Learn which elements must be considered when designing healthcare devices
Why security challenges for wearables are greater than for an endpoint in a fixed location
Elements to consider when adopting security-by-design product
Cybersecurity, FDA digital health requirements
Medical Wearables
Use Case Studies
So - guess what? Safety is not cyber security!
Managing cyber security for medical devices is a challenge for medical device vendors and regulatory consultants who are accustomed to estimating patient safety risk without having to explain and understand a complex, rapidly changing and interconnected environment of vulnerabilities, attackers, attacker entry points and zero-day threats.
In this updated version of a talk I gave 5 years ago - I show how to use threat modeling in order to provide a prioritized security countermeasure plan that will cost the medical device vendor the least amount of money and save him the grief of trying to deal with cyber threats in his safety risk analysis.
Critical Infrastructure Security by Subodh BelgiClubHack
Industrial Automation & Control Systems are an integral part of various manufacturing & process industries as well as national critical infrastructure. Concerns regarding cyber-security of control systems are related to both the legacy nature of some of the systems as well as the growing trend to connect industrial control systems to corporate networks. These concerns have led to a number of identified vulnerabilities and have introduced new categories of threats that have not been seen before in the industrial control systems domain. Many of the legacy systems may not have appropriate security capabilities that can defend against modern day threats, and the requirements for availability and performance can preclude using contemporary cyber-security solutions. To address cyber-security issues for industrial control systems, a clear understanding of the security challenges and specific defensive countermeasures is required. The session will highlight some of the latest cyber security risks faced by industrial automation and control systems along with essential security controls & countermeasures.
Kevin Wheeler, Founder and Managing Director, InfoDefense
Securing Industrial Control Systems
Our nation’s critical infrastructure is controlled by SCADA and other industrial control technologies. Water utilities, petroleum refineries, oil pipelines, food processors, manufacturers and power companies all use SCADA systems to control and monitor operations. The vast majority of these industrial control systems have been in place for decades with few, if any, enhancements to effectively protect against today’s advanced threats. As a result, industrial control system vulnerabilities are currently a major concern.
Legacy SCADA systems can be secured using many of the same best practices that are used to protect the enterprise. This presentation provides an overview of SCADA threats as well as practical solutions for protecting industrial control systems.
So - guess what? Safety is not cyber security!
Managing cyber security for medical devices is a challenge for medical device vendors and regulatory consultants who are accustomed to estimating patient safety risk without having to explain and understand a complex, rapidly changing and interconnected environment of vulnerabilities, attackers, attacker entry points and zero-day threats.
In this updated version of a talk I gave 5 years ago - I show how to use threat modeling in order to provide a prioritized security countermeasure plan that will cost the medical device vendor the least amount of money and save him the grief of trying to deal with cyber threats in his safety risk analysis.
Critical Infrastructure Security by Subodh BelgiClubHack
Industrial Automation & Control Systems are an integral part of various manufacturing & process industries as well as national critical infrastructure. Concerns regarding cyber-security of control systems are related to both the legacy nature of some of the systems as well as the growing trend to connect industrial control systems to corporate networks. These concerns have led to a number of identified vulnerabilities and have introduced new categories of threats that have not been seen before in the industrial control systems domain. Many of the legacy systems may not have appropriate security capabilities that can defend against modern day threats, and the requirements for availability and performance can preclude using contemporary cyber-security solutions. To address cyber-security issues for industrial control systems, a clear understanding of the security challenges and specific defensive countermeasures is required. The session will highlight some of the latest cyber security risks faced by industrial automation and control systems along with essential security controls & countermeasures.
Kevin Wheeler, Founder and Managing Director, InfoDefense
Securing Industrial Control Systems
Our nation’s critical infrastructure is controlled by SCADA and other industrial control technologies. Water utilities, petroleum refineries, oil pipelines, food processors, manufacturers and power companies all use SCADA systems to control and monitor operations. The vast majority of these industrial control systems have been in place for decades with few, if any, enhancements to effectively protect against today’s advanced threats. As a result, industrial control system vulnerabilities are currently a major concern.
Legacy SCADA systems can be secured using many of the same best practices that are used to protect the enterprise. This presentation provides an overview of SCADA threats as well as practical solutions for protecting industrial control systems.
Presentation on Medical device security and emerging standards for the Internet of Things. Presented by Anura Fernando of UL at The Security of Things Forum, Sept. 10, 2015.
