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true
CYBERSECURITY AT BD
Bulletins and Patches
1. About Us
2. Trust Center
3. Bulletins and Patches
4. Disclosure Process
5. Helpful Resources
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 an issue
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).
Annual Report
Download PDF
2023 PRODUCT SECURITY ANNUAL REPORT
Our Priorities
Security by design
BD products and systems are designed to be secure and are developed using
industry-leading cybersecurity standards, including those from ISO and NIST.
Security in use
BD products and systems are secured and maintained throughout their intended
life cycle, across all technologies and sites.
Security through partnership
BD maintains a culture of transparency and collaboration with customers,
industry stakeholders and suppliers to establish and uphold industry best
practices.
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.
×
Cybersecurity Maturity
* 1
* 2
* 3
* 4
* 5
* 6
* 7
* 8
--------------------------------------------------------------------------------
2017
BD established a Product Security Partnership program.
--------------------------------------------------------------------------------
2016
The FDA published Postmarket Management of Cybersecurity in Medical Devices.
--------------------------------------------------------------------------------
2014
The FDA published Content of Premarket Submissions for Management of
Cybersecurity in Medical Devices.
--------------------------------------------------------------------------------
2022
BD enterprise-level Information Security Management System achieved ISO/IEC
27001:2022 certification.
--------------------------------------------------------------------------------
2021
BD became the first medical technology company authorized as a Common
Vulnerability and Exposures (CVE®) Numbering Authority.
--------------------------------------------------------------------------------
2020
The IMDRF published Principles and Practices for Medical Device Cybersecurity.
BD received UL CAP certification for BD Synapsys™ Microbiology Informatics.
--------------------------------------------------------------------------------
2019
The HSCC published the Medical Device and Health IT Joint Security Plan (JSP).
--------------------------------------------------------------------------------
2018
BD made product security templates available via the BD Cybersecurity Trust
Center.
BD received UL CAP certification for the BD FACSLyric™ flow cytometer.
--------------------------------------------------------------------------------
2017
BD established a Product Security Partnership program.
--------------------------------------------------------------------------------
2016
The FDA published Postmarket Management of Cybersecurity in Medical Devices.
--------------------------------------------------------------------------------
2014
The FDA published Content of Premarket Submissions for Management of
Cybersecurity in Medical Devices.
--------------------------------------------------------------------------------
2022
BD enterprise-level Information Security Management System achieved ISO/IEC
27001:2022 certification.
--------------------------------------------------------------------------------
2021
BD became the first medical technology company authorized as a Common
Vulnerability and Exposures (CVE®) Numbering Authority.
--------------------------------------------------------------------------------
2020
The IMDRF published Principles and Practices for Medical Device Cybersecurity.
BD received UL CAP certification for BD Synapsys™ Microbiology Informatics.
Partners and Initiatives
* 1
* 2
* 3
IMDRF
BD participates in the International Medical Device Regulators Forum with the
shared goal of harmonizing medical device cybersecurity around the world.
MDIC
The Medical Device Innovation Consortium works with government and industry
stakeholders to advance solutions that promote patient access to innovative
medical technologies.
MEDTECH EUROPE
BD participates in the MedTech Europe Cybersecurity Working Group, which brings
cybersecurity experts together to engage with European institutions, including
the European Union Agency for Cybersecurity (ENISA).
U.S. FBI INFRAGARD
BD participates in the U.S. FBI InfraGard, a partnership between the FBI and the
private sector for the purpose of protecting U.S. Critical Infrastructure.
ADVAMED
The Advanced Medical Technology Association advocates globally for the highest
ethical standards and patient access to safe, effective and innovative medical
technologies.
AISP
The Association of Information Security Professionals, based in Singapore, is
committed to promoting the development, increase and spread of cybersecurity
knowledge.
CCAPAC
The Cybersecurity Coalition for Asia Pacific is dedicated to improving the
policy landscape for cybersecurity in Asia.
