms
Module 4: Implantable Device Protection
- Unique cybersecurity concerns in implantables
- Firmware updates and over-the-air (OTA) risks
- Ensuring availability and reliability of critical functions
- Securing remote access and diagnostics
- Incident detection and device alerts
- Ethical and legal considerations in implantable safety
Module 5: AI/ML Model Security in Devices
- Introduction to AI in medical diagnostics
- Threats to AI inference and training pipelines
- Model extraction and adversarial attack mitigation
- Privacy-preserving machine learning approaches
- Secure deployment of edge AI models
- Aligning AI features with HIPAA compliance
Module 6: VHDL/Verilog Secure Coding
- Secure design principles in hardware description
- Identifying and avoiding insecure coding patterns
- Timing and side-channel attack prevention
- Integration of test benches for secure validation
- Documentation and traceability in HDL development
- Code review and compliance audit readiness
Take the next step in securing healthcare innovation. Enroll in the HIPAA and Medical Device Cybersecurity Compliance Fundamentals Training by Tonex to gain critical insights, elevate your technical capabilities, and drive compliance in a rapidly evolving threat landscape.