Presentation during the Inaugural IEEE Smart Grid Cybersecurity Workshop (http://sites.ieee.org/ucw/). The talk was in Session 1: Overview of the Security Situation/Risk Managment. The presentation identifies 5 hurdles that need to be addressed before we can secure the grid. Other presentations from the event are available for download at the IEEE Smart Grid Resource Center http://resourcecenter.smartgrid.ieee.org/category/conferences/-/society-featured-articles/subcategory/913483
Are existing compliance requirements sufficient to prevent data breaches? This session will provide a technical assessment of the 2019 Capital One data breach, illustrating the technical modus operandi of the attack and identify related compliance requirements based on the NIST Cybersecurity Framework. Attendees will learn the unexpected impact of corporate culture on overall cyber security posture.
This talk was presented at RSA Conference 2021 (Session RMG-T15) on May 18, 2021.
Original paper available for download at SSRN: Novaes Neto, Nelson and Madnick, Stuart E. and Moraes G. de Paula, Anchises and Malara Borges, Natasha, A Case Study of the Capital One Data Breach (28/04/2020). https://ssrn.com/abstract=3570138
This slideshow was presented February 2, 2016 and developed for the Iowa Infragard team and discusses the Importance of Security Cyber-Physical Control systems, Elements of a control system, the manufacturing supply chain and consequences of cyber attacks in industrial environments. Please feel free to reach out with questions or comments.
Cyber & Process Attack Scenarios for ICSJim Gilsinn
Presented at the OPC Foundation's "The Information Revolution 2014" in Redmond, WA August 5-6, 2014
This presentation discusses the modes and methodologies an attacker may use against an industrial control system in order to create a complex process attack. The presentation then discusses some specific examples, both real and hypothetical. The presentation finishes with a description of some common ways in which an organization could defend itself against these types of attacks.
How do we get a SOC 2?” Do those words strike fear and anxiety into your heart as an infosec professional? Do you have visions of being buried under a mountain of fancy risk management software, endless numbers of spreadsheets, and losing sleep for weeks implementing complex audit logging software? Well, take a deep breath and join this talk, in which we break down how to achieve SOC 2 Type II compliance without losing your mind. Your guide today has led many companies of various sizes- but mostly tiny startups- through several years of successful SOC 2 audits, and is here to break it all down. Bring your notebook as we explain why and how.
This talk will not focus on endless checkboxes, or push compliance at the expense of security. Instead, it will be a real world view of how to achieve compliance audit success without wasting your time, creating busy work, undoing your hard work securing your users’ data, and building a resilient architecture. We’ll explore how to automate, what to automate, how to build a control set that fits your organization, and how to come out the SOC 2 hero.
Slides from panel talk at the annual IEEE Power and Energy Society meeting on Power System Cybersecurity.
After a 8 hour tutorial and a panel talk, there were a number of consistent themes and challenges that surfaced. The two that concern me the most are: a) blocking engineers from discussing security approaches at technical conferences and b) treating power system cybersecurity as only a compliance issue for the IT, legal, and compliance departments. With the hopes that this sparks a bigger conversation, I’m sharing a copy of my slides from our panel talk. Thoughts and comments are welcomed.
As legislators continue to expand the scope of the laws governing information security, we will take a look at some of the new European-level laws in this area from an open source perspective, and consider their impact on OSS management practices. The session will focus on the General Data Protection Regulation, not only because it applies to everyone, but also because its requirements are in many ways the most detailed and prescriptive. During the session we will also touch on some industry-specific developments like the Network and Information Services Directive and the Electronic Identification Regulation. Dan will cover what the new laws say (and perhaps more importantly what they don’t say), how to go about applying them to your OSS management regime, and what you might need to think about changing as a result.
Augmentation of a SCADA based firewall against foreign hacking devices IJECEIAES
An Industrial firewall is a system used to supervise and regulate traffic to and from a network for the purpose of securing appliances on a network. It analyzes the data passing through it to an already defined surveillance criteria or protocols, discarding data that does not meet the protocol’s requirements. In effect, it is a filter preventing undesirable network traffic and selectively limiting the type of transmission that occurs between a secured transmission line. In this research paper a SCADA based Firewall is implemented for protection of the data transmission to a PLC, against external hacking devices. This firewall is virtually exposed to several external hackers and the degree of vulnerability is carefully studied, in order to develop an ideal Firewall.