CVE® PROGRAM
BD is authorized as a Common Vulnerability and Exposures (CVE) Numbering
Authority by the CVE Program.
DSAC
The Domestic Security Alliance Council is a strategic alliance that includes the
U.S. Federal Bureau of Investigation (FBI), Department of Homeland Security and
private industry networking together.
H-ISAC
For maximum reach, BD shares coordinated vulnerability disclosures with the
Health Information Sharing and Analysis Center.
HSCC
BD participates in multiple Healthcare and Public Health Sector Coordinating
Council (HSCC) Cybersecurity Working Group Task Groups.
IMDRF
BD participates in the International Medical Device Regulators Forum with the
shared goal of harmonizing medical device cybersecurity around the world.
MDIC
The Medical Device Innovation Consortium works with government and industry
stakeholders to advance solutions that promote patient access to innovative
medical technologies.
MEDTECH EUROPE
BD participates in the MedTech Europe Cybersecurity Working Group, which brings
cybersecurity experts together to engage with European institutions, including
the European Union Agency for Cybersecurity (ENISA).
U.S. FBI INFRAGARD
BD participates in the U.S. FBI InfraGard, a partnership between the FBI and the
private sector for the purpose of protecting U.S. Critical Infrastructure.
ADVAMED
The Advanced Medical Technology Association advocates globally for the highest
ethical standards and patient access to safe, effective and innovative medical
technologies.
AISP
The Association of Information Security Professionals, based in Singapore, is
committed to promoting the development, increase and spread of cybersecurity
knowledge.
CCAPAC
The Cybersecurity Coalition for Asia Pacific is dedicated to improving the
policy landscape for cybersecurity in Asia.
CVE® PROGRAM
BD is authorized as a Common Vulnerability and Exposures (CVE) Numbering
Authority by the CVE Program.
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 Enterprise and BD Australia ISO/IEC 27001:2022 certificate
* BD Germany ISO/IEC 27001:2022 certificate [ENG] / [GER]
* BD Israel ISO/IEC 27001:2022 certificate: [ENG] / [HEB]
SOC2+
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
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 Synapsys™
* BD FACSLyric™ with FACSuite™
BD Product Security White Papers
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
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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 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
Product Request SOC2 report Download UL CAP certificate Request BD product
security white paper BD Intelliport™ Medication Management 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™
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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
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Report
Analyze
Communicate
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 an issue
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
Media inquiries
Contact us with cybersecurity media inquiries.
Contact us
Other inquiries
Contact us for other inquiries, including sales and customer support.
Contact us
Annual Report
BD 2023 Product Security Annual Report
Learn how BD strives to improve the security of our products.
Download
BD 2022 Cybersecurity Annual Report
Learn how BD is advancing cybersecurity in healthcare.
Download
BD 2021 Cybersecurity Annual Report
Download this report to learn more about our approach to cybersecurity.
Download
News and Media
Read All
* JUNE 13, 2024
BD Issues 2023 Product Security Annual Report
The report highlights healthcare cybersecurity trends, the company’s
methodology for securing BD products and its impact on advancing best
practices for medical device cybersecurity.
* OCTOBER 29, 2023
Cybersecurity Awareness Month: Building on our strong cybersecurity culture
As disciplines, cybersecurity and information technology (IT) are built on
the same pillars: people, process and technology. Like a three-legged-stool,
all three must be present and supported in equal measure for the foundation
to be solid.
* AUGUST 9, 2023
Vulnerability disclosures help protect patients and build trust
Communicating about potential cybersecurity vulnerabilities helps protect
patients and builds trust. Learn how BD has led the way with coordinated
vulnerability disclosures.
* February 13, 2023
Medical-Device Makers Face Push to Protect Their Wares From Hacks
MedTech companies must be proactive about protecting medical devices from
cybersecurity threats.
