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Cybersecurity at BD

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Overview

Welcome to the BD Cybersecurity Trust Center

In healthcare, cybersecurity includes more than protecting systems and data. It also includes protecting patient safety and privacy. Upholding strong cybersecurity measures and continuing to advance cybersecurity is part of our commitment to customer trust. BD works diligently to help protect the confidentiality, integrity and availability of BD products, manufacturing systems and enterprise IT. We strive to meet high security standards so our customers can focus on what matters most: caring for patients. 

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).
Sustainability Report

FY 2024 Corporate Sustanability Report

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 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. Use the form below to request SOC2+ documents.

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). The following UL CAP certificates are available for download:

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). Use the form below to request Product Security White Papers. 

Request Additional Information

With the exception of UL CAP certificates, the following resources are restricted to existing BD customers and can be requested using the form 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. For additional assistance, please contact BD Customer Support.

Dispensing
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
SOC2+ report for BD Pyxis™ Supply Technologies, BD Pyxis™ Medication Technologies, BD Pyxis™ Remote Support System (RSS) and Coordinated Care Engine (CCE)
BD Knowledge Portal for BD Pyxis™ Supply Technologies
BD Pyxis™ SupplyStation system
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
Infusion
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
SOC2+ report for the BD Alaris™ System and BD Alaris™ Remote Support System (RSS) and Care Coordination Engine (CCE)
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
Analytics
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
SOC2+ report for BD HealthSight™, BD Knowledge Portal™ and BD Arctic Sun™ Analytics
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
Software
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
BD Care Coordination Engine (CCE)
BD Remote Support Solution (RSS) / BD Remote Assist / BD Assurity Linc™
BD Regional Protected Server
Microbiology/Molecular systems
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
SOC2+ report for BD BACTEC™, BD Phoenix™, BD Viper™, BD MAX™, BD Kiestra™, BD Focal Point™ Slide Profiler, BD Totalys™, BD COR™ and Informatics Remote Support System (RSS) and Care Coordination Engine (CCE)
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
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
SOC2+ report for BD Synapsys™, BD EpiCenter™ and Informatics Remote Support System (RSS)
BD EpiCenter™
BD Synapsys™
Women's health and cancer
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
SOC2+ report for BD BACTEC™, BD Phoenix™, BD Viper™, BD MAX™, BD Kiestra™, BD Focal Point™ Slide Profiler, BD Totalys™, BD COR™ and Informatics Remote Support System (RSS) and Care Coordination Engine (CCE)
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
SOC2+ report for BD BACTEC™, BD Phoenix™, BD Viper™, BD MAX™, BD Kiestra™, BD Focal Point™ Slide Profiler, BD Totalys™, BD COR™ and Informatics Remote Support System (RSS) and Care Coordination Engine (CCE)
BD Kiestra™ InoqulA
BD Kiestra™ TLA System
BD Kiestra™ WCA System
Biosciences clinical systems
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
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
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
BD Accuri™ C6 Plus
BD FACSAria™ Fusion
BD FACSAria™ II
BD FACSAria™ III
BD FACSCanto™ 10-color
BD FACSCanto™ II
BD FACSCelesta™
BD FACSDiscover™ S8
BD FACSJazz™
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
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
BD Intelliport™ Medication Management System
Peripheral Intervention
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
Vascular access technologies
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
BD Site~Rite™ 8 Ultrasound Systems
BD Sherlock 3CG+™ Tip Confirmation System
Patient temperature management system
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
BD Arctic Sun™ Analytics
BD Arctic Sun™ 5000 Temperature Management System
BD Arctic Sun™ 6000 Stat Temperature Management System
Urology and Critical Care
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
BD Senssica™ Urine Output System
Care continuum products
Product Request SOC2 report Download UL CAP certificate Request BD product security white paper
SOC2+ report for the BD Pyxis™ RapidRx platform
BD Pyxis™ MedBank
BD Pyxis™ RapidRX
BD Rowa™ Dose
BD Rowa™ vMAX™
Request Documents
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
Communicate Communicate
Communicate
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 the vulnerability. If confirmed, our incident response team collaborates with various functional teams including Research and Development (which includes Product Security), as well as Quality and Privacy to respond to the issue.

BD follows FDA guidance to properly communicate confirmed BD product vulnerabilities in coordination with a Computer Emergency Readiness Team (CERT). We work with the Cybersecurity & Infrastructure Security Agency (CISA) to prepare coordinated vulnerability disclosures for our respective websites, and we also voluntarily report vulnerabilities unique to BD products to the FDA.

