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.
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...
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.
Medical technologies and data protection issues - food for thoughtRenato Monteiro
Document prepared towards the modernization procedure of Council of Europe´s Convention 108 on the Protection of Personal Data. Available at: http://www.coe.int/t/dghl/standardsetting/dataprotection/TPD_documents/T-PD-BUR%282014%2904Rev%20-%20Medical%20Data%20%28By%20Renato%20Leite%29.pdf
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.
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.
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...
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.
Medical technologies and data protection issues - food for thoughtRenato Monteiro
Document prepared towards the modernization procedure of Council of Europe´s Convention 108 on the Protection of Personal Data. Available at: http://www.coe.int/t/dghl/standardsetting/dataprotection/TPD_documents/T-PD-BUR%282014%2904Rev%20-%20Medical%20Data%20%28By%20Renato%20Leite%29.pdf
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.
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.
SaMD or Software as a Medical Device can be described as a software constructed to be used in medical devices. These softwares can be run on different operating systems and virtual platforms.
1. The basic programming model of a SaMD is given below.
2. Different softwares are used for medical purposes, and they include the following:
To continue Reading : https://bit.ly/31ItRVc
Contact Us:
Website : https://bit.ly/2BvO06b
Email us: sales.cro@pepgra.com
Whatsapp: +91 9884350006
Post Market Surveillance: If a Device is FDA Cleared or Approved, or EU CE Ma...Greenlight Guru
When a medical device is FDA Cleared/Approved or EU CE Marked, can we assume it’s safe and effective? In a word... NO! Post-market surveillance (PMS) is the process of watching devices perform while on the market. PMS is a vital component of the medical device lifecycle. Yet the med-tech industry has had a poor record when it comes to PMS. As a result, PMS requirements have been increasing in the US, the EU and around the globe.
Having an effective PMS system is important from both a regulatory and quality perspective. But can we assume if our PMS system meets the regulatory and quality requirements, that its effective? that its working? Absolutely not! This presentation will use the case study approach to take a broad look at medical device post-market surveillance including:
• What are the key elements of an effective PMS system?
• With increasing pre-market regulatory requirements, why do we still need PMS?
• Is passive PMS enough? What about active PMS?
• How can PMS be used for label expansions? Either via RCT and/or real-world evidence?
• What are the PMS challenges for the future? In this presentation, participants will learn best practices to avoid timely and costly mistakes as well as creative ways to use post-market surveillance to their advantage!
The post-COVID Value Shift & How MedTech Companies can CapitalizeGreenlight Guru
The ongoing COVID-19 pandemic has fundamentally shifted the perception of value globally. The healthcare industry, and MedTech (Devices, Diagnostics and Digital Health) stand to benefit enormously. While the world waits for a vaccine, it has been MedTech companies and their solutions that have protected healthcare workers, kept patients alive, and been the focus of government policy and investment. The policy and funding shifts have been aligned to value-based healthcare principals, of which MedTech was already a leader. Discover how you can align your organization, and engage with key stakeholders to capitalize on this massive shift in value perception.
Takeaways:
- How the fundamental structure of healthcare is set to change
-How this fundamental change will benefit MedTech companies
-What you need to do in order to make this change sustainable within your organization
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.
SECURED FRAMEWORK FOR PERVASIVE HEALTHCARE MONITORING SYSTEMS ijscai
Pervasive Healthcare Monitoring System (PHMS)’ is one of the important pervasive computing
applications aimed at providing healthcare services to all the people through mobile communication
devices. Pervasive computing devices are resource constrained devices such as battery power, memory,
processing power and bandwidth. In pervasive environment data privacy is a key issue. In this
application a secured frame work is developed for receiving the patient’s medical data periodically,
updates automatically in Patient Record Database and generates a Checkup Reminder. In the present
work a light weight asymmetric algorithm proposed by the authors [26] is used for encrypting the data to
ensure data confidentiality for its users. Challenge response onetime password mechanism is applied for
authentication process
Medical devices keep evolving, and with cutting edge technologies such as AI and Cloud, they are continuously adding quality to the overall patient care. Being in the medical sector, where the patient and their care is always a priority, manufacturers are required to follow the FDA regulatory guidelines which ensure that their devices are qualified enough to be released in the market. When it comes to FDA approval, it is essential to know the class of the device. The device class is one factor in determining the regulatory pathway and therefore, identifying the medical device class is a vital first step in the FDA medical device approval process...
RiskWatch for HIPAA Compliance™ is the top-rated total HIPAA compliance software that meets the risk analysis requirement and also does a TOTAL HIPAA COMPLIANCE ASSESSMENT! Use it on your laptop, desktop, server or over the web.
RiskWatch for HIPAA Compliance™ includes the entire HIPAA standard and NIST 800-66 and questions are separated by role including Medical Records, Clinical Staff, Database Administrator, etc. RiskWatch worked with regulators and auditors to make sure your RiskWatch for HIPAA Compliance™ assessment will stand up to the strictest audit. It also includes a Project Plan (in MS Project and Excel) so you can plan every aspect of your project.
RiskWatch for HIPAA Compliance™ writes all the reports for you automatically -- including charts, graphs and detailed information. The Case Summary Report includes Compliance vs. Non-Compliance graphs, where the non-compliance came from, how compliance matches requirements, and answers mapped by individual name or job category. The report can be edited to add photos, network diagrams, etc. RiskWatch for HIPAA Compliance™produces many other reports, including recommendations for improving your compliance profile. It also provides recommendations for risk mitigation and shows potential solutions by Return On Investment. Most importantly -- RiskWatch for HIPAA Compliance™ creates management level reports with complete audit trails and easy to understand recommended mitigation solutions included, and ranked by Return On Investment. Data can also be ported directly in your Business Continuity and Disaster Recovery plans.
