“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).”



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 .


So said a cyber security expert in an interview with Korea Biomedical Review on the side-lines of KIMES 2023.


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


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


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.


Medical device vulnerabilities


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.


“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.


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.


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.


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


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.


Domestic and foreign medical device cyber security requirements


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.


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


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.


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.


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.


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


Boosting cyber security


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.


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


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.


“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.
The Arena Media Brands, LLC and its partners may receive compensation for links to products and services on this website. The Sports Illustrated editorial team is not involved in the creation of this content.
Cyber Monday deals are here and they’re some of the best offering from retailers during the shopping season. You won’t find these kind of deals again until next year. From Amazon and Walmart to Samsung and Spanx, it’s time to put a cap on your holiday shopping list.
From tech and fitness to outdoors and home goods, we’re sourcing the biggest and best Cyber Monday deals happening now. Be sure to check back for more updates throughout the day, deals are ending Monday, Nov. 28.
From Roombas and Apple devices to heated blankets and home goods, Amazon is showcasing some major deals now through Cyber Monday. You’ll find a slew of Cyber Monday Deals and lightning deals happening now. If you’re looking for shopping inspiration, be sure to check out the Amazon gift guides for some of the most popular sellers.
Save up to 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} with the Cyber Savings event on BestBuy. There are limited quantities, and some exclusions apply, so be sure to shop quick.
Samsung’s The Frame TVs sport an enhanced QLED panel, an anti-reflective coating, and a Tizen smart interface. Right now you can save up to $1,000 on the 2022 models which range from 32 inches to 85 inches.
Get up to 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off the popular workout mirror featuring workout classes from world-class fitness instructors.
Save up to $500 off cardio and strength equipment from Nordictrack, including discounts on three of their most popular machines: the Commercial 14.9 Elliptical, Commercial X32i Treadmill and Vault.
REP Fitness is offering competitive deals on all their strength and fitness equipment, including 10{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off of your entire cart with the purchase of a rack.
Sole Fitness cardio equipment is designed with performance in mind, and this holiday season, they are offering major discounts (up to $1,000) across all categories plus free delivery.
Black Friday is a great time to invest in an all-in-one home gym, and Tonal is the top of the line. Save $250 on the Tonal trainer if you buy during its Cyber Monday sale.
Get fit anywhere with the all-in-one suspension trainer systems from TRX—the brand is offering 25{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sitewide this Cyber Monday.
Score 20{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off new Whoop memberships this Cyber Monday and start tracking your activity, fitness stats and more.
The Acer Aspire slim laptop comes wit ha 15.6-inch full HD display, 8GB on-board memory, two build-in stereo speakers and ports for all of your accessories. Now down to $399.99, originally $649.99.
Amazon is everyone’s go-to when it comes to shopping, from easy and quick shipping options to the vast assortment of products and services you can explore. And during Cyber Monday, Amazon will be hosting a slew of major deals across every category. Here’s a few of our favorites.
Save on some of the most powerful chargers during Cyber Monday. One of our favorite picks: The Anker 535 Power Bank with 30W output, now 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off for Cyber Monday (down to $48.99).
Get the ASUS VivoBook Flip 14 for $349.99, down from $479.99. With the latest 11th generation Intel Core i3, Widows 10 Home, a 128GB SSD and 14-inch full HD touch display, this is the most portable two-in-one laptop perfect for on-the-go. It offers four viewing modes: tablet, tent, stand and laptop.
Save up to 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} for the holiday, two-day shipping for orders $50 or more, free return shipping and a 90-day risk-free trial.
Save on Casetify’s durable phone cases in fun styles this Cyber Monday with a buy one get 15{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off or buy two get 25{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off deal. Our pick would be the Bounce Case, which can survive drops up to 15.5-feet.
For Cyber Monday, Courant is taking 25{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sitewide on products like the chic Catch:2 for wirelessly charging two devices.
Save up to 60{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of gaming PCs and accessories for the Dell Cyber Monday kickoff. Get free two-day shipping on select PCs.
Get an extra 15{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sitewide. Get the New Hero11 Black plus one-year GoPro subscription for $399.98, originally $549.98.
During JBL’s Cyber Monday event, you can save up to 70{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} on portable speakers, headphones and earbuds.
