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FDA Awards a Big Grant to Health Insurance Company For Pilot Program To Monitor Safety of Drugs and Medical Devices

When I first read this it made me think of the phenomenal amounts of data that insurers have.   Don’t be fooled though thinking this is all healthcare oriented, it has to do with money.  Carriers, HMOs all have utilization departments that this information anyway so they can “score” and use algorithmic formulas to predict what they are going to have to spend on you for your care.  It has nothing to do with your healthcare at your present state of body.  Ask any hospitalists about what a “Utilization Department” is and how they are accountable and sometimes are ripped over the coals if they keep patients in the hospital an extra day or so.  They get all the time and have to fully justify your stay.  

Let’s jump into this a little more and ponder the types of devices that will be looked at for safety, and if you haven’t guessed it, devices that report data will be in right in here, and it also gives the health insurer a deeper look into how to potentially “score” your health information while they are at it.  Again, one more reason I believe health insurance companies need to be non profit, as this safety issue is dollar oriented from the insurer side.  It may not be the intent of the FDA, but by allowing this grant, this is what will occur. 

By continuing to have health insurance companies on the stock market the confidence of the consumer is NEVER going to be there, plain and simple.  This is why today you see organizations like Kaiser Permanente gaining traction and confidence with patients, and no they are not perfect, nobody is, but they are making a lot more headway than most.  They do not have shareholders to report to and pay dividends to.

Now the data contributed is useful and if used and evaluated properly by the FDA we could see some progress made here, so again the insurance organization should not be providing the input on recommendations, but rather data only and we need some intelligence at the FDA to evaluate such.  I have written about the Sentinel system several times on this blog and if I remember correctly, Blue Cross was one of the first health insurance companies who stated they would add data.  Again, this is what we need, data for individuals at the FDA to use, not an insurance company making their recommendations based on profitability if we are in fact imagelooking to find and create safety initiatives and programs. 

FDA's Sentinel Initiative Information Revealed – Business Intelligence

Hospitals are involved here too and using information from medical records is valuable, but again not to fall into the hands of the insurer to “score” and define profitability on one’s head and body, so input from hospitals for the sake of privacy must be separate from the insurance input if we are to have privacy issues observed here.  Insurance companies love and thrive on data, all kinds, business intelligence in particular is what they live off of and it helps them create business models that will yield dividends.  The article says it’s a shift from the FDA of being reactive, which in part is true, but again there still needs to be the open line of communication from patients and physicians to add to safety issues and concerns too.  

What amazes me and I wrote about this which is a huge safety item is HRT, and the title specifically asks the FDA and insurance companies to run some numbers, something that has been asked for a long time and we still have no action, so my own personal confidence level right now is pretty low.  We all know the health insurance industry invests heavily in technology and at this point we can’t say the same for the government as most departments have one huge project of playing catch up

FDA Approved Bio Identical HRT Versus Premarin and Cancer – Where’s the Numbers FDA and Pharma?

Also I have talked about Behavioral Health care and Pilgrim, under written by Vintage Financial Services, is right up there in that area of focus as well and safety and behavioral health are somewhat going hand in hand today, biometric monitoring and other related items. 

There was not enough detail given on how the pilot program will in fact function with the Sentinel data system of the FDA to really go much further here and I do in imagefact hope that it is the data that is used by the “experts” at the FDA and not a reliance on a health insurance company’s program to run the program entirely and have the authority to here, as we all will suffer if this occurs and shareholders may receive larger dividends.  Once again I’ll say that health insurance needs to be a non profit business and if the FDA outsources this completely, they have sold us all down the river in the hopes for better healthcare.  BD   

Harvard Pilgrim Health Care Inc. has won a major grant from the Food and Drug Administration to build a system to monitor the safety of drugs and medical devices after they have gone on the market, the federal agency disclosed yesterday.

The Wellesley-based health plan will use a five-year, $72 million grant to coordinate the efforts of 28 health care organizations around the country as they design ways to make use of information they already gather, in electronic medical records or claims data, to provide early warning of potential harm.

Mass. insurer gets FDA grant - The Boston Globe

Related Reading:

FDA May Need Major Restructuring – Catch up with Technology
Study Calling For Medical Device Information To Better Serve Patients And Doctors from the FDA
First US FDA office unveiled in Beijing
Business Intelligence for the FDA on the way
A Broken Agency – China and the FDA
Medicine is a Low Tech Business - Clinical Studies still done on paper too!
Sentinel Initiative Boosts FDA Safety Oversight

CVS and AllScripts Collaborating on E-Prescribing – Minute Clinics Get Joint Commission Accreditation Award

You can read the press release here about the Joint Commission award.  CVS obviously found that additional investments with software development may not be worth the dollars spent when it is easier to perhaps partner with a company focused in this direction.

If you are a provider using the CVS software iScribe, the company will migrate you over to the Allscripts system.  One additional reason behind the move is the availability of stimulus money too, so this appears to be a win-win in that arena.

Occasionally I wonder into a Minute Clinic in Orange County and get updated on what is going on.  I do have to say one thing, the PA on duty is always up to date on technology and they do take time to help educate patients on getting started with either a Google Health or HealthVault account, so there’s some training and education in place at CVS at the Minute Clinics. 