Now also Includes Pandemic Flu Assessment! Consistently rated as the best software for HIPAA compliance, RiskWatch for HIPAA Compliance™ is used by hundreds of hospitals, health plans, insurance companies, academic medical centers and consulting organizations to meet HIPAA requirements. RiskWatch users include University of Miami, Sparrow Hospital, BlueShield of California, University of New Mexico, University of West Virginia, Harvard Pilgrim, Sisters of Mercy and St. John\'s Hospital.
The International Journal of Engineering & Science is aimed at providing a platform for researchers, engineers, scientists, or educators to publish their original research results, to exchange new ideas, to disseminate information in innovative designs, engineering experiences and technological skills. It is also the Journal's objective to promote engineering and technology education. All papers submitted to the Journal will be blind peer-reviewed. Only original articles will be published.
The papers for publication in The International Journal of Engineering& Science are selected through rigorous peer reviews to ensure originality, timeliness, relevance, and readability.
The Electronic Health Record (EHR) is a longitudinal electronic record of patient health
information generated by one or more encounters in any care delivery setting. Included in this
information are patient demographics, progress notes, problems, medications, vital signs, past
medical history, immunizations, laboratory data, and radiology reports. The EHR automates and
streamlines the clinician's workflow. The EHR has the ability to generate a complete record of a
clinical patient encounter, as well as supporting other care-related activities directly or indirectly
via interface including evidence-based decision support, quality management, and outcomes
reporting.
Digital Health and Remote Monitoring Devices: the Impact of COVID-19 on Their...Greenlight Guru
This session focuses on a few case studies for how device companies were impacted by three FDA guidance documents. Allison Komiyama, PhD, RAC, Principal Consultant at AcKnowledge Regulatory Strategies will highlight pros and cons for each.
The FDA Guidance Documents to be discussed:
• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019
• Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019
• Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019
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.
According to a report from MarketResearch.com, millions of new Internet of Medical Things (IoMT) will be added to health systems and the market segment is poised to hit $117 billion by 2020. Medical device manufacturers have traditionally focused on patient safety and time to market rather than security. Long FDA approval cycles mean that approved devices are often running outdated operating systems versions with known vulnerabilities and limited or no patching ability. This lack of adequate security in IoT and IoMT is why Gartner is predicting that by 2020 25% of all enterprise breaches will involve IoT. Securing IoMT requires close collaboration between biomedical and IT teams and a plan to address three core areas of IoMT security – physical, connection and data. This session will focus on practical steps to improving IoMT security without expensive infrastructure upgrades or wholesale legacy medical device replacements.
The Healthcare Internet of Things: Rewards and Risksatlanticcouncil
In The Healthcare Internet of Things: Rewards and Risks, a collaboration between Intel Security and Atlantic Council's Cyber Statecraft Initiative at the Brent Scowcroft Center on International Security, the report's authors—Jason Healey, Neal Pollard, and Beau Woods—draw attention to the delicate balance between the promise of a new age of technology and society's ability to secure the technological and communications foundations of these innovative devices.
Medical technologies and data protection issues - food for thoughtRenato Monteiro
Document prepared towards the modernization procedure of Council of Europe´s Convention 108 on the Protection of Personal Data. Available at: http://www.coe.int/t/dghl/standardsetting/dataprotection/TPD_documents/T-PD-BUR%282014%2904Rev%20-%20Medical%20Data%20%28By%20Renato%20Leite%29.pdf
SaMD or Software as a Medical Device can be described as a software constructed to be used in medical devices. These softwares can be run on different operating systems and virtual platforms.
1. The basic programming model of a SaMD is given below.
2. Different softwares are used for medical purposes, and they include the following:
To continue Reading : https://bit.ly/31ItRVc
Contact Us:
Website : https://bit.ly/2BvO06b
Email us: sales.cro@pepgra.com
Whatsapp: +91 9884350006
Post Market Surveillance: If a Device is FDA Cleared or Approved, or EU CE Ma...Greenlight Guru
When a medical device is FDA Cleared/Approved or EU CE Marked, can we assume it’s safe and effective? In a word... NO! Post-market surveillance (PMS) is the process of watching devices perform while on the market. PMS is a vital component of the medical device lifecycle. Yet the med-tech industry has had a poor record when it comes to PMS. As a result, PMS requirements have been increasing in the US, the EU and around the globe.
Having an effective PMS system is important from both a regulatory and quality perspective. But can we assume if our PMS system meets the regulatory and quality requirements, that its effective? that its working? Absolutely not! This presentation will use the case study approach to take a broad look at medical device post-market surveillance including:
• What are the key elements of an effective PMS system?
• With increasing pre-market regulatory requirements, why do we still need PMS?
• Is passive PMS enough? What about active PMS?
• How can PMS be used for label expansions? Either via RCT and/or real-world evidence?
• What are the PMS challenges for the future? In this presentation, participants will learn best practices to avoid timely and costly mistakes as well as creative ways to use post-market surveillance to their advantage!
