Tag: Security

[KIMES 2023] ‘Medical devices require cyber security to get approval in US, EU’ < Device/ICT < Article

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“Cyber security readiness is no longer an option but is now mandated by medical device regulatory bodies driven by the U.S., E.U., and the IMDRF (International Medical Device Regulators Forum).”

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[KIMES 2023] ‘Medical devices require cyber security to get approval in US, EU’ < Device/ICT < Article&#13
TUV Rheinland’s Asia Pacific (APAC) head of Cyber Security services, Shotaro Kaida, spoke  to Korea Biomedical Review about the need for cyber security in medical devices .
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So said a cyber security expert in an interview with Korea Biomedical Review on the side-lines of KIMES 2023.

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As Korea boasts advanced technologies and connected health systems within its tertiary care system, medical devices are susceptible to cyber-attacks.

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TUV Rheinland’s Asia Pacific (APAC) head of Cyber Security services, Shotaro Kaida, spoke about cyber security in medical devices.

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TUV Rheinland is headquartered in Germany with offices globally and in Asia like Japan and Korea. They are a third-party testing provider performing testing, inspection, and certification services.

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Medical device vulnerabilities

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Stressing the importance of medical devices, he highlighted the impacts of cyber threats in the medical field, such as leaked patient information which can indirectly interfere with life-saving equipment like extracorporeal membrane oxygenation (ECMO), even if for just 10 minutes.

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“Cybersecurity impact depends on the characteristics, function, and usage of the device. It can have a big impact on some equipment and less on others so you need to pay attention to the device you are developing and consider the impact it can have if cyber security is breached,” explained Kaida.

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He drew specific attention to the long-life span of medical devices which often cannot be updated to the latest software or operating system which can also create vulnerabilities in systems.

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Most medical devices now use some sort of software system, database, application programming language, or external communication systems which function as communication windows but can also become intrusion points for malicious attacks, he went on to say.

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For this reason, he underscored the importance of management should be considered from the moment of developing a medical device.

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He noted the overlapping requirements between the FDA, Medical Device Regulations (MDR), and the IMDRF. Accordingly, all three cyber security requirements from the aforementioned regulatory bodies generally comprise static and dynamic code analysis, vulnerability scanning, robustness testing, security feature testing, and penetration testing.

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Domestic and foreign medical device cyber security requirements

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Specifically, he mentioned that the FDA has led the way as they were the first to publish pre- and post-market submission guidance documents in 2014 and 2016 and recently published an updated draft of pre-market cyber security requirements in 2022.

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Meanwhile, the MDR and IMDRF followed suit, and both published their pre- and post-market cyber security requirements in 2019 and 2022 respectively.

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In this regard, Korea’s Ministry of Food Drug and Safety (MFDS) also published updated cyber security approval guidelines for medical devices in January last year about strengthening policies for cyber security in terms of clarifying cyber security application targets and standardizing requirements. As a result, it now reflects the IMDRF medical device cyber security standards.

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The cyber security guidelines originally pertained to medical devices that send and receive personal medical information such as patient biometric information using wired and wireless communication, control devices, and software but were expanded to medical devices that have a communication path among medical devices including software.

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Additionally, requirements that previously differed based on the device’s cyber security safety rating are now evaluated based on the degree of harm it can cause, the medical device communication method, and the specific application and environment of use.

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He also stated that Japan will implement the IMDRF medical device cyber security guidelines starting next month.

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Boosting cyber security

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However, he pointed out that cyber security requirements for medical devices should be considered from the R&D stage to develop a secure medical device. Still, many manufacturers often struggle with cyber security readiness as they just build the device to be functional.

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He recommended assessing the device against the confidentiality, integrity, and availability (CIA) principles to uncover any vulnerabilities in medical devices.

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For example, confidentiality refers to data that should not be disclosed to unauthorized persons or used for unauthorized persons while integrity is related to the device’s data which should not be converted or destroyed in an unauthorized manner. Meanwhile, availability means the data must be immediately available to authorized users in the form necessary and when necessary.

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“This should be followed by a risk level score according to the Common Vulnerability Scoring System Version (CVSS) 3.0 and risk management assessment in accordance with the ISO 14971 standard which previously only spoke to the safety of the device but now also includes cyber security,” he explained.

