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...
Due to advancement of technology and incorporation of sofrtwares and microchips, vulnerability increased for medical devices.
Outsiders are hacking the devices by advanced technologies.
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
Secure Your Medical Devices From the Ground Up ICS
The Food and Drug Administration (FDA) has recently released new guidance on cybersecurity for medical devices. This presentation will provide an overview of this guidance and review what is required for 510(k) submissions. We will also discuss the upcoming European Union (EU) cybersecurity regulations and how they compare to the FDA guidance.
This webinar with ICS and partner RTI, the largest software framework company for autonomous systems, will focus on threat modeling and cybersecurity risk assessments in light of the new guidance, and how these activities impact design requirements for medical devices. You will learn common pitfalls and mistakes to avoid when establishing organizational best practices in cybersecurity.
We will also discuss the challenges to securing data in motion for connected medical devices and describe how a data-centric software framework based on open standards, addresses the design requirements for highly reliable, scalable and secure systems.
Attendees will gain an understanding of the current regulatory expectations, best practices for cybersecurity risk assessments, and standards-based solutions for secure data connectivity.
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.
Introduction to Cybersecurity FundamentalsToño Herrera
This document provides an overview of cybersecurity fundamentals. It discusses key topics like the definition of cybersecurity and information security, protecting digital assets, risk management concepts, essential cybersecurity terminology, cybersecurity roles and responsibilities, and common threat agents. The goal is to give attendees an introduction to fundamental cybersecurity concepts.
Cybersecurity and Software Updates in Medical Devices.pdfICS
This document discusses cybersecurity and software updates in medical devices. It provides an overview of Integrated Computer Solutions (ICS) and the services it offers for medical device development. These include human factors engineering, software development, medical device cybersecurity, and software verification testing. The document also discusses Toradex and the Torizon platform it provides for over-the-air software updates in embedded systems. It notes regulations and standards driving new requirements for medical device cybersecurity and software updates. Finally, it discusses strategies for implementing secure software updates, including A/B updates, delta updates, container-based updates, and leveraging hardware encryption.
SOC and SIEM systems can help organizations detect and respond to security incidents and threats in a timely manner. A SOC acts as a security operations center to monitor, analyze, and respond to cybersecurity incidents. SIEM provides real-time analysis of security alerts and events to help identify potential threats. Implementing SOC and SIEM solutions can improve an organization's security posture through early threat detection, compliance with regulations, and reduced breach impact.
Due to advancement of technology and incorporation of sofrtwares and microchips, vulnerability increased for medical devices.
Outsiders are hacking the devices by advanced technologies.
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
Secure Your Medical Devices From the Ground Up ICS
The Food and Drug Administration (FDA) has recently released new guidance on cybersecurity for medical devices. This presentation will provide an overview of this guidance and review what is required for 510(k) submissions. We will also discuss the upcoming European Union (EU) cybersecurity regulations and how they compare to the FDA guidance.
This webinar with ICS and partner RTI, the largest software framework company for autonomous systems, will focus on threat modeling and cybersecurity risk assessments in light of the new guidance, and how these activities impact design requirements for medical devices. You will learn common pitfalls and mistakes to avoid when establishing organizational best practices in cybersecurity.
We will also discuss the challenges to securing data in motion for connected medical devices and describe how a data-centric software framework based on open standards, addresses the design requirements for highly reliable, scalable and secure systems.
Attendees will gain an understanding of the current regulatory expectations, best practices for cybersecurity risk assessments, and standards-based solutions for secure data connectivity.
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.
Introduction to Cybersecurity FundamentalsToño Herrera
This document provides an overview of cybersecurity fundamentals. It discusses key topics like the definition of cybersecurity and information security, protecting digital assets, risk management concepts, essential cybersecurity terminology, cybersecurity roles and responsibilities, and common threat agents. The goal is to give attendees an introduction to fundamental cybersecurity concepts.
Cybersecurity and Software Updates in Medical Devices.pdfICS
This document discusses cybersecurity and software updates in medical devices. It provides an overview of Integrated Computer Solutions (ICS) and the services it offers for medical device development. These include human factors engineering, software development, medical device cybersecurity, and software verification testing. The document also discusses Toradex and the Torizon platform it provides for over-the-air software updates in embedded systems. It notes regulations and standards driving new requirements for medical device cybersecurity and software updates. Finally, it discusses strategies for implementing secure software updates, including A/B updates, delta updates, container-based updates, and leveraging hardware encryption.
SOC and SIEM systems can help organizations detect and respond to security incidents and threats in a timely manner. A SOC acts as a security operations center to monitor, analyze, and respond to cybersecurity incidents. SIEM provides real-time analysis of security alerts and events to help identify potential threats. Implementing SOC and SIEM solutions can improve an organization's security posture through early threat detection, compliance with regulations, and reduced breach impact.
Operational technology (OT) and information technology (IT) security protect devices, networks, systems, and users. Cybersecurity has long been critical in IT and helps organizations keep sensitive data safe, ensure users connect to the internet securely, and detect and prevent potential cyberattacks.
This document provides an introduction to ISO/IEC 27000, which is a family of standards related to information security management systems (ISMS). It discusses why organizations implement ISO 27001 and become certified. Key points covered include how ISO 27001 provides a framework to manage information security risks, helps comply with legal/regulatory requirements, and can provide a competitive advantage for organizations. The document also distinguishes between IT security and information security, and covers basic concepts such as how ISO 27001 relates to asset management and risk assessment.
