Article abstract:

A fundamental tension exists between safety in the common case and security under adversarial conditions for wireless implantable medical devices. We propose a class of new, fail-open defensive techniques for implantable medical devices that attempt to strike a balance between these two goals. We refer to these defensive techniques as Communication Cloakers. Cloakers are externally worn devices, much like computational Medical Alert bracelets. Cloakers protect the security of an IMD when worn, but allow for open access during emergencies if removed.

Article: Absence Makes the Heart Grow Fonder: New Directions for Implantable Medical Device Security (PDF)

(hat tip: Engadget)

Seattle Times has the answer:

The federal charges stemmed from an extensive investigation by the U.S. Food and Drug Administration and Washington state Department of Health. The state investigation showed Brandt earned $807,950 in treatment fees since 1995.

At least one person — a 32-year-old Bellingham man — died while being treated by the Brandts with an unproven machine, according to a search warrant.

Donald Brandt treated the man, who was diagnosed with testicular cancer, for more than a year although the man's physician had recommended immediate surgery to save his life. After refusing surgery and spending several thousand dollars on the device treatments, the man died Dec. 14, 2004, of cancer, leaving a wife and three young children.

Here are the claims we found about the Vibe Machine from "The Center For The Future":

What is the VIBE Machine?

The VIBE Machine is an electronic device that brings the vibrational level of your body back to its natural state of being.

How does the VIBE Machine work?

The VIBE Machine uses the principle that lifeforms can absorb radio wave energy to strengthen the cells of the body against physical imbalances. The device creates a strong electromagnetic field that raises the vibration of your cells to their optimal frequency. By sitting next to the machine, one receives the benefits of this energy field.

What are the benefits of using the VIBE Machine?

Rising costs of medical treatments, prescription drugs and health insurance makes the VIBE Machine a shrewd investment in your current and future well-being. Using and / or owning a machine can put you in the driver's seat for postive preventive healthcare.

This Device promotes a feeling of well-being and energy and will restore balance to the systems of your body!

Owning a VIBE Machine is a great way to benefit yourself and others. Building your own VIBE business can also allow you to contribute greatly to your community in exciting and rewarding ways. Are there others you know of that have need of this technological breakthrough?

Retail Price
$17,800.00

More from Seattle Times...

Those wishing to go back to the scientific past can visit The Center For The Future...

So we registered the domain, installed a user-friendly publishing software, and gave it some testing. The site is now ready to go, all without any significant investments (except for our time) or outside funding. In other words, 100% independent political network for doctors.

Some features of the website: WYSIWYG (What You See Is What You Get) blog editor, drag and drop picture uploading, social networking (make friends, establish contacts), bookmarking, event announcements, polls creation, and much more. The publishing on Medpolitics is as easy as writing an email: no knowledge of HTML is necessary. Again, the site is open for blogging to US physicians only, and everyone else can follow the debate and comment. We have a person on staff to treat everyone who signs up the old fashioned way, "like a doctor." That means continuous support, a phone number to call for help or to explain how to do something, and the utmost attention to all your requests. What blogging platform will do that for you?

We are not looking for thousands of members, but just for some of you that care for the future of our profession and have the desire to have your opinions heard. So let's see if the experiment will work, and whether we can get some of the quiet voices out. Sign up now, and if you have that Blogger account that gets drowned in a sea of chatter, move it and join other physicians. A few voices together are definitely louder than individuals scattered all over.

If you have any questions, please get in touch with us via this contact form.

See you in the debate halls of Medpolitics.com!

We'd like to note and to give credit to the AMA for not officiating this discussion, for not setting limits or requesting in advance the questions we were planning to ask.

Medgadget: Dr. Rohack, my name is Michael Ostrovsky. Welcome to Medgadget, I think everything is working very well now.

Dr. Rohack: Great, very good.

Medgadget: We really appreciate you giving us this opportunity to interview the president-elect of American Medical Association. It's a great opportunity for us. Just to let you know about Medgadget. We are a physician edited blog, and we've been discussing the AMA a little bit among ourselves, and would like to ask a couple questions about the AMA and its future. First question would be.. Can you give us a little summary of the mission of the AMA at the present time, in these turbulent for physicians political times.

Dr. Rohack: From a historical perspective, as well as right now, our mission is to promote the art and science of medicine, and the betterment of public health. Our three major areas of focus, however, that we are trying to accomplish is to make sure that the 47 million Americans that are uninsured do now have health insurance. And it is through a process of changing the Federal tax code so that those that can't afford health insurance can get tax credits to purchase their own health insurance. The second is to fundamentally reform the Medicare system. Medicare was created 40+ years ago, [it] is still siloed as far is its payments, it is still backwards as far as how the system works, in that it took almost 37 years to finally get a drug benefit, and we still see that Congress, having to go to Congress to say "We need to cover immunizations" is kinda backwards. And the third thing we're focusing on is improving the quality and safety, and that's through not only continuation of our involvement in standard setting for medical education, both at the medical school, the graduate medical education, and continuing education, but more importantly taking a look at tools that we can help physicians in their offices how care is being provided in different ways, to reduce the duplication that maybe out there that maybe unnecessary, that physicians may not have the tools to help them. So, clearly there are many other areas we're involved with, but those are the top three.