The post-COVID Value Shift & How MedTech Companies can CapitalizeGreenlight Guru
The ongoing COVID-19 pandemic has fundamentally shifted the perception of value globally. The healthcare industry, and MedTech (Devices, Diagnostics and Digital Health) stand to benefit enormously. While the world waits for a vaccine, it has been MedTech companies and their solutions that have protected healthcare workers, kept patients alive, and been the focus of government policy and investment. The policy and funding shifts have been aligned to value-based healthcare principals, of which MedTech was already a leader. Discover how you can align your organization, and engage with key stakeholders to capitalize on this massive shift in value perception.
Takeaways:
- How the fundamental structure of healthcare is set to change
-How this fundamental change will benefit MedTech companies
-What you need to do in order to make this change sustainable within your organization
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.
SECURED FRAMEWORK FOR PERVASIVE HEALTHCARE MONITORING SYSTEMS ijscai
Pervasive Healthcare Monitoring System (PHMS)’ is one of the important pervasive computing
applications aimed at providing healthcare services to all the people through mobile communication
devices. Pervasive computing devices are resource constrained devices such as battery power, memory,
processing power and bandwidth. In pervasive environment data privacy is a key issue. In this
application a secured frame work is developed for receiving the patient’s medical data periodically,
updates automatically in Patient Record Database and generates a Checkup Reminder. In the present
work a light weight asymmetric algorithm proposed by the authors [26] is used for encrypting the data to
ensure data confidentiality for its users. Challenge response onetime password mechanism is applied for
authentication process
Medical devices keep evolving, and with cutting edge technologies such as AI and Cloud, they are continuously adding quality to the overall patient care. Being in the medical sector, where the patient and their care is always a priority, manufacturers are required to follow the FDA regulatory guidelines which ensure that their devices are qualified enough to be released in the market. When it comes to FDA approval, it is essential to know the class of the device. The device class is one factor in determining the regulatory pathway and therefore, identifying the medical device class is a vital first step in the FDA medical device approval process...
RiskWatch for HIPAA Compliance™ is the top-rated total HIPAA compliance software that meets the risk analysis requirement and also does a TOTAL HIPAA COMPLIANCE ASSESSMENT! Use it on your laptop, desktop, server or over the web.
RiskWatch for HIPAA Compliance™ includes the entire HIPAA standard and NIST 800-66 and questions are separated by role including Medical Records, Clinical Staff, Database Administrator, etc. RiskWatch worked with regulators and auditors to make sure your RiskWatch for HIPAA Compliance™ assessment will stand up to the strictest audit. It also includes a Project Plan (in MS Project and Excel) so you can plan every aspect of your project.
RiskWatch for HIPAA Compliance™ writes all the reports for you automatically -- including charts, graphs and detailed information. The Case Summary Report includes Compliance vs. Non-Compliance graphs, where the non-compliance came from, how compliance matches requirements, and answers mapped by individual name or job category. The report can be edited to add photos, network diagrams, etc. RiskWatch for HIPAA Compliance™produces many other reports, including recommendations for improving your compliance profile. It also provides recommendations for risk mitigation and shows potential solutions by Return On Investment. Most importantly -- RiskWatch for HIPAA Compliance™ creates management level reports with complete audit trails and easy to understand recommended mitigation solutions included, and ranked by Return On Investment. Data can also be ported directly in your Business Continuity and Disaster Recovery plans.
Now also Includes Pandemic Flu Assessment! Consistently rated as the best software for HIPAA compliance, RiskWatch for HIPAA Compliance™ is used by hundreds of hospitals, health plans, insurance companies, academic medical centers and consulting organizations to meet HIPAA requirements. RiskWatch users include University of Miami, Sparrow Hospital, BlueShield of California, University of New Mexico, University of West Virginia, Harvard Pilgrim, Sisters of Mercy and St. John\'s Hospital.
The International Journal of Engineering & Science is aimed at providing a platform for researchers, engineers, scientists, or educators to publish their original research results, to exchange new ideas, to disseminate information in innovative designs, engineering experiences and technological skills. It is also the Journal's objective to promote engineering and technology education. All papers submitted to the Journal will be blind peer-reviewed. Only original articles will be published.
The papers for publication in The International Journal of Engineering& Science are selected through rigorous peer reviews to ensure originality, timeliness, relevance, and readability.
The Electronic Health Record (EHR) is a longitudinal electronic record of patient health
information generated by one or more encounters in any care delivery setting. Included in this
information are patient demographics, progress notes, problems, medications, vital signs, past
medical history, immunizations, laboratory data, and radiology reports. The EHR automates and
streamlines the clinician's workflow. The EHR has the ability to generate a complete record of a
clinical patient encounter, as well as supporting other care-related activities directly or indirectly
via interface including evidence-based decision support, quality management, and outcomes
reporting.
Digital Health and Remote Monitoring Devices: the Impact of COVID-19 on Their...Greenlight Guru
This session focuses on a few case studies for how device companies were impacted by three FDA guidance documents. Allison Komiyama, PhD, RAC, Principal Consultant at AcKnowledge Regulatory Strategies will highlight pros and cons for each.
The FDA Guidance Documents to be discussed:
• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019
• Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019
• Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019
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.