Managing Multiple Assessments Using Zero Trust PrinciplesControlCase
ControlCase discusses the following:
•What is “One Audit” for multiple assessments
•Current Research
•Zero Trust Principles for IT security
•Remote Assessment Methodology
Utilizing the Critical Security Controls to Secure Healthcare TechnologyEnclaveSecurity
The development of the Critical Security Controls is transforming the way companies measure and monitor the success of their security programs while drastically reducing the cost of security. Fifteen of the twenty controls can be automated, some at limited cost to the organization, and the data is readily available to be presented in conference rooms and board rooms. Upon implementing, hospitals will have the ability to measure compliance, track progress, and know when they’ve reached certain goals.
They were developed and agreed upon by a consortium including NSA, US Cert, DoD JTF-GNO, the Department of Energy Nuclear Laboratories, Department of State, DoD Cyber Crime Center as well as the top commercial forensics experts and pen testers serving the banking and critical infrastructure communities. Since the US State Department implemented these controls they have demonstrated “more than 80% reduction in ‘measured’ security risk through the rigorous automation and measurement of the Top 20 Controls.”
Cyber security is not safety.
I've updated a talk I gave in 2010 to include the latest FDA guidance on mobile devices and cyber security. But really nothing has changed since then. Medical device vendors are still grappling with the notion that cyber security involves a complex, interconnected, rapidly changing landscape of vulnerabilities, threats, zero-day exploits, software security issues that does not fit the slow-moving pre-market approval and static risk analysis that FDA uses for safety.
In this presentation we show how to use a practical threat analysis methodology and present real-life examples of how to build a prioritized, cost-effective security countermeasure plan.
Practical Advice for FDA’s 510(k) Requirements.pdfICS
Don’t miss this important webinar with partners BG Networks and Trustonic, which serves as a roadmap for medical device manufacturers to navigate the complex landscape of FDA requirements and implement effective cybersecurity measures.
Patching software is a constant challenge. The Equifax hack and subsequent FTC investigation has shown us that required patches aren’t limited to those published by commercial vendors. Open source updates are just as critical; tracing new vulnerabilities and updates to applications in which those components are used isn’t just a good practice, it’s a regulatory requirement.
A focused approach to managing open source risk is essential as the legal landscape quickly evolves, including requirements under the FTC Act, HIPAA, and the European Union’s General Data Protection Regulation (GDPR). Coupled with heightened regulatory enforcement, these requirements increase the pressures on companies to maintain data privacy and security. This session will cover common misconceptions about these requirements, and explain why open source management is essential to your overall security strategy.
Presentation on Medical device security and emerging standards for the Internet of Things. Presented by Anura Fernando of UL at The Security of Things Forum, Sept. 10, 2015.
Presentation during the Inaugural IEEE Smart Grid Cybersecurity Workshop (http://sites.ieee.org/ucw/). The talk was in Session 1: Overview of the Security Situation/Risk Managment. The presentation identifies 5 hurdles that need to be addressed before we can secure the grid. Other presentations from the event are available for download at the IEEE Smart Grid Resource Center http://resourcecenter.smartgrid.ieee.org/category/conferences/-/society-featured-articles/subcategory/913483
Are existing compliance requirements sufficient to prevent data breaches? This session will provide a technical assessment of the 2019 Capital One data breach, illustrating the technical modus operandi of the attack and identify related compliance requirements based on the NIST Cybersecurity Framework. Attendees will learn the unexpected impact of corporate culture on overall cyber security posture.
This talk was presented at RSA Conference 2021 (Session RMG-T15) on May 18, 2021.
Original paper available for download at SSRN: Novaes Neto, Nelson and Madnick, Stuart E. and Moraes G. de Paula, Anchises and Malara Borges, Natasha, A Case Study of the Capital One Data Breach (28/04/2020). https://ssrn.com/abstract=3570138
This slideshow was presented February 2, 2016 and developed for the Iowa Infragard team and discusses the Importance of Security Cyber-Physical Control systems, Elements of a control system, the manufacturing supply chain and consequences of cyber attacks in industrial environments. Please feel free to reach out with questions or comments.
Cyber & Process Attack Scenarios for ICSJim Gilsinn
Presented at the OPC Foundation's "The Information Revolution 2014" in Redmond, WA August 5-6, 2014
This presentation discusses the modes and methodologies an attacker may use against an industrial control system in order to create a complex process attack. The presentation then discusses some specific examples, both real and hypothetical. The presentation finishes with a description of some common ways in which an organization could defend itself against these types of attacks.
How do we get a SOC 2?” Do those words strike fear and anxiety into your heart as an infosec professional? Do you have visions of being buried under a mountain of fancy risk management software, endless numbers of spreadsheets, and losing sleep for weeks implementing complex audit logging software? Well, take a deep breath and join this talk, in which we break down how to achieve SOC 2 Type II compliance without losing your mind. Your guide today has led many companies of various sizes- but mostly tiny startups- through several years of successful SOC 2 audits, and is here to break it all down. Bring your notebook as we explain why and how.
