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Cybersecurity at BD

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Message from the CISO

Cybersecurity is one of the most critical issues impacting the healthcare industry. At BD, we maintain an unwavering commitment to security by design, in use and through partnership. We strive to ensure our products, systems and customer environments maintain high security standards so our customers can focus on what matters most: caring for patients.

While we maintain robust security protocols, we also recognize that new security threats emerge daily, from attempts to compromise healthcare data to coordinated efforts to disrupt clinical workflows or manufacturing. We recognize that our customers cannot protect what they don’t know. That’s why we believe transparency and collaboration are essential. As we build a strong community of practice, working closely with our customers, industry regulators and security researchers, we’re improving cybersecurity and resilience across the industry.

Rob Suárez, Vice President and Chief Information Security Officer

Our Priorities
Our Framework

BD Cybersecurity Framework

BD utilizes a framework to incorporate cybersecurity into our processes for product design, manufacturing, customer support and enterprise systems. Our framework has been aligned to various industry work products including the Healthcare & Public Health Sector Coordinating Councils (HSCC) Medical Device and Health IT Joint Security Plan, the National Institute of Standards and Technology (NIST) Cybersecurity Framework, the International Organization for Standardization (ISO) 27001 standards, Underwriters Laboratories (UL) 2900 Standard for Software Cybersecurity for Network-Connectable Products and the International Society of Automation (ISA) 62443.

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Certifications and Attestations

Access BD cybersecurity resources

BD recognizes the value independent cybersecurity attestations provide to our customers. Each year a range of third-party audits are performed on BD products and internal cybersecurity controls. To demonstrate our commitment to protecting BD, our customers and patients, BD makes these industry-recognized certifications and attestation reports available through the BD Cybersecurity Trust Center.

ISO/IEC 27001:2022

ISO/IEC 27001:2022 is an independently audited certification which demonstrates that an organization meets rigorous international standards for managing information security, including establishing, implementing, maintaining and continually improving its Information Security Management System.

The following ISO/IEC certificates are available for download:

BD maintains a SOC2+ program for multiple BD products that collect and process patient health information in accordance with the HIPAA security rule. These annual audits address the Trust Principles for Security and, for our cloud-based products, Availability. These reports are prepared by an independent third party and provide assurance regarding the operational effectiveness of BD internal controls and the security of BD products.

UL CAP, which stands for Underwriters Laboratories Cybersecurity Assurance Program, is an independently audited certification that demonstrates the cybersecurity of medical device products through a rigorous program of analysis. UL CAP cybersecurity testing is extensive and challenges BD products against known cybersecurity vulnerabilities, malware, malformed input (fuzz testing), structured penetration, static source code analysis, static binary and bytecode analysis, and verification of security controls (access control, user authentication and authorization, remote communication, cryptography and software updates).

BD maintains Product Security White Papers for its software-enabled products. The purpose of these documents is to provide details on how BD security and privacy practices have been applied and what our customers should know about maintaining security throughout the entire product life cycle. Each white paper includes a Manufacturer Disclosure Statement for Medical Device Security (MDS2 attestation).

Download and Request Information

SOC2+ reports and Product Security White Papers are restricted to existing BD customers and can be requested below. UL CAP certificates display the scope (product and version), validity period and certifying UL Manager and can be downloaded below. Prospective customers that wish to obtain copies of SOC2+ reports or Product Security White Papers can request these from their sales representative following approval of a Confidential Disclosure Agreement (CDA). Select the documents you would like to access and use the icons at the bottom of the page to trigger the download or request.