* January 25, 2023
BD Publishes 2022 Cybersecurity Annual Report
The third annual BD cybersecurity report highlights the company’s ongoing
efforts to advance cybersecurity maturity, protect against cyberattacks and
empower customers with information about cyber risks and vulnerabilities.
* January 25, 2023
Cybersecurity ‘more critical than ever’ in era of connected care: BD
Find out how BD strives to protect against sophisticated cybersecurity
threats.
* January 25, 2023
Three cybersecurity trends to impact health care in 2023
The health care industry continues to face escalating cybersecurity threats.
Find out what trends we expect to see in the year ahead.
* January 25, 2023
How BD is getting more proactive about medtech cybersecurity
Learn about some of the proactive measures BD takes to protect cybersecurity.
* October 31, 2022
Cybersecurity engagement is part of our culture at BD
While some view people as the weakest link in security, BD CISO Rob Suárez
sees them as cybersecurity’s biggest ally.
* October 26, 2022
BD Achieves ISO Certification for its Enterprise-Level Information Security
Management System
Our enterprise-level Information Security Management System (ISMS) has been
certified to a rigorous set of independently audited international standards:
ISO/IEC 27001:2022.
* June 2, 2022
MDIC, HSCC Team Up to Establish Medical Device Security Benchmarks
Learn how a new self-assessment tool is helping the industry establish
benchmarks for medical device cybersecurity maturity.
* January 6, 2022
BD Publishes 2021 Cybersecurity Annual Report
The second annual BD cybersecurity report details the state of health care
cybersecurity, the company's impact on advancing cybersecurity maturity and
anticipated trends for 2022.
* October 28, 2021
Cybersecurity awareness: How BD fosters a strong cybersecurity culture
Learn how BD fosters a strong cybersecurity culture by providing
opportunities to hear directly from customers and partners, conducting
phishing simulations and providing ongoing, tailored cybersecurity training.
* October 13, 2021
Industry experts share best practices for reducing ransomware risks at
hospitals
Two industry experts share strategies for reducing ransomware risks, from
training staff to recognize threats to boosting cyberattack preparedness.
* June 2, 2021
BD Advances Leadership in Cybersecurity Preparedness, Transparency
BD becomes the first medical technology company authorized as a Common
Vulnerability and Exposures (CVE®) Numbering Authority by the CVE Program,
further demonstrating company's leadership in health care cybersecurity.
* December 14, 2020
BD Publishes its Inaugural Cybersecurity Annual Report
Through the BD 2020 Cybersecurity Report, the company seeks to address
cybersecurity challenges specific to health care and offer guidance about
cybersecurity practices for working with medical device manufacturers.
* November 16, 2020
Cybersecurity recommendations for hospitals on the front lines of COVID-19
The COVID-19 pandemic continues to place unprecedented demands on the
healthcare system. Many hospitals have had to reconfigure their facilities,
from expanding remote monitoring and telemedicine to adding dedicated
COVID-19 units.
* July 22, 2020
Industry experts urge greater collaboration in medical device cybersecurity
With this growth comes broad and complex challenges, which health care
providers, medical device manufacturers and industry regulators must address
to secure connected health devices and protect patient safety and privacy.
* July 01, 2020
Increasing medical device cybersecurity with Zero Trust principles
To improve the resilience of healthcare during a pandemic or any other
crisis, we need to adopt Zero Trust principles. In other words, we need to
assume nothing and verify everything.
* May 22, 2020
Three cybersecurity trends that have emerged from the COVID-19 pandemic
Even as healthcare professionals put their own lives at risk to save
patients, cybercriminals are diligently honing their craft. They are
exploiting the need for faster, less stringent security vetting processes and
conducting their own version of A/B testing to determine which phishing and
smishing campaigns are most effective in the current environment.
* February 20, 2020
BD Synapsys™ microbiology informatics solution receives UL Cybersecurity
Assurance Program (UL CAP) certification
The BD Synapsys informatics solution is among the first life-science
diagnostics informatics platforms to meet all UL CAP cybersecurity standards.
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