Minute Clinic Visits Pricing and What you Should Bring with You – Medical Information and History

Just for the record, NEPSI, provides a lite version of Allscripts e-Prescribing that is free to any provider.  Even if you don’t use it, sign up and get an awakening on how they make sure you are a provider with what is mined from the internet, you will amazed and learn how much privacy really is not there at times on the web.  BD

NEW YORK (AP) — CVS Caremark Corp. said Thursday it will partner with electronic health records maker Allscripts-Misys Healthcare Solutions Inc., and begin switching clients to Allscripts' e-prescribing tool.
CVS said it will stop offering its iScribe prescription tool and transition thousands of clients to products made by Allscripts. E-prescribing allows physicians to send prescriptions directly to a pharmacy by e-mail, and gives the physician information about potential drug interactions and the patient's health insurance. They can also use it to follow up with patients about unfilled prescriptions.
CVS, of Woonsocket, R.I., said current iScribe users will have the opportunity to switch to a full electronic health record system made by Allscripts. That would allow the customers to qualify for up to $64,000 in federal economic stimulus funding starting in 2011.

CVS will collaborate with Allscripts on electronic prescribing, retire iScribe product - latimes.com

FDA Approved Bio Identical HRT Versus Premarin and Cancer – Where’s the Numbers FDA and Pharma?

I have been writing about this for a while now, but I wonder why can’t we get some numbers crunched here?  We keep hearing about the Bio Identical hormone treatments that are customized, but why can’t we get some numbers that compare “FDA Approved” Bio identical hormones compared to Premarin? 

image

Myself and I’m sure there’s a ton of other women who would like to see some statistics on this.  Again, I am not talking customized Bio Identical drugs as what makes the news today, I want:

FDA Approved Bio Identical HRT and Premarin Numbers that show cases of breast and ovarian cancer

The FDA and Health Insurance companies have numbers on this so why can’t we get some SQL query statements run to show some numbers?   The FDA with their new Sentinel system were supposed to get raw data to provide some of this, so what’s happened here?  Health insurance companies could run their own analysis with all the data they have collected with no identities, but rather just women with cancer taking Premarin, and those with cancer taking bio identical drugs, past and present.

How safe are Estrace, Evamist, Vagifem, Estraderm and Climara, inquiring women want to know! 

Last year I had this discussion with Dr. Erika Schwartz, who speaks frequently at Harvard and at many other institutes and we pondered this, and here we are today wit no numbers yet!  This is an important issue that is being overlooked, and is it because the companies who make the FDA approved bioidentical HRT drugs don’t make enough money on their sales?  I don’t know but again would like to know if they are safe and how they compare.  I would think with all the “scoring” that health insurance companies do today with risk assessment that this would have been long done as they dance around all other areas that involve women’s health to include scrutinizing who gets the Myriad genomic breast test. 

Myriad's BRACAnalysis Tests Scrutinized by Insurance Carriers – Many Do Not Qualify and Myriad Marketing Questioned

I would think for their own information use that this issue would be some business intelligence the insurers would want as it goes hand in hand with the genomic testing! 

Here’s a bit of what Dr. Erika and I talked about last year and the full article can be read at the link below.  BD 

Bioidentical Hormone Replacement Therapy– Interview with Dr. Erika Schwartz

I had the opportunity to chat with Dr. Erika Schwartz recently about Bio Identical Hormone Therapy, one of the foremost experts in the United States on the subject. She has written 4 best selling books and is also seen on Extra Lifechanger. Dr. Erika trained at Kings County Hospital Center in Brooklyn, NY in Internal Medicine and Critical Care on the front lines and became the Director of Emergency Medicine at Westchester County Medical Center. She also lectured on the topic of bioidentical hormones at Harvard University/Massachusetts General Hospital.

Bio-identical hormones to many, and self included here are a confusing issue as there are both the drugs which are standardized dosages and approved by the FDA, and those that are personally compounded at pharmacies, which means is a custom mix and not out of the box or bottle. When many today seem to think of bio-identical hormones, we automatically believe that they are only drugs compounded by the pharmacy, and that is simply not true. Bioidenticals are synthesized hormones that mimic those produced in women's ovaries, more natural than those produced from

horses. You can read more about Estradiol and Levonorgestrel here.

Dr. Schwartz named several FDA-approved drugs that are bio identical to include Estrace, Evamist, Vagifem, Estraderm, and Climara for estrogen and Prochieve, Prometrium, and Crinone for progesterone. Well guess what, I had been using an FDA bio identical drug and didn’t even know it, so there again is where my education on hormones began.

Jon Stewart and the Daily Show Discuss C-Span, Transparency, Healthcare Reform and the Peter Orszaq Sex Scandal

Nobody is safe on this one, good job and great humor as always.  Best help here is for everyone to get on the technology wagon to make this happen.

The Daily Show With Jon Stewart Mon - Thurs 11p / 10c
Stealth Care Reform
www.thedailyshow.com
Daily Show
Full Episodes
Political Humor Health Care Crisis

Samantha Bee thinks President Obama should never have made a concrete pledge to televise health negotiations on C-SPAN.

If this is not enough, let’s pass on Tiger Woods and look at the Peter Orszaq sex scandal.  What does OMB stand for?  Hilarious. “Ladies put your husbands to bed and hide your ovaries:)”

The Daily Show With Jon Stewart Mon - Thurs 11p / 10c
Peter Orszag Sex Scandal
www.thedailyshow.com
Daily Show
Full Episodes
Political Humor Health Care Crisis

The Daily Show with Jon Stewart Official Website | Current Events & Pop Culture, Comedy & Fake News

Researchers Are Taking on The FDA – Good Cause and About Time

This is very timely as cardiovascular devices are changing rapidly, now many are devices that report data too.  So many still seem to think Health IT and the clinical side of the business are 2 separate items, they are not.  All of healthcare is changing in this area and they are married at at hip. 

If you are only looking at the clinical side of the business as relates to medical devices, then only half is getting done.  Kudos to the researchers who are bringing this to the limelight.  I write about this item quite frequently and again the ramifications on what happens with both entities combined is largely over looked.  I will definitely be a follower on this effort.  BD

The Medical Quack: Wireless Healthcare Medical Devices and the FDA ...