Medgadget: Also, I'm sure you know that there is a lot of disagreement among doctors, some would even say discontent among doctors, with the AMA, with the organization itself. Do you feel this is a time when the AMA is having more difficulty reaching physicians with its message. Specifically, are you seeing any evidence of this discontent among physicians in your membership numbers?

Dr. Rohack: Well, certainly our historical process that we've had for getting feedback from physicians has been tied to our house of delegates that assembles twice a year with physicians representing every state and specialty. However, it's also a recognition that the technology has changed. We've also looked at weblogs and other venues where physicians are being engaged for us to get an experience if that's something we should be more involved with, to interact with our members. A few years ago we started to do what's called 'Member Connect surveys', where we sent electronically to our membership individual questions, that they could respond to, to help shape our annual agenda that we put together. So I think that one of the things that the American Medical Association has done over the last decade is recognize that the historical past of how communication occurred with doctors... that is doctors coming to the AMA twice a year, the doctors then returning back to their community, and then those doctors being responsible for communication, has left the average AMA member, in fact has left the average doctor, completely unaware of what the AMA is doing. The other recognition that we have, our house of delegates which meets twice a year, is a very open, deliberative, democratic body. We don't bar the press from those deliberations. And it is so democratic, that any individual can bring a resolution to that debate, so that any time the resolution that is introduced happens to be on social policy, where the country hasn't come up with a consensus, unfortunately sometimes the press, that becomes the headlines, and it really distorts all the things the AMA does to help the actual practice and doctor in their every day life.

Here's the nugget from the American Medical Association press release:

Remko van der Togt, M.Sc., of Vrije University, Amsterdam, the Netherlands, and colleagues conducted a study in a controlled, non-clinical setting to assess and classify incidents of electromagnetic interference by RFID on critical care equipment. The tests were performed in a one-bed patient room in an intensive care unit (ICU) and with no patients present. Electromagnetic interference by two RFID systems (active [with batteries and ability to transmit information] and passive [without batteries, information retrieved by RFID reader] was assessed in the proximity of 41 medical devices (in 17 categories, 22 different manufacturers). The devices included items such as external pacemakers, mechanical ventilators, infusion/syringe pumps, dialysis devices, defibrillators, monitors and anesthesia devices. Incidents of EMI were classified according to a critical care adverse events scale as hazardous, significant, or light.

All 41 medical devices were submitted to 3 EMI tests resulting in 123 EMI tests. A total of 34 EMI incidents were found; 22 were classified as hazardous, 2 as significant, and 10 as light. The passive signal induced a higher number of incidents (26 in 41 EMI tests; 63 percent), and hazardous incidents (17), compared with the active signal.

Hazardous incidents included: total switch-off and change in set ventilation rate of mechanical ventilators; complete stoppage of syringe pumps; malfunction of external pacemakers; complete stoppage of renal replacement devices, and interference in the atrial and ventricular electrogram curve read by the pacemaker programmer.

The median (midpoint) distance between reader and device at which all types of incidents occurred was 11.8 inches. Hazardous incidents occurred at a median distance of 9.8 inches.

Press release: ELECTROMAGNETIC INTERFERENCE FROM SOME RADIO FREQUENCY IDENTIFICATION DEVICES MAY POSE HAZARDS TO MEDICAL EQUIPMENT ...

Abstract: Electromagnetic Interference From Radio Frequency Identification Inducing Potentially Hazardous Incidents in Critical Care Medical Equipment JAMA. 2008;299(24):2884-2890.

Image credit: lyzadanger @ Flickr: Tags Before Surgery

Pharmalot reports:

In a new report, the agency maintains it is now faster at approving applications than in 2002. In fiscal 2006 the FDA, on average, took 335 days to approve the devices, which range from X-ray machines to syringes, compared with 438 days in 2005, Reuters writes.

But approval of devices under a separate, abbreviated “510K” application process required, on average, 95 days in 2006, compared with 87 days in 2005. Nonetheless, the FDA argues “the average review time from receipt to final decision has declined” since Congress passed a law overhauling device regulations in 2002. Approval data for fiscal 2007, which ended last Sept. 30, was not yet available.

More from Pharmalot..

FDA Office of Device Evaluation report: Part 5 - Key Performance Indices

A summary of the results from the PLoS Medicine article:

The daily delivery of news stories about new treatments, tests, products, and procedures may have a profound—and perhaps harmful—impact on health care consumers.

A US Web site project, HealthNewsReview.org (http://HealthNewsReview.org/), modeled after similar efforts in Australia and Canada, evaluates and grades health news coverage, notifying journalists of their grades.

After almost two years and 500 stories, the project has found that journalists usually fail to discuss costs, the quality of the evidence, the existence of alternative options, and the absolute magnitude of potential benefits and harms.