This talk will not focus on endless checkboxes, or push compliance at the expense of security. Instead, it will be a real world view of how to achieve compliance audit success without wasting your time, creating busy work, undoing your hard work securing your users’ data, and building a resilient architecture. We’ll explore how to automate, what to automate, how to build a control set that fits your organization, and how to come out the SOC 2 hero.
Slides from panel talk at the annual IEEE Power and Energy Society meeting on Power System Cybersecurity.
After a 8 hour tutorial and a panel talk, there were a number of consistent themes and challenges that surfaced. The two that concern me the most are: a) blocking engineers from discussing security approaches at technical conferences and b) treating power system cybersecurity as only a compliance issue for the IT, legal, and compliance departments. With the hopes that this sparks a bigger conversation, I’m sharing a copy of my slides from our panel talk. Thoughts and comments are welcomed.
As legislators continue to expand the scope of the laws governing information security, we will take a look at some of the new European-level laws in this area from an open source perspective, and consider their impact on OSS management practices. The session will focus on the General Data Protection Regulation, not only because it applies to everyone, but also because its requirements are in many ways the most detailed and prescriptive. During the session we will also touch on some industry-specific developments like the Network and Information Services Directive and the Electronic Identification Regulation. Dan will cover what the new laws say (and perhaps more importantly what they don’t say), how to go about applying them to your OSS management regime, and what you might need to think about changing as a result.
Augmentation of a SCADA based firewall against foreign hacking devices IJECEIAES
An Industrial firewall is a system used to supervise and regulate traffic to and from a network for the purpose of securing appliances on a network. It analyzes the data passing through it to an already defined surveillance criteria or protocols, discarding data that does not meet the protocol’s requirements. In effect, it is a filter preventing undesirable network traffic and selectively limiting the type of transmission that occurs between a secured transmission line. In this research paper a SCADA based Firewall is implemented for protection of the data transmission to a PLC, against external hacking devices. This firewall is virtually exposed to several external hackers and the degree of vulnerability is carefully studied, in order to develop an ideal Firewall.
Managing Multiple Assessments Using Zero Trust PrinciplesControlCase
ControlCase discusses the following:
•What is “One Audit” for multiple assessments
•Current Research
•Zero Trust Principles for IT security
•Remote Assessment Methodology
Utilizing the Critical Security Controls to Secure Healthcare TechnologyEnclaveSecurity
The development of the Critical Security Controls is transforming the way companies measure and monitor the success of their security programs while drastically reducing the cost of security. Fifteen of the twenty controls can be automated, some at limited cost to the organization, and the data is readily available to be presented in conference rooms and board rooms. Upon implementing, hospitals will have the ability to measure compliance, track progress, and know when they’ve reached certain goals.
They were developed and agreed upon by a consortium including NSA, US Cert, DoD JTF-GNO, the Department of Energy Nuclear Laboratories, Department of State, DoD Cyber Crime Center as well as the top commercial forensics experts and pen testers serving the banking and critical infrastructure communities. Since the US State Department implemented these controls they have demonstrated “more than 80% reduction in ‘measured’ security risk through the rigorous automation and measurement of the Top 20 Controls.”
Cyber security is not safety.
I've updated a talk I gave in 2010 to include the latest FDA guidance on mobile devices and cyber security. But really nothing has changed since then. Medical device vendors are still grappling with the notion that cyber security involves a complex, interconnected, rapidly changing landscape of vulnerabilities, threats, zero-day exploits, software security issues that does not fit the slow-moving pre-market approval and static risk analysis that FDA uses for safety.
In this presentation we show how to use a practical threat analysis methodology and present real-life examples of how to build a prioritized, cost-effective security countermeasure plan.
Practical Advice for FDA’s 510(k) Requirements.pdfICS
Don’t miss this important webinar with partners BG Networks and Trustonic, which serves as a roadmap for medical device manufacturers to navigate the complex landscape of FDA requirements and implement effective cybersecurity measures.
Patching software is a constant challenge. The Equifax hack and subsequent FTC investigation has shown us that required patches aren’t limited to those published by commercial vendors. Open source updates are just as critical; tracing new vulnerabilities and updates to applications in which those components are used isn’t just a good practice, it’s a regulatory requirement.