Protecting America’s Medical Supplies is a Bipartisan National Security Priority

The us is beholden to individuals who supply us. Institutions from the navy to hospitals depend on imports from a broad assortment of nations, and not all of them are welcoming. Relying on non-allied international locations for significant merchandise tends to make us vulnerable. We can only make improvements to that reality with bipartisan collaboration it is really what introduced a Tennessee Republican and a Democrat from California with each other.

The pandemic showed us how tough and gradual it is to reorganize complex intercontinental provide chains. Think about how substantially even worse the circumstance would be in the course of an armed conflict, and you are going to get started to comprehend our newest nationwide security disaster.

The reasons for the crisis aren’t sophisticated. Like any other purchaser, the United States governing administration seems to be for the most stable, most affordable-value suppliers. Sad to say, this has established an overreliance on goods like medical materials produced in nations, mainly China, that could weaponize the incredibly offer chains that sustain us.

The escalating stress in between the United States and China has introduced that vulnerability into sharp aid. If Americans’ accessibility to critical clinical and pharmaceutical supplies were abruptly interrupted, our countrywide stability would be in serious jeopardy.

The United States will have to fortify its existence sciences provide chain by shifting it to nations with whom we share far more amicable relations and strategic alignment. This method will entail turning diplomatic achievement into solid financial associations, and a promising possibility has just lately opened up.

Protecting America’s Medical Supplies is a Bipartisan National Security Priority
Workers generate antigen test kits for the Covid-19 coronavirus at a factory in Nantong, in China’s eastern Jiangsu province on December 19, 2022.
STR/AFP by way of Getty Pictures

Brokered by the United States, the Abraham Accords recognized peaceful associations involving our strong ally, Israel, and a variety of Arab states in the Center East and North Africa. Health care innovation and financial development have adopted scorching on the heels of these watershed agreements, and we are well positioned to notice the added benefits as effectively.

If The usa pursues this bipartisan friendshoring option, the initially stage would entail the establishment of an Fda bureau in the Middle East. By generating a staging ground there, we diversify our offshore professional medical and lifetime sciences supply chain although shifting our dependence absent from China.

The two Israel and the United Arab Emirates have strong biopharmaceutical industries that make them natural allies in the United States’ quest to safeguard its entry to crucial health-related products that are now predominantly created in China.

These allies also boast reducing-edge health-related engineering, investigate, and enhancement. With the Food and drug administration in their community to expedite regulatory assessments and partnerships, People would appreciate expanded accessibility to lifesaving medical systems whilst accelerating pioneering health care and biomedical technologies.

It would also direct to the producing of higher-demand health care products for sale in the U.S. like biopharmaceuticals, clinical gadgets, diagnostics, and nutraceuticals.

We need to have to get started this course of action as quickly as achievable, due to the fact we have a large hill to climb.

As of now, lively pharmaceutical ingredients imported from China comprise about 90 {bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the American offer of lifetime-preserving antibiotics like penicillin, azithromycin and cephalosporins. It should also be famous that in 2019, China was liable for 95 {bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the United States’ imports of ibuprofen, 91 p.c of hydrocortisone, 70 percent of acetaminophen, 40–45 {bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of penicillin, and 40 {bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of heparin.

That similar yr, a report by an Food and drug administration-commissioned task drive claimed that drug shortages are a persistent trouble and are hard to resolve, often long lasting for decades.

A main obstacle is that we have no in depth list of every single biopharmaceutical product created in China and imported by the U.S. The suspicious absence of this essential record begs the thoughts: Who is hiding what, and why? Whose accountability is it to sustain accountability for this crucial source chain inventory?

If China have been to inflict even a small stoppage on the United States, the American population and armed forces would locate by themselves acutely susceptible and unprepared.

Friendshoring some of our pharmaceutical requirements to the Abraham Accords international locations, like Israel, the United Arab Emirates, Bahrain, and Morocco, will make America safer.

This friendshoring collaboration will not absolutely take care of America’s dependence on China, but noteworthy precedents have already been set. The Countrywide Defense Authorization Act for Fiscal Year 2021 provided the “Expanding Healthcare Partnerships with Israel to Reduce Dependence on China Act,” which authorizes $4,000,000 per year to help collaborative existence sciences analysis.