According to a report from MarketResearch.com, millions of new Internet of Medical Things (IoMT) will be added to health systems and the market segment is poised to hit $117 billion by 2020. Medical device manufacturers have traditionally focused on patient safety and time to market rather than security. Long FDA approval cycles mean that approved devices are often running outdated operating systems versions with known vulnerabilities and limited or no patching ability. This lack of adequate security in IoT and IoMT is why Gartner is predicting that by 2020 25% of all enterprise breaches will involve IoT. Securing IoMT requires close collaboration between biomedical and IT teams and a plan to address three core areas of IoMT security – physical, connection and data. This session will focus on practical steps to improving IoMT security without expensive infrastructure upgrades or wholesale legacy medical device replacements.
The Healthcare Internet of Things: Rewards and Risksatlanticcouncil
In The Healthcare Internet of Things: Rewards and Risks, a collaboration between Intel Security and Atlantic Council's Cyber Statecraft Initiative at the Brent Scowcroft Center on International Security, the report's authors—Jason Healey, Neal Pollard, and Beau Woods—draw attention to the delicate balance between the promise of a new age of technology and society's ability to secure the technological and communications foundations of these innovative devices.
Medical technologies and data protection issues - food for thoughtRenato Monteiro
Document prepared towards the modernization procedure of Council of Europe´s Convention 108 on the Protection of Personal Data. Available at: http://www.coe.int/t/dghl/standardsetting/dataprotection/TPD_documents/T-PD-BUR%282014%2904Rev%20-%20Medical%20Data%20%28By%20Renato%20Leite%29.pdf
Due to advancement of technology and incorporation of sofrtwares and microchips, vulnerability increased for medical devices.
Outsiders are hacking the devices by advanced technologies.
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.
NEST – Improving the Regulatory Process for Medical DevicesEMMAIntl
Innovating the medical device regulatory process is a goal that the FDA’s Center for Devices and Radiological Health (CDRH) is constantly striving towards. Among several other programs introduced or changed over the past couple years, the National Evaluation System for Health Technology (NEST) is a program the FDA is building upon to generate better real-world evidence to guide their decision-making around medical devices...
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.
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
This paper discusses the efficacy of the Implantable Medical Devices (IMDs), at the same time it also highlights the possibilities of security attacks on commercially available IMDs. Keeping in mind the challenges and constraints posed by the IMDs, the paper also proposes some viable solutions to address the security threats.
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...
A Proposed Framework for Regulating AI Based Applications in SaMDEMMAIntl
One of the backbones of the current Industry 4.0 is Artificial Intelligence (AI). It is the process of simulating human intelligence in machines such as learning and problem-solving. Machine Learning (ML) forms a subset of AI and it provides the ability for computers to constantly learn from huge data sets and improve themselves to perform human functions. Presently, AI and ML are widely used in several domains such as financial, e-commerce, real estate, and most significantly in health care and medical devices...
The International Journal of Pharmacetical Sciences Letters (IJPSL) is an international online journal in English published everyday. The aim of this is to publish peer reviewed research and review articles without delay in the developing field of engineering and science Research.
Protecting Privacy, Security and Patient Safety in mHealthTAOklahoma
Patricia D. King, J.D., M.B.A.
Associate General Counsel
Swedish Covenant Hospital
Oklahoma Telemedicine Conference 2014: Telehealth Transition
October 16, 2014
Data Mining as A Service in Medical DevicesEMMAIntl
Data mining is the field of Computer Science that forms the basis for data analytics. As the term specifies, it is utilized for ‘mining’ or extracting the most significant data from ‘Big Data’ or massive data sets. It not only serves as an extraction tool but also assists manufacturers and researchers in deriving hypotheses or conclusions from the existing Big Data sets, which can be applied toward improving existing services. Even though Data Mining is extensively utilized in commercial domains such as e-commerce or finance, it is indeed also proving to be vital for improving services in the health care domain. When utilized for developing or enhancing medical services, manufacturers should make sure their mining tool is safe and qualified enough to be integrated with medical devices...
A Survey on Current Applications for Tracking COVID-19EMMAIntl
The COVID-19 pandemic is still creating headlines in the health care domain. Around the world, governments, and organizations such as World Health Organization (WHO), European Medical Agency (EMA), and FDA are working together to eliminate lockdowns and get our society back up and running. In such cases, several companies, firms, and universities have found opportunities to provide critical services such as virus detection, tracking, data-driven decision-making algorithms, and visual analytic applications...
With the Sony Entertainment hacks, data security has become an issue in the press and a headache for database administrators. Sensitive data generated by wearable devices are presumably no exception. Are there any particular security concerns with data from wearable devices? Are doctors doing enough to protect patient data? We asked Doctor Seyedmostafa Safavi, an associate fellow at the Cyber Security Unit at the National University of Malaysia and co-author of a recent review on the subject to elaborate.
Similar to The FDA and BYOD, Mobile and Fixed Medical Device Cybersecurity (20)
Abstract: Today data privacy at the software testing level is too often treated as a non-functional requirement. Software security is tested, but seldom with data privacy-specific testing. This paper's goal has been to present a new method for developing a data privacy security metric during software testing that incorporate privacy-specific threat analysis.
This new metric is based on a quantified version of the LINDDUN Privacy framework based on Deng, Wyuts, All doctoral research. [Deng 2010]
This presentation is intended for the customer facing risk managers, sales staff, and IT staff of a medical device manufacturer and their medical doctors and IT hospital and clinical counterparts.
It is intended to give an overview and highlight process considerations for incident management and reporting of cybersecurity issues.
It is based on the technical paper published by Pam Gilmore and Valdez Ladd in the ISSA Journal in 2014.
Cloud Breach - Forensics Audit Planning
The goal of this presentation is to assist IT Risk and Security professionals with adding Cloud computing forensics to their Incident Response team.
