• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    'Graft-on-a-Chip' Built to Improve Vascular Graft Success

    Abbott Invests €440 in New Irish Facility

    FDA Approves Guardant Health's NGS-Based Companion Diagnostic

    Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment

    NanoVibronix Strengthening its Supply Chain to Address Potential Delays
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cooling and Melting the Pain Away

    What Are the Fundamentals of Go-To-Market Strategy in Medical Devices?

    Minding the Gap: How Harmonizing Quality Systems Pays Off

    Building Strong Partnerships Between Medtech and Surgeon-Learning Platforms

    Four Key Considerations for OEMs Transferring a Product Program
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    BMP Medical

    JBC Technologies

    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    Xact Wire EDM Corp.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Medical Computing: COM Express Processes Real-Time Data at the Edge

    The Importance of Building Successful Supplier Relationships

    The Benefits of Outsourcing Innovation in Medtech Manufacturing

    Patching Healthcare Cybersecurity Risks in the Internet of Medical Things

    Leveraging Open Healthcare Data Standards to Improve Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    BMP Medical

    JBC Technologies

    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    Xact Wire EDM Corp.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA and DHS Begin Partnership to Address Medical Device Cybersecurity Threats

    Under the agreement, DHS will continue to serve as the central medical device vulnerability coordination center.

    FDA and DHS Begin Partnership to Address Medical Device Cybersecurity Threats
    U.S. Food and Drug Administration10.17.18
    As part of the Administration’s ongoing efforts to strengthen cybersecurity in healthcare, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.
     
    “As innovation in medical devices advances and more devices are connected to hospital networks or to other devices, ensuring that devices are adequately protected against cyber intrusions is paramount to protecting patients. The FDA has been proactive in developing a robust program to address medical device cybersecurity concerns,” said FDA Commissioner Scott Gottlieb, M.D. “But we also know that securing medical devices from cybersecurity threats cannot be achieved by one government agency alone. Every stakeholder has a unique role to play in addressing these modern challenges. That’s why this announcement is so important. Our strengthened partnership with DHS will help our two agencies share information and better collaborate to stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities and assist the healthcare sector in being well positioned to proactively respond when cyber vulnerabilities are identified. This agreement demonstrates our commitment to confronting cybersecurity risks and the unscrupulous cybercriminals who may seek to put patient lives at risk.”
     
    “Ensuring our ability to identify, address and mitigate vulnerabilities in medical devices is a top priority, which is why DHS depends on our important partnership with the FDA to collaborate and provide actionable information. This agreement is another important step in our collaboration,” said Christopher Krebs, Undersecretary for the National Protection and Programs Directorate at DHS. “DHS has some of the top experts on control systems technology, and we look forward to continuing to leverage this expertise for the sake of improving the lives and safety of people across the country. DHS has enjoyed a great working relationship with the FDA for several years and look forward to this agreement making that working relationship even stronger and more effective.”
     
    The agreement, between the FDA’s Center for Devices and Radiological Health and DHS’ Office of Cybersecurity and Communications, is meant to encourage even greater coordination and information sharing about potential or confirmed medical device cybersecurity vulnerabilities and threats. Such collaboration can lead to more timely and better responses to potential threats to patient safety.
     
    The two agencies have already worked together on many aspects of medical device cybersecurity, most notably around coordination of vulnerability disclosures. This helps medical device manufacturers receive technical information from cybersecurity researchers regarding identified vulnerabilities in their products in a way that enables all parties to respond to potential threats in a timely way. The agencies have also collaborated on planning, executing and conducting after-action reviews of DHS-led exercises that simulate real-world cybersecurity attacks and enable the government and stakeholders to practice and improve their responses to these threats. The goal of the agreement is to expand these types of collaboration by increasing the sharing of information between the two agencies to enhance mutual awareness of potential or known threats, thereby heightening coordination when vulnerabilities are identified. And to enhance shared technical capabilities, such as conducting collaborative assessments regarding the level of risk a potential vulnerability may pose to patient safety and coordinate testing of devices as warranted.
     
    Under the agreement, DHS will continue to serve as the central medical device vulnerability coordination center and interface with appropriate stakeholders, including consulting with the FDA for technical and clinical expertise regarding medical devices. The DHS’ National Cybersecurity and Communications Integration Center will continue to coordinate and enable information sharing between medical device manufacturers, researchers and the FDA, particularly in the event of cybersecurity vulnerabilities in medical devices that are identified to the Department of Homeland Security. The FDA will continue to engage in regular, ad hoc, and emergency coordination calls with DHS and advise DHS regarding the risk to patient health and potential for harm posed by identified cybersecurity threats and vulnerabilities.
     