A focused approach to managing open source risk is essential as the legal landscape quickly evolves, including requirements under the FTC Act, HIPAA, and the European Union’s General Data Protection Regulation (GDPR). Coupled with heightened regulatory enforcement, these requirements increase the pressures on companies to maintain data privacy and security. This session will cover common misconceptions about these requirements, and explain why open source management is essential to your overall security strategy.
Outstanding innovations come with the heavy burden of dealing with new risks and threats. Especially when public health is at risk, FDA and other regulatory agencies attempt to provide guidance for companies to develop safe and effective products. With all the technological advancements in the digital health arena, medical devices are susceptible to attacks by hackers...
Data Security and Confidentiality in eCTD Publishing Tools Safeguarding Sensi...JustinFinch11
In the current era of digitalization life sciences has seen a major change in the way that regulatory submissions are developed and presented. Electronic Common Technical Document (eCTD) publishing has transformed the process of submission by making it faster and more efficient. However, with the ease that digital technologies offer comes the vital responsibility of ensuring security and privacy.
Visit Us :- https://www.aquilasolutions.us/
Network Connected Medical Devices - A Case StudySophiaPalmira
In this session, we welcome Shankar Somasundaram, CEO of Asimily, Priyanka Upendra, Quality Compliance Director at Banner Health, and Carrie Whysall. Director of Managed Security Services at CynergisTek.
Together, they will discuss medical device security, covering all you need to know from medical device assessments to remediation efforts. Attendees will leave this session knowing how to apply what they have learned about medical device security in real life.
Ensuring the security of information and applications is a critical priority fir all organizations, particularly those on the healthcare field. The architecture and features of the right enterprise image-viewer enable medical images and information to be securely and conveniently accessible to users from anywhere in the world, without compromising network or information security.
This guide describes strategies to ensure your enterprise images are fully secure, even when you provide the flexibility of mobile health solutions to practitioners.
http://offers.calgaryscientific.com/resolutionmd4-guides
Killed by code - mobile medical devicesFlaskdata.io
There is a perfect storm of consumer electronics, mobile communications and customer need - the need to help people manage chronic disease like Parkinson, diabetes and MSA and sustain life with pacemakers and ICDs
Understanding Cybersecurity in Medical Devices and ApplicationsEMMAIntl
One of the major pillars of the current Industry 4.0 is Automation. Indeed, technology is intervening in almost every domain to “automate” the workforce and make human life easier and better. In the present age, machines are getting integrated with the Internet of Things, Cloud Computing, and Artificial Intelligence with the data flow being transferred and processed via the Internet. These changes indeed catalyze the overall productivity, but also expose data to the public
domains.
In cases of continuous data transfers and exposition, Cybersecurity becomes a pivotal element where it not only protects the data but also proactively provides mechanisms to defend against malicious attacks and malware. In the case of medical devices that include sensitive medical data flows and software-controlled hardware devices like heart implants or Continuous Glucose Monitoring (CGM) devices, Cybersecurity becomes an important factor for contributing towards system safety and quality...
This presentation is intended for the customer facing risk managers, sales staff, and IT staff of a medical device manufacturer and their medical doctors and IT hospital and clinical counterparts.
It is intended to give an overview and highlight process considerations for incident management and reporting of cybersecurity issues.
It is based on the technical paper published by Pam Gilmore and Valdez Ladd in the ISSA Journal in 2014.
5 Ways Technology Vendors Put Their Healthcare Customer's PHI at RiskClearDATACloud
Healthcare PHI breaches resulting from technology vendor mistakes and misunderstandings have spiked over the past 2-3 years. Litigation, fines, remediation, and restitution can reach into the millions of dollars. This presentation will cover five common, but frequently overlooked, ways that technology vendors put their healthcare customer's PHI at risk. Just as importantly, it provides real world examples and pragmatic recommendations for addressing these issues to significantly reduce risk to you and your customers.
In the new world of connected healthcare, medical device manufacturers are challenged with cybersecurity issues to comply with the new FDA regulations. We examine the 5 domain areas of cybersecurity which apply to IoT HealthCare Vendors/ Providers.
Breakout Session: Cybersecurity in Medical DevicesHealthegy
Presentation by PwC at Medtech Conference 2016.
Participant:
Geoff Fisher, Director – PwC
Powered by:
Healthegy
For more healthcare innovation
Visit us at Healthegy.com
Roadmap to Healthcare HIPAA Compliance and Mobile Security for BYODSierraware
Simplifying BYOD deployments while satisfying HIPAA and other healthcare regulations. Virtual Mobile Infrastructure with strong biometric authentication and 4096-bit encryption. Android-based VDI for mobile security.
