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Examining the cybersecurity of our medical health devices

Examining the cybersecurity of our medical health devices | healthcare technology | Scoop.it

Healthcare data is the number one target for cybercriminals and is 10 times more valuable than credit card data alone.

 

During the "Are your Medical Devices Cybersecure?" webinar on 14 July, moderator Andrew Pearce, Senior Digital Health Strategist of Analytics at HIMSS spoke with two subject matter experts on cybersecurity trends in healthcare, as they shared their recommendations on identifying and addressing gaps.

 

Contextualising the imminent threat of cybersecurity in healthcare, Richard Staynings, Chief Security Strategist of Cylera said, "These changes (in healthcare) have led to the emergence of a gap between advances in digital maturity and advances in security maturity, as digital transformation outpaces the industry’s ability to secure new technology."

 

Staynings pointed out that most healthcare providers might have "at best a poor inventory of IoT assets'', with few understanding the associated risks. He said that this creates “massive gaps in security risk management just waiting to be exploited".

 

Adding that providers cannot risk-assess what they do not know about, he shared that the industry needs better tools and processes to identify and assess growing IoT "connected" assets.

 

read more at https://www.healthcareitnews.com/news/apac/examining-cybersecurity-our-medical-health-devices

 

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FDA Unveils Plan for ‘Software as a Medical Device’ Review

FDA Unveils Plan for ‘Software as a Medical Device’ Review | healthcare technology | Scoop.it

The Food and Drug Administration is proposing to pre-certify vendors of certain medical device software, including various mobile apps, allowing the companies to skip the agency's much more rigorous pre-market approval process for hardware-based medical devices.

 

The proposed voluntary program is for review of "software-as-a-medical-device" products, or SaMD - software that is "intended to treat, diagnose, cure, mitigate or prevent disease or other conditions." Today, such software faces the same regulatory review as medical device hardware.

 

Examples of SaMD range from software that allows a smartphone to view images obtained from a MRI for diagnostic purposes to computer-aided detection software used to help detect breast cancer.

 

The FDA says its current regulation of medical device hardware "is not well-suited for the faster, iterative design, development, and type of validation used for SaMD," according to the agency's draft "working model" document spelling out its proposals.

 

more at: https://www.govinfosecurity.com/fda-unveils-plan-for-software-as-medical-device-review-a-10925

 

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Apple vs. Google: An mHealth Face-Off

Apple vs. Google: An mHealth Face-Off | healthcare technology | Scoop.it

Industry observers like myself have often painted the competitive mHealth landscape with a brush that wages computer manufacturer Dell and software behemoth Microsoft versus Apple--the reigning mobile healthcare champion. However, the real battle for the heart, mind and soul of the still-emerging mHealth market places Apple and search engine giant Google squarely in the commercial trenches.



Apple's iPhone and iPad have set the standard for other mobile devices in healthcare. Doctors, in particular, simply love their iPhones and iPads. But, now, the mHealth war between Apple and Google appears to be entering a new battlefield, namely wearable devices. 

At the center of Apple's efforts in this area is its long-awaited iWatch, a wristwatch-like computing device with smartphone/tablet and health/activity tracking capabilities. Reportedly, iWatch includes a pedometer for counting steps and sensors for monitoring health-related data such as heart rate.


Apple is growing its team of medical sensor specialists by hiring some of the world's premiere experts in mobile medical technologies. Presumably, this expertise will be heavily leveraged by Apple in their development of the iWatch or some other device.    


Simultaneously, Google has been working on its much-heralded Google Glass, high-tech glasses which contain a heads-up display, camera and a microphone, and can ostensibly support mobile health apps directly on the device. Google Glass, developed by the company's secretive Google X lab, has strong potential for healthcare, particularly in the ER where physicians could use the glasses to scroll through lab and radiology results and in the OR providing surgeons with hands-free access to critical clinical information.


In addition, earlier this month, Google unveiled its contact lenses, which use a tiny sensor and wireless transmitter, to monitor and measure glucose levels in tears, potentially replacing the self-administered blood tests from finger pricks that diabetics must endure on a daily basis. Not surprisingly, Google employees recently met with U.S. Food and Drug Administration officials at FDA headquarters who regulate eye devices. 


Who will be first to market with these wearable devices--Apple or Google--remains to be seen. What is certain, however, is that the two technology leaders with track records for building strong brands will no doubt dazzle the marketplace with innovative, leading-edge products that put sensor-based devices in the hands of consumers and medical professionals. That kind of competition in mHealth can only serve to benefit us all as this nascent industry moves forward

More at  http://www.fiercemobilehealthcare.com/story/apple-vs-google-mhealth-face/2014-01-27


Ricardo Rocha's curator insight, February 16, 2014 7:53 PM

"wearable devices"  .... Estamos falando apenas do começo, as possibilidades e benefícios são incontáveis!!!! Imagine não ter que tomar uma agulhada por dia para medir a glicose?