Nixplay is taking 20{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off all smart digital photo frames that they currently have in-stock. Get an extra $20 off your order when buying two or more frames.
Get 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sitewide, including cases for iPhone 14, power stations, MagSafe products and more. We love the leather loops for AirTags, now on sale for $9.95 (down from $14.95).
Get up to $1,000 enhanced trade-in credit on your first device, and a regular trade-in credit on a second device. Get $300 guaranteed trade-in credit on any condition Galaxy device.
Score 25{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off all orders under $150 with code BFCM25 and 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off orders more than that with code BFCM30 at Satechi. We’re fans of the USB-C Apple Watch Charger which is great for travel and eligible for 25{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off.
Up to 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off on tech deals, including headphones, home theater, video games, cameras and more.
Gainful is known for high quality supplements such as pre-workout, protein powder, superfood greens and more. This Cyber Monday, get 40{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off your first order.
Get 20{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off your first order from Jacked Factory this Cyber Monday, and try out any one of their well-reviewed (and good-tasting) pre-workouts, protein powders and other wellness supplements.
From immune support and hydration to weight loss and meal replacement, Kaged has got you covered with 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sitewide this Cyber Monday with code SAVE30.
Take your performance to the next level with protein, sports nutrition and dietary supplements from Naked Nutrition: The brand is offering 15{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sitewide.
Feel confident in your supplement routine with multivitamins, protein, gut health support and more from Ritual—the brand is offering 40{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off your first month when you bundle with Synbiotic+.
Save 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off everything for Cyber Monday, including some of the most popular small indoor planters such as the Sprout, starting at $69.95 (originally $99.95).
Get Cyber Monday deals across every major category, including bath and bedding, kitchen and dining, holiday décor and more. Take 25{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off one single item.
If you’ve been looking to spice up your home office with a new desk and chairs, it’s never been a better time. During the Branch Cyber Week sale, get up to 20{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off and free shipping.
Shop everything from bread machines and indoor grills, to air fryers and toaster ovens on Amazon, averaging 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off for Black Friday. The most popular COSORI Air Fryer Toaster Oven is now $135.99, originally $199.99 for Cyber Monday.
Take 40{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off all regular price purchases with code 40ENTIRE1128, online only and ends Tuesday, Nov. 29.
Ninja Woodfire™ Outdoor Grill (base package): $369.60 MSRP. Take $40 off with promo code SI40 at checkout.
Ninja Woodfire™ Pro Outdoor Grill with Built-in Thermometer and Premium Package: $459.60 MSRP. Take an additional $30 off with promo code SI30 at checkout.
Get 25{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off for Cyber Monday, including carry-ons down to $265 (originally $355), and Grand Carry-on suitcases up to 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off, down to $270 (originally $385).
Get up to 38{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sparkling water makers and bundles on Amazon. The most popular SodaStream on Amazon is the SodaStream Fizzi One Touch Sparkling Water Maker, and is now $124.99, originally $189.99. This is perfect if you’re a huge Bubly fan.
Snag all of your Cyber Monday deals now. From tools and appliances to holiday, home and bath décor. Get up to 45{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off select tools and tool accessories, and free two-day delivery.
Get some fabulous finds up to 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off. You can find some pretty interesting and unique gifts, and even the PhoneSoap Smartphone Sanitizer now down to $39.95.
Get up to 20{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off on Amazon during Cyber Monday. Take up to 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} when you shop directly at Vitamix.com, sale ends tonight.
Get up to 80{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off during Wayfair’s Cyber Monday sale. Check out the doorbuster deals for even larger discounts on must-have home products.
Sleep soundly this season on a Bear mattress, beloved by athletes and fitness-lovers alike. The brand is offering 35{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off plus free sleep accessories with your purchase.
Enjoy 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sitewide from the popular online mattress retailer, including the Brooklyn Bedding Signature, Aurora and many others.
DreamCloud’s luxurious yet affordable mattresses are even more budget-friendly this Cyber Monday: Take 25{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off everything plus $599 of free accessories.
Helix’s customizable mattresses are designed to meet your unique sleep needs—and this Black Friday is the right time to shop. The brand is offering up to $450 off mattresses plus two free pillows.
If you’ve been dreaming about a new memory foam mattress, this is your chance to score one on the cheap: Nectar is offering 33{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sitewide during its Cyber Monday sale.
Take up to $700 off and receive two free pillows from Nolah, the popular bed-in-a-box company known for their hybrid, memory foam and latex mattresses.
Get that hotel room sleeping experience at a fraction of the price with up to $500 off Saatva mattresses, including latex, hybrid and innerspring options.
