Some Articles of Interest Before the 4th

I came across two long investigative articles that I thought could be of interest those in the medical products field. One article is from the National Journal and the other from Pro Publica. Here are the links to the articles with short clips.

Spinal Product Controversy Raises Red Flags on Medical Journals’ Disclosure Policies

Medical journals have long had to wrestle with the possibility that financial bias influences the work they publish, but if the growing controversy over Medtronic's Infuse spinal product is any indication, they may not be doing enough.

Comment: This is an area that should concern everyone in the field of medical devices and device research. I am very aware that companies fund a lot of empirical and academic research much of which is published in peer-reviewed and respected medical journals. On the face of it, nothing wrong with that. When I was a graduate student, some of my research was funded the research and development division of a well-known (non-medical) company. The funding had absolutely no bearing of the design of the research program, the data collected or interpretation of the data. The concern expressed in this article is whether data maybe suppressed or not reported in an unbiased fashion particularly when it comes to reporting data related to the risks. You be the judge.

How the Media Fell for McKinsey's Twisted Health Care Report

Critics of last year’s health care law pounced on what seemed like a damning new survey, but the details were a lot murkier than the headlines.

Comment: This is an interesting article well worth your time to read.


Finally, here's a short article that just came across indicating how rural health may well be the driver behind telemedicine. Here's the link to the article:


Rural Healthcare to Drive the Global Telemedicine Industry

...[C]ountries face various problems in the provision of medical services and health care, including funds, expertise, and resources. To meet this challenge, the governments and private health care providers are making use of existing resources and the benefits of modern technology. Besides, with limited medical expertise and resources, telecommunication services have the potential to provide a solution to some of these problems. As telemedicine has the potential to improve both the quality and the access to health care regardless of the geography; the rural market is driving the incessant growth of the telemedicine market.

Are Electronic Prescription Systems Failing to Trap Errors?

A Brief Introduction

Before I jump into the topic of electronic prescription systems, I want to make known how I came across the article I am about to post. I am creating a website that includes a substantial portion of the human factors related work I have produced over the years. That website also includes posting articles on the home page related specifically to human factors - and that includes article related to medical errors: a topic of interest to me.

The new human factors website is not yet ready for viewing. I have just created a usable home page. The bulk of the work is to come. I'll post the address when it's reached a usable state.


What's Going on with Electronic Prescription Systems?


Bloomberg news recently reported the results of a study that indicated that prescription errors are as frequent whether handwritten or written through an electronic prescription system. Here is the address of the Bloomberg article:
http://www.bloomberg.com/news/2011-06-29/errors-occur-in-12-of-electronic-drug-prescriptions-matching-handwritten.html

I have not yet had the opportunity to read the study. However, I shall and I'll continue to update this blog on this topic based on what I find. 


With respect to the Bloomberg article, this quote caught my eye:


"The most common error was the omission of key information, such as the dose of medicine and how long or how many times a day it should be taken, the researchers said. Other issues included improper abbreviations, conflicting information about how or when to take the drug and clinical errors in the choice or use of the treatment, the researchers said."


I have been a human factors professional for a long time and as I read the quote above my jaw dropped. The errors described in the quote are some of the most fundamental and easily trappable and correctable errors. It seems beyond belief that an electronic prescription system would allow a user to make such errors. In the environments where I have worked, I have designed and installed subsystems to insure that users do not make the kinds of errors as described in the Bloomberg article. When I have a chance to read the report, I'll cover specific errors, their detection and correction. And means to insure that patients are not harmed.


Here's a link to another publication that reported on the same study:


http://www.eurekalert.org/pub_releases/2011-06/bmj-oep062811.php

Hacking Grandpa's ICD: Why do it?

Background

I am part of another professional discussion group with an interest in Medical Data, System and Device security.  One of the topics was whether medical devices are a likely target for cyber-attacks.  I made a contribution to the discussion and stated that I believed that although unlikely, I thought that medical devices will eventually be targets of cyber-attacks.  But putting data security measures into medical devices is at odds with the directions that the medical device industry wants to take its product lines.  The trends are for smaller and less power-hungry devices.  Adding data security measures could increase power demands, increase battery sizes and thus increase device size.  Nevertheless, I believe that starting the process of putting data security measures into the medical devices has merit.

I received a well-reasoned response that hacking medical devices was highly unlikely and research funding on security measures for medical devices would be money best spent elsewhere.  That response started a thought process to develop a threat scenario to address his points.