Jay Gadani's curator insight, August 6, 2014 11:44 PM

Competition is always great! 

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Medical Device Cybersecurity - Regional Incident Preparedness and Response Playbook by MITRE for US FDA

Medical Device Cybersecurity - Regional Incident Preparedness and Response Playbook by MITRE for US FDA | healthcare technology | Scoop.it

Cybersecurity attacks on Healthcare and Public Health (HPH) critical infrastructure, such as healthcare delivery organizations (HDOs), are occurring with greater frequency.  Disruptions in clinical care operations can put patients at risk.

Securing critical infrastucture is a shared responsibility across many stakeholders, and with respect to medical
devices the primary stakeholders are FDA, Medical Device Manufacturers (MDMs), and HDOs.

 

A common preparedness and response challenge FDA heard from its stakeholders in the aftermath of the aforementioned attacks is that

  • HDOs did not know with whom to communicate (e.g. MDM-HDO interactions);
  • what actions they might consider taking;
  • and what resources were available to aid in their response.

 

Without timely, accurate information and incorporation of medical device cybersecurity into their organizational emergency response plans, it was difficult for HDOs to assess and mitigate the impact of these attacks on their medical devices.

 

To address this unmet need, the MITRE team (with the support of FDA), engaged with a broad distribution of stakeholder groups to understand the gaps, challenges, and resources for HDOs participating in medical device cybersecurity preparedness and response activities.

 

Their efforts resulted in the creation of this playbook that may serve as a resource for HDOs.

 

The playbook provides a stakeholder-derived, open source, and customizable framework that HDOs may choose to leverage as a part of their emergency response plans in order to ultimately limit disruptions in continuity of clinical care as well as the potential for direct patient harm stemming from medical device cyber security incidents.

 

The link to the PDF of the first version of the playbook -> https://www.mitre.org/sites/default/files/publications/pr-18-1550-Medical-Device-Cybersecurity-Playbook.pdf

 

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Implantable biosensor monitors real-time metabolism of drugs

Implantable biosensor monitors real-time metabolism of drugs | healthcare technology | Scoop.it

Researchers and collaborators of the Soh lab at UC Santa Barbara have developed an implantable device to monitor real time concentrations of medications in the blood. The device, called the MEDIC (Microfluid Electrochemical Detector for In Vivo Concentrations), aims to address an increasingly identified problem in medicine – that people metabolize and respond to the same medication at the same dose in very different ways.

A great deal of focus has been on identifying genetic polymorphisms and other markers that can be used to identify patients who are either resistant to certain medications or at risk for adverse effects – think HLA typing prior to initiating Tegretol therapy.


The device itself consists of a chamber through which a constant stream of the patient’s blood runs. At the base of the chamber, small sensing molecules called aptamers bind the drug molecules. Once the drug molecule is bound to the aptamer, a tiny jolt of current is sent to an external device so the drug concentration can be calculated.


The researchers have overcome the problem of particles in natural blood sticking to and coating the sensor by adding a buffer layer to the chamber.


This device aims to open new opportunities into the personalization of medicine.





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Edible Batteries to Power Edible Devices

Edible Batteries to Power Edible Devices | healthcare technology | Scoop.it

Batteries made from pigments found in cuttlefish ink may lead to edible, dissolvable power sources for new kinds of medical devices. Researchers led by Carnegie Mellon University materials scientist Christopher Bettinger demonstrated the new battery. “Instead of lithium and toxic electrolytes that work really well but aren’t biocompatible, we chose simple materials of biological origin,” Bettinger says.


Conventional battery materials are not safe inside the body unless they’re encased in bulky protective cases that must eventually be surgically removed. Electronics that can either be swallowed or implanted in the body without causing harm could monitor wound healing and disease progression, release drugs, and enable more sensitive neural and cardiovascular sensors and stimulators.


The prototype sodium-ion battery from the CMU researchers uses melanin from cuttlefish ink for the anode and manganese oxide as the cathode. All the materials in the battery break down into nontoxic components in the body.


These batteries could  be a potential source of power for the next generation of “smart pills” and biodegradable medical devices.


curated from http://www.technologyreview.com/news/522581/biodegradable-batteries-to-power-smart-medical-devices/


and 


http://medcitynews.com/2013/12/wow-week-3/


and 


http://www.cmu.edu/news/stories/archives/2013/december/dec9_cuttlefishbatteries.html


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