We see our condition as a massive bipartisan possibility to fortify our countrywide protection though rising America’s accessibility to innovation and cutting-edge professional medical technology—but the clock is ticking rapidly.

Rep. Juan Vargas (D-CA) who serves on the Committee on Money Services and Rep. Diane Harshbarger (R-TN) who serves on the Electrical power and Commerce Committee not long ago returned from a USIEA bipartisan Congressional tour to Israel.

The views expressed in this article are the writers’ very own.

Palo Alto Networks Announces Medical IoT Security to Protect Connected Devices Critical to Patient Care

SANTA CLARA, Calif., Dec. 5, 2022 /PRNewswire/ — As healthcare providers use digital devices such as diagnostic and monitoring systems, ambulance equipment, and surgical robots to improve patient care, the security of those devices is as important as their primary function. Today, Palo Alto Networks (NASDAQ: PANW) announced Medical IoT Security — the most comprehensive Zero Trust security solution for medical devices — enabling healthcare organizations to deploy and manage new connected technologies quickly and securely. Zero Trust is a strategic approach to cybersecurity that secures an organization by eliminating implicit trust by continuously verifying every user and device.

“The proliferation of connected medical devices in the healthcare industry brings a wealth of benefits, but these devices are often not well secured. For example, according to Unit 42, an alarming 75{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of smart infusion pumps examined on the networks of hospitals and healthcare organizations had known security gaps,” said Anand Oswal, senior vice president of products, network security at Palo Alto Networks. “This makes security devices an attractive target for cyberattackers, potentially exposing patient data and ultimately putting patients at risk.”

While a Zero Trust approach is critical to help protect medical devices against today’s innovative cyberthreats, it can be hard to implement in practice. Through automated device discovery, contextual segmentation, least privilege policy recommendations and one-click enforcement of policies, Palo Alto Networks Medical IoT Security delivers a Zero Trust approach in a seamless, simplified manner. Medical IoT Security also provides best-in-class threat protection through seamless integration with Palo Alto Networks cloud-delivered security services, such as Advanced Threat Prevention and Advanced URL Filtering.

The new Palo Alto Networks Medical IoT Security uses machine learning (ML) to enable healthcare organizations to:

  • Create device rules with automated security responses: Easily create rules that monitor devices for behavioral anomalies and automatically trigger appropriate responses. For example, if a medical device that typically only sends small amounts of data unexpectedly begins to use a lot of bandwidth, the device can be cut off from the internet and security teams can be alerted.
  • Automate Zero Trust policy recommendations and enforcement: Enforce recommended least-privileged access policies for medical devices with one click using Palo Alto Networks Next-Generation Firewalls or supported network enforcement technologies. This eliminates error-prone and time-consuming manual policy creation and scales easily across a set of devices with the same profile.
  • Understand device vulnerabilities and risk posture: Access each medical device’s Software Bill of Materials (SBOM) and map them to Common Vulnerability Exposures (CVEs). This mapping helps identify the software libraries used on medical devices and any associated vulnerabilities. Get immediate insights into the risk posture of each device, including end-of-life status, recall notification, default password alert and unauthorized external website communication.
  • Improve compliance: Easily understand medical device vulnerabilities, patch status and security settings, and then get recommendations to bring devices into compliance with rules and guidelines, such as the Health Insurance Portability Accountability Act (HIPAA), General Data Protection Regulation (GDPR), and similar laws and regulations.
  • Verify network segmentation: Visualize the entire map of connected devices and ensure each device is placed in its designated network segment. Proper network segmentation can ensure a device only communicates with authorized systems.
  • Simplify operations: Two distinct dashboards allow IT and biomedical engineering teams to each see the information critical to their roles. Integration with existing healthcare information management systems, like AIMS and Epic Systems, helps automate workflows.

Healthcare organizations are using Palo Alto Networks products to secure the devices that deliver cutting-edge care to millions of patients all over the world.