A presentation by Tracy Rausch, CEO of DocBox and Chip Block of Evolver Inc. on medical device security & patient monitoring. Presented at The Security of Things Forum on Sept. 10, 2015.
Security Fact & Fiction: Three Lessons from the HeadlinesDuo Security
Real-word breaches are often caused by simple lapses of judgment.
Hollywood movies and some of the media representations of data breaches are sensationalized and over-complicated compared to reality.
Similar to Security for Healthcare Devices - Will Your Device Be Good Enough? (20)
Sachpazis:Terzaghi Bearing Capacity Estimation in simple terms with Calculati...Dr.Costas Sachpazis
Terzaghi's soil bearing capacity theory, developed by Karl Terzaghi, is a fundamental principle in geotechnical engineering used to determine the bearing capacity of shallow foundations. This theory provides a method to calculate the ultimate bearing capacity of soil, which is the maximum load per unit area that the soil can support without undergoing shear failure. The Calculation HTML Code included.
Overview of the fundamental roles in Hydropower generation and the components involved in wider Electrical Engineering.
This paper presents the design and construction of hydroelectric dams from the hydrologist’s survey of the valley before construction, all aspects and involved disciplines, fluid dynamics, structural engineering, generation and mains frequency regulation to the very transmission of power through the network in the United Kingdom.
Author: Robbie Edward Sayers
Collaborators and co editors: Charlie Sims and Connor Healey.
(C) 2024 Robbie E. Sayers
CFD Simulation of By-pass Flow in a HRSG module by R&R Consult.pptxR&R Consult
CFD analysis is incredibly effective at solving mysteries and improving the performance of complex systems!
Here's a great example: At a large natural gas-fired power plant, where they use waste heat to generate steam and energy, they were puzzled that their boiler wasn't producing as much steam as expected.
R&R and Tetra Engineering Group Inc. were asked to solve the issue with reduced steam production.
An inspection had shown that a significant amount of hot flue gas was bypassing the boiler tubes, where the heat was supposed to be transferred.
R&R Consult conducted a CFD analysis, which revealed that 6.3% of the flue gas was bypassing the boiler tubes without transferring heat. The analysis also showed that the flue gas was instead being directed along the sides of the boiler and between the modules that were supposed to capture the heat. This was the cause of the reduced performance.
Based on our results, Tetra Engineering installed covering plates to reduce the bypass flow. This improved the boiler's performance and increased electricity production.
It is always satisfying when we can help solve complex challenges like this. Do your systems also need a check-up or optimization? Give us a call!
Work done in cooperation with James Malloy and David Moelling from Tetra Engineering.
More examples of our work https://www.r-r-consult.dk/en/cases-en/
Explore the innovative world of trenchless pipe repair with our comprehensive guide, "The Benefits and Techniques of Trenchless Pipe Repair." This document delves into the modern methods of repairing underground pipes without the need for extensive excavation, highlighting the numerous advantages and the latest techniques used in the industry.
Learn about the cost savings, reduced environmental impact, and minimal disruption associated with trenchless technology. Discover detailed explanations of popular techniques such as pipe bursting, cured-in-place pipe (CIPP) lining, and directional drilling. Understand how these methods can be applied to various types of infrastructure, from residential plumbing to large-scale municipal systems.
Ideal for homeowners, contractors, engineers, and anyone interested in modern plumbing solutions, this guide provides valuable insights into why trenchless pipe repair is becoming the preferred choice for pipe rehabilitation. Stay informed about the latest advancements and best practices in the field.
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Security for Healthcare Devices - Will Your Device Be Good Enough?
1. Security for Healthcare Devices –
Will Your Device Be Good Enough?
