Breakout Session: Cybersecurity in Medical DevicesHealthegy
Presentation by PwC at Medtech Conference 2016.
Participant:
Geoff Fisher, Director – PwC
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Healthegy
For more healthcare innovation
Visit us at Healthegy.com
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.
Due to advancement of technology and incorporation of sofrtwares and microchips, vulnerability increased for medical devices.
Outsiders are hacking the devices by advanced technologies.
Medical Device Security: State of the Art -- NoConName, Barcelona, 2011 shawn_merdinger
High level overview of current security issues in medical device security, what is being hacked by security researchers, who are the major security players, hacking predictions, FUD vs. Reality.
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
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.
Due to advancement of technology and incorporation of sofrtwares and microchips, vulnerability increased for medical devices.
Outsiders are hacking the devices by advanced technologies.
Medical Device Security: State of the Art -- NoConName, Barcelona, 2011 shawn_merdinger
High level overview of current security issues in medical device security, what is being hacked by security researchers, who are the major security players, hacking predictions, FUD vs. Reality.
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.
Medical device security presentation - Frank SiepmannFrank Siepmann
Since I am not presenting (due to personal reasons) at the Medical Device Security conference 25/26 July 2016 in Arlington, VA I thought I post my slides about the current problems with Medical Device security and what can be done on a tactical level and what is needed at a strategic level.
Let Medigate inventory all of your connected devices, assign them clinically-based risk scores, generate risk assessment reports, and provide actionable remediation and mitigation insights to keep your patients, PHI and network safe. Learn more: Let Medigate inventory all of your connected devices, assign them clinically-based risk scores, generate risk assessment reports, and provide actionable remediation and mitigation insights to keep your patients, PHI and network safe. Learn more: https://www.medigate.io/
EU cybersecurity requirements under current and future medical devices regula...Erik Vollebregt
Presentation delivered at Q1 MEDICAL DEVICE CYBERSECURITY RISK MITIGATION conference in Washington on 25 July 2016 concerning EU cybersecurity requirements under current and future medical devices regulation
Nearly one in five healthcare CIOs have had a security breach within the past 12 months. Learn how TCS can help you keep sensitive patient data secure and protected.
DR. STEVEN GORIAH,
Vice President of Information Technology & CISO
Westchester Medical Center Health Network
The U.S Healthcare system is seeing a
staggering amount of security breaches each
year. In this session, you’ll learn about the role
of a cybersecurity framework, best practices in
choosing a framework, and which framework
best fits your organization and why. Dr. Goriah
will also speak on implementation, roles and
responsibilities and why it's essential to create
a culture of privacy and security
One of the main objective of HIPAA (Health Insurance Portability and Accountability Act) legislation is to provide data privacy and security provisions for safeguarding medical information. It requires healthcare organizations to ensure that applications are secure, and sensitive patient data is protected when in use, during transmission or when stored in a mobile device
Security for Healthcare Devices - Will Your Device Be Good Enough?Rio Valdes
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
Meaningful Use and Security Risk AnalysisEvan Francen
Presentation delivered by FRSecure president, Evan Francen to the 100+ Iowa CPSI User Group attendees on October 18th, 2011.
Meaningful Use Core Requirement "Security Risk Analysis"
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...
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.
Speeding up Healthcare Application with HTTP/2CitiusTech
Healthcare data is being increasingly accessed over the public internet. With the rapid adoption of EHRs and patient portals, more and more healthcare technology providers are looking at providing the same features over the internet in a SaaS model to reduce feature to market time. As they embrace trends and begin supporting new use cases such as wearables, mobile health, AI and chat bots, more data gets transferred over the same public internet infrastructure
Secondly, there is a pressing need to optimize the time healthcare professionals spend on IT per patient instead of patient care. Hence, getting timely and accurate information is of utmost importance to ensure better patient care.