Wireless Healthcare Medical Devices and the FDA – The Reasons They Are Slow to Come to Terms

Researchers Sanket Dhruva and Rita Redberg on the hornet's nest they stirred up with their study of the Food & Drug Administration's approval process for high-risk cardiovascular devices.

It's not often that a few doctors ensconced in the ivy towers of academia can get a lumbering dinosaur like the Food & Drug Administration to turn on a dime, let alone during the week between Christmas and the new year.

But that's exactly what University of California at San Francisco researchers Sanket S. Dhruva, Lisa Bero and Rita Redberg did after the Journal of the American Medical Assn. published their paper "Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices."

The study, which looked at 78 pre-market approvals for cardiovascular devices from 2000 to 2008, touched such a nerve at the Rockville, Md., headquarters of the FDA that acting Center for Devices and Radiological Health head honcho Jeffrey Shuren had the watchdog agency's own internal study of the device approval process released early. Shuren, during a spin control session with the New York Times, conceded the researchers' main point: The agency needs to do a better job regulating the evidence used to clear medical devices

Researchers take on the FDA | Medical Device Industry Features & Profiles - MassDevice

Tablet PCs – The Best Thing Since Sliced Bread -This Knowledge Has Been Valued by a Very Small Group – Participants and Users – Lesson Learned, Be A Tablet PC Goober No Matter What Everyone Else Thinks!

I dearly love all this talk about Tablet PCs and those who know the value are the users and participants.  We have log of “Magpies” here too, those who just talk about it and are afraid to break the paradigms of the keyboard.  As everyone knows I have been an avid user for years, why, because I saw value and was not afraid to experiment with other means of interacting.  That fear is alive and well today and has been for years.

I have had a hospital CEO in Long Beach run for the hills to hide when I would show up with my Tablet, in other words the Medical Quack was here again with that “thing”, darn I don’t want to have to deal with it and learn something new that might help me and show value (grin).  I used to just sit there and watch the shear look of panic that would come over his face.  What was also funny was the look of anger I would get if the battery alert went off, it was like shut that thing up. 

I used to do some training for Intel at retail locations and sometimes I would have a representative from HP show up and we worked together.  It was funny that the HP rep would show up with old paper files to have the Best Buy or Circuit City attendees sign in.  What did I do? I scanned an Intel sign in sheet on the tablet pc and had everyone sign in that way – paperless.  I used to sit and wonder why a progressive company like HP didn’t train their “own” employees on value, but yet were there to pitch and promote their technology savvy products?  What was up with that picture?  HP reps couldn’t use their own tablets?  Most of them I met didn’t even own one, but they could sure tell you how to connect a TV to a notebook, again I mention this as it relates to where our focus is, entertainment and not knowledge. 

What was really great was the ability to use the touch screen capabilities of the Tablet PC to show Intel flash videos to help educate.  I even had a couple store managers who thought that was very cool, and then I had the old school folks who didn’t get it and thought I was showing cartoons, go figure (grin). 

Even when I was at HIMMS in 2008 the paradigms of the keyboard were strong and alive.  There were many vendors selling and promoting Tablet PCs, but the unspoken rule of thumb was “don’t take that thing out of the booth, show the value here instead of showing value on how it could be used at a convention”.  I did it but was seen as a bit of “goober” as folks just saw this as “not being cool”.  I laughed and generated a lot of interest when I visited other booths and was prepared with my One Note Intelligence Files, ready to take notes, and hey the EHR vendors were impressed too.   Panasonic, Motion and more, would they step outside the booth and use a tablet in real life – heck no – you would look like a “goober” if you did that (grin).  God forbid if you actually walked around with a device that you had incorporated into your own personal and professional lifestyle, that was just not cool and appearance as a disguised Magpie was all. 

HIMMS 2008 summary - getting organized is the trick

At HIMMS it was back to the old “Magpie” philosophy of I’m going to tell you what you can do with a tablet pc, but for God’s sakes don’t expect me to use one, I’m just here to sell you.  Below is a video of me live at HIMMS 2008, just being me and using technology, defying the “Magpie” code of honor. 

I used to frequently run into drug reps that were given Tablet PCs to use for the course of their work and would chat. Do you think any of them knew how to go beyond their installed programs and use Windows Journal to take notes in meetings, not a one and most just complained about having to use a Tablet pc.  This comes back to education and participation once again. 

It was and still is  truly a sad note to see frustration and anger from those who would choose to be non participants and thus saw very little value with Tablet PCs, but hopefully we are now overcoming some of this. 

I have an entire section on this blog devoted to Tablet PCs, so be a “goober” and explore and find some value (grin). 

According to CNN, tablet-sized computers are now "a much-hyped category of electronics." True. The Associated Press says, "Tablet-style computers that run Windows have been available for a decade." Yes, and a lot longer than that. And a PC World editor states, "Tablet PC's are not new.

The slate form factor portable computer has been around for almost a decade, since Microsoft initially pushed the concept with its Windows XP Tablet PC Edition." Nope. Microsoft did not initially push the concept with the XP Tablet PC Edition. Microsoft released a tablet OS way before that, in 1991, and even then it was just a reaction to what others had done before.

Tablet PCs: Learning From The Past -- Table PCs -- InformationWeek

Related Reading:

The Medical Quack: Selling the bitter EMR pill (HIMSS meeting ...

Easy to swallow - the tablet pc

Final Health Care Bill May Roll the IRS Into Policing Whether or Not One Has Health Insurance On Tax Returns

Well my thoughts on this think the IRS is already over burdened with audits so add this now?  The whole idea of penalizing citizens for not having health insurance is a crock and just creates another layer of red tape and more importantly, more bad will.  Can’t we have a Congress that can begin creating “good will” instead?image

From a tech side of things I wonder if the data capabilities are there to even do this when I read about Social Security still living off of Cobol?   If this idea is further entertained, then I think changing the way insurance companies operate to going back to being non-profit and functioning in that capacity as originally designed should also be changed, as how can you penalize people who can’t afford it when government funds are running out all over the place to subsidize? 

