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524B

Section 524B refers to the section added to the FD&C Act outlining the FDA’s regulatory requirements around cyber devices.

A

Access Control

The process of limiting access to system resources only to authorized users, programs, processes, or devices.

ANSI/ISA 62443-4-1

An industrial cybersecurity standard recommended by the FDA as an example to consider when designing a vulnerability testing plan for medical devices.

Attack

An intentional attempt by a threat actor to exploit vulnerabilities in a medical device or its associated systems to gain unauthorized access, cause disruption, or compromise the integrity, confidentiality, or availability of the device’s data or functions. Attacks can range from malware insertion and data breaches to denial-of-service (DoS) assaults, potentially jeopardizing patient safety and privacy.

Attack Surface

The total sum of all potential entry points (vulnerabilities, interfaces, and access points) that an attacker can exploit to gain unauthorized access to a medical device or its associated systems. The attack surface includes all the ways in which a device can be accessed, including network connections, software applications, hardware components, and even human interactions.

Authentication

A process that verifies the identity of a user, device, or other entity in a computer system.

Authorization

The process of granting or denying access to system resources once the entity has been authenticated.

B

Bluetooth

A short-range wireless communication technology that enables the exchange of data between devices over short distances, typically within 10 meters (33 feet). In the context of medical devices, Bluetooth is often used to connect devices like glucose monitors, heart rate monitors, or wearable health trackers to smartphones, computers, or other devices for data collection, monitoring, and analysis. While convenient, Bluetooth connections must be secured to prevent unauthorized access or data breaches.

C

Compliance

Adherence to established regulations, standards, and guidelines set by regulatory bodies, such as the FDA, to ensure that medical devices meet the necessary safety, quality, and performance requirements. In the context of cybersecurity, compliance also involves following specific protocols and best practices to protect sensitive data and maintain the integrity and security of medical devices throughout their lifecycle. Compliance is essential for legal operation, market approval, and maintaining trust with users and stakeholders.

Cyber Device

The US FDA defines a cyber device as any device that (1) includes software as a device or in a device, (2) has the ability to connect to the internet, and (3) contains any such technological characteristics that could be vulnerable to cybersecurity threats.

Cybersecurity Risk Management

The process of identifying, assessing, and mitigating risks to ensure the cybersecurity of a medical device.

D

DoS (Denial of Service)

A type of cyberattack in which an attacker overwhelms a device, system, or network with excessive traffic or requests, rendering it unable to function properly or respond to legitimate users. A DoS attack can disrupt critical functions, potentially endangering patient safety by preventing the device from operating or communicating as intended.

E

EHR (Electronic Health Record)

A digital record of a patient’s comprehensive health information that is designed to be shared across different healthcare settings. EHRs integrate data from various sources, including primary care providers, specialists, laboratories, and other healthcare organizations, providing a holistic view of a patient’s health history. They facilitate better coordination of care and improve the accessibility of patient information.

EMR (Electronic Medical Record)

A digital version of a patient’s chart used primarily within a single healthcare practice or organization. EMRs contain clinical data specific to the provider’s practice, such as diagnoses, treatment plans, and medication records. While EMRs streamline internal processes and improve record-keeping within a practice, they are generally not designed for sharing outside of that specific organization.

Encryption

The process of converting data into a code to prevent unauthorized access.

End Of Life (EOL)

The stage in a product’s lifecycle when it is no longer supported or maintained by its manufacturer. For medical devices, EOL indicates that the device will no longer receive updates, patches, or technical support, and it may eventually become obsolete or unsafe to use. Proper management of EOL devices is crucial to ensure continued patient safety and compliance with regulatory requirements.

End Of Support (EOS)

The point at which a manufacturer or service provider ceases to offer technical support, updates, or maintenance for a product or service. For medical devices, EOS signifies that the device will no longer receive security patches, software updates, or technical assistance, potentially exposing it to vulnerabilities and compliance risks. It is essential for healthcare organizations to plan for the transition to new technologies or solutions before EOS to ensure continued functionality and security.

End Of Support (EOS)

The extent to which a vulnerability or weakness in a system can be exploited by an attacker to gain unauthorized access or cause harm. In the context of medical devices, exploitability refers to the ease or difficulty with which a security flaw can be used to compromise the device’s functionality, data integrity, or patient safety. Assessing exploitability helps in prioritizing security measures and responses to address the most critical risks.