Meet FDA and CE requirements, and avoid
embarrassing and expensive security breaches
2. AGENDA
2
The Concern: Devices in Healthcare
• Cybersecurity and privacy issues have been on the increase
Security for Wearables is More Important
• FDA digital health requirements
Security By Design for Healthcare Devices
• How to start security by design and get it right
3. The Concern: Devices in Healthcare
3
Medical Systems Hacks
Are Scary, but Medical Device
Hacks Could Be Even Worse
Harvard Business Review, 2017
Medical Devices Are
the Next Security
Nightmare
Wired, 2017
4. of health care organizations have
been the victim of a cyberattack
Source:
SANS Institute94%
Critical medical devices can be hacked, potentially creating
life threating patient safety issues
Notable attacks on smart devices and infrastructure
St. Jude Medical pacemakers
vulnerable to hacking – 465,000
devices recalled – fear that hackers can
deplete batteries or even alter patient’s
heartbeat (Source: The Guardian)
Owlet’s Baby Heart Monitor
vulnerable to exploits –
unencrypted network, no
authentication required
(Source: CBS News)
20172016
TRENDnet Webcam hacking – hackers
posted live feeds of 700 cameras to the
web – failure to secure IP addresses,
unencrypted log in, not password
protected (Source: TechNewsWorld)
2012
4
5. Consumer product companies are
open to lawsuits
5
Quick Facts:
• Recent Incident: December
2019
• Hackers broke into Ring
security cameras of two families
• Hackers used device speakers
to broadcast racial slurs
• Ring advised customers to
enable two-factor
authentication, use strong
passwords on their accounts
(Source: Vice)
Now:
• Ring has faced growing
criticism over its security
practices
• Two couples who had
their devices hacked
initiated class action
lawsuits against Ring
(Source: Business Insider)
6. Ring Class Action Lawsuit
6
What is it about?
Multiple class action lawsuits have been filed against the Amazon-owned
company, Ring. The suit accuses Ring of negligence, breach of implied
contract, invasion of privacy, etc. They claim Ring has failed to
implement “even the most basic” security measures to protect its
customers.
Who is affected?
Anyone who owns a Ring home security device.
What could the class action do?
Force Ring to put stronger safeguards in place to protect user’s privacy
and award money to device owners.
(Source: ClassAction.org)
7. What Now?
Ask Questions.
7
• What elements must be considered
when designing healthcare
devices?
• Why security challenges for
wearables are greater than for an
endpoint in a fixed location.
• How to do security by design?
8. Security challenges for wearables are higher than an
endpoint in a fixed location
8
Why?
The device may not
be the correct device.
The wearer can wander around
and be almost anywhere.
The device may be used
by the wrong person.
9. How to determine if it’s authorized to send data?
9
Fall detection capabilities
Take the Apple watch for example.
The Apple Watch Series 4 and its key features were cleared by FDA in the US.
3 new heart monitoring capabilities
• Low heart rate alert
• Heart rhythm detection
• Personal electrocardiogram (ECG) monitor
Apple Watch Series 4 as a serious medical device:
(Source: Forbes)
10. How to determine if it’s
authorized to send data?
10
So, the API requires the Apple Watch to:
The Apple Watch does not have the UI
to grant data authorization.
(Source: Learning Swift)
Let the user know they need to grant that
permission on the iPhone.
Prompt the user with the health authorization
dialog on the iPhone.
Make the call once the authorization is complete
on the iPhone.
Handle the result of the authorization from the
iPhone on the Apple Watch.
11. Other Questions to Think About
11
Has it been spoofed? Is there a different
device sending data?
Is the device sending the right data?
Is the device sending data accurately?
Was data taken at the right time?
1
2
3
4
12. Security Regulations for Wearables are Changing
12
Food and Drug Administration’s (FDA) Digital Health Requirements
Issued on Oct.
18, 2018
Defined by FDA
“Content of Premarket
Submissions for
Management of
Cybersecurity in
Medical Devices”
Final release is
still pending
Non-biding later
guidance is
advisable for use
Security requirements Draft guidance only 2014 version
applies for now
13. FDA requirements
13
Higher level of security if
1. Device connects to another product or
network (wired or wirelessly)
2. A cybersecurity incident could directly result
in harm to multiple patients
Tier 1
Standard security
Tier 2
15. Medical Devices Needing High Security,
Based on NIST Cybersecurity Framework
15
Tier 1 recommends the following:
Prevent unauthorized use
• Limit access to trusted users and devices only
• Authenticate and check authorization of safety-critical
commands
Ensure trusted content by maintaining
code, data, and execution integrity
Maintain confidentiality of data
Design the device to detect cybersecurity
threats in a timely fashion
A
B
C
Design the device to respond to
and contain the impact of a
potential cyber security incident
Design the device to recover
capabilities or services that
were impaired due to a cyber
security incident
E
D
F
16. 16
Cryptographic Verification and
Authentication
Secure Configuration
Cybersecurity BOM (CBOM)
Patches and Updates (Rapid verification,
validation testing, and deployment)
Autonomous Functionality
Session Time Out
Intrusion Detection System
Routine Security and Antivirus Scanning
Forensic Evidence Capture
Vulnerability Analysis
Breach Notification
Retention and Recovery
Other Resilience Measures
Other Tier 1 design recommendations include:
17. 17
but items may be ignored if a risk-based rational shows
they are not appropriate.