Bulletins are published on the BD Cybersecurity Trust Center and the CISA website in a coordinated fashion. For maximum awareness, we also share BD vulnerability disclosures with Information Sharing and Analysis Organizations (ISAOs) where BD participates, including the Health Information Sharing and Analysis Center (H-ISAC). H-ISAC sends hundreds of targeted alerts to its members each year from their Threat Operations Center. This practice helps healthcare delivery organizations of all sizes stay current with vulnerability disclosures across the industry.

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).

CONTACTS

Requirements

BD Cybersecurity Requirements for Suppliers

General Security: The Supplier (hereafter, "Provider") shall utilize at least industry standard security efforts to prevent loss, destruction or leakage of BD Data, which may include, but are not limited to ISO/IEC 27001, 27002, 27017 and 27018 certifications, SOC 2 Type II standards, NIST CFS, CIS benchmarks and/or OWASP Top 10. The use of these standards is situational and shall depend on the type of BD Data the Provider utilizes and the nature and purpose of the processing.

Notwithstanding the above, Provider shall maintain the minimum security standards when processing BD Data, at all times, without limitation:

Testing

  • Provider shall perform, on an annual basis, vulnerability/penetration testing in line with industry recognized standards, at Provider’s sole cost and expense.
  • When requested, Provider shall provide reasonably detailed results of the testing relating solely to BD clients and BD Data.

 

Prevention of Loss or Damage

  • Provider shall use any and all commercially reasonable efforts to prevent the unintended or malicious loss, destruction, or alteration of BD Data.

 

Detection

  • Provider shall continuously monitor its system(s) for security breaches and suspicious activity.
  • Provider shall review and maintain its internal procedures to reflect best practices to ensure any potential security threats and/or security breaches are minimized.
  • Provider shall monitor and report to BD any reasonable threat to the processing, storage, or integrity of BD Data or the timely delivery of contracted goods. This shall include, but not be limited to the actual, attempted, or threat of, unauthorized access, possession, use, transmission, or knowledge of BD Data.

 

Response

  • Provider shall notify BD promptly (but no later than 24 hours thereafter) of any actual or suspected security breaches including, without limitation, service attacks (e.g., denial of service attacks) that cause material performance or manufacturing issues, or unauthorized access to BD data, information or products.
  • Provider shall take all steps necessary to promptly contain and remediate the Security Breach including, without limitation:
    • Provider shall determine if BD Data was involved during the security breach or if shipment of goods per contractual terms will be impacted.
    • Provider shall ensure the breach response is conducted by a reputable third party.
    • Provider shall update BD daily, or as otherwise agreed between the parties, during any investigation or remediation of a cybersecurity incident that may have affected BD’s use of the Service, delivery of goods, and/or BD Data.
    • Upon request, the Provider will share with BD the scope, methodology, and reasonably detailed results relating to BD Data.

 

Third party

  • Provider shall ensure its third-party service providers with access to BD Data have processes and procedures in place to protect such BD Data, and those processes and procedures shall be no less stringent than those herein.
  • Provider retains responsibility and liability for any Services performed by third-party service providers as though Provider performed them itself.

 

Servers

  • BD Data shall be stored and processed on secure servers only, with access restrictions in line with current industry practices.

 

Written Information Security Protocol

  • Provider shall have a written information security Protocol (“WISP”). The Provider’s WISP shall include, but shall not be limited to, the following:
    1. Name of Provider’s information security liaison, who shall be available to BD to discuss any Provider policies, standards, and practices.
    2. Methods for how Provider identifies and assesses reasonably foreseeable internal and external risks to the security, confidentiality, and/or integrity of its systems.
    3. Methods for evaluating and improving the effectiveness of current safeguards, including without limitation, (i) ongoing Provider training of its personnel, and (ii) means for detecting and preventing security system failures.
    4. Security policies that prevent Provider from storing, accessing, or transporting records containing BD Data outside of business premises.
    5. A review of the scope of the WISP at least annually or whenever there is a material change in business practices that may reasonably implicate the security or integrity of records containing BD Data.

 

Passwords

  • For Software/Software Services, unless otherwise agreed by BD in writing: all BD logins shall be single sign-on logins, with no transmission of any Personally Identifiable Information.

 

Access Control

  • BD Data access shall be restricted to Provider personnel having a need to process BD Data to perform the Services.
  • Provider shall maintain a password protected system that requires a unique identifier, password and multi-factor authentication for each of Provider’s personnel who need access.

 

Encryption

  • Provider, to the extent technically feasible, shall encrypt all BD Data while in transit and while being stored or processed. Provider shall alert BD to any technical issues that would prevent this.
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