Patient engagement initiatives such as patient education, medication and visit reminder, positively impact patient outcomes and are a huge success if the applications built for the same provide seamless user experience. Internet based applications rely on HTTP. As web application became more prevalent, inefficiencies of HTTP need to be addressed. HTTP/2 (Hypertext Transfer Protocol Version 2) is the update to HTTP protocol that has been built with the aim of improving performance and reducing end user perceived latency, reducing network and server resource usage.This document introduces the features and benefits of HTTP/2 and how you can start using HTTP/2
Presentations that briefly covers HIPAA and concentrates of the Risk Assessment portion which is a requirement for overall compliance and meaningful use.
Data Breaches and Security: Ditching Data Disasters-Michael McNeil, Philips H...IT Network marcus evans
Michael McNeil, Global Product Security & Services Officer, Philips Healthcare delivered his presentation entitled Data Breaches and Security: Ditching Data Disasters at the marcus evans CIO Summit 2016 in Los Angeles, CA
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.
Medical device security presentation - Frank SiepmannFrank Siepmann
Since I am not presenting (due to personal reasons) at the Medical Device Security conference 25/26 July 2016 in Arlington, VA I thought I post my slides about the current problems with Medical Device security and what can be done on a tactical level and what is needed at a strategic level.
Let Medigate inventory all of your connected devices, assign them clinically-based risk scores, generate risk assessment reports, and provide actionable remediation and mitigation insights to keep your patients, PHI and network safe. Learn more: Let Medigate inventory all of your connected devices, assign them clinically-based risk scores, generate risk assessment reports, and provide actionable remediation and mitigation insights to keep your patients, PHI and network safe. Learn more: https://www.medigate.io/
EU cybersecurity requirements under current and future medical devices regula...Erik Vollebregt
Presentation delivered at Q1 MEDICAL DEVICE CYBERSECURITY RISK MITIGATION conference in Washington on 25 July 2016 concerning EU cybersecurity requirements under current and future medical devices regulation
Nearly one in five healthcare CIOs have had a security breach within the past 12 months. Learn how TCS can help you keep sensitive patient data secure and protected.
DR. STEVEN GORIAH,
Vice President of Information Technology & CISO
Westchester Medical Center Health Network
The U.S Healthcare system is seeing a
staggering amount of security breaches each
year. In this session, you’ll learn about the role
of a cybersecurity framework, best practices in
choosing a framework, and which framework
best fits your organization and why. Dr. Goriah
will also speak on implementation, roles and
responsibilities and why it's essential to create
a culture of privacy and security
One of the main objective of HIPAA (Health Insurance Portability and Accountability Act) legislation is to provide data privacy and security provisions for safeguarding medical information. It requires healthcare organizations to ensure that applications are secure, and sensitive patient data is protected when in use, during transmission or when stored in a mobile device
Security for Healthcare Devices - Will Your Device Be Good Enough?Rio Valdes
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
Meaningful Use and Security Risk AnalysisEvan Francen
Presentation delivered by FRSecure president, Evan Francen to the 100+ Iowa CPSI User Group attendees on October 18th, 2011.
Meaningful Use Core Requirement "Security Risk Analysis"
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...
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.
Speeding up Healthcare Application with HTTP/2CitiusTech
Healthcare data is being increasingly accessed over the public internet. With the rapid adoption of EHRs and patient portals, more and more healthcare technology providers are looking at providing the same features over the internet in a SaaS model to reduce feature to market time. As they embrace trends and begin supporting new use cases such as wearables, mobile health, AI and chat bots, more data gets transferred over the same public internet infrastructure
Secondly, there is a pressing need to optimize the time healthcare professionals spend on IT per patient instead of patient care. Hence, getting timely and accurate information is of utmost importance to ensure better patient care.