“Establishing and maintaining acute situational awareness of the Internet of Medical Things (IoMT) environment is paramount to establishing an effective enterprise cybersecurity program. The ability to accurately detect, identify and respond to cyber threats is critical to ensuring minimal operational impact to clinical operations during a cyber event,” said Tony Lakin, CISO, Moffitt Cancer Center. “Palo Alto Networks IoT capability seamlessly integrates with our continuous monitoring processes and threat-hunting operations. The platform consistently provides my teams with actionable information to allow them to proactively manage the threat surface of our medical device portfolio.”

“With thousands of devices to manage, healthcare environments are extremely complex and require intelligent security solutions capable of doing more. Palo Alto Networks understands this requirement and is leveraging machine learning (ML) for Medical IoT security. Adding intelligence will enable providers to improve operational efficiency, which will enhance patient and practitioner experience and alleviate the burden of an ongoing IT skills shortage,” said Bob Laliberte, principal analyst, ESG.

“Healthcare providers continue to be high-value targets for attackers. This reality, combined with the diversity of medical IoT devices and their inherent vulnerabilities, points to a real need for device security that is purpose-built for healthcare use cases. The ability to defend against threats targeting critical care devices while maintaining operational availability and strengthening the alignment of device governance responsibilities between IT and Biomed engineering teams is quickly becoming a necessity for the protection of patient data and lives,” said Ed Lee, research director, IoT and Intelligent Edge Security, IDC.

More Information

  • Learn more about Medical IoT Security here.
  • Read the Medical IoT Security announcement blog here.
  • Register to attend the Palo Alto Networks Ignite Conference on December 12th – 15th, 2022, here.
  • Follow Palo Alto Networks on Twitter, LinkedIn, Facebook and Instagram.

Availability

Medical IoT Security will be available in January 2023.

About Palo Alto Networks

Palo Alto Networks is the world’s cybersecurity leader. We innovate to outpace cyberthreats, so organizations can embrace technology with confidence. We provide next-gen cybersecurity to thousands of customers globally, across all sectors. Our best-in-class cybersecurity platforms and services are backed by industry-leading threat intelligence and strengthened by state-of-the-art automation. Whether deploying our products to enable the Zero Trust Enterprise, responding to a security incident, or partnering to deliver better security outcomes through a world-class partner ecosystem, we’re committed to helping ensure each day is safer than the one before. It’s what makes us the cybersecurity partner of choice.

At Palo Alto Networks, we’re committed to bringing together the very best people in service of our mission, so we’re also proud to be the cybersecurity workplace of choice, recognized among Newsweek’s Most Loved Workplaces (2021), Comparably Best Companies for Diversity (2021), and HRC Best Places for LGBTQ Equality (2022). For more information, visit www.paloaltonetworks.com.

Palo Alto Networks and the Palo Alto Networks logo are registered trademarks of Palo Alto Networks, Inc. in the United States and in jurisdictions throughout the world. All other trademarks, trade names, or service marks used or mentioned herein belong to their respective owners. Any unreleased services or features (and any services or features not generally available to customers) referenced in this or other press releases or public statements are not currently available (or are not yet generally available to customers) and may not be delivered when expected or at all. Customers who purchase Palo Alto Networks applications should make their purchase decisions based on services and features currently generally available.

SOURCE Palo Alto Networks, Inc.

American Fitness Has National Security Implications

Fiscal year 2023 is projected to be the most difficult calendar year for army recruiting given that the inception of the all-volunteer force in 1973. Every department of the military is reporting extreme difficulties in recruiting adequate volunteers to fill their ranks. Not only are fewer folks volunteering, but there are less qualified Us residents to recruit as the prevalence of weight problems grows and disqualifies an ever-raising selection from armed forces provider.

The Army is possessing the worst time of it. By the finish of the 2022 fiscal 12 months on September 30, the Military noted a 25{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} shortfall in their wanted numbers—about 15,000 soldiers quick. When the other expert services just barely satisfied their recruitment targets, they are struggling with comparable troubles that have established them powering for the coming year.

Wherever commonly the Maritime Corps would have as significantly as 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of its recruiting intention by now pleased, officers say they have only a very little about 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}. The Air Pressure has roughly 10{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} wherever it would commonly see 25{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}, and the Navy sits at an equally meager 10{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}.

In the midst of this developing disaster, there has been a swirl of dialogue all over how to incentivize much more Individuals to sign up for the military. That is an significant discussion, but normally neglected is the query of how to increase the percentage of Americans even capable to sign up for the military services at all.