I reviewed my earlier article on "hacking medical devices," http://medicalremoteprogramming.blogspot.com/2010/04/how-to-hack-grandpas-icd-reprise.html.  I revisited the paragraph in my regarding the motivation for hacking a medical device, an extortion scheme. 

When I wrote that article, I did not have any particular scheme in mind.  It was speculation based more on current trends.  Furthermore, I did not other motivations as particularly viable - data theft, not much money or value in stealing someone's implant data or killing a specific person, there are easier ways to do this although it might make a good murder mystery.

I did come up with a scenario, and when I did, it was chilling.





The Threat Scenario

First, as I had previously suggested, the motivation for hacking medical devices would be extortion.  The target of the extortion would be the medical device companies.  Before getting into the specifics of the extortion scenario requires that you understand some of the technologies and devices involved.

The wireless communications of interest occurs between a "base station" and a wirelessly enabled implanted device as shown in the figure below.

The base station need not be at a permanent location, but could be a mobile device (such as with the Biotronik Home Monitoring system).  The base station in turn communicates with a large enterprise server system operated by the medical device company.


The two systems communicate use wireless or radio communication.  For example, St. Jude Medical uses the MICS band - a band designed by the FCC for medical devices in the range of 400Mhz.  To insure that battery usage for communications is minimal, the maximum effective range between is stated as 3 meters.  (However, I have seen a clear connection established at greater 3 meters.)  


In general, the implant sends telemetry data collected it has collected to the base station.  The base station sends operating parameters to the implant.  Changing the operating parameters of the medical device is know as reprogramming the device and define how the implant operates and the way the implant exerts control over the organ to which it is connected.


Device Dialogue of Interest to Hackers

As you probably have guessed, the dialogue of interest to those with criminal intent is the one between the base station and the device.  The "trick" is to build a device that looks like a legitimate base station to the medical device.  This means that the bogus device will have to authenticate itself with the medical device, transmit and receive signals that the device can interpret.  In an earlier article (http://medicalremoteprogramming.blogspot.com/2010/03/how-to-hack-grandpas-icd.html), I discussed an IEEE article (http://uwnews.org/relatedcontent/2008/March/rc_parentID40358_thisID40398.pdf**) where the authors had constructed a device that performed a successful spoofing attack on a wireless Medtronic ICD. So, based on the article, we know it can be done.  However, based on the IEEE article, we know that it was done at distance of 5 cm.  This was aptly pointed out in a comment on my "How to Hack Grandpa's ICD" article.


Could a Spoofing/Reprogramming Attack be Successful from Greater than 5 cm or Greater than 3 meters?


I believe the answer to the question posed above is "yes."  Consider the following lines of reasoning ...

1. As I had mentioned earlier, I know that base stations and medical devices communicate at distances of 3 meters and can communicates greater distances.  The limitation is power.  Another limitation is the quality of the antenna in the base station.  The communication distance could be increased with improvements in the antenna and received signal amplification. 
2. The spoofing/reprogramming attack device could be constructed to transmit at significantly greater power levels than current base station.  (Remember, this is something built by a criminal enterprise.  They need not abide by rules set by the FCC.)  Furthermore, a limited number, maybe as few as one or two, of these systems need be constructed.  I shall explain why later.
3. A base station can be reverse-engineered.  Base stations can be easily obtained by a variety of means.  Medical devices can be stolen from hospitals.  Documentation about the communication between the medical device and the base station can be obtained.

Thus, I believe the possibility exists that a device that emulates a base station and could successfully perform a spoof/reprogramming attack from a significant distance from the target is possible.  The question is, what is to be gained from such an attack?


Attack Motivations


Extortion: Earlier I mentioned that in an other article, I suggested that the motivation would be extortion: money, and lots of it.  I think the demands would likely be in the millions of US dollars.

In this scenario, the criminal organization would contact the medical device companies and threaten to attack their medical device patients.  The criminal organization might send device designs to substantiate their claims of the ability to injure or kill device patients and/or send the targeted company with news reports sudden unexplained changes in medical devices that have caused injuries or deaths in device patients.


Market Manipulation: Another strategy would be as a means to manipulate the stock prices of medical device companies - through short-selling the stock.  In this scenario the criminal organization will create a few base station spoofing/reprogramming systems. Market manipulation such as placing the value of the stock at risk could be a part of the extortion scheme.




Book of Interest: Hacking Wall Street: Attacks And Countermeasures (Volume 2)


In another article I'll discuss how someone might undertake an attack.




** Halperin, D, Heydt-Benjamin, T., Ransford, B., Clark, S., Defend, B., Morgan, W., Fu, K., Kohno, T., Maisel, W. Pacemakers and Implantable Cardiac Defibrillators: Software Radio Attacks and Zero-Power Defenses, IEEE Symposium on Security and Privacy, 2008, pp 1-14.