Good question, so again, if this is brought in as law, insurance companies should also be non profits and we should have an agency or the SEC that can run audits and certify their algorithms they use for scoring and calculating payments and qualifying, only fair. BD 

As if U.S. tax forms aren't complicated enough, Congress is expected to include in its final health care reform bill a requirement that nearly all Americans have health insurance -- and prove it on their tax returns or face a fine.

The Internal Revenue Service would be tasked with enforcing this new health insurance mandate, prompting some in the tax preparation business to say this is going to add a whole new burden to the tax agency.

"Just the audits of this is going to be huge because our system is a voluntary compliance system," said Terry Jones a private certified public accountant. "The IRS can audit, of course, and this is a whole new area opening up that the IRS is going to have to be on top of."

In addition, the health care reform bill likely would require the IRS to dole out taxpayer dollars -- subsidies -- to low-income Americans to help them pay for health insurance, administer tax credits to small businesses to help them offer health insurance to workers and collect billions of dollars in new taxes on employers, insurance companies and medical device companies.

FOXNews.com - Final Health Care Bill May Require Proof of Insurance on Tax Returns

In Case of a Bio Attack The Us Post Office Could be the Agency We Rely on for Counter Measure Distribution

HHS and Homeland Security are seriously working on developing a dispensing model for the the Post Office, as in the case of anthrax for a simple example.  This effort is a result of the Christmas Day airline attempted attack.  BD  image

WASHINGTON — The US Post Office could play a key role in distributing medical aid in the event of a biological attack, according to an executive order released by the White House.

The order signed by President Barack Obama directs government agencies, local law enforcement and the US Post Office to work on a model for distribution of medical countermeasures in the wake of a biological attack.

"This policy would seek to: (1) mitigate illness and prevent death; (2) sustain critical infrastructure; and (3) complement and supplement State, local, territorial, and tribal government medical countermeasure distribution capacity," the order said.

"The US Postal Service has the capacity for rapid residential delivery of medical countermeasures for self administration across all communities in the United States," the order added.

AFP: In bio attack, US Post Office could distribute aid

Penile Story of the Week – One More Call for the Fire Department to Help in Surgery But New Treatments Are on the Horizon for ED

When I keep saying we need more education in healthcare, well this latest story from a man in England somewhat confirms this once again.   This was one more case imagewhere the fire department was called to the rescue as the man’s organ was stuck in a pipe and the patient offered no explanation as to why this occurred.  It is amazing what restricted blood flow will do.  No word on whether or not he was taking any ED drugs to cause any of this.  I am glad women do not have this issue and are built different so I don’t have to be writing about the irrational placements of female organs.(grin).  We’re smarter than that I believe. 

A couple months ago in the OC where I live, we had this crazy story about the man who with the same problem with blood flow it sounds, had a weight stuck and the fire department had to scrub and go into surgery with the physicians.  The full story can be read a the link with a preview below.  That story was a real screamer as he waited 3 days to call for help, ouch. 

Gym Weights Cut From Man's Genitals – This Part of the Body Was Not Designed to Lift Weights

Only in the OC….this is a very unusual story and embarrassing to say the least.  Did he somehow read something that was misleading here on how to increase his imagesize?  This is one for the dumb and dumber files literally with dumbbells!  The article said he waited 3 days before getting help.  The procedure to remove the weight took 2 hours and the hospital kept the patient under psychiatric hold after the patient muttered “this will make me the chief of my tribe”.  I guess we now have tribes in the OC too.  The fire fighters had to dress in full surgical garments when removing the weight.

If you are male and have issues, there are solution in the works, first from Wake Forest they are using stem cells and have created one, transplanted to a rabbit and it worked and produced off spring, so just be patient and stop trying to solve the issue yourself and go see your doctor.

Regenerative Medicine News – Fully Functional Rabbit Penis Created That Worksimage

Well this process obviously is a success as it took only one minute for the males to begin the reproduction process after being introduced to female rabbits.  In the past only scaffolding had been used and that portion alone was not a success.  Earlier this year, Dr. Oz did a show going through the Wake Forest Center where all this is taking place. 

If this news is not enough, recent clinical trials using a shock wave device too are showing favorable results, so in the near future, drugs may not be the only option.  The trial from the shockwave treatment actually “cures” the arterial blood flow problem with many men and thus they no longer need Viagra, Cialis and Levitra, so this could stand to be some good news for many.  I’m sure we will be seeing more of this trial and study in the news in days to come. 

Shock Wave Therapy for Treating and Curing ED

Anyway, back to the story at hand, the saga of the pipe below, we really do need education and training to help some folks along here and with some of theimage information on the 2 links above, it looks like progress is being made by either soon having one grown or via shock treatment, but please don’t rely on these home methods that end up in the news and on blogs like for everyone’s amusement. 

Medics at Southampton General Hospital could not get the man's penis out of the stainless steel pipe because the restricted blood flow had caused it to become aroused.

So they called in Hampshire Fire and Rescue Service.  The firefighters used the four-and-a-half-inch grinder to cut the pipe from around the man's penis and it took about 30 minutes.

The patient was given an anesthetic and his penis was left bruised and swollen but otherwise unharmed.  The anxious man aged about 40 gave hospital staff no explanation about how the pipe got stuck after he turned up on Tuesday morning.

