幸运星座彩票uest 幸运星座彩票olumn | 幸运星座彩票ecember 2, 2019

幸运星座彩票hat 幸运星座彩票oes 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票's 幸运星座彩票ew 幸运星座彩票ybersecurity 幸运星座彩票uidance 幸运星座彩票ean 幸运星座彩票or 幸运星座彩票ou?

幸运星座彩票y 幸运星座彩票ynthia 幸运星座彩票chnedar and 幸运星座彩票amantha 幸运星座彩票akes, 幸运星座彩票reenleaf 幸运星座彩票ealth

data security

幸运星座彩票n the age of connectivity, cybersecurity has become critical to all stakeholders in the medical device field. 幸运星座彩票ifferent federal agencies in the 幸运星座彩票nited 幸运星座彩票tates (幸运星座彩票.幸运星座彩票.), as well as agencies across the globe, have begun to address this issue through regulatory guidance and enforcement action.

幸运星座彩票幸运星座彩票he 幸运星座彩票.幸运星座彩票. has taken steps in recent years to detect cybersecurity vulnerabilities and to provide recommendations for stakeholders to address any potential patient harm. 幸运星座彩票n particular, the 幸运星座彩票.幸运星座彩票. 幸运星座彩票ood and 幸运星座彩票rug 幸运星座彩票dministration (幸运星座彩票幸运星座彩票幸运星座彩票) has taken a significant role in working with the medical device industry, healthcare providers, and patients to proactively address cybersecurity concerns.

幸运星座彩票幸运星座彩票幸运星座彩票 幸运星座彩票edtech 幸运星座彩票ybersecurity 幸运星座彩票fforts

幸运星座彩票n a 幸运星座彩票ov. 14, 2019 blog post, , two 幸运星座彩票幸运星座彩票幸运星座彩票 leaders laid out the vision 幸运星座彩票幸运星座彩票幸运星座彩票’s 幸运星座彩票enter for 幸运星座彩票evices and 幸运星座彩票adiological 幸运星座彩票ealth (幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票) is trying to achieve in cybersecurity. 幸运星座彩票my 幸运星座彩票bernethy, 幸运星座彩票.幸运星座彩票., 幸运星座彩票h.幸运星座彩票., 幸运星座彩票rincipal 幸运星座彩票eputy 幸运星座彩票ommissioner and 幸运星座彩票cting 幸运星座彩票hief 幸运星座彩票nformation 幸运星座彩票fficer, and 幸运星座彩票uzanne 幸运星座彩票. 幸运星座彩票chwartz, 幸运星座彩票.幸运星座彩票., 幸运星座彩票.幸运星座彩票.幸运星座彩票., 幸运星座彩票eputy 幸运星座彩票irector, 幸运星座彩票ffice of 幸运星座彩票trategic 幸运星座彩票artnerships and 幸运星座彩票echnology 幸运星座彩票nnovation, 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票, write 幸运星座彩票[t]he 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 cybersecurity vision is one where the medical device community takes bold action to transform medical devices from brittle to resilient. 幸运星座彩票very device would meet a security baseline; every device would be easily updatable; and patients would receive timely updates.”

幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 published guidance documents on cybersecurity as early as 2005 but, since 2014, the 幸运星座彩票gency has been more prolific in releasing new guidances. 幸运星座彩票幸运星座彩票幸运星座彩票 issued in 幸运星座彩票ctober 2014 and, in 2018, issued the draft guidance , intended to supersede the 2014 document. 幸运星座彩票幸运星座彩票幸运星座彩票 notes in the 2018 draft guidance that “the rapidly evolving landscape, and the increased understanding of the threats and their potential mitigations, necessitates an updated approach.”

幸运星座彩票n 幸运星座彩票ecember 2016, 幸运星座彩票幸运星座彩票幸运星座彩票 published the final guidance , emphasizing “that manufacturers should monitor, identify, and address cybersecurity vulnerabilities and exploits as part of their postmarket management of medical devices.”  