How to Hack Grandpa's ICD: New Develoments

A little over a year ago I published a couple of articles in this blog regarding "Hacking Grandpa's ICD." Here are the links: 

• How to hack grandpa's ICD - Reprise
• How to hack grandpa's ICD

I receive a bit of flack from some people regarding the unlikelihood of such a thing occurring. I even wrote another article that I never published because I had convinced myself that ICD hacking scenario would be so unlikely. 

Well, it suffices to say that I have changed my mind. It seems that McAfee has take this seriously. Here are two articles for your consideration.

• McAfee hires elite hackers to break into devices
• Next health hazard: Hackable medical implants

After this, I'm publishing the article that I had originally decided not to publish.

HE-75 Topic: Cleaning Up the Mess

I received a reminder this week of what usability professionals are often called on to do – cleaning up the mess created by a failed process. Somehow, the persons responsible for designing an awful, unusable and in some case, useless user interface expect the usability expert to come in, take one look and create a beautiful user interface. This is absurd!  It was the "nightmare" come true - something related to one of my other postings: HE-75 topic: Design first and ask questions later

Writing from my own perspective, there is nothing that a usability professional likes to do less than to correct a failed design that resulted from a failed design process. This week I was asked to save a group of programmers and user interfaced designers from the monstrosities that they had created. What was particularly strange was that the leader of the project thought that I could just redesign something by looking at what they had created. It was bizarre. Unfortunately, I had to deliver several harsh messages regarding the design process and the design, that were not well received. (Nevertheless, that is my job.)

Here is the point I want to make to anyone who reads this. Process and the resulting design should be considered as two sides of the same coin. Good design process nearly always results in a good design. A nonexistent or poor design process leads to a poor design. HE-75's design process can serve as a foundation design process for designing user interface in nearly any industry, particularly in those industries where the harm is particularly severe. Where I am currently working, I plan to use HE-75 as one of the foundation documents to set user interface design standards. And as I mentioned, I am not currently working in the medical or medical device industry. However, I have come to believe that in this industry, the level of harm can be significant. Thus, I shall incorporate HE-75.

 

Next time, I'll review so of the literature that might be of some use to the community.

Advanced Technology

I mentioned in an earlier article that I have move out of medical devices for the time being.  However, I have moved out of remote monitoring or remote programming (it is called "remote configuration" where I am now.)

We have been given the go ahead to explore a variety of new and what some may consider, off the beaten path technologies.  Although I shall not be able to discuss specific studies or approaches, I shall be able to discuss how some technologies not currently used by the medical and medical device communities might be useful to them.

I shall have periodic updates on this topic from time to time.

Here are some platforms to consider for mobile technology.  (This is not part of the work that I am doing now.  It is more related to my earlier work.)

Useful Verses Usable

This is a discussion that you are not likely to read in usability texts – the topic of useful verse usability, and the value of each. Just recently I had a discussion with someone on just this topic. Furthermore, I have had numerous discussions with others and each time it surprises me that people often do not know the difference between the two and the value of each.

Useful and Usable

If you go to the dictionary, you will discover that “useful” means “to be of serviceable value, beneficial” and in addition “of practical use.” Pretty straight forward.

On the other hand, the definition of “usable” is “capable of being used” and “convenient and viable for use.” Also a straightforward definition.

However, if you probe more deeply into the definitions, you will note that “useful” is the first, necessary quality of a tool or system. It must be useful or why use it? Usable is a quality of a tool or system. However, it is not primary in relationship with the quality of the being “useful.” It is secondary. Necessary, yes, nevertheless, it is still secondary.

The usefulness as a quality of a tool or system is not addresses in HE-75, or any other usability standard that I have encountered. (If any one knows of a standard where usefulness is addressed, please add a comment to this discussion.) Usefulness is assumed.

However, I have learned that in the real world, the usefulness of any tool or system should not be assumed. It should be tested. Furthermore, with complex systems, the fundamental capabilities of a system or tool are often useful. However, not all of the capabilities of that system may be.

I direct experience with a remote monitoring system where the primary or fundamental capabilities of the system have clear use. However, with each release of this system, as more capabilities are added, the useless capabilities may be on the verge of out numbering the useful ones.

Bottom Line

• 
  
  Usefulness is always more important than usability. If it is not useful, it is fundamentally worthless or at best, excess baggage, and a drag on the actual and perceived quality of the tool or system.
• 
  
  Usefulness should never be assumed. It should be demonstrated. I know of too many projects where usefulness was not demonstrated. This lead to capabilities being developed that waste time and money, and can damage reputations.

