Cybersecurity for Medical Devices and Hospital Networks. Well, we had to know that this was coming... But, why did it take so long??? Maybe I missed the first Memo... I don't know. But, this is not a new issue. And it's is one, that could have some very big and bad consequences for many people, all over the world. In the areas of, Privacy, of course. Then there's that little issue of, Life or Death. By Hacking!:O And What about the Liberty to Hack, Crack and Customize your own Medical Devices, in order to get them to do what you want and need them to do? Most Proprietary Medical Devices that I have seen. Have some functionality, built into them. Such as getting the Data out of them and into your Computer. So, that you and your Doctor can compare and study, trends in Blood Sugar, for instance. Great Features, that are Crippled. Or Only works with a very expensive Proprietary Software, Cables or Add-on Devices. Which cost's too much money to buy, for many of US. And the cost of these, may even surpass the cost of the initial Device. Health Problems, almost always cause another problem. A very large Financial Problem. Which severely limits our ability to access these Proprietary Features. If a person is even able to afford one of these "Electronic Medical Devices" at all, that is. So, if the Governments of the World, want to actually Protect Patients, Hospitals and Doctors, as well. Maybe they should think about setting up a Standard. One by which these Medical Devices. Would be both be Secure and have Standardized Interfaces. Non Proprietary Interfaces, that are reasonable to purchase or even come with the Device, in the first place. Such as a Standard USB Cable. So, that we can get the Data from the Device into our Computers, Phones and Tablets etc. For Data analysis, by the many Free and Open Source Medical Applications, that are already available for use by our Doctors and our Selves. Just, a crazy and idealistic thought... What if, Medical Business were to care more about helping People Get and Stay Well? Than they do about Making Huge Profits, from out Sufferings??? What am I ranting on about??? You say... Read the Report below and see... Keeping in mind that I personally have owned several Glucometers (Blood Sugar Monitors), since around 1998. So, I speak from experience. Note: "A glucose meter (or glucometer) is a medical device for determining the approximate concentration of glucose in the blood. It is a key element of home blood glucose monitoring (HBGM) by people with diabetes mellitus or hypoglycemia." Some of my Glucometers, had no Computer Data interface at all. But, Several of Mine, came with these Proprietary Computer interfaces. Which make the Data Analysis features useless to me. I did buy the high priced Proprietary Cable for one of them. But, the "Free" version of the Proprietary Software was useless to me. And yes, the cost of the "Full Version" of the "Free" Software was not worth the Price, to me. Ya, that's what I'm talking about...

Don

MedWatch The FDA Safety Information and Adverse Event Reporting Program

Safety Information

Safety Alerts for Human Medical Products - Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication

[Posted 06/17/2013]

AUDIENCE: Biomedical Engineering, Health Professional, Risk Manager

ISSUE: FDA is recommending that medical device manufacturers and health care facilities take steps to assure that appropriate safeguards are in place to reduce the risk of failure due to cyberattack, which could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks.

Recently, the FDA has become aware of cybersecurity vulnerabilities and incidents that could directly impact medical devices or hospital network operations (refer to the FDA Safety Communication for examples). FDA is not aware of any patient injuries or deaths associated with these incidents nor do we have any indication that any specific devices or systems in clinical use have been purposely targeted at this time.

FDA has been working closely with other federal agencies and manufacturers to identify, communicate and mitigate vulnerabilities and incidents as they are identified. FDA also released a draft guidance on how manufacturers should address cybersecurity in their pre-market submissions, as well as guidance on how manufacturers should address cybersecurity issues related to products that use off-the-shelf software.

BACKGROUND: Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches. In addition, as medical devices are increasingly interconnected, via the Internet, hospital networks, other medical device, and smartphones, there is an increased risk of cybersecurity breaches, which could affect how a medical device operates.

RECOMMENDATION: The FDA is recommending that you take steps to evaluate your network security and protect your hospital system. In evaluating network security, hospitals and health care facilities should consider:

Restricting unauthorized access to the network and networked medical devices.
Making certain appropriate antivirus software and firewalls are up-to-date.
Monitoring network activity for unauthorized use.
Protecting individual network components through routine and periodic evaluation, including updating security patches and disabling all unnecessary ports and services.
Contacting the specific device manufacturer if you think you may have a cybersecurity problem related to a medical device. If you are unable to determine the manufacturer or cannot contact the manufacturer, the FDA and DHS ICS-CERT may be able to assist in vulnerability reporting and resolution.
Developing and evaluating strategies to maintain critical functionality during adverse conditions.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[06/13/2013 - FDA Safety Communication - FDA]
[06/14/2014 - Cybersecurity in Medical Devices - Draft Guidance - FDA]

Page Last Updated: 06/17/2013
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http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm357090.htm

Glucometers (Blood Sugar Monitors) glucose meter (or glucometer) is a medical device for determining the approximate concentration of glucose in the blood for home blood glucose monitoring (HBGM) by people with diabetes mellitus or hypoglycemia