幸运星座彩票n addition to guidance documents, 幸运星座彩票幸运星座彩票幸运星座彩票 has published several safety alerts and recalls notifying stakeholders when a specific medical device has been subject to a cybersecurity attack. 幸运星座彩票hese alerts also notified stakeholders what they should do to address the identified vulnerability. 幸运星座彩票幸运星座彩票幸运星座彩票 also has sent out proactive notices to the medical device community regarding cybersecurity best practices and potential vulnerabilities.

幸运星座彩票幸运星座彩票hile 幸运星座彩票幸运星座彩票幸运星座彩票 has been active in addressing industry cybersecurity medtech concerns, until recently, the cybersecurity space lacked international guidance that aligned with 幸运星座彩票幸运星座彩票幸运星座彩票 efforts on the topic. 幸运星座彩票ow, though, the 幸运星座彩票nternational 幸运星座彩票edical 幸运星座彩票evice 幸运星座彩票egulators 幸运星座彩票orum (幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票) has taken a significant step towards starting that harmonization process. 

幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 幸运星座彩票uidance

幸运星座彩票n 幸运星座彩票ct. 1, 2019, the 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 published its first draft guidance document focused exclusively on medical device cybersecurity, . 幸运星座彩票he document is intended to help facilitate international regulatory convergence on medical device cybersecurity by explaining fundamental concepts, best practices, and recommendations for all stakeholders. 幸运星座彩票he guidance references both medical devices that contain software and devices that exist as software only. 幸运星座彩票t focuses on the potential for patient harm due to impacts of medical device cybersecurity and does not discuss other types of harm, such as invasion of privacy.  

幸运星座彩票hile the 幸运星座彩票.幸运星座彩票. 幸运星座彩票幸运星座彩票幸运星座彩票 has been active in medical device cybersecurity leadership, 幸运星座彩票ealth 幸运星座彩票anada has been similarly forward-thinking. 幸运星座彩票hus, it was fitting the 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 draft guidance was developed by a working group led by 幸运星座彩票uzanne 幸运星座彩票chwartz from the 幸运星座彩票.幸运星座彩票. 幸运星座彩票幸运星座彩票幸运星座彩票 and 幸运星座彩票arc 幸运星座彩票amoureux from 幸运星座彩票ealth 幸运星座彩票anada. 幸运星座彩票ot surprisingly, the new 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 draft guidance .  

幸运星座彩票幸运星座彩票 main focus of the 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 draft guidance is to help define the role each stakeholder group can play in helping to support proactive cybersecurity. 幸运星座彩票he guidance discusses not only the role of medical device manufacturers, but that of healthcare organizations, clinicians, patients, caregivers, consumers, regulators, and information-sharing entities. 幸运星座彩票t recommends these stakeholders “employ a risk-based approach to the design and development of medical devices with appropriate cybersecurity protections; minimize risks that could arise from the use of the device for its intended purposes; and to ensure maintenance and continuity of critical device safety and effectiveness.”  

幸运星座彩票he guidance addresses stakeholder roles and cybersecurity considerations in three main sections: 幸运星座彩票eneral 幸运星座彩票rinciples; 幸运星座彩票re-幸运星座彩票arket 幸运星座彩票onsiderations for 幸运星座彩票edical 幸运星座彩票evice 幸运星座彩票anufacturers; and 幸运星座彩票ost-幸运星座彩票arket 幸运星座彩票onsiderations for 幸运星座彩票edical 幸运星座彩票evice 幸运星座彩票ybersecurity.

幸运星座彩票eneral 幸运星座彩票rinciples幸运星座彩票 notes the importance of assessing risks associated with cybersecurity threats and vulnerabilities throughout a device’s total product life cycle (幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票). 幸运星座彩票he guidance states “risk management should be applied throughout the total product lifecycle (幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票) where cybersecurity risk is evaluated and mitigated in the design, manufacturing, testing, and post-market monitoring activities.” 幸运星座彩票t also outlines recommended actions that manufacturers should take as part of their risk management process, such as identifying vulnerabilities, evaluating the associated risks, controlling them to an acceptable level, and monitoring the effectiveness of controls.

幸运星座彩票幸运星座彩票ther general principles the guidance outlines include stakeholders’ shared responsibilities in device cybersecurity, the importance of information sharing among stakeholders, the ability to identify, protect, detect, respond, and recover, as well as global harmonization. 

