FDA Cybersecurity Premarket Workshop, Premarket Submissions for Management of Cybersecurity in Medical Devices

FDA Cybersecurity Premarket Workshop, Premarket Submissions for Management of Cybersecurity in Medical Devices

Medical equipment is increasingly connected to the Internet, hospital networks and other medical equipment to provide functions that can improve healthcare and enhance the ability of healthcare providers to treat patients.

These same functions also increase the risk of potential cyber security threats. Like other computer systems, medical equipment may be vulnerable to security breaches, which may affect the safety and effectiveness of the equipment.

Threats and vulnerabilities can't be eliminated; therefore, reducing cybersecurity risks is particularly challenging.

The heath care environment is complex, and makers, hospitals, and facilities must work together to manage cybersecurity risks.

The FDA has issued pre-market and post-market guidelines. These guidelines provide recommendations for the comprehensive management of medical device cybersecurity risks, continuous improvement throughout the product lifecycle, and incentives for ever-changing listings and distributed medical devices to reduce risks.

Even with these guidance, the FDA is still addressing myths about the cybersecurity of medical devices

The FDA encourages medical device manufacturers to deal with cybersecurity risks to stay patients safe and better protect the general public health. This includes monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices once they're on the market.

Working collaboratively with industry and other federal agencies, the FDA continues its efforts to make sure the security and effectiveness of medical devices, in the least stages in their lifecycle, within the face of potential cyber threats.

However, now the FDA’s guidance on better protecting the safety of medical devices is very clear. It can help the industry by identifying issues related to cybersecurity.

Manufacturers should design and develop medical devices and prepare pre-market applications for these devices. solve these problems.

FDA’s current cybersecurity pre-sales guidelines for medical devices cover 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

With the increasing use of wireless, Internet and network-connected 84 kinds of devices, portable media (such as USB or CD), and frequent electronic exchanges of medical devices, the need for effective cybersecurity to ensure the function and safety of medical devices has become more and more important. Related health information.

Cybersecurity threats to the healthcare industry have become more frequent, more serious, and more clinically influential.

Many cybersecurity incidents have occurred, causing medical equipment and hospital networks to fail to operate, thereby disrupting patient care services between medical facilities in the United States and the world. Such cyber attacks and exploits can delay diagnosis and/or treatment and may cause harm to patients.

The FDA's cybersecurity pre-sales guidelines for medical devices can facilitate an effective pre-sales review process and help ensure that medical devices on the market are sufficiently resilient to cyber security threats.

The Trusted Medical Devices Are:

• Reasonably prevent cybersecurity intrusion and abuse
• Provide a reasonable level of availability, reliability and correct operation
• Reasonably fit to perform its intended function
• Follow recognized safety procedures.

In addition, documentation that proves the trustworthiness of the device will help the FDA to evaluate the safety and effectiveness of the device in terms of cybersecurity more quickly and effectively. 

Tonex Provides FDA Cybersecurity Premarket Workshop Training

It will introduce participants to pre-market submissions for medical device cybersecurity management.

Participants will understand the need for effective cybersecurity, and how to ensure the functionality and safety of medical devices, devices connected to wireless, Internet and network, portable media (such as USB or CD), and frequent electronics related to health conditions related to medical devices exchange information.

Who Should Attend?
This course is designed for:

• Engineers
• Technicians
• Analysts
• Managers
• Anyone else working with medical industry.

What You Will Learn?

• General principles of cybersecurity and risk assessment
• Design reliable equipment
• Application of NIST Cyber ​​Security Framework
• Analyze devices with cybersecurity risks.
• Pre-market submission of devices containing software or programmable logic
• Pre-listing notice (510(k)) submission
• De Novo requests
• Premarket Approval Applications (PMAs)
• Product Development Protocols (PDPs)
• Humanitarian Device Exemption (HDE) applications.

Course Outline:

• Cybersecurity 101
• FDA Recommendation to Address Cybersecurity
• NIST Cybersecurity Framework
• The Five Framework Core Functions

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

Learn More:

FDA Cybersecurity Premarket Workshop Training