What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
Certified in Risk and Information Systems Control™ (CRISC™) is the most current and rigorous assessment which is presently available to evaluate the risk management proficiency of IT professionals and other employees within an enterprise or financial institute.
CRISC help enterprises to understand business risk, and have the technical knowledge to implement appropriate IS controls.
This CRISC Certification training course accredited by ISACA is ideal for IT professionals, risk professionals, control professionals, business analysts, project managers, compliance, professionals and more.
To know more about CRISC Certification training worldwide,
please contact us at -
Email: support@invensislearning.com
Phone - US +1-910-726-3695,
Website: https://www.invensislearning.com
The Stuxnet worm was designed to target Siemens industrial control systems used in Iran's uranium enrichment centrifuges. It spread to these systems through infected USB drives and exploited multiple Windows vulnerabilities. It then took control of centrifuges and varied their speeds, damaging around 1,000 centrifuges and slowing Iran's nuclear program. While not intended to spread beyond Iran, it ended up infecting systems in other countries as well through file transfers.
Information Security Committee Presentation Sampleoaes2006
The document summarizes the findings of an information security risk assessment conducted for a bank. It identified risks related to the disposal of used fax machine film cartridges containing confidential information. To address this issue, the committee analyzed options for replacing existing fax machines, destroying cartridges on-site at branches, or using a third party destruction service. Replacing fax machines with newer models that eliminate film cartridges would eliminate the risk but require an initial investment, while in-house or third party cartridge destruction would mitigate the risk but involve ongoing costs and require internal controls or reliance on an external vendor.
Integrating security into the development of an application or software is necessary to decrease its risk of susceptibility to attacks and exploits. Traditional methods of security testing were performed on a finished product. However, with the rise in the intensity and the number of attack vectors, it has become necessary for organizations to include it as a part of every phase of an SDLC.
THE FDA and Medical Device Cybersecurity GuidancePam Gilmore
The document discusses the FDA's guidance on medical device cybersecurity. It outlines that the FDA's scope goes beyond HIPAA and includes risk analysis for devices and networks. Researchers identified vulnerabilities in 300 medical devices in 2013. The FDA issued a safety communication in 2013 calling for cybersecurity safeguards for devices and networks. A risk analysis model for devices includes privacy, availability, authentication, integrity, non-repudiation and safety factors. Manufacturers must now include cybersecurity risk analyses and protections in device design submissions to the FDA and disclose security features through an industry standard form. Intrusion detection aims to identify unauthorized access attempts and advanced persistent threats can be detected through Splunk monitoring of foreign access attempts.
SOC presentation- Building a Security Operations CenterMichael Nickle
Presentation I used to give on the topic of using a SIM/SIEM to unify the information stream flowing into the SOC. This piece of collateral was used to help close the largest SIEM deal (Product and services) that my employer achieved with this product line.
This document provides an overview of cyber security and discusses recent issues in India. It begins with definitions of cyberspace and discusses the rapid growth of internet connectivity globally and in India. It then covers cyber security challenges, the evolution of threats, and recent cyber attacks impacting India. The document concludes with 10 steps for organizations to improve cyber security, such as network security, malware protection, user education, and information risk management.
Learn about threat modeling from our CTO and co-creator of the DREAD threat modeling classification, Jason Taylor. Understand more about what threat modeling is, dive into real life examples, and use techniques you can leverage at every phase of the SDLC.
Cybersecurity involves protecting information systems and networks from attacks, accidents, and failures. It aims to protect corporate and national operations and assets. Some key aspects of cybersecurity include user accounts, configuration management, contingency plans, mobile device security, and incident response. Common cyber threats include viruses, hackers, identity theft, and spyware/adware. Basic cybersecurity actions people can take include installing updates, running antivirus software, using firewalls, avoiding spyware, backing up files, and protecting passwords. Education about cybersecurity risks and proper security practices is important for users at home and work.
The document discusses internet security and proposes three key points:
1. The Obama administration proposed an international effort to bolster internet security as cyberspace has become both a communications tool and a potential security threat in the 21st century.
2. The internet has become integral to many aspects of modern life from banking and medical records to infrastructure and national security. However, this increased reliance on the internet also increases security risks.
3. Proper browser security settings can help prevent malware infections, protect personal information, and limit damage from cyber attacks by disabling potentially risky features like ActiveX controls and configuring privacy, history, and download options.
This document provides guidance for building an effective IT security awareness and training program as required by FISMA and OMB Circular A-130. It discusses key roles and responsibilities, components of an awareness and training program, and a lifecycle approach for designing, developing, implementing and evaluating such a program. The goal is to ensure all IT users understand security policies and responsibilities to protect systems and data.
This document discusses cyber resilience and provides guidance on developing a cyber resilience strategy. It defines cyber resilience as an organization's ability to continue operations despite adverse cyber events. The document recommends that organizations implement the five pillars of cyber resilience: prepare/identify, protect, detect, respond, and recover. For each pillar, it provides examples of specific activities organizations can undertake such as conducting risk assessments, implementing security controls, establishing incident response plans, and developing disaster recovery processes. The overall message is that cyber resilience requires a strategic, comprehensive approach across people, processes, and technologies to withstand various cyber threats.
Its is project based on one of the most interesting and wide topic of Computer Science, named Cyber Security
CONTENT :
1. What is Cyber Security
2. Why Cyber Security is Important
3. Brief History
4. Security Timeline
5. Architecture
6. Cyber Attack Methods
7. Technology for Cyber Secuirty
8. Development in Cyber Security
9. Future Trend in Cyber Security
William F. Crowe presented on the cybersecurity kill chain, which models the stages of a cyber attack based on military doctrine. The model developed by Lockheed Martin includes stages of reconnaissance, weaponization, delivery, exploitation, installation, command and control, and actions on objectives. ISACA and the European Union Agency for Network and Information Security also use similar kill chain models to analyze the process of advanced persistent threats targeting critical systems and data.