BD Pyxis™ supply technologies
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BD Knowledge Portal for BD Pyxis™ Supply Technologies
BD Pyxis™ SupplyStation system
BD Pyxis™ medication technologies
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BD Cato™
BD Knowledge Portal for BD Pyxis™ Medication Technologies
BD Pyxis™ Anesthesia Station ES
BD Pyxis™ Anesthesia Station
BD Pyxis™ CIISafe
BD Pyxis™ Connect
BD Pyxis™ DuoStation system
BD Pyxis™ EcoStation system
BD Pyxis™ Enterprise Server
BD Pyxis™ Inventory Connect
BD Pyxis™ IV Prep
BD Pyxis™ Logistics system
BD Pyxis™ MedStation
BD Pyxis™ ParAssist
BD Pyxis™ PARx system
BD Pyxis™ PharmoPack System
BD Pyxis™ Remote Manager Temp Monitor
BD Pyxis™ Tissue and Implant System
BD Infusion Pumps
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BD Alaris™ 8015 System
BD Alaris™ CQI Reporter
BD Alaris™ Gateway Workstation
BD Alaris™ neXus CC Syringe Pump
BD Alaris™ neXus Editor
BD Alaris™ neXus GP Volumetric Pump
BD Alaris™ neXus PK Syringe Pump
BD Alaris™ Technical Utility Software
BD Alaris™ Communication Engine
BD BodyComm™ Software
BD BodyGuard™ Infusion Pump
BD BodyGuard™ Duo Pump
BD BodyGuard™ Epidural Pump
BD BodyGuard™ Pain Manager
BD BodyGuard™ T Syringe Pump
BD HealthSight™ analytics
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BD HealthSight™ Benchmarks
BD HealthSight™ Clinical Advisor
BD HealthSight™ Data Manager
BD HealthSight™ Diversion Management
BD HealthSight™ Infection Advisor
BD HealthSight™ Inventory Optimization
BD HealthSight™ Medication Safety Analytics
BD software
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BD Care Coordination Engine (CCE)
BD Remote Support Solution (RSS) / BD Remote Assist / BD Assurity Linc™
BD Regional Protected Server
Microbiology/Molecular systems
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BD BACTEC™ FX Instrument
BD BACTEC™ FX40 Instrument
BD BACTEC™ MGIT™ 320 Instrument
BD BACTEC™ MGIT™ 960 Instrument
BD MAX™
BD Phoenix™ AP
BD Phoenix™ M50
BD Veritor™ Plus
Informatics
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BD EpiCenter™
BD Synapsys™
Women's health and cancer
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BD COR™ System
BD DataLink
BD FocalPoint™ GS imaging system
BD Totalys™ Multiprocessor
BD Totalys™ SlidePrep
BD Viper™ LT System
Laboratory automation systems
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
BD Kiestra™ InoqulA
BD Kiestra™ TLA System
BD Kiestra™ WCA System
Biosciences clinical systems
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BD FACSCalibur™
BD FACSCanto™ 10-color
BD FACSCanto™ II Clinical
BD FACSCount™ System
BD FACSDuet™
BD FACSLink™
BD FACSLyric™ (IVD)
BD FACSPresto™
BD FACS™ Sample Prep Assistant (SPA) III
BD FACSVia™
BD FACS™ Lyse Wash Assistant™ (LWA)
BD FACS™ Workflow Manager
Biosciences research systems
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BD Accuri™ C6 Plus
BD FACSAria™ Fusion
BD FACSAria™ II
BD FACSAria™ III
BD FACSCanto™ 10-color
BD FACSCanto™ II
BD FACSCelesta™
BD FACSJazz™
BD FACSLyric™ (RUO)
BD FACSMelody™
BD FACSVerse™
BD FACSymphony™ A1
BD FACSymphony™ A3/A5
BD FACSymphony™ S6
BD FlowJo™ Desktop
BD Influx™
BD™ LSR II
BD LSRFortessa™ Flow Cytomenter
BD LSRFortessa™ X-20 Cell Analyzer
BD Rhapsody™ Single-Cell Analysis System
BD SeqGeq™ Desktop
Anesthesia delivery
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BD Intelliport™ Medication Management System
Vascular access technologies
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BD Site~Rite™ 8 Ultrasound Systems
BD Sherlock 3CG+™ Tip Confirmation System
Patient temperature management system
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BD Arctic Sun™ Analytics
BD Arctic Sun™ 5000 Temperature Management System
BD Arctic Sun™ 6000 Stat Temperature Management System
Diabetes care
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BD™ Diabetes Care App
Urology and Critical Care
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BD Senssica™ Urine Output System
Care continuum products
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BD Pyxis™ MedBank
BD Pyxis™ RapidRX
BD Rowa™ Dose
BD Rowa™ vMAX™
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Process Overview

Coordinated Vulnerability Disclosure

BD has established a routine practice of seeking, communicating and addressing cybersecurity issues in a timely fashion. Vulnerability disclosure is an essential component to our approach to transparency by enabling customers to manage risk properly through awareness and guidance.

Process

Report Report
Report
Analyze Analyze
Analyze
Coordinate Coordinate
Coordinate
Disclose Disclose
Disclose

BD welcomes vulnerability reports from security researchers, customers, third-party component vendors and other external groups that wish to report a vulnerability in a BD software-enabled device.  

BD partners with the issue reporter to investigate and confirm the vulnerability. If confirmed, we follow an Incident Response and Vulnerability Management Plan, which is a strategy BD established to effectively respond to reported cybersecurity issues. Once validated, our incident response team collaborates with various functional teams including Product Security, Research and Development, Quality and Privacy to determine objectives, scope, severity, analysis and the appropriate actions needed to accurately respond to the issue.

BD follows the U.S. Food and Drug Administration's Postmarket Management of Cybersecurity in Medical Devices guidance to properly communicate confirmed vulnerabilities in BD products in coordination with a Computer Emergency Readiness Team (CERT). We work with the Cybersecurity and Infrastructure Security Agency (CISA) to prepare coordinated vulnerability disclosures for our respective websites, and we also voluntarily report the vulnerability to the FDA.

Bulletins are published on the BD Cybersecurity Trust Center and the CISA website in coordinated fashion. For maximum awareness, we also share BD vulnerability disclosures with Information Sharing Analysis Organizations (ISAO) where BD participates, including the Health Information Sharing and Analysis Center (H-ISAC).

Report a potential product-related security issue, such as an incident, breach or vulnerability

Report a Cybersecurity Issue
Transparency and close coordination with our customers and industry stakeholders is a key element of the BD Cybersecurity program. Please complete the cybersecurity issue report form to report a potential product-related privacy or security issue (incident, data breach or vulnerability).

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