Tier 2 has the same recommendations,
18. 18
Separate from security, but you must have
security to meet HIPAA.
Patient data security is very serious.
HIPAA – Patient Data Privacy
19. HIPAA is focused on the user
HIPAA Requirements
19
Requires end-to-end security
• From device to database
• Physical access control at database
If data is transmitted without patient ID, no
privacy concern
• Match a code with the patient name at the database
20. CE Security Requirements
20
CE requirements are not as specific as FDA guidance,
but have similar requirements.
Devices must be safe, effective, and secure.
There is a focus on data protection (see GDPR),
which is more strict than U.S. patient data requirements.
Documents that apply:
• Annex I of the Medical Device Regulations (MDR)
• EN62304 on software
• EN14971 on hazard analysis
21. CE Security Required Practices
21
Security managementPractice 1
Specification of security requirementsPractice 2
Secure by designPractice 3
Secure implementationPractice 4
Security verification and validation testingPractice 5
Management of security-related issuesPractice 6
Security update managementPractice 7
Security guidelines - documentationPractice 8
22. 22
CE Security Requirements
It is the manufacturers’ responsibility to determine the
minimum requirements for the operating environment
as regards IT network characteristics and IT security
measures that could not be implemented through the
product design.
From MDCG 2019-16 Guidance on Cybersecurity for
medical devices
23. Elements to consider when adopting a
security-by-design approach
23
The only way to meet FDA
and CE requirements
Benefits:
Effective and early
security flaws removal
Built-in rather than
bolt-on security
Reduced risk of liabilityMore resilient systemsLower costs
24. How to do security by design?
24
Identify requirements
before starting
product design.
Be aware of
regulatory
requirements.
Design security
as part of the
product design.
Test to ensure
the requirements
are met.
25. Medical
wearable
design
Factors to keep in mind when designing
a medical wearable, Part 1
25
Choice of Technology
Are you building your wearables on proven technology?
Technology Weaknesses
Does the technology platform have known exploits?
System Design
Where are the risks in the system? Data at rest has different vulnerability
than data in flight.
Risk Assessment
Overall Risk should be broken down into individual items each with
risk and effort required.
Cryptography
What level of cryptography is needed? Too high requires more
power and more time
Encryption
Encryption is not just protecting the data with an encryption
algorithm. Key management is actually more important.
26. Medical
wearable
design
Factors to keep in mind when designing
a medical wearable, Part 2
26
Threat Detection
How can one detect a threat before any damage is done?
Penetration testing
Ethical hackers hired to attempt to attack a system.
Developers
Are they involved in threat modeling?
Are they aware of your organization's security-by-design practice?
Maintainability
Are requirements for maintainability and tools to measure it in place?
Privacy by Design
Is privacy included in your approach (HIPAA and GDPR)?
Further Improvements
How can you continuously improve device development?
Security will get more challenging during the life of the product.
27. Security By Design for
A Consumer Product
27
Product Feature:
XEEDA cryptocurrency hardware wallet and integrated app
Voler completed the challenging design
on-time and on-budget.
About the Product:
It allows for access, exchange, and management of bitcoins
and other digital currency assets directory from a smartphone.
About the Client:
XEEDA is a blockchain and transactions startup company.
28. Voler’s security by design at every step
of product development
28
Voler developed the device with very high security (EAL Level 5), using multi-factor
authentication and built-in biometric security features.
Fingerprint
sensor and
passcode
Other security features of cold storage cryptocurrency device:
Secure
microcontroller
for private keys
Encrypted links
within and
outside the unit
OLED display for secure
storage – password is not
displayed on the phone
29. Secure Microcontroller Features
29
Advanced Physical
Level Security that
wipes data upon tamper
True Random
Number Generator
AES, DES, and
SHA accelerators
Modulo Arithmetic
Accelerator for common
crypto algorithms
Secure Boot Loader -
allows only authorized
code to run on the
processor
Fault detection –
detects tampering
with the hardware
Supports EAL
level 5 security
30. Choosing Security
by Design
30
• Have you mapped your technical
and commercial requirements
against available technical
capabilities?
• There are many technologies with
widely varying capabilities, cost,
and availability.
• Voler can help select the right
security design for your device.
• We design medical, IoT, and
wearable devices.
31. Let Voler Help You Succeed!
Voler designs IoT and wearable devices with
expertise in wireless communication and sensors
•Walt Maclay, Voler Systems
•Walt@volersystems.com
•408-245-9844 ext 101
Quality Electronic Design & Software
Wearable Devices | Sensor Interfaces | Wireless | Medical Devices