1) Employee training and awareness is a critical element for cybersecurity resilience. Successful programs focus on changing employee behavior and aligning security practices both inside and outside of work.
2) Traditional awareness programs often fail because they are not engaging for employees and do not lead to real behavior change. Effective programs treat security messaging like marketing and use multiple channels, contexts, and reminders to reinforce the message.
3) Measuring outcomes is important for security awareness programs. Objectives should be clearly defined and focused on discrete, measurable goals rather than vague concepts like "increasing awareness."
The term “wireless” in Industry 4.0 is not limited to only wireless communication; it is backed up by modern technologies such as the Internet of Things (IoT) and Cloud Computing for effective and robust system functionality. In the health and medical domain, medical devices are labeled as wireless medical devices when the device itself, or a part of the device, fulfills a health service using wireless communication protocols. Indeed, since patient care and safety are the highest priorities, these devices should follow FDA safety guidelines before they are released in the market...
Operational technology (OT) and information technology (IT) security protect devices, networks, systems, and users. Cybersecurity has long been critical in IT and helps organizations keep sensitive data safe, ensure users connect to the internet securely, and detect and prevent potential cyberattacks.
This document provides an introduction to ISO/IEC 27000, which is a family of standards related to information security management systems (ISMS). It discusses why organizations implement ISO 27001 and become certified. Key points covered include how ISO 27001 provides a framework to manage information security risks, helps comply with legal/regulatory requirements, and can provide a competitive advantage for organizations. The document also distinguishes between IT security and information security, and covers basic concepts such as how ISO 27001 relates to asset management and risk assessment.
What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.
This article explains what IEC 62304 is, when medical devices must comply with it and how IEC 62304 compliance is assessed.
Certified in Risk and Information Systems Control™ (CRISC™) is the most current and rigorous assessment which is presently available to evaluate the risk management proficiency of IT professionals and other employees within an enterprise or financial institute.
CRISC help enterprises to understand business risk, and have the technical knowledge to implement appropriate IS controls.
This CRISC Certification training course accredited by ISACA is ideal for IT professionals, risk professionals, control professionals, business analysts, project managers, compliance, professionals and more.
To know more about CRISC Certification training worldwide,
please contact us at -
Email: support@invensislearning.com
Phone - US +1-910-726-3695,
Website: https://www.invensislearning.com
The Stuxnet worm was designed to target Siemens industrial control systems used in Iran's uranium enrichment centrifuges. It spread to these systems through infected USB drives and exploited multiple Windows vulnerabilities. It then took control of centrifuges and varied their speeds, damaging around 1,000 centrifuges and slowing Iran's nuclear program. While not intended to spread beyond Iran, it ended up infecting systems in other countries as well through file transfers.
Information Security Committee Presentation Sampleoaes2006
The document summarizes the findings of an information security risk assessment conducted for a bank. It identified risks related to the disposal of used fax machine film cartridges containing confidential information. To address this issue, the committee analyzed options for replacing existing fax machines, destroying cartridges on-site at branches, or using a third party destruction service. Replacing fax machines with newer models that eliminate film cartridges would eliminate the risk but require an initial investment, while in-house or third party cartridge destruction would mitigate the risk but involve ongoing costs and require internal controls or reliance on an external vendor.
Integrating security into the development of an application or software is necessary to decrease its risk of susceptibility to attacks and exploits. Traditional methods of security testing were performed on a finished product. However, with the rise in the intensity and the number of attack vectors, it has become necessary for organizations to include it as a part of every phase of an SDLC.
THE FDA and Medical Device Cybersecurity GuidancePam Gilmore
The document discusses the FDA's guidance on medical device cybersecurity. It outlines that the FDA's scope goes beyond HIPAA and includes risk analysis for devices and networks. Researchers identified vulnerabilities in 300 medical devices in 2013. The FDA issued a safety communication in 2013 calling for cybersecurity safeguards for devices and networks. A risk analysis model for devices includes privacy, availability, authentication, integrity, non-repudiation and safety factors. Manufacturers must now include cybersecurity risk analyses and protections in device design submissions to the FDA and disclose security features through an industry standard form. Intrusion detection aims to identify unauthorized access attempts and advanced persistent threats can be detected through Splunk monitoring of foreign access attempts.
SOC presentation- Building a Security Operations CenterMichael Nickle
Presentation I used to give on the topic of using a SIM/SIEM to unify the information stream flowing into the SOC. This piece of collateral was used to help close the largest SIEM deal (Product and services) that my employer achieved with this product line.
This document provides an overview of cyber security and discusses recent issues in India. It begins with definitions of cyberspace and discusses the rapid growth of internet connectivity globally and in India. It then covers cyber security challenges, the evolution of threats, and recent cyber attacks impacting India. The document concludes with 10 steps for organizations to improve cyber security, such as network security, malware protection, user education, and information risk management.
Learn about threat modeling from our CTO and co-creator of the DREAD threat modeling classification, Jason Taylor. Understand more about what threat modeling is, dive into real life examples, and use techniques you can leverage at every phase of the SDLC.
