• 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
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    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
    Beckman Coulter Helping Labs Comply With Annex 1 Regulation

    FDA Clears MeMed BV Direct From Whole Blood

    Biostrap Debuts Tool to Measure Stress Resilience, Heart Rate Variability

    EndoTheia Announces Positive Study Results for Endoscopic Surgery Device

    Abbott Completes Acquisition of Bigfoot Biomedical
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Medtech’s Most Powerful M&A Drivers

    The Link Between Medtech and Connected Medical Devices

    Is the FTC Partly Responsible for Muted M&A Activity?

    Holistic Risk Management: Navigating the Future’s Uncertainties

    Defining End of Life for Medical Devices
    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
    Medbio LLC

    Halkey-Roberts Corporation

    NDH Medical Inc.

    JBC Technologies

    Cirtec Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    A One-Stop-Shop, Turnkey Solution Is Paramount for Success

    How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

    Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing

    How In Silico Simulations Can Slash Medical Device Development Risk

    The Top 7 AI Applications Transforming Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medbio LLC

    Halkey-Roberts Corporation

    NDH Medical Inc.

    JBC Technologies

    Cirtec Medical
    • 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
    Online Exclusives

    What Is This Thing Called 'Cybersecurity' Anyway?

    A look at what cybersecurity really means in terms of the development of medical device software.

    What Is This Thing Called
    Anura Fernando, Chief Innovation Architect for Medical Systems Interoperability & Security, Underwriters Laboratories (UL)12.10.18
    Today, most people in the world communicate using electronic devices and the majority have at least heard the word “cybersecurity.” However, how many people really understand what cybersecurity is? The security pundits and purists might argue about technical distinctions, using terms like “information security” or “cyber physical systems’ security,” or any of a dozen other related terms; but ultimately, whatever this problem is, most of the world thinks about one thing when they hear the term: “Could I be hacked?” In order to answer this question, the term cybersecurity needs to be well understood, and this will help us all improve the cybersecurity posture of the technologies we deal with every day, whether it’s the cell phones through which we communicate, the medical devices we use at home, or the products we design. So, let’s take a deeper dive together to see what cybersecurity really entails, and you won’t need to be a “hacker” or a security engineer to understand it.
     
    A System-Level Definition
    Cybersecurity is a facet of a multidisciplinary “systems” problem. Some say that it is just a subset of software quality requirements, but we will see that it is really an aspect of complete system-level quality management. Why? Simply because “software” by itself cannot do anything. It merely exists until it is installed on a hardware platform that allows it to interact with the world.
     
    Just 15 to 20 years ago, many consumer product development companies had separate “hardware” teams and “software” teams, even for the development of electronic controls. When control system problems arose in the field, fingers would start pointing in both directions. “Systems Engineering” was a relatively new discipline, at least within the consumer product space, and most systems engineering at that time was practiced in the defense, aerospace, and transportation sectors. Today, most electrical engineers leave school with quite a bit of software training, and many computer scientists leave school having built some type of hardware on which their software can operate.
     
    Understanding Cybersecurity In ‘Sociotechnical’ Terms
    So, if we are now developing a more capable, multidisciplinary workforce than we’ve had in the recent past, why are we still encountering all these cybersecurity problems? The core answer to this question is that cybersecurity is not just a technical problem, but rather a “sociotechnical” problem. To better understand this, we will look to try to understand more about the opposite of cybersecurity, which is “interoperability.”
     
    Interoperability is basically the ability of things to interact with each other in established ways. In cybersecurity, we are often generally trying to prevent things from being accessed or acted upon by others. However, doing so in an exclusive way would significantly limit the potential benefits to be gained from intercommunication. Would you have a television in your home if it were fully secure from any incoming signals? Likely not. Therefore, product designers often must think carefully about what interactions are needed and then design mechanisms by which certain other authenticated products or people (i.e., those deemed to be acceptable members of the ecosystem) can be authorized (i.e., given permission) to interact with the product that the product designer is responsible for developing. This formation of ecosystems of interoperable products has been modeled in a variety of ways, but a particularly useful model for this discussion is that of the Coalition Interoperability model, developed by Andreas Tolk as shown in the graphic1.
     

    Coalition Interoperability (Tolk)1

    In the graphic, we see that for technologies to be “interoperable” there are many layers of interaction that must be carefully managed. In theory, all of these interdependencies could be perfectly aligned, and information flow could be perfectly controlled through authentication and authorization mechanisms, but unfortunately, as we all know, we don’t live in a perfect world. It is the “real world” mismatches in the alignment of these layers and the imperfections in authentication and authorization processes that create the cybersecurity phenomena known as “vulnerabilities.”
     