It should assist them with understanding the technical ways of capturing forensic data from cloud service providers using security controls that incorporate and integrate logging, chain of evidence, virtualization and cloud security architecture
Federal Agencies & Cloud Service Providers meeting FISMA requirements via FedRAMP
This presentation covers Federal Risk Authorization Management Program with FISMA, SCAP and Federal Data Center Consolidation Initiative to clarify how US government agencies purchase cloud services need to meet Federal Information Security Management Act (FISMA) requirements.
January 2013 - The FedRAMP Joint Authorization Board has granted its first provisional authorization to Autonomic Resources, who used Veris Group as their FedRAMP accredited 3PAO.
Risk Management of Medical Devices Connected To IT Networks per ANSI / IEC 8001
Published 2011 for informational awareness, non-profit, non-consulting purposes of publicly available resources.
Disclaimer
This document is made available at this web site for educational informational purposes only. It is not intended for the purpose of providing legal advice or regulatory advise as ISO 8001 was in draft form in 2011 when this document was originally published.
You should contact your attorney and corporate security / risk management officer(s) to obtain advice with respect to any particular security risk issue or problem. No obligations, rights or indemnification is given or implied by the public sharing of this document. Use of and access to this document on this Web site or any of the e-mail links, materials, etc., contained within the document do not create an attorney-client relationship, consulting between the author(s), legal and / or medical risk management advice in any context between the user or browser.
The opinions expressed at or through this site are the opinions of the individual author to the best of public knowledge in 2011 only. Therefore it does not reflect the opinions of any firm, ISO 8001 committee or any individual attorney or legally binding statue, regulation,etc.
HIPAA HITECH Privacy & Security Rules for E-prescribing
Disclaimer
The materials available on this document and web site are for informational purposes only and not for the purpose of providing legal and or clinical advice.
You should contact your attorney and information security officer to obtain proper advice with respect to any particular issue or problem. Use of and access to this document or any of the e-mail links, materials, etc., contained within the document do not create an attorney-client relationship, consulting between the authors, legal and / or medical advice . between the user or browser. Only guidance from U.S. Government agencies directly should be used.for decision making.
Welocme to ViralQR, your best QR code generator.ViralQR
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Orchestrator execution result
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The FDA and BYOD, Mobile and Fixed Medical Device Cybersecurity
1. The FDA and BYOD,
Mobile and Fixed Medical Device Cybersecurity
Published originally for ISSA Journal, September 2013 issue (www.ISSA.org)
Authors: Pam Gilmore, BS Business Administration, ISSA Raleigh, NC member.
Valdez Ladd, CISSP, CISA, COBIT 4.1, CIW-SP, CNSS NSTISSI 4011 ISSP,
MBA. MAIA, Member ISO Technical Committee 215 Health Informatics
Working Group 4 - Privacy & Security
Abstract:
In June 2013, the U.S. Food and Drug Administration (“FDA”) released draft guidance: “Content of
Premarket Submissions for Management of Cybersecurity in Medical Devices”. This was followed
on August by the FDA's “Radio Frequency Wireless Technology in Medical Devices Guidance for
Industry and Food and Drug Administration Staff”.
This article is intended for the customer facing risk managers, sales staff, and IT staff of a medical
device manufacturer and their medical doctors and IT hospital and clinical counterparts. It is
intended to give an overview and highlight process considerations for incident management and
reporting of cybersecurity issues.
Disclaimers: This article is an IT security awareness document only. It is not to be considered an
official FDA document guide or consulting tool. Please seek legal counsel and consult your own
corporate IT security along with any additional external professional expertise as deemed necessary
for your business.
Also note that the views expressed here in this article are those of the authors soley and do not
necessarily reflect the positions of any current or former employers or organizations.
2. In June 2013, the U.S. Food and Drug Administration (“FDA”) released draft guidance on
titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”.
Its goal is to begin the process of bringing network connected or accessible medical device's
cybersecurity under their jurisdiction. This draft will be accessible for public comment until
mid-September 2013. Final rules are expected to be published in early 2014.
Healthcare is a high security environment. One which is constantly under constant attack. It
is always combating the risk of exposure of protected patient health information (PHI). This
requires using technical, administrative, and physical security controls for network connected
medical devices. Though mobile smartphone and table applications are not covered currently, it is a
good assumption that a security requirement is coming modelled on the current network device
connected draft that this research paper covers.
Therefore it is important that information technology (IT) security professionals not view
this FDA draft through the prism of the customary CIA (confidentiality, integrity & availability)
triad. It is too limited for use within the medical sector. A better heuristic is the more complete
PAINS, (privacy, availability, authentication, integrity, non-repudiation and safety) to account for
the stringent demands of medical devices and applications for patient requirements. (Sloan)
1. Sloane , Elliot B. (PAINS) “Medical Device Security HITECH-AARA and FDA related Security Issues”-NIST/OCR
HIPPA Conference, (11, 12 May 2010) – http://csrc.nist.gov/news.../HIPAA.../1-4-health-devices-sloane-drexel.pdf
Though it surprised some people outside the medical
field, it can be seen as regulations trying to catch up to
the explosion of Internet and network devices. This ranges
from implanted devices such as insulin pumps, patient
medical imaging storage, and wireless medical BYOD
devices to X-Ray, MRI, ultrasound units, and other
diagnostic equipment. Though this is a US regulation, it is
sure to influence many other nations across the world as
they consider their medical device review, acceptance, and
procurement processes and laws to address cybersecurity
risks to patients and their privacy. see figure 1.