Man's penis removed from pipe - Telegraph

Blue Tooth Healthcare Device Being Shown at CES in Las Vegas – Oximeter for Pulse And Blood Oxygen Information

I posted about this blue tooth pulse device back in September of 2009 and did a copy and paste below, and now we are seeing healthcare with Continua standards imagebeing show at the CES show this week.  I keep telling everyone that devices that report data are quickly becoming integrated into the world of healthcare and how advanced they have become, so clinical information is not always going to be done by humans in all areas.  Devices that report vitals are clearly emerging into the picture and this area seems to be so widely ignored by many, especially when we enter into the “meaningful use” arena as the focus still revolves around data input via patients and clinicians.  Devices are on the move with blue tooth, which has changed the entire picture here and they need to be included, but perhaps it’s more of a denial factor or lack of wanting to learn that hinders this.

Last year at CES the product was voted Best of CES for 2009

Just yesterday, we had Steve Ballmer tell everyone to break the keyboard habit and entertain other ways of reacting with computers, a very slow going process as we don’t like or accept change very well as humans.  BD

Blue Tooth Wireless Fingertip Pulse Oximeter – Taking Your Pulse Gone Wireless

Just when you think you have heard it all, you haven’t.  This certainly makes it easier than using a USB cord and it will automatically shut itself off when not in use.  It will give around 600 readings and uses standard 2 AAA batteries. 

The distance is stated at 100 meters and will send the information to a PC, PDA, etc.  Of course you also get an entire audit and data trail of everything submitted and sent.  All these “smart” medical devices pretty much have this all built in.  Once more, this would be a nice device to connect to a PHR, like HealthVault.  The device was approved by the FDA a couple months ago.  I just wrote about the Blue Tooth Stethoscope and here it appears we have a companion if needed.  BD 

With the increased need for remote disease management, there is an opportunity to provide oximetry device monitoring solutions to simplify the exchange of secure information. The integration of interoperable, Bluetooth® wireless technology in health monitoring devices will allow patients, along with their clinicians, to monitor vital signs as they go about their daily lives.

image

Breakthrough devices such as the Onyx II, Model 9560 will enable clinicians to remotely monitor patients with chronic diseases such as Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF) or Asthma. Wireless oximetry gives patients a new level of freedom and control.

 Press Release:

Nonin Medical's Fingertip Oximeter Demonstrated in the First End-to-End Connected Health Solution Based on Continua Standards

The Onyx(R) II, Model 9560 is Showcased in the Industry's First End-to-end Continua Connected Health Solution at CES

MINNEAPOLIS, Jan. 6 /PRNewswire/ -- Nonin Medical, Inc., a leading innovator of physiological monitoring solutions and the inventor of fingertip pulse oximetry, will demonstrate the World's first Continua(TM) Certified Bluetooth® fingertip pulse oximeter, the Onyx® II, Model 9560, as part of the historic first end-to-end Continua(TM) connected health solution. Based on Continua standards, the complete system will be showcased at the 2010 Consumer Electronics Show in Las Vegas on Jan. 7-10 at Booth #2817 in the CES Digital Health Zone.

Together with Continua member companies IBM and Vignet Inc., Nonin Medical will demonstrate how data from consumer health devices can be securely transmitted to a variety of destinations, including hospitals, medical offices, social media and patient information systems for a complete healthcare management tool. The simple three-stage solution using Continua standards features the secure transmittal of accurate vital sign data from the Onyx® II, Model 9560 to a PC manager running the Vignet Connected Health Services platform. The manager will upload the data to an IBM server and can send the data to various service providers such as healthcare facilities, disease management services or personal health record services.

"Continua member companies like Nonin Medical are driving the development of an interoperable, end-to-end ecosystem of personal connected health solutions based on Continua Design Guidelines," said Rick Cnossen, President and Chairman of the Board for Continua Health Alliance. "By providing a framework of standards-based interfaces, Continua is having a significant impact on the future roll-out of these systems by expanding the ability of Continua members to deliver compelling products while removing barriers to global implementation and adoption."

With rising healthcare costs driving care into the home, Nonin Medical's vision of remote monitoring has focused on how to provide cost-effective, accurate physiological data exchange with no proprietary boundaries. This connected health solution realizes that vision and promotes secure information exchange and interoperability to simplify delivery of healthcare for telemedicine systems, healthcare systems, systems integrator partners and patients worldwide. "Vignet is pleased to partner with Nonin Medical on this comprehensive connected health solution," said Praduman Jain, Vignet CEO. "We're proud that the first demonstration of a Continua end to end solution is built using the Vignet platform. Solutions that empower both patients and providers to share and access medical information will play a critical role in accelerating the adoption of connected health devices, EMRs and PHRs."

Nonin Medical's physiological monitoring products for telemedicine are the prevailing gold standard for vital sign assessment of a wide range of chronic disease conditions, such as COPD, CHF and asthma. "We are excited with this historic accomplishment of an interoperable Personal Health ecosystem," said Jayant Parthasarathy, Ph.D., eHealth Business Manager for Nonin Medical and Chair of Continua's Technical Working Group. "By working with our team members at the Continua Health Alliance, we are part of an end-to-end solution that allows us to participate in large-scale, cost-effective implementations of connected healthcare."

Trusted by clinicians worldwide, Nonin Medical's products touch millions of individuals daily. Making its vision of an interoperable personal health ecosystem a reality, Nonin Medical continues to actively invest and develop innovative technologies and education tools for patient empowerment, wellness advocates, healthcare providers, and manufacturers.

About Nonin Medical, Inc. - www.nonin.com

Minneapolis-based Nonin Medical, Inc. is a privately owned company specializing in the design and manufacturing of noninvasive physiological monitoring solutions. Nonin distributes its products to health professionals in more than 125 countries and has over 100+ OEM partners worldwide. With over 20 years of industry-leading capabilities in signal processing and sensor design expertise, Nonin's innovative noninvasive physiological technologies enable clinicians to accurately monitor a patient's true condition in the most challenging environments.