F

FDA (Food and Drug Administration)

The U.S. federal agency responsible for regulating medical devices, including ensuring their cybersecurity.

Firmware

A specialized type of software embedded into hardware devices that provides low-level control and functionality for the device’s operations. Firmware is stored in non-volatile memory, such as ROM or flash memory, and is crucial for the device’s basic functions and interactions with other hardware and software. In medical devices, firmware controls essential operations, updates, and configurations, and maintaining its security and integrity is vital to prevent potential vulnerabilities and ensure reliable performance.

FSL (Facility Security Level)

A specialized type of software embedded into hardware devices that provides low-level control and functionality for the device’s operations. Firmware is stored in non-volatile memory, such as ROM or flash memory, and is crucial for the device’s basic functions and interactions with other hardware and software. In medical devices, firmware controls essential operations, updates, and configurations, and maintaining its security and integrity is vital to prevent potential vulnerabilities and ensure reliable performance.

Fuzzing

A software testing technique used to discover vulnerabilities and bugs by inputting a large volume of random, malformed, or unexpected data into a program or system. The goal of fuzzing is to identify weaknesses or security flaws that could be exploited by attackers. In the context of medical devices, fuzzing helps ensure that the device’s software can handle unexpected inputs gracefully and securely, minimizing the risk of crashes, data corruption, or other security issues.

H

Hardware

The physical components and devices that make up a computer system or electronic device. In the context of medical devices, hardware includes elements such as processors, memory, sensors, connectors, and any other physical parts that enable the device to perform its intended functions.

HIPAA (Health Insurance Portability and Accountability Act)

U.S. legislation that provides data privacy and security provisions for safeguarding medical information.

I

ISO 27001

An international standard for information security management systems (ISMS). ISO 27001 provides a systematic approach to managing sensitive company information, ensuring its confidentiality, integrity, and availability through a framework of policies, procedures, and controls. ISO 27001 helps organizations establish, implement, maintain, and continually improve their information security practices, ensuring compliance with regulatory requirements and protecting patient data from security threats.

ISO 271002

An international standard that provides guidelines for information security management in the context of medical devices. It is designed to assist organizations in identifying and managing risks associated with the security of medical device data and ensuring compliance with relevant regulatory requirements. ISO 271002 complements other standards like ISO 27001 by focusing specifically on the unique challenges and requirements of securing medical devices and their associated data.

IoT (Internet of Things)

A network of physical devices, vehicles, appliances, and other objects embedded with sensors, software, and connectivity, enabling them to collect, exchange, and act on data over the internet. In the context of medical devices, IoT refers to the integration of these devices into healthcare systems to monitor, diagnose, and treat patients more effectively.

L

Legacy Device

A medical device that is outdated or no longer supported by its manufacturer, but is still in use. Legacy devices may not receive updates or maintenance, making them potentially more vulnerable to security threats and less compatible with newer technologies. Managing legacy devices often involves addressing security and compliance challenges to ensure they continue to function safely and effectively within a modern healthcare environment.

M

Malware

Short for “malicious software,” malware refers to any software intentionally designed to cause harm, exploit vulnerabilities, or gain unauthorized access to systems. In the context of medical devices, malware can include viruses, worms, trojans, ransomware, and other malicious code that can compromise the device’s functionality, corrupt data, or disrupt its operation.

MDM

Short for “malicious software,” malware refers to any software intentionally designed to cause harm, exploit vulnerabilities, or gain unauthorized access to systems. In the context of medical devices, malware can include viruses, worms, trojans, ransomware, and other malicious code that can compromise the device’s functionality, corrupt data, or disrupt its operation.

R

Risk Assessment

The process of identifying and evaluating risks to an organization’s information assets and determining the potential impact.

S

SaMD

“The term Software as a Medical Device (SaMD) is defined as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

SBOM

“Software Bill of Materials”, a list of all the software components and dependencies within a device, helping to manage and mitigate security vulnerabilities One of the documents required in FDA regulatory applications for cyber devices.

T

Threat Modeling

The process of systematically identifying and addressing potential security threats in a system.

V

Vulnerability

A weakness in a system or device that can be exploited to cause harm or unauthorized access.