WinkBeds is known for producing bed-in-a-box mattresses designed to fit every sleep need. This Cyber Monday, take an additional $300 off their already competitively-priced beds.
Take up to 45{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off Amazon Essential fashion items, from vests and t-shirts to robes and pajamas.
Use code THANKFUL for 20{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off all in stock items for Arctix’s Black Friday and Cyber Monday sale. You can get tons of ski gear, bibs, jackets, pants and more.
Get up to 70{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off select gear and apparel for Cyber Monday. Take 25{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off full-price North Face gear, and 10{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off skis, boards and outerwear kits.
Cyber Monday sale ends today at Coach. It’s your final chance to snag up to 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off hundreds of styles, and 25{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off select styles.
Get up to 60{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off almost everything at ColeHaan.com, and members get an extra 10{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off with code CYBER for Cyber Monday.
From outdoor apparel to exercise and wellness equipment, save up to 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} on thousands of gifts for the family, and take $20 off $100 when you purchase through the app.
Take 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off everything, with hundreds of styles for women and men to pick from. From jeans and faux-leather pants to sweater sets and coats, you can find something for everyone on your list.
Shop women and men’s shoes, gifts and more during the FitFlop Cyber Monday sale. Take up to 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off and an extra 10{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off with code FLASH10.
Get up to 60{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off women, men and kid clothes, home, beauty, shoes and more–including clearance.
The J.Crew Cyber Monday Event is offering prices as low as $19.50, featuring over 65{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off for some of the best sellers.
Get 50-70{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off select styles of pajamas, coats and jackets. Take 60{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off heated blankets and throws. Women’s tops start at $11.99 (regularly $60), and beauty tools up to 40{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off.
Save up to 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sitewide during Kenneth Cole’s final Cyber Monday event, using code CMGLITCH at checkout.
Cyber Monday exclusive–get a free six piece gift set with your purchase of $200 or more. Take 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off specials.
60{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off all fleece and 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of everything else.
Get 10{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off your entire order, plus free shipping wit ha $50 purchase. Use code WONDER10. Sale ends Tuesday, Nov. 29.
Take an extra 40{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off for Cyber Monday, including clothing, shoes, designer clothing, handbags and much more.
Shop the Cyber Monday Sale and get 40{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sitewide plus additional Cyber Monday specials. This includes polos, golf gear, shoes and accessories, and more.
Get 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sitewide and up to 70{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off OV Extra.
Get $50 off every $200 spent with code CYBER22SF. Plus take an extra 15{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off beauty online only today.
Take 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off your entire purchase for the last Cyber Monday savings event. Take 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off jackets, sweaters, beanies and more.
Get 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off select exclusives, including cozy slippers to some of the most fashionable styles of the season.
The Victoria’s Secret sale ends tonight. Shop 40{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sitewide for the Cyber Monday sale, including bras, sleepwear, lingerie, beauty, sport and lounge and more.
Get 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off sitewide for Cyber Monday, and free shipping on all orders. Plus, get a select deluxe gift on order $100 or more.
This Camp Chef gas grill is 48{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off for Black Friday, now $249.10 (originally $474.99) on Amazon.
If you’re an avid cyclist, don’t miss these deals. From rearview radars to GPS mapping computers, you can find huge Cyber Monday deals across a slew of Garmin products on Amazon.
Find a huge selection of collapsible camp and outdoor chairs on Amazon, up to 35{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off. The most popular is the Outdoor Roadtrip Rocker, down to $70.28, originally $90.
Get up to 40{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off Cyber Monday top sellers, including a WWE Championship fanny pack, a retro picnic basket cooler (down to $39.99, originally $54.99) and so much more.
Get up to 55{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off select Lifestraw products on Amazon. The Lifestraw personal water filter is down to $12.74, originally $50.
Solo Stove is offering a number of deals including $50 off the Mesa Tabletop Fire Pit, and $225 of the Pi Pizza Oven. Get 45{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off fire pit bundles, 35{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off accessories and 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} off camp stoves.
![[KIMES 2023] ‘Medical devices require cyber security to get approval in US, EU’ < Device/ICT < Article](https://cdn.koreabiomed.com/news/photo/202303/20732_20858_1834.jpg "[KIMES 2023] ‘Medical devices require cyber security to get approval in US, EU’ < Device/ICT < Article")