: Very Low Blood Sugar Linked to Dementia; Very Low Blood Sugar Linked to Dementia; Drinking Water May Cut Risk of High Blood Sugar; Could Coffee Bean Extract Help Control Blood Sugar? – WebMD; Normal Blood Sugar Levels May Harm the Brain; Blood Sugar Levels of “Normal” Could Still Cause Brain Shrinkage | WebProNews; Glucose Meter - Type 2 Diabetes Support Group at WebMD; Glucose Meter - Type 2 Diabetes Support Group at WebMD; Glucose meter - Wikipedia, the free encyclopedia; Bayer CONTOUR Blood Glucose Meter and Ascensia CONTOURTM Test Strips User Guide | ManualsOnline; Safety Alerts for Human Medical Products > LifeScan, Inc. OneTouch Verio IQ Blood Glucose Meter – Class I Recall: Failure to Provide a Warning at Extremely High Blood Glucose Levels; Safety Alerts for Human Medical Products > LifeScan, Inc. OneTouch Verio IQ Blood Glucose Meter – Class I Recall: Failure to Provide a Warning at Extremely High Blood Glucose Levels; Safety Alerts for Human Medical Products > Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result; Safety Alerts for Human Medical Products > Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result; LifeScan OneTouch Ultra Blood Glucose Meter; LifeScan OneTouch Ultra Blood Glucose Meter; LifeScan OneTouch Ultra Blood Glucose Meter; LifeScan OneTouch UltraSmart Blood Glucose Meter; LifeScan OneTouch UltraSmart Blood Glucose Meter; OneTouch Blood Glucose Meter Upgrade Offer; OneTouch Blood Glucose Meter Upgrade Offer; Glucometer - Google Search

May 2013 Drug Safety Labeling Changes

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS
AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

DRUG NAME	SECTIONS MODIFIED
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Codeine Sulfate Solution * Risk of respiratory depression and death in children	X	X	X	X
Codeine Sulfate Tablets * Risk of respiratory depression and death in children	X	X	X	X
Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules * Risk of respiratory depression and death in children	X	X	X	X
Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) Capsules * Risk of respiratory depression and death in children	X	X	X	X
Promethazine and Codeine Syrup * Risk of respiratory depression and death in children	X	X	X	X
Promethazine, Phenylephrine and Codeine Syrup * Risk of respiratory depression and death in children	X	X	X	X
Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate) Tablets * Risk of respiratory depression and death in children	X	X	X	X
SynalgosDC (dihydrocodeine bitartrate, aspirin and caffeine) Capsules * Risk of respiratory depression and death in children	X	X	X	X
Vivelle-Dot (estradiol transdermal system)	X	X	X	X	X	PI
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Kombiglyze XR (saxagliptin + metformin XR FDC) tablets		X		X	X	PCI
Onglyza (saxagliptin)		X		X	X	PCI
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Dyna-Hex 0.75 (chlorhexidine gluconate 0.75% solution)			X
Gemzar (Gemcitabine for injection), 1g and 200 mg			X	X	X
Humira (adalimumab)			X	X	X
Inspra (eplerenone) 25 mg and 50 mg Tablets			X	X
Magnesium Sulfate in dextrose 5 percent injection, USP			X	X
Magnesium Sulfate Injection, USP, 50 percent			X	X
Magnesium Sulfate in Water for Injection, USP, in Flexible Plastic Container			X	X
Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) Neoral Oral Solution (cyclosporine oral solution, USP)			X	X	X
Rituxan (rituximab)			X	X
Sandimmune Injection (cyclosporine USP) Sandimmune Oral Solution (cyclosporine USP) Sandimmune Soft Gelatin Capsules (cyclosporine USP)			X	X
Tasmar (tolcapone) 100 mg Tablets			X	X
Tysabri (Natalizumab) injection			X	X		PCI/MG
Yervoy (ipilimumab)			X	X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Exjade (deferasirox) Tablets				X	X
Megace ES (megestrol acetate) Oral Suspension, 625 mg/5 ml				X
Metadate CD (methylphenidate HCl) Extended-Release Capsules 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg				X	X	MG
Prilosec (omeprazole) Delayed- Release Granules for Oral Suspension, 2.5 mg and 10 mg Prilosec (omeprazole) Delayed-Release Capsules, 10 mg, 20 mg, and 40 mg				X
Ritalin LA 10mg, 20mg, 30mg, and 40mg Capsules				X		MG
Stivarga (regorafenib) Tablets, 40 mg				X
Viracept (nelfinavir mesylate) Oral Powder, 50 mg/g Viracept (nelfinavir mesylate) Tablets, 250 mg Viracept (nelfinavir mesylate) Tablets, 625 mg				X
Zyvox (linezolid) Tablets Zyvox (linezolid) IV Injection Zyvox (linezolid) for Oral Suspension				X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Arimidex (anastrozole) Tablets, 1 mg					X
Concerta (methylphenidate HCL) 18 mg, 27 mg, 36 mg, and 54 mg Extended-Release Capsules					X
Optimark and Optimark Pharmacy Bulk Package Injection					X
Stelara (ustekinumab)					X
Uroxatral (alfuzosin hydrochloride) extended-release tablets					X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
PegIntron (peginterferon alfa-2b)						MG
Samsca (tolvaptan) 15 mg, and 30 mg Tablets						MG
Rebetol (ribavirin USP) 200 mg Capsules and 40 mg/mL Oral Solution						MG