2. ElBoghdady, Dina. Health apps under the microscope. 2012. Photograph. chicagotribune.com, Chicago. Web. 7 17
2013.
<http://articles.chicagotribune.com/2012-06-26/business/ct-biz-0626-health-apps-20120626_1_smartphone-application-
mobile-apps-android>.
Illustration 1: (El Boghdady)
3. While the FDA document did not reference outside technical reference there are several
useful expert authoritative documents to consider. First the NIST SP 800-124 Revision 1 covers
securing both organization-provided and personally-owned (bring your own device) mobile
devices.
Also the NIST Special Publication 800-53 (Rev. 4) and 800-53A (Rev. 1) Security Controls
and Assessment Procedures for Federal Information Systems and Organizations should be added to
the list. Finally be familiar with ISO/DTR 17522 Health informatics --Provisions for Health
Applications on Mobile/Smart Devices 2013-01-29 30.20 and ISO/AWI TR 80001-Application of
risk management for IT-networks incorporating medical devices.
Existing Quality documentation processes for existing regulated device error reporting will
have to include cybersecurity knowledge or subject matter expertise. This will allow for capturing
relevant data in the case of a fast moving major security incident. This information should be made
available to the medical device manufacturer's technical support per modality (ultrasound, X-Ray,
blood serum diagnostic, etc.,) and quality control staff. Each may have training for serious incident
hazard reporting, but will need to incorporate cybersecurity. This process will require expert
training and review so their reporting processes can be efficient and compliant.
The degree of harm caused by a major virus infection, rootkit or other malware can be
extensive and possibly fatal. Time will be essential as mobile medical devices increase grows and
connection via wireless networks grows. The same will be true for stationary and mobile imaging
devices. Professional expertise will be needed for the preliminary incident. Basic data gathering
only can be handled over the telephone with the customer.
Beyond the basic five questions of who, what, when, where, and how (if possible) will
require more training and on-site investigation by the manufacturer’s experts for the malware
affected medical device. Semi-automated forensic hardware-and-software tool and processes have
to be made available for deployment by device manufacturers in the USA and other countries that
adopt similar levels of assurance and investigation. The manufacturer's customer facing IT and
modality engineer staff will face growing to incorporate first responder capabilities within this area.
Wireless Radio Frequency (RF) Devices
The FDA's “Radio Frequency Wireless Technology in Medical Devices Guidance for
Industry and Food and Drug Administration Staff” pressures manufacturers to consider the use of
wireless technology in their medical devices. Also it encourages a risk based assessment of RF
wireless technology in the device's design. The report states “The correct, timely, and secure
transmission of medical data and information is important for the safe and effective use of both
wired and wireless medical devices and device systems”. see figure 2.
FDA (2013, August 13). Radio Frequency Wireless Technology in Medical Devices.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/4GuidanceDocuments/ucm077210.htm
4. The newest and fast growing area in medicine is bring-your-own-device (BYOD). The
range of services and medical references that doctors and clinical staff have at their disposal is a
powerful incentive to use the smartphone, tablet or other mobile device they have learned and
mastered. However as one security expert stated,” Wireless implantable devices and other patient
monitoring equipment "could be a back door into your network," noted Peter Swire, an Ohio State
University law professor and former presidential adviser on privacy issue”. (Desta)
3. Desta, A.,"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices-Draft guidance
or Industry and Food and Drug Administration Staff.US-FDA (2013, 06) -
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments
4. csrc.nist.gov/publications/drafts/800-124r1/draft_sp800-124-rev1.pd
5. csrc.nist.gov/publications/nistpubs/800-53A.../sp800-53A-rev1-final.pdf
6. csrc.nist.gov/publications/drafts/800-53-rev4/sp800-53-rev4-ipd.pdf
7. www.iso.org/iso/catalogue_detail.htm?csnumber=59949
FDA Cybersecurity Draft details:
On June 13, 2013, the U.S. Food and Drug Administration (“FDA”) released draft guidance
on titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Draft Guidance for Industry and Food and Drug Administration Staff”. It proposes cybersecurity
controls should be incorporated into vulnerable medical devices that are connected via wireless,
Internet and wired networks. The documentation for this mainly contained in the Premarket
Notification (510(k) and approval process for new medical devices.
Illustration 2: (Gollakota)
5. In addition to the draft guidance, the FDA published a FDA Safety Communication. It was
addressed to medical device manufacturers and their engineers. It was intended for our nation’s
hospitals, clinics, and other health care facilities including their health care information technology
(IT), and procurements staff. This was due to increased publications of cybersecurity issues.
prominent publication was when the US Government Accountability Office (GAO) issued a report
titled, “Medical Devices: FDA Should Expand Its Consideration of Information Security for Certain
Types of Devices” on August 31, 2013. (GAO)
Later in January 2013 cybersecurity Cylance researchers Billy Rios and Terry McCorkle
discovered default embedded passwords for a Phillips, Inc. medical systems. They contacted the
company to communicate the vulnerabilities. However when no response came they contacted the
US Dept. of Homeland Security. (DHS), the Federal Drug Administration (FDA) and the US
Industrial Control Systems Cyber Emergency Response Team (ICS CERT) to persuade Phillips, Inc.
to correct the security flaws quickly.
