Length: 2 Days
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FDA Cybersecurity Premarket Workshop

Due to mounting security concerns in healthcare in the 5G era, the U.S. Food and Drug Administration (FDA) has changed the way it views cybersecurity in regards to premarket submissions for medical devices.

In October 2014, the FDA released the first version of its Premarket Cybersecurity Guidance. This early version conveyed the FDA’s heightened interest in ensuring secure medical devices do no patient harm, but was unclear about exactly what steps needed to be taken in order to meet the FDA’s expectations.

But now that FDA guidance for better securing medical devices is quite clear to assist industry by identifying issues related to cybersecurity that manufacturers should address in the design and development of their medical devices as well as in preparing premarket submissions for those devices.

Current FDA cybersecurity premarket guidelines for medical devices address a wide range of digital security topics including:

  • Preventing unauthorized use
  • Designing trustworthy devices
  • Maintaining confidentiality of data
  • Attack detection capabilities
  • Software configuration management
  • Incident management

The need for effective cybersecurity to ensure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network- connected 84devices, portable media (e.g., USB or CD), and the frequent electronic exchange of medical device-related health information.

Additionally, cybersecurity threats to the healthcare sector have become more frequent, more severe and more clinically impactful. Recent cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the U.S. and globally.

Such cyber-attacks and exploits can delay diagnoses and/or treatment and may lead to patient harm.

The FDA cybersecurity premarket guidelines for medical devices can facilitate an efficient premarket review process and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats.

The United States is the No. 1 medical device market in the world, accounting for more than 40% of all healthcare spending worldwide. The U.S. has 310 million people and the highest per-capita spending on healthcare worldwide.

FDA Cybersecurity Premarket Workshop Course by Tonex

FDA Cybersecurity Premarket Workshop is a 2-day training workshop. It will introduce participants to Premarket Submissions for Management of Cybersecurity in Medical Devices.

Participants will learn about the need for effective cybersecurity and how to ensure medical device functionality and safety along with wireless, Internet- and network- connected devices, portable media (e.g. USB or CD), and the frequent electronic exchange of medical device-related health information.

Trustworthy devices: (1) are reasonably secure from cybersecurity intrusion and misuse; (2) provide a reasonable level of availability, reliability, and correct operation; (3) are reasonably suited to performing their intended functions; and (4) adhere to generally accepted security procedures.

In addition, documentation demonstrating the trustworthiness of a device will help FDA more quickly and efficiently assess the device’s safety and effectiveness with respect to cybersecurity

WHO SHOULD ATTEND

This course is designed for engineers, technicians, analysts, managers and anyone else working with medical industry.

WHAT YOU WILL LEARN

  • General Principles of Cybersecurity and  Risk Assessment
  • Designing a Trustworthy Device
  • Application of NIST Cybersecurity Framework
  • Analyzing Devices with Cybersecurity Risks.
  • Premarket submissions for devices that contain software (including firmware) or programmable logic
  • Premarket Notification (510(k)) submissions
  • De Novo requests
  • Premarket Approval Applications (PMAs)
  • Product Development Protocols (PDPs)
  • Humanitarian Device Exemption (HDE) applications.

COURSE CONTENT

Cybersecurity 101

  • Authentication and Authenticity
  • Authorization
  • Availability
  • Confidentiality
  • Cryptographic transformation of data
  • Encryption
  • Integrity
  • Denial of Service
  • Malware

FDA Recommendation to Address Cybersecurity

  • Cybersecurity risks
  • Trustworthy devices
  • Considerations for manufacturers
  • Vulnerability analysis
  • Risk analysis Address cybersecurity during the design and development of medical devices
  • identification of assets, threats, and vulnerabilities
  • Assessment of the impact of threats and vulnerabilities on device functionality and end users/patients
  • Assessment of the likelihood of a threat a
  • Determination of risk levels and suitable mitigation strategies
  • Assessment of residual risk and risk acceptance criteria
  • Software devices, documentation related to design controls, and specifically design validation and software validation and risk analysis in 21 CFR 820.30(g)
  • Cybersecurity and Cybersecurity Bill of Materials (CBOM)

NIST Cybersecurity Framework

  • Framework for improving critical infrastructure cybersecurity
  • Risk Management and the Cybersecurity Framework
  • Components of the Framework
  • Uses and Benefits of the Framework
  • The Five Functions
  • Introduction to the Framework Roadmap
  • Framework Core
  • Implementation Tiers
  • Profiles

The Five Framework Core Functions

  • Identify
  • Protect
  • Detect
  • Respond
  • Recover

Workshop: Designing a Trustworthy Device: Application of NIST Cybersecurity Framework

  • Develop an organizational understanding to manage cybersecurity risk to systems, people, assets, data, and capabilities.
  • Protect – Develop and implement appropriate safeguards to ensure delivery of critical services.
  • Detect – Develop and implement appropriate activities to identify the occurrence of a
  • cybersecurity event.
  • Respond – Develop and implement appropriate activities to act regarding a detected cybersecurity incident.
  • Recover – Develop and implement appropriate activities to maintain plans for resilience and to restore any capabilities or services that were impaired due to a cybersecurity incident.

 

 

FDA Cybersecurity Premarket Workshop

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