Gadgets of the Future

An interesting and to some degree a light-hearted article about future systems that could monitor us.  This was published in the Chicago Tribune.


Here's the link: http://www.blogger.com/post-create.g?blogID=1944904461287889974

HE-75, Usability and When to Prototype and Usability Test: Take 1

Prototyping and Testing will be a topical area where I shall have much to contribute.  Expect numerous articles to appear on this topic.

I had a discussion a few days ago with one of my colleagues who has worked as a user interface designer, but has little knowledge of human factors.  He was completely unaware of the concepts of "top-down" and "bottom-up" processes to user interface design.  I provide for you the essence of that discussion.

Top-Down Approach

The top-down approach begins with a design.  Most often the initial design is a best or educated guess based on some set of principles.  Could be aesthetics or "accepted" standards of good design, or something else.  The design is usability and/or acceptance tested in some manner.  (Anywhere from laboratory testing to field-collected data.)  In response to the data, the design reworked.  The process is continual.  Recent experience has suggested that the top-down approach has become predominant design methodology, particularly for the development of websites.

Top-down is a valid process, particularly for the deployment of new or unique products where the consequences of a failed design do not lead to serious consequences.  It can get a design into user hands more quickly.  The problem with a top-down approach (when practiced correctly) is that it relies on successive approximations to an ill-defined or unknown target.  To some degree it's similar to throwing darts blindfolded with some minimal correction information provided after each throw.  The thrower will eventually hit the bull's eyes, but it may take lots and lots of throws.

The top-down approach may have a side benefit in that it can lead to developing novel and innovative designs.  Although, it can have the opposite effect when designs are nothing more than "knock-offs" of the designs from others.  I have seen both coming out of the top-down approach.

Bottom-Up Approach

HE-75 teaches the use of a bottom-up approach where first one defines and researches the targeted user population.  Contextual Inquiry is also a bottom-up approach.  Since I have already discussed researching the targeted user population in depth, I'll not cover it here.  

With the bottom-up approach, the target is clear and understood.  And tailoring a design to the user population(s) should be a relatively straight forward process.  Furthermore, the bottom-up approach directly addresses the usefulness issue with hard data and as such, more likely to lead to the development of a system that is not only usable, but useful.

Useful vs. Usable

I'll address this topic more deeply in another article.  It suffices to say that usability and usefulness are distinctly different system qualities.  A system may be usable, that is, the user interface may require little training and be easy to use, but the system or its capabilities are not useful.  Or, and this is what often happens particularly with top-down approaches, much of what the system provides is not useful or extraneous.

Personal Preference

I am a believer in the bottom-up approach.  It leads to the development of systems that are both usable and useful sooner than the top-down approach.  It is the only approach that I would trust when designing systems where user error is of particular concern.  The top-down approach has its place and I have used it myself, and will continue to use it.  But, in the end, I believe the bottom-up approach is superior, particularly in the medical field. 

HE-75 Touch Screen Recommendations

I have found HE-75 to be one of the best human factors standards ever produced.  However, I have found their analysis and recommendations regarding touch screens lacking, and out of date.  To place a perspective on the HE-75 touch screen recommendations ... in the late 1980's and early 1990's, I ran a user interface design and implementation project inside of a larger project at Bell Laboratories.  To make a long story short, one of the user interfaces we needed to design and produce was a touch screen interface.  The touch screen used a CRT as a display device and it was as flat as we could make it.  In addition, the distance between the touch screen surface and the display was about 35 mm.  When I read of the issues related to touch screens and the recommendations in HE-75, I experience deja vu and I feel as if I've been transported back to that time.

Some of the most significant advances in user interfaces have been in the areas of display technology and touch screens with respect to hardware and in particular software.  Apple Computer has been a leader in combining the advances in both display technology, touch screen design and touch screen interface software.  I would have expected the HE-75 committee to have incorporated these advances and innovations in touchscreen software into the standard.  However, what I have found appears to me as ossified thinking or ignoring what has transpired.  

People in the medical field are using smart phones with their advanced touch screen interfaces in their medical practice.  Smart phone touch screens and now the Apple iPad have become the de facto standard in touch screen technology.  My previous article related to consistency ... here's a consistency issue.  Is it wise to suggest that medical device touch screen interfaces look and operate in a way different from the accepted standard in the field?  I know this is not a simple question, but I think it is one that will need to be addressed in future editions of HE-75.