In addition Cyberlance's Mr. Rios and Mr. McCorkle examined and discovered
vulnerabilities and weak access controls in almost 300 medical devices. An alert published on the
US government's Industrial Control Systems Cyber Emergency Response Team (ICS-CERT)
website, cited research from Billy Rios and Terry McCorkle of the cyber security firm Cylance Inc.,
who said they have identified more than 300 pieces of medical equipment that are vulnerable to
cyber-attacks to their firmware, embedded passwords and weak authentication. They include
surgical and anaesthesia devices, ventilators, drug infusion pumps, patient monitors and external
defibrillators.
8. ics-cert.us-cert.gov/alerts/ICS-ALERT-13-164-01, The Industrial Control Systems Cyber Emergency Response Team
(ICS-CERT). (13 June, 2013). Retrieved from http://www.gao.gov/products/GAO-12-816
Note the public draft has non-binding recommendations open for the public until
mid-September after ninety (90) days have passed since its June 13th publication. Final rules would
follow and go into effect next year in 2014. The draft itself states that in principle the cybersecurity
requirements should be as least burdensome as practical, while still meeting requirements. Patches
to medical devices for updating cybersecurity would not require FDA approval unless patient safety
is affected. This include Anti-Virus updates.
“Manufacturers should develop a set of security controls to assure medical device
cybersecurity to maintain the information’s [data] confidentiality, integrity, and availability. This
goal of avoiding compromised device functionality implicitly includes data at in-motion on the
network and at-rest on the medical devices.”
9. GAO. MEDICAL DEVICES, FDA Should Expand Its Consideration of Information Security for Certain Types of
Devices (31 August, 2012). Retrieved from http://www.gao.gov/products/GAO-12-816
10. Marianne Kolbasuk McGee, “Medical Device Security: A New Focus, Former Presidential Privacy Adviser
Addresses Mobile Security (15 April, 2012) -
http://www.healthcareinfosecurity.com/interviews/medical-device-security-new-focus-i-1882
11. Abiy Desta, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Draft
Guidance for Industry and Food and Drug Administration Staff" (14 June 2013) -
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM356190.pdf
12. Op. Cit GAO
13. Darren Pauli, "Patient Data Revealed in Medical Device Hack", (17 Jan 2013) -
http://www.scmagazine.com.au/News/329222,patient-data-revealed-in-medical-device-hack.aspx
14. Ransdell Pierson, Jim Finkle.,"FDA urges protection of Medical Devices from Cyber Threats" (13 June 2013) -
http://www.reuters.com/article/2013/06/14/us-devices-cybersecurity-fda-idUSBRE95C1IB20130614
6. Prior FDA Cybersecurity guidance:
Since medical devices that were not originally designed with networking capabilities were
isolated from the growing number of hospitals with local area networks (LAN) running TCP/IP
their usefullnes was seen as diminished. Hospitals wanted more capabilities without buying totally
new expensive medical devices. Manufacturers responded by connecting their medical devices
with computer workstations running TCP/IP. This was important as the use of digital imaging of
patient radiological (X-Ray & CT) and ultrasound images became more prominent.
The FDA responded with it draft report the "Cybersecurity for Networked Medical Devices
Containing Off-the-Shelf (OTS) Software,” issued on January 14, 2005. It noted that manufacturers
would generally not be reportable as a correction or removal under 21 C.F.R. part 806, “because
most software patches are installed to reduce the risk of developing a problem associated with a
cybersecurity vulnerability and not to address a risk to health posed by the device". The FDA was
setting boundaries on liability for software patches to enhance safety without penalty to medical
device manufacturers. It was an important and needed step for medical device cybersecurity.
Risk Analysis:
Below is a list of the risk analysis that the FDA's cybersecurity was invoking using many of
the concepts found in the NIST special publications for cybersecurity. Note the documentation
requirements are generic to many risk analysis at the design stage. Building security into a product
at the design stage is always considered cheaper, more reliable and manageable. Bolting on security
solutions or compensating controls after a product launch is more expensive and difficult to defend
against highly skilled hackers.
Under FDA 21 CFR 820.30(g) the risk analysis includes three requirements. First
Identification of assets, threats, and vulnerabilities and the impact assessment of their exploit
probability. Next the determination of risk levels and suitable compensating controls. Finally the
residual risk assessment and risk acceptance criteria for the medical device must be included to
complete the risk analysis.
- Intentionally left blank -
7. Security Capabilities
Access Controls
• Remove “hardcoded” passwords (those that can not be changed)
• Limit Access to Trusted Users who are authenticated with multi-factor authentication
• Employ role based access control with time limited user sessions
• Physical locks on devices must be used and on their communication ports when possible
15. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments
/UCM356190.pdf
Incident Response
Ensuring Trusted Content is another requirement. Trusted software or firmware updates with
strong authentication is the foundation for this functionality. This leads to software whitelisting,
blacklisting (anti-virus), and secure software code signing becoming part of the security design.
This will also require secure data transfers to and from the medical device using encryption and
with authentication, authorization and accounting (AAA).
While people and processes are listed as parts within the scope of the solution. The creation
of a customer notification system that is standarized, procedurized and accessible to the hospital IT
staff so that authorized users can download the correct dentifiable software and firmware updates
from the manufacturer in cases of incident responses.
Note that the range of security for existing devices and their current design will limit their
security capabilities. For example implantable medical devices use simple PIN codes similar to a
bank ATM. Smartphone and tablets have more computing power and can support encryption with
authentication, authorization and accounting (AAA).