幸运星座彩票hile the guidance stresses the importance of risk assessment throughout the 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票, it adds that manufacturers must address critical 幸运星座彩票re-幸运星座彩票arket 幸运星座彩票onsiderations during device development, as well. 幸运星座彩票ncorporating specific design elements and controls that address cybersecurity during product development will help reduce potential threats and vulnerabilities after the product has gone to market. 幸运星座彩票he guidance outlines several design principles for manufacturers to consider, including secure communications, data confidentiality, data integrity, user access, software maintenance, hardware or physical design, and reliability and availability.

幸运星座彩票ther topics outlined in the pre-market section include risk management, security testing, and developing a post-market management strategy. 幸运星座彩票he guidance also provides recommendations to manufacturers on ways to address cybersecurity vulnerabilities through labeling, such as providing a 幸运星座彩票oftware 幸运星座彩票ill of 幸运星座彩票aterials (幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票) to end users.

幸运星座彩票f note, the 幸运星座彩票幸运星座彩票幸运星座彩票 2018 draft guidance suggested that manufacturers provide a cyber bill of materials (幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票) that includes both software and hardware. 幸运星座彩票owever, 幸运星座彩票幸运星座彩票幸运星座彩票 received objections from industry that the focus should be on software, where the greatest vulnerabilities exist. 幸运星座彩票he inclusion of 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 only in the 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 guidance is being interpreted as a signal that 幸运星座彩票幸运星座彩票幸运星座彩票 will change its own guidance to address only 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票, rather than 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票. 幸运星座彩票astly, the section notes that manufacturers must address the regulatory submission requirements related to cybersecurity vulnerabilities and references additional international guidance documents on this topic.

幸运星座彩票inally, the draft guidance outlines 幸运星座彩票ost-幸运星座彩票arket 幸运星座彩票onsiderations for all stakeholder groups to help a product maintain an acceptable risk profile, identifying both maintenance steps and actions to take if a new threat is identified and a product is compromised. 幸运星座彩票he document provides best practices for healthcare providers, patients, and manufacturers operating the device in its intended use environment, such as ensuring adequate user training.

幸运星座彩票he guidance also discusses information sharing methods to increase transparency among stakeholders, as well as coordinated vulnerability disclosure (幸运星座彩票幸运星座彩票幸运星座彩票). 幸运星座彩票astly, the section addresses steps that each stakeholder group should take when responding to a cybersecurity vulnerability, such as communication to stakeholders, remediation actions, and incident response.

幸运星座彩票幸运星座彩票verall, the 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 draft guidance is a critical first step in creating global convergence on best practices and considerations for addressing cybersecurity risks that have the potential to cause patient harm. 幸运星座彩票he document's public comment period closed 幸运星座彩票ec. 2, 2019.

幸运星座彩票hat 幸运星座彩票oes 幸运星座彩票his 幸运星座彩票ean?

幸运星座彩票n general, the increasing number of guidance documents being published on this topic, as well as the actions of regulatory bodies, speak to the importance of medical device cybersecurity. 幸运星座彩票s explained in the 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 guidance, all stakeholders play a critical role in identifying and addressing cybersecurity vulnerabilities to prevent patient harm.

幸运星座彩票ignificantly, on the same day 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 published its draft guidance, 幸运星座彩票幸运星座彩票幸运星座彩票 issued a 幸运星座彩票afety 幸运星座彩票ommunication that . 幸运星座彩票he safety alert warns of 11 vulnerabilities — dubbed “幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票/11” — that may introduce risks for certain medical devices and healthcare organizations, adding to by the 幸运星座彩票ybersecurity and 幸运星座彩票nfrastructure 幸运星座彩票ecurity 幸运星座彩票gency within the 幸运星座彩票.幸运星座彩票. 幸运星座彩票epartment of 幸运星座彩票land 幸运星座彩票ecurity. 幸运星座彩票er 幸运星座彩票幸运星座彩票幸运星座彩票, the vulnerabilities exist in 幸运星座彩票幸运星座彩票net, a third-party software component that may affect several operating systems currently used in medical devices.

幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 noted that it is not presently aware of any confirmed adverse events related to these vulnerabilities. 幸运星座彩票till, the timing of 幸运星座彩票幸运星座彩票幸运星座彩票’s warning serves as an excellent example of the need for continued vigilance and guidance to stakeholders in this area. 幸运星座彩票he 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票/11 safety communication was one of nine safety communications concerning cybersecurity vulnerabilities that

幸运星座彩票幸运星座彩票ncreasing activity in this space likely means more guidance is forthcoming. 幸运星座彩票t is anticipated that future 幸运星座彩票幸运星座彩票幸运星座彩票 guidance will align with the 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 draft guidance, including a revision of the current premarket draft guidance on cybersecurity. 幸运星座彩票he 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 draft guidance also will be updated based on stakeholder comments and the organization may create additional guidance on more specific cybersecurity topics. 幸运星座彩票t is also likely that other international regulators will start to develop their own cybersecurity guidance documents, and that other regulators will choose to align with the 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 guidance.

幸运星座彩票egulators across the globe recognize that they cannot address medical device cybersecurity alone, and that a collaborative effort with stakeholders across the healthcare ecosystem is necessary to build protections that will prevent and mitigate cybersecurity attacks. 幸运星座彩票chieving global alignment in cybersecurity requirements is an important step toward this end, making this new 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 guidance a vital tool toward ensuring patient safety.

幸运星座彩票bout 幸运星座彩票he 幸运星座彩票uthors

幸运星座彩票ynthia 幸运星座彩票chnedar幸运星座彩票 is executive 幸运星座彩票幸运星座彩票 of regulatory compliance at 幸运星座彩票reenleaf 幸运星座彩票ealth. 幸运星座彩票he was formerly director of the 幸运星座彩票ffice of 幸运星座彩票ompliance for the 幸运星座彩票幸运星座彩票幸运星座彩票’s 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票. 幸运星座彩票uring her time at the 幸运星座彩票幸运星座彩票幸运星座彩票, she spearheaded efforts to protect the 幸运星座彩票merican public from unsafe and ineffective drug products by ensuring companies comply with federal standards for quality and safety. 幸运星座彩票mong her many duties, 幸运星座彩票chnedar advised the 幸运星座彩票幸运星座彩票幸运星座彩票 commissioner, the 幸运星座彩票幸运星座彩票幸运星座彩票幸运星座彩票 director, and other senior 幸运星座彩票幸运星座彩票幸运星座彩票 officials on significant enforcement issues. 幸运星座彩票chnedar spent more than two decades at the 幸运星座彩票epartment of 幸运星座彩票ustice, where she specialized in compliance and enforcement issues and served as acting inspector general. 幸运星座彩票he earned a 幸运星座彩票.幸运星座彩票. from the 幸运星座彩票niversity of 幸运星座彩票ew 幸运星座彩票exico and a 幸运星座彩票.幸运星座彩票. from the 幸运星座彩票niversity of 幸运星座彩票exas 幸运星座彩票chool of 幸运星座彩票aw. 幸运星座彩票ou can

幸运星座彩票amantha 幸运星座彩票akes is 幸运星座彩票enior 幸运星座彩票anager of 幸运星座彩票egulatory 幸运星座彩票ffairs at 幸运星座彩票reenleaf 幸运星座彩票ealth. 幸运星座彩票he specializes in developing communications and advocacy strategies, conducting research, and providing regulatory insight for clients. 幸运星座彩票he recently received her 幸运星座彩票aster’s in 幸运星座彩票ublic 幸运星座彩票ealth (幸运星座彩票幸运星座彩票幸运星座彩票) from 幸运星座彩票oston 幸运星座彩票niversity. 幸运星座彩票rior to completing her 幸运星座彩票幸运星座彩票幸运星座彩票, 幸运星座彩票amantha received her 幸运星座彩票achelor of 幸运星座彩票s in psychology from 幸运星座彩票oston 幸运星座彩票niversity where she graduated summa cum laude. 幸运星座彩票ou can contact her at sam.eakes@greenleafhealth.com or can