Patient engagement initiatives such as patient education, medication and visit reminder, positively impact patient outcomes and are a huge success if the applications built for the same provide seamless user experience. Internet based applications rely on HTTP. As web application became more prevalent, inefficiencies of HTTP need to be addressed. HTTP/2 (Hypertext Transfer Protocol Version 2) is the update to HTTP protocol that has been built with the aim of improving performance and reducing end user perceived latency, reducing network and server resource usage.This document introduces the features and benefits of HTTP/2 and how you can start using HTTP/2
Presentations that briefly covers HIPAA and concentrates of the Risk Assessment portion which is a requirement for overall compliance and meaningful use.
Data Breaches and Security: Ditching Data Disasters-Michael McNeil, Philips H...IT Network marcus evans
Michael McNeil, Global Product Security & Services Officer, Philips Healthcare delivered his presentation entitled Data Breaches and Security: Ditching Data Disasters at the marcus evans CIO Summit 2016 in Los Angeles, CA
Cloud Platform for Remote Patient Monitoring. Case: Stroke Remote Care.pselonen
Presentation at AI morning in April 13th at Tampere University of Technology Kampusklubi.
"AI Morning in April 13th experiments with a new distinctive concept and remixes together machine learning and analytics in the two verticals of healthcare and industry! There is a huge common ground in diagnostics of people and machines, and the same algorithms can be used in both. The presenters from healthcare and industry keynote a conversational networking forum in theme: 'Health: analytics'."
See http://www.aiaamu.fi/
HXR 2017: Bakul Patel: How the FDA Is Promoting Innovation and Protecting the...HxRefactored
Health care entrepreneurs have described the FDA as a barrier to the market. Most of the time companies do not know when the FDA is regulating their app, device, or software. With new hands-off policies instituted to promote innovations to the market, Bakul will provide insights on the FDA's plans to regulating health technology as well as protecting the patients who are using the products.
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Perficient, Inc.
Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors and CROs in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.
Perficient's Chris Wocosky, an expert in signal detection and management, shows how your organization can use Empirica Signal, Oracle's state-of-the-art signal detection system to data mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. This presentation and demonstration willhelp you bettter understand how this solution can be used in daily pharmacovigilance activities.
Computer Software Assurance (CSA): Understanding the FDA’s New Draft GuidanceGreenlight Guru
Understand the FDA's new draft guidance on Computer Software Assurance (CSA).
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Reforming Medical Device approval processes especially in software requires careful consideration of shifting risks to patients without adequate protections.
Design Considerations to Maximize Medical Device Cloud ConnectivityGreenlight Guru
Medical device manufacturers are faced with a myriad of design decisions during product development. Several key decisions affecting market readiness must be addressed between bench-top prototypes and initiation of clinical trials. Among the most important are cloud connectivity considerations surrounding firmware, hardware, and use cases. The earlier cloud connectivity factors are identified, considered, and integrated into the design process, the more successful the resulting commercial roll-out in terms of cost, certification, and market acceptance.
• Key design factors medical device manufacturers should consider
• Advantages of considering connectivity early in the design process
• Practical use-case examples highlight more cost-effective clinical trials, wider market acceptance, and reduction in operational costs
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Usability Validation Testing of Medical Devices and SoftwareUXPA Boston
The U.S. FDA and international regulatory bodies require usability testing of medical devices, products, software, and systems as part of their overall validation. Manufacturers must demonstrate that all potential use-related hazards have been identified, prioritized, and mitigated. The method for demonstrating this is human factors/usability engineering (HF/UE) validation testing. However, the way we conduct these studies is in many ways different from the way we conduct studies of non-medical products and systems.
This topic is relevant to the Boston UX community given the convergence of consumer and medical devices, as well as the rise of wearable technologies and the apps that interact with them. This presentation will cover the key aspects of HF/UE validation (a.k.a. ‘summative’) testing and what the FDA expects in the final HF/UE summary report.
Importantly, this session will consist of half presentation and half Q&A, with the audience driving the discussion toward current issues, questions, and challenges that are relevant to them.