Reporters and writers have been receptive to the feedback; editors and managers must be reached if change is to occur.

Time (to research stories), space (in publications and broadcasts), and training of journalists can provide solutions to many of the journalistic shortcomings identified by the project.

To note, Medgadget was not one of the sources reviewed by the study.

Full article in PLoS Medicine: How Do US Journalists Cover Treatments, Tests, Products, and Procedures? An Evaluation of 500 Stories

(hat tip: WSJ Health Blog)

...Microsoft and Google, the authors note, are not bound by the privacy restrictions of the Health Insurance Portability and Accountability Act, or Hipaa, the main law that regulates personal data handling and patient privacy. Hipaa, enacted in 1996, did not anticipate Web-based health records systems like the ones Microsoft and Google now offer.

The authors say that consumer control of personal data under the new, unregulated Web systems could open the door to all kinds of marketing and false advertising from parties eager for valuable patient information.

Despite their warnings, Dr. Mandl and Dr. Kohane are enthusiastic about the potential benefits of Web-based personal health records, including a patient population of better-informed, more personally responsible health consumers.

“In very short order, a few large companies could hold larger patient databases than any clinical research center anywhere,” Dr. Mandl said in an interview.

But the authors see a need for safeguards, suggesting a mixture of federal regulation — perhaps extending Hipaa to online patient record hosts — contract relationships, certification standards and consumer education programs.

More from the NYT...

Full article in The New England Journal of Medicine: Tectonic Shifts in the Health Information Economy

Much of this "information" stems from the nature of the Internet itself. When one's expertise in a subject often counts for naught, people, who for whatever personal reason tend to provide their uneducated version of truth to an unsuspecting public, become experts.

Dutch filmmaker IJsbrand van Veelen has been extremely critical of this trend and the dangers that it implies, and has produced a film with a particular focus on Wikipedia and the nature of its content:

More at TechCrunch...

Professor Dorothy Bishop, a Wellcome Trust Principal Research Fellow at the University of Oxford, led a study that revisited 38 adults, aged between 15-31, who had been diagnosed with having developmental language disorders as children rather than being autistic. Professor Bishop and colleagues looked at whether they now met current diagnostic criteria for autistic spectrum disorders, either through reports of their childhood behaviour or on the basis of their current behaviour. The results are published this month in the journal ‘Developmental Medicine and Child Neurology’.

Developmental language disorders, which include specific language impairment, are diagnosed when a child has unusual difficulty in his or her grasp of the spoken language, despite normal development in other areas. This may range from a child who has very limited ability to produce or understand spoken sentences, to one who does speak in long and complex utterances but nevertheless has problem communicating effectively because of problems in conveying a point or grasping what others mean.

Autistic spectrum disorders, which include autism and Asperger’s syndrome, are developmental disorders affecting how a person communicates with and relates to other people and how they make sense of the world around them.

Participants in the study were drawn from a pool of children who had participated in a series of studies of developmental language disorder conducted during the period 1986 to 2003 and about whose conditions detailed information was known. All attended special schools or classes for children with language impairments, and would have been diagnosed by educational psychologists, paediatricians or speech therapists as having developmental language disorders; none had previously been diagnosed as autistic. However, when reassessed by Professor Bishop and colleagues using current criteria, around a quarter were identified as having autistic spectrum disorder.

In recent years, the criteria for diagnosing developmental language disorders and autism have changed. This has coincided with a marked rise in the rates of diagnosis of autism. According to the Special Needs and Autism Project, the figure until the 1990s was widely accepted as being about 5 people per 10 000; even using the narrowest definition of autism, this rose to almost 40 in 10 000 by 2006.

There are two main hypotheses to explain this rise: the 'autism epidemic' hypothesis and the 'diagnostic substitution' hypothesis. While the former says that the rise is genuine, the latter maintains that the true prevalence of the disorder is constant but that changes in diagnostic criteria mean that more children are being diagnosed as autistic. The latter theory is supported by a UK study (see point 3 below) using the General Practice Research Database, which found that the rise in autism was mirrored by a decline in frequency of language disorders and now by Professor Bishop's study.

"Our study shows pretty direct evidence to support the theory that changes in diagnosis may contribute towards the rise in autism," says Professor Bishop. "These were children that people were saying were not autistic in the 1980s, but when we talk to their parents now about what they were like as children, it's clear that they would be classified as autistic now.

The question is whether big media will pick up on this study or not, as it is strangely not covering it so far.

Study supports theory that rise in autism is related to changes in diagnosis...

Abstract: Autism and diagnostic substitution: evidence from a study of adults with a history of developmental language disorder (Dorothy V M Bishop DPhil, Andrew J O Whitehouse PhD, Helen J Watt BA, Elizabeth A Line BSc (2008)
Autism and diagnostic substitution: evidence from a study of adults with a history of developmental language disorder
doi:10.1111/j.1469-8749.2008.02057.x )