Cybersecurity involves protecting information systems and networks from attacks, accidents, and failures. It aims to protect corporate and national operations and assets. Some key aspects of cybersecurity include user accounts, configuration management, contingency plans, mobile device security, and incident response. Common cyber threats include viruses, hackers, identity theft, and spyware/adware. Basic cybersecurity actions people can take include installing updates, running antivirus software, using firewalls, avoiding spyware, backing up files, and protecting passwords. Education about cybersecurity risks and proper security practices is important for users at home and work.
The document discusses internet security and proposes three key points:
1. The Obama administration proposed an international effort to bolster internet security as cyberspace has become both a communications tool and a potential security threat in the 21st century.
2. The internet has become integral to many aspects of modern life from banking and medical records to infrastructure and national security. However, this increased reliance on the internet also increases security risks.
3. Proper browser security settings can help prevent malware infections, protect personal information, and limit damage from cyber attacks by disabling potentially risky features like ActiveX controls and configuring privacy, history, and download options.
This document provides guidance for building an effective IT security awareness and training program as required by FISMA and OMB Circular A-130. It discusses key roles and responsibilities, components of an awareness and training program, and a lifecycle approach for designing, developing, implementing and evaluating such a program. The goal is to ensure all IT users understand security policies and responsibilities to protect systems and data.
This document discusses cyber resilience and provides guidance on developing a cyber resilience strategy. It defines cyber resilience as an organization's ability to continue operations despite adverse cyber events. The document recommends that organizations implement the five pillars of cyber resilience: prepare/identify, protect, detect, respond, and recover. For each pillar, it provides examples of specific activities organizations can undertake such as conducting risk assessments, implementing security controls, establishing incident response plans, and developing disaster recovery processes. The overall message is that cyber resilience requires a strategic, comprehensive approach across people, processes, and technologies to withstand various cyber threats.
Its is project based on one of the most interesting and wide topic of Computer Science, named Cyber Security
CONTENT :
1. What is Cyber Security
2. Why Cyber Security is Important
3. Brief History
4. Security Timeline
5. Architecture
6. Cyber Attack Methods
7. Technology for Cyber Secuirty
8. Development in Cyber Security
9. Future Trend in Cyber Security
William F. Crowe presented on the cybersecurity kill chain, which models the stages of a cyber attack based on military doctrine. The model developed by Lockheed Martin includes stages of reconnaissance, weaponization, delivery, exploitation, installation, command and control, and actions on objectives. ISACA and the European Union Agency for Network and Information Security also use similar kill chain models to analyze the process of advanced persistent threats targeting critical systems and data.
1) Employee training and awareness is a critical element for cybersecurity resilience. Successful programs focus on changing employee behavior and aligning security practices both inside and outside of work.
2) Traditional awareness programs often fail because they are not engaging for employees and do not lead to real behavior change. Effective programs treat security messaging like marketing and use multiple channels, contexts, and reminders to reinforce the message.
3) Measuring outcomes is important for security awareness programs. Objectives should be clearly defined and focused on discrete, measurable goals rather than vague concepts like "increasing awareness."
The term “wireless” in Industry 4.0 is not limited to only wireless communication; it is backed up by modern technologies such as the Internet of Things (IoT) and Cloud Computing for effective and robust system functionality. In the health and medical domain, medical devices are labeled as wireless medical devices when the device itself, or a part of the device, fulfills a health service using wireless communication protocols. Indeed, since patient care and safety are the highest priorities, these devices should follow FDA safety guidelines before they are released in the market...
Privacy and Security by Design Spotlight Presentation at HIMMS Privacy and Security Forum, December 5th 2016. Presented by Jeff R. Livingstone, PhD, Vice President and Global Lead, Life Sciences & Healthcare, Unisys Corporation.
Security and privacy issues with io t healthcare devicesZoe Gilbert
Read this blog to know the challenges that come with security and privacy with IoT healthcare devices be it unauthorized access, device hijack, privacy violations, so this write may help you understand the top ways to cope up with by analyzing the security, using a secured cloud platform.
Cybersecurity risks to medical devices and healthcare systems have increased due to greater connectivity of devices, software use, and data sharing. Recent incidents highlight vulnerabilities that could disrupt care, compromise data, or directly endanger patients if devices are attacked. Regulators and industry stakeholders must collaborate to address both security and safety issues through coordinated risk management and standards application over medical device lifecycles.
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.
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.
Finnish Information Security Cluster meeting on March 21st in Helsinki. IoT in healthcare and the various current and emerging cyber security risks IoT brings into healthcare environment, especially hospitals, and their security requirements and frameworks; includes some examples of dark web activity.
Medical Device Cybersecurity : A Regulatory PerspectiveJon Lendrum
The document summarizes a presentation on cybersecurity regulations for medical devices. It discusses how the FDA regulates cybersecurity through guidance documents and interpretations of quality system regulations, despite no explicit authority. The presentation reviews FDA recommendations for documenting cybersecurity in premarket submissions and debunks common myths. Senator Blumenthal introduced legislation to further require cybersecurity testing and transparency.
ybersecurity is an increasing
concern for many in the
medical cybersecurity and
information technology
professions. As computerized
devices in medical facilities
become increasingly networked
within their own walls and
with external facilities, the risk
of cyberattacks also increases,
threatening confidentiality,
safety, and well-being. This
article describes what health
care organizations and
imaging professionals should
do to minimize the risks.
The fda and byod mobile and fixed medical device cybersecurity[1]Pam Gilmore
The document discusses two recent FDA guidance documents around managing cybersecurity for medical devices. The first draft guidance from June 2013 proposes incorporating cybersecurity controls into medical devices connected via networks during the premarket review process. The second guidance from August 2013 encourages assessing risks of wireless technology in medical device design. The document provides an overview of considerations for medical device manufacturers and healthcare providers around cybersecurity processes like incident reporting and management. It also references external standards and guidelines relevant to medical device cybersecurity.
