What is going on with all aspects of wireless medical connectivity both across the integrated delivery network, the enterprise model, and at the medical device point of care. The goal of this blog is to transform healthcare in 2013 and beyond. It is to improve ultimately patient care and the total clinical experience.
Please find the first DRAFT Guidance document distributed for comments only that came out yesterday June 13, 2013. "Content of Premarket Submissions for Management of CyberSecurity in Medical Devices. Please also refer to www.seclingua.com as this DRAFT Guidance validates the technology behind www.seclingua.com
This guidance has been developed by the FDA to assist industry by identifying issues related to cybersecurity that manufactures should consider in preparing premarket submissions for medical devices. The need for more effective cybersecurity to assure medical device functionality has become more important with the increasing use of wireless, internet, network connected devices, and the frequent electronic exchange of medical device related health information.
Integra Systems, Inc. is glad to see the detailed white paper published May 2013. It advocates what we have always considered the best practices design since our involvement in the Wi-Fi space since 2000 and approval of 802.11b in 1999. We will additionally validate the "quality of service deployment content" of this white paper by the upcoming web based event on 18 June 2013 with www.ixiacom.com and www.welchallyn.com.
Integra Systems, Inc. is working with the largest medical device company to enable www.zigbee.org and www.continuaaliance approval for the first ever M2M (machine to machine), cloud based wireless solution.
On the behalf of www.ixiacom.com; Integra Systems, Inc. will be attending and speaking at the IXIA booth at the Cisco LIVE event in Orlando, FL. This will be specific to value proposition of using IXIA test tools for an enterprise healthcare and medical device converged WLAN environment. This is a follow on to the recently published white paper and the web based event planned for June 18, 2013.
EPFL is Europe’s most cosmopolitan technical university. It receives students, professors and staff from over 120 nationalities. With both a Swiss and international calling, it is therefore guided by a constant wish to open up; its missions of teaching, research and partnership impact various circles: universities and engineering schools, developing and emerging countries, secondary schools and gymnasiums, industry and economy, political circles and the general public.
Integra Systems, Inc., is currently working with www.epfl.ch and will be present at http://swissnexboston.org/activities/venture-leaders-2013. This conference will be from June 11 to June 21, 2013. Our interest lies in helping SmartCardia by bringing together the right resources of potential technology partners, business and scientific advisors, regulatory/ testing partners, and potential investors during this meeting. Please find a short video featuring Dr. Srinivasan Murali, Chief Executive Officer. Srinivasan.email@example.com describing the SmartCardia solution.
In 1999, 802.11b got approved....and as they say...the rest is history. 802.11a/g/n has found itself into literally almost every medical device as well has pretty revolutionized how healthcare interacts with the EMR. Now the "smart phone" is changing the game. In reality is it not really used so much as a phone, but a multi-modal wireless gateway. GSM or CDMA and they we have on board WLAN as well as now LPBT (Low Power Bluetooth).
As folks tell me, I do not wear a watch, because I have a smart phone! However, I think if you could provide a lot more value, in other words a communication device, then I think the evolution of the dumb watch..."could become in reality the smart watch". LPBT (Low Power Bluetooth) changes the game again. Integra Systems, Inc., is looking to develop applications surrounding healthcare and the communications model with the AGENT Smart Watch. Most do not equate NYC as a technology place; but it is fast becoming quite a unique incubator of start up technology firms. Through KickStarter Agent Watches has raised over $700,000.00 to date in a very short time.
Integra Systems, Inc. recently viewed the episode of of Homeland where it shows the apparent host hacking into a pacemaker. This week I read an article in a IT magazine that was a reference to this where apparently several authors talk about how implantable medical device security could be exploited. Also this article in general touts that networked medical devices wired and wireless are very vulnerable.
Implantable medical device companies as well as medical device companies look at the following: Safety and reliability has everything to do with system engineering, design controls, hazards analysis, requirements & traceability, and overall quality system controls. Security and privacy requires similar quality system controls, but different mitigations than safety and reliability.
As one who has been in the cardiac pacing industry, what was shown on Homeland is science fiction. First for a pacemaker to actually have it's parameters to be changed, it has to be interrogated. This requires a specific proprietary programmer only to that company, be used with only that device and/or specific models. These programmers are controlled devices and requires multiple levels of security inherent in use. It then requires a programming head to be put on the patient's chest that activates a reed switch which places the pacemaker in an specific mode so that the parameters can be read. A magnet in the programming head activates this switch. Then and only then on the programmer can you make changes, and then these changes can be inputted into the device. The programming head must in place over the patient's chest for this to occur. In terms of monitoring the pacemaker while implanted, this only unidirectional, not duplex communications. There are all kinds of safety mechanisms and interlocks in place and our previous Vice President, Dick Cheney has had a pacemaker in place for years. You can imagine the level of scrutiny regarding his care. There are ten's of thousands of pacemakers and ICD(s), (implantable cardiac defibrillators) that have been implanted over the years and there has "never" been in instance of a pacemaker being hacked into that was implanted in a patient.
All enterprise grade embedded wireless 802.11a/b/g/n has to subscribe to WPA2. (See attached). Cisco Systems, Aruba Networks, Motorola, etc., all have as a part of their enterprise solutions sophisticated WLAN IDS (Intrusion Detection Systems). So for any person to tamper with or get into the embedded OS of a medical device, then would have to get around all the enterprise grade security in place.As I tell folks pretty much all the financial transactions of NASDAQ and NYSE amounting to million of $$ each day goes through a secure and bullet proof wireless network. I would suspect if someone wanted to hack into this network..well it may be a little more higher on the radar screen. As a side, Integra Systems, Inc., had to finish a WLAN design on highly secure government facility. We had to demonstrate that security on multiple levels was in place.