Use Fail-Safe and Recovery Features
The FDA specifice the mplementation of fail-safe device features that protect the device’s
critical functionality, even when the device’s security has been compromised. These features allow
for security breaches to be recognized, logged, and acted upon. Also it provide methods for forensic
retention and recovery of device configuration by an authenticated system administrator. This
allows the medical technician, or clinical staff to ramp down a treatment or examination for patient
safety when notified of a security breach.
8. Logging
Today major diagnostic and radiological examination devices are often remotely monitored
by medical device manufacturers for maintenance purposes. Mobile medical devices will need
added capacity for logging more diagnostic data. While medical implants such as pacemakers and
insulin pumps have very limited logging capabilites. Therefore forensic investigation using device
logging will vary depending on the medical devices.
16. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments
/UCM356190.pdf
Forensics
Forensics data and evidence now must be captured within the medical device manufacturer's
Hazard Report which will be produced when any medical device incident occurs. This is an
existing standard report. So, the forensics will only need to be appended to the medical
manufacturer's FDA complaint handling processes. This will drive demand for greater numbers of
medical device forensic specialist by manufacturer's. HIPAA Privacy rules many be in conflict with
the forensic rules unless addition compensating privacy controls are put into place.
Cybersecurity Design Documentation
The 501(K) premarket submission by the medical device manufacturers should provide
attestment with supporting documentaton of the cybersecurity design of their medical device.
Rather than going over each requirements which is highly redundant; we will highlight the most
critical areas not covered earlier. This will better serve the reader.
1. Hazard analysis, mitigations, and design
This documentation considers both intentional and unintentional cybersecurity risks
associated with the medical device under review. This is an important liability issue as the
definition for unintentional risks will need clarification in the future. Does the principal of
unintended consequences (R. Merton) come into scope? Every Security design is a trade off
between usability and security. How will the FDA judge this as unintend risks are not the ones
intended by the medical device's purposeful design elements?
17. Merton, Robert K."The Unanticipated Consequences of Purposive Social Action". American Sociological Review 1
(6): 895. August 21, 2013.
http://www.d.umn.edu/cla/faculty/jhamlin/4111/2111-home/CD/TheoryClass/Readings/MertonSocialAction.pdf
9. 2. Security Requirements Traceability Matrix
The key document for the Hazard analysis, mitigations, and design process will be the
Traceability Matrix (Security Requirements Traceability Matrix ) document. It will link the actual
intentional and unintentional cybersecurity controls to the cybersecurity risks that were considered
at the time of design. The security requirements traceability matrix (STRM) should identify all IT
security requirements for the medical device's design per the FDA. In addition it will map the the
requirements to the existing IT security policy framework of the medical device manufacturer.
Lastly it should serve as an IT policy assessment checklist for internal and external auditors.
18. The Institute of Internal Auditors (2008). 12 Steps to IT Security Compliance. Gap News,3(1). Retrieved from
http://www.theiia.org/gap/index.cfm?act=GAP.printa&aid=2464
Anti virus (AV)
The FDA has called for an end to the tug-of-war between hospitals and medical device
manufacturers over anti virus software. Higher pricing for customized anti virus software from
manufacturers was justified by FDA safety mandates per manufactures to avoid damage to the
device's operation while patients are being treated. However many hospitals and clinics have had
their own anti virus contracts under theirr own central administration. Now the FDA is mandating
that detailed instructions for the end-user operations and product specifications related to
recommended anti-virus (AV) software and any device firewall settings. This includes both the
manufacturer's recommended use of anti-virus software safely. It also includes how the hospital
should use and operate their own anti-virus software safely equally. Again the issue of liability in
case of an AV infection by a hospital using the manufacturer's instructions for third party AV
software will have to be resolved by the FDA or a court of law later.
Summary:
The FDA's guidance raises the standard for cybersecurity and risk management for the
medical devices. Newer devices sold starting in 2014 and afterward when the final cybersecurity
guidance takes effect will over time phase out older less secure networked medical devices. The
FDA's goal of managing the medical device's cybersecurity product life-cycle from design to
operation to disposal is timely and needed. Overtime this standard may become de facto for
purchasers world wide of networked medical devices.
PAINS, (privacy, availability, authentication, integrity, non-repudiation and safety) will
become key components of the medical devices security risk analysis. It will serve to reinforce the
scope of patient and device risks. It can be expected that the FDA cybersecurity guidance will
strengthen the HIPAA Privacy Rule and Security Rule in the areas of risk analysis and mitigation
also. Though a work in progress it presents another avenue of reducing the attack surface of the
medical operations for hospitals and clinics.
Therefore the increased cybersecurity of medical devices that the FDA is working on in its
draft guidance is a positive for reducing risk to patients and their privacy. Hospitals and medical
device manufacutrers will have to establish new processes and procedure to communicate and work
together to create a successful transformation. This convergence of security, risk management and
secure product design may be seen as a future model of cybersecurity for other regulated industries.
10. 19.”FDA Safety Communication: Cybersecurity for Medical Devices and hospital Networks”,
(6 June 2013) - http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm356423.htm
20. Sloane, Elliot B. (PAINS) “Medical Device Security HITECH-AARA and FDA related Security
Issues”-NIST/OCR HIPPA Conference, (11, 12 May 2010) –
http://csrc.nist.gov/news.../HIPAA.../1-4-health-devices-sloane-drexel.pdf