A recent survey commissioned by Synopsys was designed to understand the risks to clinicians and patients due to insecure medical devices. The resulting report identified some expected findings, but others were extremely surprising. For instance, 67% of medical device manufacturers and 56% of healthcare delivery organizations believe an attack on a medical device built or in use by their organization is likely to occur over the next 12 months. Join Larry Ponemon of the Ponemon Institute and Mike Ahmadi of Synopsys as they discuss report highlights. They provide insight and predictions regarding the future of security in the medical device and healthcare industries.
Doug Copley presented on cybersecurity challenges in healthcare including threats, trends in healthcare, practical steps and building security without boundaries.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
Under Pressure : Kenneth Kruk's StrategyKenneth Kruk
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Cold Sores: Causes, Treatments, and Prevention Strategies | The Lifesciences ...The Lifesciences Magazine
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The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
Trauma Outpatient Center is a comprehensive facility dedicated to addressing mental health challenges and providing medication-assisted treatment. We offer a diverse range of services aimed at assisting individuals in overcoming addiction, mental health disorders, and related obstacles. Our team consists of seasoned professionals who are both experienced and compassionate, committed to delivering the highest standard of care to our clients. By utilizing evidence-based treatment methods, we strive to help our clients achieve their goals and lead healthier, more fulfilling lives.
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2. The Problem
• More and more Medical Devices are
being designed to be networked
with other patient care systems
Ø Networked devices include software that may
be vulnerable to cybersecurity threats
• Safety and Effectiveness Impact
• Risk to Public Health
Ø
3. The Impact
• Compromised Device Functionality
• Loss of Data Availability or Integrity
Ø Medical
Ø Personal
• Exposure of other connected devices
or networks to security threats
Ø All of the above may lead to potential patient
illness, injury, or death
4. Scope
• Software containing Medical Devices
• Software that is a Medical Device
Note: Guidance Not Applicable to Experimental or Investigational
Devices
5. The Solution - FDA’s
Expectation
• Holistic
Ø Includes the entire Product Lifecycle of the device
– from conception to obsolescence
• Not just a point-in-time intervention
Ø Continual monitoring, including post market
Ø E.g. Monitoring vulnerabilities inadvertently
introduced during patch releases
• Device Manufacturers responsible
Ø Proactive, not reactive, posture expected from
manufacturers
Ø Active, voluntary participation in an ISAO
ISAO: Information Sharing Analysis Organizations, per Executive
Order # 13691, released 13th Feb 2015
6. FDA’s Guidance
• Cybersecurity for Networked Medical
Devices containing OTS Software
Ø Jan 14, 2005
• Content of Premarket Submissions for
Management of Cybersecurity in
Medical Devices
Ø Oct 2, 2014
• Post Market Management of
Cybersecurity in Medical Devices
(Draft)
Ø Jan 22, 2016
Purchasing
Post market
monitoring
Design
7. Key Themes
• Collaboration
• ISAO Participation
• Shared Responsibility
Ø Cognate terms for collaboration and sharing occur
24 times in the document
• Proactive approach
• Risk based approach
• Essential Clinical Performance
Ø This term occurs 58 times in the document
Ø Idea borrowed from IEC 60601-1, but ‘clinical’
added in this document
You approach your
cybersecurity program with
this…
…to preserve
this.
15. End Note
• The NIST Framework is mentioned here at
the very highest level
• The purpose of its mention is to simply
raise an awareness
• A separate slide deck is warranted to
delve deeper into what it is and how it
can be implemented
• Individuals are encouraged to ask
questions or provide comments on the
FDA guidance on post market
management of cybersecurity in medical
devices until April 21st of 2016
Editor's Notes
1
2
3
4
Software includes firmware and/orprogrammable logic
5
6
Implications are:responsible purchasing, recognizing cybersecurity issues up front; Cybersecurity as a design consideration; and continual ongoing monitoring of patches post market