SOURCE Nonin Medical, Inc.
http://www.nonin.com

Nonin Medical's Fingertip Oximeter Demonstrated in the First End-to-End Connected Health Solution Based on Continua Standards -- MINNEAPOLIS, Jan. 6 /PRNewswire/ --

Related Reading:

Blue Tooth Wireless Fingertip Pulse Oximeter – Taking Your Pulse Gone Wireless

Pulse Oximeter Transmits Wirelessly

Ingenix (Subsidiary of United Healthcare) To Offer Interest Free Loans for Their EHR System - CareTracker

This is interesting as one of the most profitable entities of United Healthcare is making the loan available, and in past posts it has been noted that United makes more revenue from Ingenix than it does selling policies.  Ingenix is perhaps not as well known for their EHR as they are with the out of network lawsuits from one of their other divisions and they make a lot of money buying and selling our medication records too.  It may make you wonder if you are perhaps insured by an insurance or technology company, or pose the question.  image

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“Fair Database” to Replace Unfair Ingenix Data Base – Run by Non Profit ...
AMA Announced Settlement of Class Action Suit of $350 Million with ...
With all the money they make it appears that is the least they can do with doctors and hospitals struggling to survive in many areas of the US.  There are also many other EHR vendors who are not financed or part of an insurance company that can help as well.  Also worth noting is the anti fraud division of Ingenix that “scores” medical claims and the link below tells a story of several dermatology offices and their perils with non payment as the business intelligence arm detected potential fraud and all 20 offices within 5 days stopped receiving payment, another item tied up in legal proceeding.

Skins game With Dermatology Offices in California – All Insurance Carriers Quit Paying For Treatment Within a 5 Day Period

Health Fraud Scores Could Be a Contributing Factor to Medical Claims Being Denied
All in all the company is diverse and has interests and holdings in many areas of healthcare outside of medical records to be aware of.  Recently in the news the State of Washington contracted with the company to “score” Medicaid claims and Sutter hospitals also is using their services to again score and use business intelligence algorithms to look at cost.  BD 
Minneapolis-based health insurance giant UnitedHealth Group told the Tribune this week that it will offer interest-free loans to small doctor practices that adopt Ingenix CareTracker, a Web-based medical record system. Chicago-based Allscripts- Misys Healthcare Solutions Inc. said it is offering a six-month, no-payment program for qualifying purchasers of its electronic health records software.
Under terms of the federal legislation, physicians can receive more than $40,000 in Medicare payments over five years beginning in 2011 for implementing an electronic health record system. The Obama administration last week announced it was seeking public comment on new regulations officials say "lay a foundation for improving quality, efficiency and safety through meaningful use of certified electronic health record technology."
Electronic medical records: Extra payments designed to get more doctors on board - chicagotribune.com

Walgreens and HealthVault Connection Now Available

Back in June of 2009 the announcement was made about the connectivity and today it is available.  You can read more at the Walgreen’s site.

 

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Also worth a mention here is that Walgreens has retail clinics available in some parts of the country so connect your records with HealthVault as well. 

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Take charge of your family's health and make more informed health decisions for yourself and your loved ones. 

HealthVault lets you ...

  • Organize your health information, with everything in one place
  • Simplify your life: enter health info once, use it in many ways
  • Gain insight with data that helps you make informed decisions 

Link Your Microsoft HealthVault Profile to Walgreens.com | Microsoft HealthVault | Walgreens

Related Reading:

Walgreens Partners with Microsoft HealthVault to Populate Medication History in PHR
Walgreen Purchasing Rite-Aid and Drug Fair stores
Google Health Vendors you can connect with and import records – Personal Health Records
Walgreen CEO: Bad Economy Hurts Prescriptions

Couple Doctors Indicted This Week and Octomom MD Accused of Negligence

This a short round up of doctors in the news this week, perhaps not good news, but we have everything from planting a bomb, to the physician who helped image Octomom with the fertility implants.  The first link here seems to be the most disturbing with the physician planting a bomb in Arkansas, Dr. Mann a native of India with the finding of more than 100 automatic weapons in his home too.  Secondly the second link explores a liver transplant not following procedure and allegedly going to the wrong patient. 

Lastly, the California Medical Board is looking at Dr. Kamrava and his procedures in helping women become pregnant, in this case it certainly looks like 8 was enough.  In the world of emerging technologies we live in today, data trails and surveillance items are making it much more difficult to work under the carpet and transparency efforts and methodologies are making potential crimes a bit more difficult to hide, as evidenced by the 3 links below.  BD 

Doctor Indicted in Attack on Medical Board Chairman

LITTLE ROCK, Ark. — A doctor who had been repeatedly penalized by the Arkansas Medical Board was charged in federal court here on Wednesday with planting a bomb that critically injured the board chairman as he left his home for a meeting of the panel last February.

The indictment accused Dr. Randeep Singh Mann, 51, of London, Ark., of employing “a weapon of mass destruction” in the attack on Dr. Trent P. Pierce, a family practitioner, as Dr. Pierce approached his car in the driveway of his West Memphis, Ark., home to travel some 130 miles to a medical board meeting here on Feb. 4.

Surgeon indicted over 2003 liver transplant

The ex-head of the now-defunct transplant program at St. Vincent Medical Center is accused of covering up the misallocation of a liver to a Saudi Arabian national who was 52nd on the waiting list.

Dr. Richard R. Lopez Jr., 54, is accused of lying to national transplant officials and directing his staff to falsify records involving a September 2003 transplant. For two years, the Cheviot Hills surgeon allegedly concealed the identity of the Saudi Arabian national who had received the organ despite being more than 50 places down on the transplant waiting list.