    The agreement formalizes a long-standing relationship between the FDA and DHS. Through this agreement, both agencies are renewing their commitment to working with not only each other, but also all stakeholders to create an environment of shared responsibility when it comes to coordinated vulnerability disclosure for identifying and addressing cybersecurity risks. This kind of coordination and information sharing can ultimately help protect patients who rely on lifesaving medical devices. 
     
    The FDA promotes and protects the public health by ensuring the safety, efficacy, and security of medical products, including medical devices. The agency has taken significant steps to create an environment of shared responsibility between government agencies, industry, healthcare delivery organizations, and cybersecurity researchers. Interconnected devices increase cybersecurity risks which, if exploited, may affect device performance. The agency is committed to enhancing patient safety by mitigating cybersecurity risk throughout the life cycle of medical devices, which includes monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they are on the market. 
     
    The DHS mission includes preventing terrorism and enhancing security; managing U.S. borders; administering immigration laws; securing cyberspace; and ensuring disaster resilience. Information sharing is a critical part of the DHS mission to create shared situational awareness of malicious cyber activity. DHS works to prevent or minimize disruptions to critical information infrastructure in order to protect the public, the economy, and government services.
    Related Searches
    • monitoring
    • health
    • medical device
    • safety
    Related Knowledge Center
    • Software & IT
    Loading, Please Wait..

    Trending
    • Cardinal Health CEO Mike Kaufmann Steps Down
    • BD Recalls Intraosseous Products Over Multiple Issues
    • Abbott Invests €440 In New Irish Facility
    • Medidata Unveils New Tech To Improve Clinical Trial Oversight
    • Chronic, Infectious Disease Prevalence To Benefit Vital Signs Monitoring Market
    Breaking News
    • 'Graft-on-a-Chip' Built to Improve Vascular Graft Success
    • Abbott Invests €440 in New Irish Facility
    • FDA Approves Guardant Health's NGS-Based Companion Diagnostic
    • Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment
    • NanoVibronix Strengthening its Supply Chain to Address Potential Delays
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • Parylene Coatings for Medical Device Technologies
    • Nearshoring Trends in Medtech Manufacturing
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    Tazo Transitions to Regenerative Organic Agriculture
    Coatings World

    Latest Breaking News From Coatings World

    SONGWON Industrial Group Reports Strong Q2 Financial Results
    PPG Completes COLORFUL COMMUNITIES Project for Boys & Girls Clubs of Greater Houston
    Paul N. Gardner Now Offers Bacharach Sling Psychrometer
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    'Graft-on-a-Chip' Built to Improve Vascular Graft Success
    Abbott Invests €440 in New Irish Facility
    FDA Approves Guardant Health's NGS-Based Companion Diagnostic
    Contract Pharma

    Latest Breaking News From Contract Pharma

    AskBio Appoints Clinical Ops Executives
    SpectrumX Partners With UK Contract Manufacturer
    GL Chemtec Partners with Edgewater Capital to Accelerate Growth
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Arkay Chairman Emeritus Howard Kaneff Has Died
    Nutricosmetics Market to Hit $13.7 Billion by 2030
    Estée Lauder Pledges 100% Electric Fleet of Vehicles by 2030
    Happi

    Latest Breaking News From Happi

    J&J To Stop Global Sales of Talc-Based Products by 2023
    Net Sales Increase 2% for Naples Soap Company in Second Quarter
    Net Revenue Down 12% for Grove Collaborative in Second Quarter
    Ink World

    Latest Breaking News From Ink World

    Heidelberg Enjoys Successful Start to 2022-23 Fiscal Year
    Mimaki Announces New LATAM Website
    Paul N. Gardner Offers Bacharach Sling Psychrometer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Esko, Constantia Flexibles announce acquisitions and more
    Hybrid Software joins The Flexo Xperience Center
    Flexo Wash LLC and Mike Potter celebrate 20 years
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Focke & Co. to Host Destination: Your Hygiene Hub on August 31
    Exports Dominate Chinese Trade of Tissues, Hygiene Products and Wipes
    Freudenberg to Present Friction Inserts for Wind Energy
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Dental 3D Printing Market is Expanding 20% Annually
    Study Results Released for Abbott's Concussion Blood Test
    Bone Growth Stimulators Market to Top $3B by 2030
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    eMagin Corporation Announces 2Q 2022 Results
    Zebra Technologies’ Emission Reduction Targets Validated by SBTi
    Identiv Delivers Impressive 41% Year-over-Year Growth in RFID Business

    Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login