The document discusses two recent FDA guidance documents regarding cybersecurity for medical devices. The June 2013 guidance addresses cybersecurity controls that should be incorporated into medical devices connected via networks. The August 2013 guidance encourages risk assessments of wireless technology in medical device design. The document provides an overview of the guidance and considerations for medical device manufacturers and healthcare facilities for incident response and reporting of cybersecurity issues related to networked medical devices.
This document discusses improving the security of a health care information system. It begins by describing vulnerabilities in software applications and how connected systems can be exploited. The document then proposes a 3-tier architecture with encryption and file replication to strengthen security. Database backups and regular vulnerability checks are also recommended to defend the system from attacks and allow recovery of data. The goal is to develop a secure electronic health records system that protects sensitive patient information.
security and privacy for medical implantable devicesAjay Ohri
The document discusses security and privacy concerns for implantable medical devices (IMDs) as they increasingly incorporate wireless capabilities and coordination between devices. It presents a framework for balancing traditional goals of IMD design like safety and utility with new security and privacy goals. Some key tensions identified include restricting unauthorized access to device data and settings while still allowing necessary access in emergencies, and keeping IMD operations secure without compromising energy efficiency. The framework can help manufacturers and regulators address challenges from evolving IMD technologies.
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
Exploring Vulnerabilities and Attack Vectors Targeting Pacemaker Devices in H...IJCI JOURNAL
This technical paper investigates the vulnerabilities and potential threats posed by emerging technologies, specifically Bluetoothenabled patient pacemakers. With the advancements in healthcare technology, pacemakers now utilize Bluetooth connectivity for real-time monitoring and data transmission, offering patients and healthcare providers an important convenience. However, this technology also introduces significant security risks, leaving these life-sustaining devices susceptible to malicious attacks.
Through an in-depth analysis of existing research, real-life incidents, and vulnerabilities identified by experts in the field, this paper will underscore the critical vulnerabilities present in pacemaker systems. Examples, including findings from researchers such as Billy Rios, Jonathon Butts, and Marie Moe, demonstrate the potential severity of these vulnerabilities. From remote control manipulation to unauthorized access to sensitive medical data, the threats posed by these vulnerabilities are substantial and potentially life-threatening.
Moreover, this paper outlines advanced mitigation strategies essential for protecting patient pacemakers against these security risks. Recommendations include end-to-end encryption, whitelist device pairing, intrusion detection systems, and regular firmware updates, highlight the collaborative efforts required from patients, healthcare providers, and manufacturers to mitigate these risks effectively. This paper’s findings underscore the urgent need for robust cybersecurity measures in the design, implementation, and maintenance of pacemaker systems. Addressing these vulnerabilities is key for ensuring patient safety, maintaining privacy, and building trust in healthcare technology. The implications of this research extend beyond pacemaker security, emphasizing the broader importance of cybersecurity in medical devices and the importance of ongoing research and regulatory initiatives to protect patient health.
Part of the "2016 Annual Conference: Big Data, Health Law, and Bioethics" held at Harvard Law School on May 6, 2016.
This conference aimed to: (1) identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; (2) understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; (3) determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and (4) examine potential solutions (industry best practices, common law, legislative, executive, domestic and international) for better use of big data in health care and health research in the U.S.
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 2016 annual conference was organized in collaboration with the Berkman Center for Internet & Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.
Learn more at http://petrieflom.law.harvard.edu/events/details/2016-annual-conference.
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.
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...
This document proposes an e-health cloud solution to securely store patient health records and reports in the cloud. Previously, patient documents were stored physically taking up space and making it difficult to access old records. The cloud solution aims to address these issues by digitizing records and storing them securely in the cloud. This allows easy access to records from anywhere and saves space. The document discusses challenges with healthcare cloud computing like data security and privacy. It proposes using encryption and multi-factor authentication for cloud data and user access security.
Similar to Understanding Cybersecurity in Medical Devices and Applications (20)
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Understanding Cybersecurity in Medical Devices and Applications
1.
2. Understanding Cybersecurity in Medical Devices and Applications
1. Introduction
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.1
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. To ensure that medical devices, software, and applications (web
or mobile-based) are safe and effective before releasing them in the market, FDA mandates
Cybersecurity measures be implemented to protect against cyber-attacks. Also, the FDA mandates
that medical device manufacturers be compliant with the industry-accepted Cybersecurity
protocols.2
In this paper, we begin by specifying the vulnerabilities identified in the medical systems.
The vulnerabilities include the potential data access points which later might be identified by
patients, clinicians, device manufacturers, or cybersecurity/software engineers as the points of data
breaches. The later part of the paper discusses the recent attacks in the field of healthcare and
medical services. In the next key section of the paper, we provide the guidance methodologies for
pre and post device submission which includes the steps taken by the device manufacturers and
software engineers if they identify a threat in the system after the product is live, or if the system
has suffered a cyber-attack. The same section also includes the cybersecurity standards accepted
by the FDA. Before concluding the paper, we outline strategies that may be used to mitigate
Cybersecurity risks which also include the roles and responsibilities of device manufacturers,
patients, health care personnel, software developers, and the FDA to ensure data security and
patient safety.
2. Vulnerabilities in Medical Devices & Software Applications
Vulnerabilities can be defined as the data access points through which computer malware,
worms, or viruses can be injected. These malicious elements are small, scripted code snippets
which function to disrupt the normal functioning of a computing system, such as filling the server
with continuous iterative request calls, which overloads the server outside its handling capacity
and eventually crashes the machine. In some cases, these viruses may also function to block certain
functionalities like permanently changing device and system access passwords.