At first, the hospital reported the name of the actual recipient to the United Network for Organ Sharing, which oversees transplantation nationwide. But later that day, Lopez directed his staff to retract that notification and report the name of the man for whom the liver had been initially offered, the indictment says.
Though the intended recipient was removed from the waiting list, Lopez continued to tell him he was still in line, according to the indictment. He died several months later.image

Octomom physician accused of gross negligence

Fertility doctor, Michael Kamrava, has been accused by the California Medical Board which could result in his license either being suspended or revoked. The fertility doctor had already helped Suleman to conceive six children before transferring the fresh embryos that resulted in the pregnancy with eight babies. All previous pregnancies were single pregnancies, except the fifth, which was a twin pregnancy.

Each time Suleman gave birth, four months later she was back asking for help conceiving more children. Each time, Dr. Kamrava repeatedly transferred fresh embryos even though frozen ones were available from previous IVF’s. This placed Suleman at higher risk for problems associated with high levels of hormones and also placed her future children at risk. After repeated pregnancies within such short amounts of time in between, it was apparent that the woman needed some type of mental health evaluation. Unfortunately, the fertility doctor failed to refer her for an evaluation.

Prime Time TV “The Biggest Loser” Working with “Know Your Number” to Help Individuals Assess Personal Health Risk – Behavioral Health Monitoring and Predictions

It appears education is beginning to take part in television, and use through TV media can help reach some of those who may not use the internet as a prime source imageof healthcare information via using shows as such.  If you are not familiar with the television show, individuals are enrolled to basically lose weight.  Now the show is incorporating technology from the internet to show individuals how to evaluate their healthcare, make changes and re-evaluate.  This program is not free though and costs $89.99.  I see some sales and marketing here as well as an opportunity to reach out, so there’s a little bit of both.

If you use the internet there are several sites that can help you for free as well.  Let’s face it, self included, we are perhaps not the best at realizing what we can do all the time to create a healthier lifestyle.  Time and interest also enters the picture here too as it is a new paradigm that has a bit of a learning curve.  Right now as a country the US is already voted as the #1 stressed society in the world and part of this is technology driven as there are many choices and we are marketed from many directions, and there is stress created too simply from those who do not quite understand how things are changing too, so a little of both.image

The television show is going to have the participants assess their health risk, so you can see how it works.  One other item of note, is that BioSignia is run by former bankers, biotech and software individuals as well as some health insurance people so you get the message that health insurance of course is behind such a move as it will save them money on care expenditures too.  It appears to also be marketed towards employers and the website states it “outperforms conventional underwriting technology”, underwriting being what is evaluated when offering insurance to a client. Most insurance companies are now either active or are exploring “behavioral underwriting” in order to predict and control healthcare needs and costs.  More can be read here on that topic.  BD 

Press Release:

NBC’s “The Biggest Loser” Unveils Health Kit for Contestants and Viewers to Lead Longer, Healthier Lives
NBC, Reveille Partner with North Carolina-Based BioSignia to Offer Know Your Number System to Help Predict Key Health Risks
Know Your Number Featured on “The Biggest Loser” as Contestants Learn Health Risks and How to Address Them

Durham, N.C. – January 6, 2010 – Imagine knowing your precise personal risk for heart disease, diabetes or stroke. Would you improve your lifestyle to reduce your risk? Of course! Contestants in this season’s “The Biggest Loser,” will for the first time be shown their risk of developing the nation’s top three killer diseases, as well as how to reduce their risk of contracting these and other diseases.
NBC Universal Television DVD, Music and Consumer Products Group and Reveille, the company behind “The Biggest Loser,” have partnered with leading, NC-based biotechnology company BioSignia, to use The Biggest Loser Know Your Number HealthScore on the program. The revolutionary health risk assessment identifies the contestant’s disease risk, as well as their “internal age,” life expectancy and estimated preventable medical expenses.

 
On Tuesday, January 12, contestants will hear their HealthScore number for the first time under the supervision of the show’s medical advisor, Dr. Robert Huizenga. In addition to revealing the risk of disease, the test will also indicate how many years of life contestants can recover if they make healthy lifestyle changes. The system then provides a personalized roadmap to achieving a longer, healthier life by showing contestants how to reduce their disease risk.
“I’m quite excited by The Biggest Loser Know Your Number HealthScore; knowing the years being robbed by excess fat, inadequate diets and cigarettes is- as evidenced by contestant’s reactions- both eye-opening and motivational,” says Dr.Robert Huizenga, Medical Advisor on “The Biggest Loser” and one of the leading health and fitness experts in the country. “I believe accurately communicating risks in this powerful fashion could wake up America and save lives.”