    Cyber Vulnerabilities in Healthcare
    We can look at how this might affect our critical national infrastructure through an examination of the healthcare supply chain. Hospitals have the overarching political objective of providing the best possible affordable care to patients. Many hospitals have recognized that security vulnerabilities in hospital infrastructure, including medical devices, could compromise the safety of their patients. They have therefore developed strategies and doctrine for mitigating these vulnerabilities. However, there are still many hospitals that have not taken such measures. It is important to recognize this fact in the context that it is increasingly becoming a necessity for patient data to be captured in electronic health records (EHRs), often from mobile medical devices or even home healthcare products. This trend is occurring both for purposes of reducing healthcare costs as well as improving care by giving patients faster and more direct access to their own health information. This can also help patients play a more proactive role in the management of their own care, often from the comfort of their own homes.
     
    When we look at the graphic in this context, we can ask ourselves some questions:
    • What happens when one network-connected device is replaced by another during the patient care regimen?
    • What happens when a patient’s care shifts from one department in the hospital to another?
    • What happens when a patient is transferred from one hospital to another in the same hospital network?
    • What happens if the patient is sent home with a monitoring device?
    • What happens when a patient moves to another hospital network or to another state?
    • What happens when a patient moves to another country?
     
    In all these situations, it is important to understand the fine balance between convenience, care, security, and the many different views of patient privacy that may be jurisdiction dependent.
     
    Managing Cyber Vulnerabilities
    So now that we understand the word “cybersecurity” a little better, we can see what tools are available to help us better manage these inevitable vulnerabilities. First and foremost is the Cyber Security Framework (CSF) from the National Institute of Standards and Technology (NIST). This framework serves as the foundation for many of the current best practices and standards. The NIST CSF has served as the foundation for the development of standards such as UL 2900-2-1, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems. As an FDA Recognized Consensus Standard, this standard applies to both organizational process requirements and technical product requirements aligning medical device capabilities with the needs of system integrators such as hospitals. The use of such standardized requirements in the procurement process helps to better align interests and minimize the kinds of mismatches that we saw when examining the Coalition Interoperability model.
     
    So, now that we understand what “cybersecurity” is, perhaps at least a little bit more, let’s use that knowledge to better protect our critical healthcare infrastructure.
     
    Reference
    1 Information from Figure 3 from System of Systems Interoperability (SOSI): Final Report https://pdfs.semanticscholar.org/d649/3a57552eda7031283d5e660f6d3ad9923326.pdf?_ga=2.59466090.614929910.1544472172-1979073409.1544472172
    Related Searches
    • mobile
    • standards
    • data
    • institute
    Related Knowledge Center
    • Software & IT
    • Digital Health
    Suggested For You
    Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021 MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021
    Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products
    Picarro Unveils EtO Gas Concentration Analyzer Picarro Unveils EtO Gas Concentration Analyzer
    PTI Engineered Plastics Wins a 2021 Macomb Business Award PTI Engineered Plastics Wins a 2021 Macomb Business Award
    Improved Outcomes Proven With Insulet’s Omnipod 5 System Improved Outcomes Proven With Insulet’s Omnipod 5 System
    Molli Surgical Molli Surgical's Breast Tumor Marker
    Quanta Raises $245 Million in Series D Funding Round Quanta Raises $245 Million in Series D Funding Round
    Glytec Appoints Nausheen Moulana as Chief Technology Officer Glytec Appoints Nausheen Moulana as Chief Technology Officer
    Roche to Acquire Long-Term Partner TIB Molbiol Roche to Acquire Long-Term Partner TIB Molbiol
    Luis J. Malavé Joins Integrity Applications Board Luis J. Malavé Joins Integrity Applications Board
    Stryker Buys Gauss Surgical Stryker Buys Gauss Surgical
    Mayo Clinic, Google Research AI Software Could Boost Brain Stim Devices Mayo Clinic, Google Research AI Software Could Boost Brain Stim Devices
    Baxter to Acquire Hillrom in $10.5 Billion Deal Baxter to Acquire Hillrom in $10.5 Billion Deal
    GE Healthcare Reveals AMX Navigate Portable X-Ray System GE Healthcare Reveals AMX Navigate Portable X-Ray System

    Related Breaking News

    • Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

      Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

      The two deals will strengthen Heraeus' healthcare and medtech portfolio.
      Heraeus 09.22.21

    • MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021

      MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021

      Attendees of The MedTech Conference, powered by AdvaMed, will vote for the Grand Prize winner.
      MedTech Innovator 09.21.21

    • Surgical
      Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products

      Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products

      Deliver consistent sealing reliability in an ergonomic, multifunctional design that promotes procedural efficiency.
      Olympus Corporation 09.21.21


    • Picarro Unveils EtO Gas Concentration Analyzer

      Picarro Unveils EtO Gas Concentration Analyzer

      Analyzers are now available for CEMS, stack testing, fenceline, and ambient monitoring systems.
      PR Newswire 09.20.21

    • PTI Engineered Plastics Wins a 2021 Macomb Business Award

      PTI Engineered Plastics Wins a 2021 Macomb Business Award

      Organization Receives Top Honors in Hometown Hero Category

    Loading, Please Wait..

    Trending
    • Diabetes Innovation: MIT Engineers Unveil Implantable Device With Oxygen Factory
    • Medtronic Obtains EU Nod For Simplera CGM
    • A New Approach To Post-Market Surveillance
    • Danaher Names New Environmental And Applied Solutions Company Veralto
    • Hologic, Bayer Team Up For Contrast-Enhanced Mammography
    Breaking News
    • Beckman Coulter Helping Labs Comply With Annex 1 Regulation
    • FDA Clears MeMed BV Direct From Whole Blood
    • Biostrap Debuts Tool to Measure Stress Resilience, Heart Rate Variability
    • EndoTheia Announces Positive Study Results for Endoscopic Surgery Device
    • Abbott Completes Acquisition of Bigfoot Biomedical
    View Breaking News >
    CURRENT ISSUE

    September 2023

    • Superior Subtractive Solutions for Machining Medtech
    • Medical Device Industry Experts' Thought on Assembly & Automation
    • Power Trip: A Discussion of Custom Medical Electronics
    • The MDR Transition: An Opportunity for Design Change?
    • 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

    GOED Releases Sustainability Report for Omega-3s Industry
    ABC’s Journal HerbalGram Celebrates 40th Anniversary
    Curcumin May Be As Effective as PPI for Indigestion
    Coatings World

    Latest Breaking News From Coatings World

    Nouryon Manufacturing Network Transitions to 100% Electricity From Renewable Sources in Brazil
    Jay Doubman Named President and CEO of ICP Group
    “MyCarbonFootprint”: BASF Launches Dashboard for Sustainable Procurement
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Beckman Coulter Helping Labs Comply With Annex 1 Regulation
    FDA Clears MeMed BV Direct From Whole Blood
    Biostrap Debuts Tool to Measure Stress Resilience, Heart Rate Variability
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Eftilagimod Cleared for Clinical Trial Use in the UK
    Veranova Names William Sanders Global VP of Chemical Development Ops
    Chime, Panolos Partner to Advance Multi-specific Therapeutic Proteins
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Hailey Bieber's Rhode Expands Into Makeup
    Avon Enters Retail Partnership with Superdrug
    IT Award Winners Announced at MakeUp in NY
    Happi

    Latest Breaking News From Happi

    Divi Expands in Stores at Ulta Beauty Tripling Footprint
    Huda Beauty Adds Easy Bake and Snatch Pressed Brightening and Setting Powder
    Detergent for Baby Bottles Contains an Odor Absorber
    Ink World

    Latest Breaking News From Ink World

    INKBANK Lays Foundation for Science and Technology Park
    Successful Labelexpo Europe 2023 Concludes in Brussels
    Recyclable, Deinkable Stand-Up Pouch Wins Gold
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Flexo Wash to exhibit at FTA Fall Technical Conference
    Recyclable, deinkable stand-up pouch wins Gold in Germany
    Elkem highlights thermal protection and battery assembly products
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Lenzing Earns EU Ecolabel at Indonesian Plant
    Albis Completes Work On Extra Wide Carding, Blending Line
    Ahlstrom Launches Nonwoven Laundry Care Product
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Anika Releases RevoMotion Reverse Shoulder Arthroplasty System
    Exactech's Activit-E Polyethylene OK'ed for Vantage Total Ankle
    Tyber Nets Several Regulatory Nods for K-Wires, Steinmann Pins
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    HMI Specialist RAFI Acquires Xymox Technologies Inc.
    Infineon Heads EECONE European Research Project
    NXP Honored with Prestigious Automotive Awards

    Copyright © 2023 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