It is vital to understand the access points in medical devices and applications since
proactively securing and isolating them will prevent the very first step that is showcasing the data.
One of the platforms currently all applications and devices are migrating to is the Internet of Things
(IoT). In IoT, devices speak to one another via data transfer and automate the software process
with help of sensors and communication tools like Bluetooth, Radio Frequency (RF) Tools, Zigbee
3. [which is a communication tool for devices placed in proximity], LAN based networks, and in the
end, the Internet.
Bluetooth has revolutionized the way devices communicate and is actively used as a data
transfer tool in almost every computing device. But it is also one of the devices which makes the
entire system most vulnerable. If the latest Bluetooth firmware and updates are not installed, it
makes devices highly vulnerable as hackers can access these tools using a technique called
“Bluebugging”. If hackers access a Bluetooth-enabled device using Bluebugging, they have
complete control of the device. Such devices include examples like Bluetooth-based printers,
cameras, vehicles, and remotely controlled machines.3
Another major vulnerability is using information systems locally with outdated
technologies. Examples of information systems include Hospital Management Systems and data
repositories such as Blood Banks and Organ Preservation Repositories. If attackers get access to
one of these systems, they can relay attacks to other connected information systems. These attacks
may be induced by clicking malicious email links or keeping the system active without secured
sessions. One of the similar reasons for vulnerability is using old pieces of hardware, software,
middleware, and firmware.4
New or current devices may include frameworks to secure themselves
against the latest viruses, but with old systems installed, they may not even possess the mechanism
to understand new malware and viruses, which results in the system getting attacked and hampered
in terms of functionality.
3. Real Cases of Cyberattacks & FDA Concerns in Medical Devices and Applications
On June 18, 2018, the Fetal Diagnostic Institute of the Pacific was hit by a ransomware
attack which breached the data of 40,800 patients. An employee of Philadelphia-based Blue Cross
hospital exposed online the data of 16,762 patients by uploading the patient data file to a public
website. In Orlando, at the Orlando Orthopedic Center, a third-party software upgrade resulted in
exposing data of 19,101 patient records for two months. A Missouri-based Blue Springs Family
Care stated that they suffered a data breach of 44,979 patient records after hackers peppered the
provider with a variety of malware, including ransomware.6
In 2020, Netwalker, a ransomware
operator that threatens to publish data online if ransoms aren't paid, hacked Springfield, Pa.-based
Crozer-Keystone Health System and tried to auction it’s data online. Houston based Harris Health
System reported the loss of 2,298 patient records. In June 2020, the Florida orthopedic group was
hit with a $99M lawsuit due to personal patient data exposure because of a malware attack.5
The
most recent incident recorded was by the University of California San Francisco stating they paid
$1.14 million to hackers after a June 1, 2020 ransomware attack on servers blocked access to their
medical school's computer systems.6
In 2013, the FDA started observing and reporting cybersecurity concerns in medical
devices and applications. In the 2020 safety communication section, FDA posted the case of the
“SweynTooth” vulnerabilities which are 12 risks identified in Bluetooth Low Energy-based
devices that may crash the device, add interference in working, or allow access to an unauthorized
user. The manufacturers affected by such attacks include Texas Instruments, NXP, Cypress, and
many more. In January 2020, the FDA raised awareness in GE’s Healthcare Clinical Information
Central Stations and Telemetry Servers which are used mainly in health care facilities for
displaying information, such as the physiologic parameters of a patient (temperature, heartbeat,
blood pressure), and monitoring patient status from a central location. In October 2019, 11
4. vulnerabilities, named “URGENT/11” were recorded by a security firm in the third-party off-the-
shelf software component IPnet, a tool that supports network communications between computers.
These vulnerabilities may allow anyone to remotely take control of the medical device and change
its function, causing a denial of service, or causing information leaks with logical flaws. The FDA
also expressed concerns for the Medtronic MiniMed insulin pumps (unauthorized access through
the wireless network to control pump activities, June 2019), Medtronic cardiac implantable
cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) (
they do not use any kind of encryption, authorization, or authentication which may lead to
unauthorized access)7
, and Abbott’s implantable cardiac pacemakers (unauthorized access to
program commands in the implanted pacemaker, August 2017).8
Even though device manufacturers and software engineers are always working on patches,
which are programs developed to repair software components, device manufacturers are now
engaging in proactive activities and using frameworks to secure devices and applications based on
the history of cybersecurity attacks and the concerns expressed by the FDA. The following section
describes the standard Cybersecurity protocols and frameworks that device manufacturers should
meet to be compliant with the FDA regulatory requirements.
4. Cybersecurity Protocols Recommended by the FDA
There are specific standards given by the International Organization for Standardization (ISO),
International Electrotechnical Commission (IEC), and the Association for the Advancement of
Medical Instrumentation (AAMI) that the FDA approves and encourages developers to utilize
while implementing a Cybersecurity framework. The selected framework should meet these
standards, which should also be documented during the pre-market submission for FDA approval.
Some of the standards include:
4.1 ISO/IEC 81001-1 and IEC 80001-5-12
ISO/IEC 81001-1 relates to the Health software and health IT systems safety, effectiveness, and
security – Part 1: Foundational principles, concepts, and terms, and IEC 80001-5-1 relates to the
Safety, effectiveness, and security in the implementation and use of connected medical devices or
connected health software – Part 5: Security – Part 5-1: Activities in the product lifecycle.
