To combat the rising incidence of counterfeit medical products, medical device manufacturers can implement removable memory tokens that contain product authentication keys and other security features. However, the continued reuse of these small, detachable tokens in demanding hospital and healthcare settings can be problematic.
With this in mind, Datakey Electronics produces an anti-counterfeit memory token system that is not only rugged, but can survive repeated sessions of high temperature sterilization without failure, while retaining data. And according to Datakey,
[Using] removable memory for product authentication/anti-counterfeit…opens up a host of other capabilities, including: tracking (and limiting) the number of times an attachment has been used, automatically identifying the model of the attachment and uploading any model-specific parameters, uploading any calibration information that is unique/specific to that particular attachment, and recording settings and other usage data to ensure the device was used properly according to the manufacturer’s instructions.
In addition, the Receptacle on the base controller can be used for secondary uses, including: in-field firmware updates, medical personnel access control, rights management, and more!
A recent article in The New York Times offers a look at the latest in implantable defibrillator technology. Profiling devices from multiple manufacturers, the article discusses the development of state-of-the-art implanted medical devices that wireless communicate to a patient’s physician.
They are part of a new wave of smart implantable devices that is transforming the care of people with heart disease…. The hope is that the devices, now being tested in clinical trials, will save lives, reduce medical expenses and nudge heart patients toward managing their symptoms…. Patients, who often are frail or live far from their doctors, can be spared frequent office visits. Doctors can learn immediately if devices are malfunctioning or if patients’ hearts are starting to fail. [...]
The big leap forward came a few years ago when device companies figured out how to make transmitters that send data over a broader range, 20 or 30 feet. That meant that…[a patient] did not have to wait till her doctor could put a receiver directly on her chest. Instead, she simply went near a small box, which is attached to a phone jack near her bed. Once a week…that information is automatically transmitted to her doctor. If there are problems, the machine alerts her doctor.
According to one manufacturer’s study, heart patients with a heart device that transmitted information to their doctor spent less time admitted to the hospital than did those with traditional, non-communicating devices. And the hospital costs were also significantly less per admission for those patients with smart defibrillators.
We’ve previously posted a number of articles on medical device technology and the security concerns that come along with them.
According to a recent article in The Pierce County Herald, the sudden failure of an onboard oxygen system resulted in a Minnesota woman’s death aboard an ambulance on April 22.
Although investigations are still ongoing, the ambulance manufacturer believes that it was an error in the embedded software that controls the built-in oxygen system that ultimately caused the unexpected failure. Pending further investigation, the fire department has placed portable oxygen systems in all the ambulances.
An official at the US Department of Veterans Affairs has testified before Congress that malware-infected medical devices are to blame for security compromises in VA systems.
As recently reported in InformationWeek, protecting medical devices from cyber threats has become one of the department’s “critical challenges,” according to assistant secretary for information and technology Robert Baker.
The major challenge with securing medical devices is that, because their operation must be certified, the application of operating system patches and malware protection updates is tightly restricted…. This inherent vulnerability can increase the potential for cyber attacks on the VA trusted network by creating risk to patient safety.
The VA states that not only do these security compromises have the potential to diminish the quality of patient care, but that the process of cleansing malware-infected devices has proven extremely costly. Over 122 VA medical devices have been infected with malware during the last 14 months and these attacks have occurred despite extensive preventative measures implemented last year. The department of Veteran Affairs is currently working to ensure that their more than 50,000 medical devices are equipped with isolation architecture by the end of 2010.
A British researcher–using simple RFID technology–has become the first human “infected” with a computer virus. Using a contaminated implanted chip, he successfully transmitted the virus to other external systems.
By making use of RF communications on the low power frequency range of 402 – 405 MHz, designers can endow medical devices — such as implanted defibrillators and EKG monitors — with a wider applicability and compact geometrical properties. To maximize successful operation while minimizing physiological impact and power consumption, antennae design becomes essential.
A recent article on Embedded.com addresses the technical requirements for optimal antenna performance in medical device design through four parameters: Gain Ratio, Return Loss, Efficiency and Operating Bandwidth. Because implanted transmission occurs in an environment of skin, fat, blood, muscle and bone, the potential for data loss and detuning is higher than in radiation from open air sources.
Through specialized geometry and material selection, there can be seen a great difference in antenna efficiency. As an example, the implantable patch antenna is shown to achieve optimization of geometric design, superior in transmission to a loop antenna design wherein most of the radiated power becomes dissipated within the body. Through successful antenna design, the practical power of implantable devices is increased as greater communication power is realized.
In an effort to match the engineering prowess of Silicon Valley with the increasing use of new technology in the development of medical treatments, a new master’s program incorporates UC Berkeley and UC San Francisco, both leaders of their respective fields. The new program has been given a $1.5 million jump start by former Intel CEO Andrew Grove, whose personal experience with prostate cancer and Parkinson’s disease sparked an interest in streamlining the development of medical technology.
“What we have learned from decades of rapid development of information technology is that the key is relentless focus on ‘better, faster, cheaper’ — in everything,” Mr. Grove said in a statement. “The best results are achieved through the cooperative efforts of different disciplines, all aimed at the same objective.”
As reported by The New York Times, this type of interdisciplinary approach to the growing field of “translational medicine” is gaining steam, viewed by many as yielding greater results than traditional research and development within big pharmaceutical companies.