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Coinciding with its use on the show, The Biggest Loser Know Your Number HealthScore is also available to the public. ”We are excited to bring a new tool to the marketplace that helps our contestants and will help our viewers take such a critical part of their healthcare into their own hands,” says Mark Koops, Executive Producer of “The Biggest Loser.” "Our program inspires so many people to commit to a healthier lifestyle and The Biggest Loser Know Your Number HealthScore takes our message to a whole new level. This system takes the guesswork out of getting healthy before it’s too late."
"The Know Your Number system is an important development in ‘The Biggest Loser’ product line," adds Kim Niemi, Senior Vice President, NBC Universal. "Millions of Americans are at risk of developing diabetes, heart disease or stroke, and most of that risk is preventable. This unique tool gives users a window into their own future and can set people on the path to healthier living."
Contestants will be re-tested and given their new numbers at mid-season and again at the end of the season. Both contestants and viewers will be amazed at how drastically their "numbers" have improved.
How it Works
The Biggest Loser Know Your Number HealthScore takes a person’s unique health information, including weight, blood pressure, family history, lifestyle habits and key blood values. It then uses BioSignia’s proprietary technology, called Synthesis Analysis, to produce a detailed report on that person’s risk of developing specific obesity related diseases. The report also shows specific steps the person can take to reduce their risk and live a longer, healthier life.
"Heart disease, diabetes and stroke are the nation’s top deadly diseases and the Biggest Loser Know Your Number HealthScore will show people their risks for getting these diseases and how to avoid them," says Dr. David Michael, M.D., BioSignia Medical Director who uses the Know Your Number test to examine patients in his N.C. medical practice. "The results inspire people to be more proactive about their health and start on a path to a healthier lifestyle."
How to Buy The Kit
Coinciding with the season premiere of “The Biggest Loser,” viewers will be able to go online to purchase the same Biggest Loser Know Your Number HealthScore test used in the show. This is the first time a prime-time TV show will incorporate this high tech wellness technology and make it available to consumers.
The Biggest Loser Know Your Number HealthScore Kit sells for $89.99. When consumers buy the kit, they complete a private questionnaire and send in their measurements, blood pressure and blood sample to the BioSignia offices in North Carolina where their results will be tabulated. Within three weeks, consumers receive their HealthScore complete with their "numbers" and suggested customized remedies to improve their health. BioSignia encourages customers to consult their personal physician about the HealthScore’s findings and recommendations and to take the test more than once so as to monitor their progress as they implement the suggested lifestyle changes. The test is available for purchase online at www.biggestloserknowyournumber.com and www.biggestloser.com.

About The Biggest Loser
The first reality series where everybody loses, “The Biggest Loser” challenges and encourages overweight contestants to shed pounds in a safe and recommended manner through comprehensive diet and exercise as they compete for a grand prize of $250,000. Hosted by Alison Sweeney (Days of our Lives), the series provides the contestants with challenges, temptations, weigh-ins and eliminations until the final contestant remains to claim the title of "the biggest loser." Each team works out under the supervision of professional trainers Jillian Michaels and Bob Harper. “The Biggest Loser” is a production of Reveille LLC, 25/7 Productions and 3 Ball Productions.
Beyond the U.S. where more than 100 episodes of the show have aired, “The Biggest Loser” has become a worldwide hit appearing in over 90 countries and produced in 25 countries. Since its debut in 2004, “The Biggest Loser” has grown to become a standalone health and lifestyle brand by developing tools and products inspired by the show and approved by its doctors and experts. Anchored by the online, subscription-based extension of the show, Biggestloserclub.com, “The Biggest Loser” consumer products program has generated over $100 million in spending, with presence at more than 25,000 major retailers to date. The program currently features a wide variety of health and fitness products including The Biggest Loser video game for Wii and Nintendo DS & DSi, The Biggest Loser Resort at Fitness Ridge, which is a full-service, destination health & fitness spa, The Biggest Loser Meal Plan, a New York Times best-selling books series, a best-selling fitness DVD series, a line of appliances, fitness equipment, protein supplements and several other health and lifestyle based products. “The Biggest Loser” was recognized as a top brand of the year in Advertising Age’s 2008 Marketing 50. Check out www.biggestloser.com for more information.
About The Biggest Loser Know Your Number HealthScore
The Biggest Loser Know Your Number HealthScore provides a personalized roadmap to know the current status of your key health risk factors, specifically identify behavioral changes that will increase your likelihood of achieving the longest, healthiest life possible and allow one to continually track his/her progress to stay on course.
The Biggest Loser Know Your Number HealthScore was developed by scientists and medical experts at BioSignia, a leading biotechnology company based in the Research Triangle Park, N.C., who created a patented, state of the art tool for understanding health factors that is superior to standard methods. This unique predictive tool was based on the results of more than 100 clinical studies, and was validated at the highly regarded Duke University Medical Center, a pioneer in preventive health and wellness.
The Know Your Number disease risk assessment tool was first made available to physicians for use in predicting the risk of chronic diseases in patients. For developing Know Your Number, BioSignia has received the Disease Management Association of America’s prestigious award for Best Enabling Tool for Disease Management in 2004.
Visit www.BiggestLoserKnowYourNumber.com for more on the consumer product or visit www.biosignia.com to learn more about the company behind the technology.


About NBC Universal Television DVD, Music, and Consumer Products Group
NBC Universal is a leader in providing entertainment programming to the domestic and international marketplaces. NBC Universal Television DVD, Music, and Consumer Products Group manages all global ancillary television business endeavors for the NBC Universal Television Group, including third-party home entertainment distribution, consumer products, musical soundtracks, special markets projects and the NBC Universal Online Store.
About Reveille
Reveille is a leading independent studio focused on exploiting worldwide intellectual property rights in scripted and unscripted television and digital entertainment, and a world leader in creating integrated marketing opportunities for advertisers. Reveille is known for popular and award-winning hit series including THE BIGGEST LOSER, THE OFFICE, UGLY BETTY, THE TUDORS, IT'S ON WITH ALEXA CHUNG, TABATHA'S SALON TAKEOVER, SHEAR GENIUS and PARENTAL CONTROL. Reveille has developed many original online series for brands including the series FIT TO BOOM for Subway and IT'S EVERYBODY'S BUSINESS WITH JACK AND SUZY WELCH for Microsoft. Upcoming television series include THE BURIED LIFE, MASTERCHEF, GIGANTIC and BREAKTHROUGH WITH TONY ROBBINS. Through its distribution arm, Shine International, Reveille distributes its extensive library of programming to more than 150 countries. Reveille is part of the Shine Group, one of the world's foremost multinational entertainment and drama companies.