Both standards provide the terminology and an in-depth definition of components while designing
a healthcare system. ISO/IEC 81001-1 provides the definitions for significant actors and
components in the software lifecycle process including customer, developer, hazard, hazard
management, residual risk (risk remaining after risk control), risk management, control,
assessment, root cause, vulnerability, and weakness. The terminologies given by this standard can
be used as a reference mechanism while designing and implementing a Cybersecurity framework.
IEC 80001-5-1 provides the actual measures that manufacturers should include in the designing,
development, verification, and validation phases.
4.2 IEC 60601-4-5 Guidance and interpretation – Safety-related technical security
specifications for medical devices2
The standard family IEC 60601 is mostly applicable to medical electrical devices with IEC 60601-
4-5 being an exception. This standard applies to all medical products that are integrated into IT
5. networks, affecting Software as a Medical Device (SaMD). The standard provides three types of
security level (SL) requirements:
• SL-T: The Target Security Level - for medical devices and networks to achieve the set
protection goal.
• SL-C: The Capability Security Level – for medical devices and networks while improving
IT security.
• SL-A: The Achieved Security Level, the level one achieves.
At each security level, IEC 60601-4-5 proposes five levels, from SL 0 (nothing implemented) to
SL 4, the highest level. The security levels help control the requirements and expenses of IT
security. The following table provides an example of the mapping between the aspects of security
requirements and the corresponding security levels:
Security Requirements SL0 SL1 SL2 SL3 SL4
VPNs No No Yes Yes Yes
Basic Form/ Interface Validation Yes Yes Yes Yes Yes
User Authorization No Yes Yes Yes Yes
Multi-factor Authentication at all Points No No No Yes Yes
Role-based Authorization No No Yes Yes Yes
Malware/ Virus/ Ransomware Protection No Yes Yes Yes Yes
Table 1: An example specifying the mapping between the security requirements and the
security levels.9
4.3 IEC 62304 Medical device software – Software life cycle processes2
This standard provides a framework of life cycle processes with activities and tasks necessary for
the safe design and maintenance of medical device software. Also, it provides requirements for
each life cycle process. Each life cycle process is further divided into a set of activities, with
most activities further divided into a set of tasks. The major addition given by this standard to the
previously developed standards for developing safe medical software is providing the processes
for software configuration management and software problem resolution.
4.4 The Secure Product Design Life Cycle – Best Practices for Device Manufacturers2
Utilizing practices developed in IEC 62443-4-1 Product Development Requirements, IEC 62443-
4-2 Technical Security Requirements for industrial control system components, and IEC 61508
Functional safety of electrical/electronic/programmable electronic safety-related systems, medical
device manufacturers can leverage these standards from the design to the deployment stage. These
standards emphasize on the design phase, verification, and testing phases.
6. Fig 1. The Secure Product Design Life Cycle
4.5 AAMI TIR97/Ed. 1, Principles for medical device security – Post-market security
management for device manufacturers2
This Technical Information Report (TIR) based protocol addresses post-market security risk
management within the risk management framework defined by ANSI/AAMI/ISO 14971. While
it is based on the ANSI/AAMI/ISO 14971 framework for medical device risk management, most
of the concepts apply to any healthcare product that requires post-market management of security.
With this protocol, manufacturers can set up a system or enterprise level process to manage
security. Also, this protocol provides a way of performing post market interactions with users.
Other functionalities include creating post-market management security risk design features,
integrating with Health Care Delivery Organizations (HDOs) security components like their
policies and technologies, and relaying manufacturer’s safety requirements to medical devices
deployment team. Moreover, using this protocol, manufacturers can provide processes for:
• Monitoring devices with new vulnerabilities
• Take appropriate actions after assessing safety and security risks
• Develop vulnerability disclosure processes and implement security patch management
• Develop plans for device replacement and retirement.10
4.6 AAMI SW96/Ed. 1, Medical Devices – Application of security risk management to
medical devices2
This standard is being developed based on the AAMI TIR97. Even though this project has been
approved, it is currently on hold due to the development of AAMI TIR97.
5. Pre and Post Market Submission Guidance
5.1 Pre-market Submission Guidelines
7. The Pre-market submission FDA guidelines emphasize the “Level of Concerns”. These levels
indicate the level of risks associated with a device or a software system. FDA recommends that
these levels should be determined before the mitigation of any identified relevant hazards. The
concern levels include Major (Results in serious injury or death), Moderate (May result in minor
injury), or Minor (Minimal functional effect). Also, device manufacturers should describe how
they selected a specific level of concern. At every stage, each document shall address these levels
of concerns associated with potential risks in the system.
• Documentation based on Minor, Moderate, and Major Concerns: Level of Concern
document, Software Description, Device Hazard Analysis, Traceability Analysis, and
Revision Level History
• Documentation based on Moderate and Major Concerns: Architectural Design Chart,
Software Design Specification (SDS), Software Development Environment Description,
List of remaining software anomalies (Bugs or Defects) annotated with an explanation of
the impact on safety or effectiveness, including operator usage and human factors.
• Software Requirements Specification (SRS): For Minor Level: Summary of functional
requirements from SRS. For Moderate/ Major Level: Complete SRS document.