As medical back office systems become increasingly high-tech — with medical records contained across a number of different IT systems — Dassault Systèmes, creators of data management suite ENOVIA V6, have paired with application developer echoBase to bring secure E-Medical records access to Apple’s iPhone and iPad devices. This new technology will give medical professionals mobile access to comprehensive patient data across the growing Nationwide Health Information Network (NHIN).
“The adoption of the iPhone and other mobile devices in the healthcare industry is just the latest example of how technology is creating greater transparency and an improved experience for consumers when dealing with service providers of all kinds. As a result, we see this as a natural use of ENOVIA V6’s data management and federation capabilities,” says Michel Tellier, CEO, ENOVIA, Dassault Systèmes.
As reported at Product Design & Development, the convenience of secure medical record access on mobile devices like the iPhone will ensure a more consistent patient experience with multiple providers, as well as freeing up 30-50 percent of doctor’s time spent entering patient data.
The U.S. Patent and Trademark Office has revealed a patent application submitted by Apple that details plans for a hidden iPhone sensor that can receive cardiac signals when held in human hands. These signals would be analyzed to form a unique imprint of the bearer’s heart beat that would function as a security measure to lock out unauthorized users.
Official text from the application, featured at AppleInsider, describes a series of intervals within a single heartbeat that can be used as biometric data. This data can be used not only to identify the distinct pattern of the phone’s owner, but also as a way to judge the user’s heart rate and mood, which can then potentially be implemented within fitness and entertainment applications.
As reported on AppleInsider,
…[T]he electronic device can identify media having beats per minute or other characteristics that are associated with or related to a user’s cardiac signal or heart rate, and play back the identified media…. As another example, the media provided can have beats per minute faster or slower than the user’s current heart rate to direct the user to work harder (e.g., during a workout) or to cool or calm the user down (e.g., at the end of a workout).
Among the wide range of medical devices currently in use, the infusion pump has become one of the most commonplace–and most problematic. Over two million pumps currently operate in clinical settings, and hundreds of thousands more can be found in private homes. Over the last five years some 700 deaths have been linked to infusion pumps, and more than 40,000 related complaints have been made in that time. Because these devices administer the delivery of drugs and vital substances to patients, their risk of malfunction has become an industry concern. Although many of these incidents can be attributed to user error, the FDA has decided it’s not taking any chances on critical medical devices, and has issued a new set of guidelines requiring manufacturers to supply test data on their products.
As reported in the New York Times, current FDA policy requires manufacturers of life-sustaining devices to conduct clinical trials of new designs, however the agency is known to clear them for sale without testing based on their similarity to existing products. While infusion pumps are the immediate focus of these new guidelines, it is expected that other products will also be subject to more rigorous testing, and that this higher level of scrutiny will slow down the approval of new devices. The FDA has also supplied its own open-source testing software to manufacturers, in an effort to help them determine the effectiveness of their products.
But the problems plaguing the infusion pump market are creating more serious consequences for device manufacturers than just the delaying of new devices. As reported on Medical Device Network, the FDA has ordered Baxter Healthcare–a leading infusion pump manufacturer–to recall and destroy all of their “Colleague” model pumps due to the company’s failure to remedy a number of longstanding technical defects.
To combat the rising incidence of counterfeit medical products, medical device manufacturers can implement removable memory tokens that contain product authentication keys and other security features. However, the continued reuse of these small, detachable tokens in demanding hospital and healthcare settings can be problematic.
A recent article in 
According to a 
An official at the US Department of Veterans Affairs has testified before Congress that malware-infected medical devices are to blame for security compromises in VA systems.
By making use of RF communications on the low power frequency range of 402 – 405 MHz, designers can endow medical devices — such as implanted defibrillators and EKG monitors — with a wider applicability and compact geometrical properties. To maximize successful operation while minimizing physiological impact and power consumption, antennae design becomes essential.
In an effort to match the engineering prowess of Silicon Valley with the increasing use of new technology in the development of medical treatments, a new master’s program incorporates UC Berkeley and UC San Francisco, both leaders of their respective fields. The new program has been given a $1.5 million jump start by former Intel CEO Andrew Grove, whose personal experience with prostate cancer and Parkinson’s disease sparked an interest in streamlining the development of medical technology.
As medical back office systems become increasingly high-tech — with medical records contained across a number of different IT systems — Dassault Systèmes, creators of data management suite ENOVIA V6, have paired with application developer echoBase to bring secure E-Medical records access to Apple’s iPhone and iPad devices. This new technology will give medical professionals mobile access to comprehensive patient data across the growing Nationwide Health Information Network (NHIN).
The U.S. Patent and Trademark Office has revealed a patent application submitted by Apple that details plans for a hidden iPhone sensor that can receive cardiac signals when held in human hands. These signals would be analyzed to form a unique imprint of the bearer’s heart beat that would function as a security measure to lock out unauthorized users.
Among the wide range of medical devices currently in use, the infusion pump has become one of the most commonplace–and most problematic. Over two million pumps currently operate in clinical settings, and hundreds of thousands more can be found in private homes. Over the last five years some 700 deaths have been linked to infusion pumps, and more than 40,000 related complaints have been made in that time. Because these devices administer the delivery of drugs and vital substances to patients, their risk of malfunction has become an industry concern. Although many of these incidents can be attributed to user error, the FDA has decided it’s not taking any chances on critical medical devices, and has issued a new set of guidelines requiring manufacturers to supply test data on their products.