Since 2014, scientific tests have proven that only a meager 29{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of People in america ended up skilled to provide with no getting granted a waiver for one particular of the benchmarks for entry into provider. In a Senate hearing earlier this calendar year, Army Chief of Personnel Basic James McConville described that number has now fallen to just 23{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}.

In an period the place nations like China and Russia are each day violating international norms, the reality that significantly less than a fourth of the U.S. population is certified to serve in a armed forces which is by now suffering from a recruitment crisis need to be deeply disturbing. The environment is turning into far more harmful with each and every passing day, and The usa requirements the U.S. navy to be completely ready to protect our pursuits.

So, what disqualifies men and women from armed service services? There are a number of variables, such as education, felony track record, and wellness. Styles in the previous two classes are tough to establish, but detrimental health developments are escalating much more and far more prevalent in potential servicemembers and ordinary Us citizens alike. Between these trends, the major standout—making up 17{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of well being-connected disqualifications—is obesity.

In 2010, 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of adults in between 18 and 39 endured from being overweight. In 2020, just 10 several years later on, that statistic experienced skyrocketed to 36.3{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} and is expected to continue to rise to 43{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} by 2030. With this tragic pattern will come raises in heart ailment, most cancers, diabetes, superior blood tension, joint problems, and other significant conditions.

This yr, the Army announced the start of a new pilot method for enthusiastic volunteers who frequently fulfill most prerequisites but both want to improve their exam scores, reduce weight, or increase their fitness. Rather than transform these volunteers away, the Army is managing them through a method at Fort Jackson, South Carolina, to assistance them fulfill the expectations. The initiative is an outstanding to start with go, but it will just take far more than the military’s effort and hard work and ingenuity to genuinely address the difficulty at hand.

Combatting obesity begins at a younger age, instilling the wish to construct wholesome behavior, dietary knowledge, and own inspiration to remain lively in our youth. Sad to say, childhood obesity and action figures show that The usa is failing in that regard, with 21{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of small children concerning ages 12 and 19 by now suffering from weight problems.

Centers for Ailment Control and Prevention research have unveiled that only one-quarter of school-age youngsters meet the healthful bare minimum of 60 minutes of physical exercise a working day. Hardly 50 percent of large school college students attend frequent bodily education and learning classes weekly, with only a 3rd executing so daily.

Although there is no 1 cure-all remedy to this problem, there is remarkably minimal community work for the trigger at all. Previous 1st Lady Michelle Obama’s Let us Move initiative was a step in the suitable course, confronting the problem directly, raising nourishment visibility benchmarks, and encouraging kids to eat healthier and exercise in tandem with big food providers and famous people. Preferred tradition, nevertheless, seems established to walk that hard work back.

American youth go through from overall body picture challenges in document quantities, but pop culture’s response has been to dismiss the worth of challenging oneself to increase in favor of loose suggestions about overall body positivity and healthy dwelling with several actionable specifics.

At the identical time, pop society fails to uphold any purpose products of explained healthful living for American youth to comply with. Actors, athletes, and celebrities who really should be making use of their platforms to inspire modify in the face of a serious danger to our little ones and country are silent. Even the President’s Council on Sports activities, Exercise & Diet, which need to be serving as the national voice on conditioning, has been remarkably silent on this problem in its weblog posts and initiatives.

But all hope is not misplaced. The far more serious the difficulty turns into, the more challenging it is to miss, and educational facilities across the nation are starting to take motion on youth exercise. For instance, educational facilities in Lincoln, Nebraska, are building a total wellness software with a total-time coordinator at the head bodily activity breaks designed into the schedule partnerships with regional farmers and after-faculty pursuits, athletics, and courses.

The troubles, complexities, and sensitivities surrounding the subject areas of weight problems and conditioning could sometimes make them complicated to go over, but the gravity of their consequences make it crucial we do so, rallying behind communities like Lincoln to attempt toward alternatives that can be styles for other individuals.

Foreseeable future generations need an American populace that is healthy, energetic, and educated in stewarding their individual individuals. It is time for navy leaders, politicians, educators, and parents alike to critically look at the upcoming of American young children, the armed service, and the country at large and to change our recent route for the better.

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