• Verification and Validation: For Minor Level: Software functional test plan, pass/fail
criteria, and a summary of the test results. For Moderate/ Major Level: Description of V&V
activities at the unit, integration, and system level. System-level test protocol for Moderate
Concern. Unit, integration, and system-level test protocols for Major Concern.8
Moreover, manufacturers should establish design inputs for their device related to
cybersecurity and establish a cybersecurity vulnerability and management approach as part of the
software validation and risk analysis that is required by 21 CFR 820.30(g). The approach should
appropriately address the following elements: Identification of assets, threats, and vulnerabilities,
assessment of the impact of threats and vulnerabilities on device functionality and end
users/patients, Assessment of the likelihood of a threat and vulnerability being
exploited, determination of levels of concerns and suitable mitigation strategies, assessment of
residual risk, and risk acceptance criteria.
5.2 Post-market Submission Guidelines
As medical devices and applications evolve, so do the risks associated with them. Hence, it is
not always possible to completely mitigate the risks only by using premarket controls.
Cybersecurity risk management programs should focus on addressing vulnerabilities that avoid
unauthorized access or the unauthorized use of information that is stored, accessed, or transferred
from a medical device to an external recipient, resulting in patient harm.
Manufacturers should be proactive when they identify vulnerabilities. When the product is
running, manufacturers should implement measures including identifying sources of
vulnerabilities, monitor third party-software for new risks, and use a robust software lifecycle.
Additionally, they should subject the updates and patches built for risk mitigation through the
verification and validation phases. Also, they should establish a sophisticated process for
vulnerability handling. Besides accepted protocols, the FDA recommends that manufacturers use
the ISAO (Information Sharing and Analysis Organization) platform and standards to share threats
that affect the running medical devices. Sharing and spreading of such cybersecurity information
about vulnerabilities results in a successful post-market cybersecurity surveillance program.8
8. To manage post-market cybersecurity risks for medical devices, the key measures are risk
management and quality management systems which are compliant with 21 CFR part 820. Also,
the FDA recommends using a strong framework like NIST for Improving Critical Infrastructure
Cybersecurity which has a significant data flow for identifying and mitigating risks: Identity,
Protect, Detect, Respond, and Recover.11
6. Cyber Risks Mitigating Measures
In the early stages of development, medical device manufacturers should always select a
Cybersecurity framework that identifies components that could potentially cause data breaches. A
framework like NIST, which identifies risks and protects system against malicious data elements,
responds and recovers after system has undergone attack. Also, with cybersecurity researchers,
they should include the designed framework in every software development phase. While
capturing the system’s functional and security requirements, manufacturers should ensure their
system meets FDA’s device and software regulatory requirements.
For information systems, the security measures can be initiated by maintaining a centralized
entity that performs profile access and identity management. Additionally, systems would be more
secure if the access is designed using multi-layered models like VPNs, multifactor, or token-based
authentication. The information system mitigation part also includes designing a sophisticated
employee training program, with logging and third-party assessment tools that provides
information on links where users might have exposed the data. Manufacturers and software
engineers should implement an extensive cyber-risks mitigation plan for overall data and system
privacy and security.12
In the end, manufacturers should monitor third-party software components for new
vulnerabilities throughout the product’s lifecycle, report issues to FDA or Homeland Security in
case of new vulnerabilities, and also identify design verification and validation strategies for
software updates that are used to remediate vulnerabilities, including those related to Off-the-shelf
software. Major responsibilities fall on medical device manufacturers (MDMs) and health delivery
organization (HDOs) when it comes to mitigating cyber-risks and vulnerabilities. MDMs should
be vigilant about new or old risks and hazards associated with their devices. HDOs should
implement measures for protecting their information systems and network with the latest available
cybersecurity frameworks. Both entities should add mechanisms for ensuring complete system
security including device safety, quality and effectiveness.8
For any observed anomalies, it is
mandatory for manufacturers and facility personnel to submit device reports to the FDA. Reports
maybe also submitted voluntarily by patients, consumers, and healthcare professionals.13
7. Conclusion
Platforms like IoT facilitate abilities such as continuous health monitoring and device
control. But with recent developments in medical devices and applications, the flow of the data
through public domains is increasing, making the system vulnerable. Indeed, devices which do not
implement authorization, data encryption and authentication are highly vulnerable. Hence,
Cybersecurity becomes a vital factor to be considered as a part of system and data security. Based
on the past cybersecurity attacks and the concerns stated by FDA, there are tons of modern
Cybersecurity frameworks available in the market. Also, FDA has provided several protocols
which device manufacturers can implement in their systems through which they will meet the FDA
9. Cybersecurity requirements. With protocols like IEC 60601-4 implemented in the system, FDA
would consider the device to be robust and fault tolerant against the malware and ransomware
attacks, thus securing the system.
Our company, EMMA International, specializes in quality, regulatory, and compliance
solutions and services which also include providing the right guidance for including the correct
Cybersecurity frameworks, or verifying if the implemented Cybersecurity model meets the FDA
standards. If you have a medical device, or an application with Cybersecurity needs, our regulatory
and software experts can help ensure your device is FDA compliant. Call us today at 248-987-
4497 or email us at info@emmainternational.com for more information.
10. Bibliography
1
Danny Palmer (Nov 2018) IoT security: Why it Will Get Worse Before It Gets Better. Retrieved on 09/19/2020
from https://www.zdnet.com/article/iot-security-why-it-will-get-worse-before-it-gets-better/.
2
FDA. (2019) FDA Selection of Cybersecurity-related Standards in Development for Medical Devices. Retrieved
on 09/19/2020 from https://www.fda.gov/media/123070/-
download#:~:text=IEC%2062304%20is%20a%20foundational,and%20provide%20clarity%20for%20users.
3
Danny Palmer (June 2019) Cybersecurity: These are the Internet of Things Devices that are Most Targeted by
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