Jumat, 29 Juli 2011

Americans in Denial about Death

Not really news anymore, but yet another new poll suggests Americans are in denial about death. Only 40% have a will (for property).  



Rabu, 27 Juli 2011

Four Big Obstacles to Rational Health Policy

A few weeks ago, the Institute of Medicine released For the Public’s Health: Revitalizing Law and Policy to Meet New Challenges.  In this second of three commissioned reports, the IOM reviews how statutes and regulations prevent injury and disease, save lives, and improve the health of the population.  The IOM examines the legal and regulatory authority for public health activities, identifies past efforts to develop model public health legislation, and describes the implications of the changing social and policy context for public health laws and regulations.


In Chapter One, the IOM notes four obstacles to more rational health policy.  These are readily adaptable to clinical medicine and to end-of-life bioethics in particular.
  • The rescue imperative (or the rule of rescue). People are more likely to feel emotionally moved and motivated to act in the case of specific individual misfortune (e.g., the plight of baby X highlighted on the evening news), but far less inclined to respond to bad news conveyed in terms of statistical lives (Gostin, 2004; Hadorn, 1991;Hemenway, 2010);

  • The technological imperative. Cutting-edge biomedical technologies have far greater appeal (and historically, government funding) than population-based interventions, including public policies (Fuchs, 1998;Gillick, 2007;Koenig, 1988);

  • The visibility imperative. Activities that occur behind the scenes, such as public health practice, remain invisible and are taken for granted in the public sphere until and unless a crisis arises, such as an influenza pandemic or radiation threats. The other contributor to the invisibility of public health is the fact that the fruits of its labors are often far in the future (Hemenway, 2010); and

  • The individualism imperative. American culture generally values individualism, heavily favoring personal rights over public goods (Gostin, 2004).



When is postponing removal of the ventilator after the diagnosis of brain death justifiable?

The "Ask the Ethicist" column in the latest Lahey Clinic Medical Ethics Journal argues that postponing removal of the ventilator after the diagnosis of brain death is often justifiable.  As I argued a few years ago, this seems to be a common position.


The Prospects of Immortality

Robert Ettinger, the father of the cryonics movement, died on Saturday.  


Adherents of cryonics believe that future developments in medical technology will allow their frozen bodies to be brought back to life.  (Daily Maverick;  Telegraph).  The idea is that the dead might be "cured" by the doctors of the future.  The Cryonics Institute promises it is "Your Last Best Chance For Life--and Your Family's."  It has nearly 1000 members, 103 now in cryostasis + 78 pets.


German Researchers Use iPS Skin Cells to Correct Gene Defect in Mice With Liver Disease–Mice Were Cured

iPS stem cells can be reprogrammed to take on another identity and in this case it looks like the mice with liver disease were cured with using their own skin stem cells.  The ISP cells were returned to an embryonic state and corrected the gene imagedefect.  This is the first time that  a living organism has been cured using iPS cells.

There have been questions raised with iPS cells and according to this article the process provided here with re-programming didn’t create any issues and the one researcher stated the cells are just as stable as working with embryonic cells.  If this progresses, the idea would be to take a person's stem cells and treat them and then re-inject back into the patient to hopefully cure the liver disease.  There would be no rejection since it is the patient's own cells.  If this could be perfected, it would be a huge answer to liver transplants.  BD 

German medical researchers have cured serious liver disease in mice using induced pluripotent stem (iPS) cells in an important first that shows promise for use in people with liver metabolism ailments.

The researchers from Muenster and Hanover took skin cells from the mice, returned them to an embryonic state and subsequently corrected a gene defect in the cells. The cells were then used to create healthy mice.

“For the first time, a living organism has been cured of an illness using iPS cells repaired using genetic methods,” researcher Tobias Cantz told the German Press Agency dpa.

“We have de—programmed the skin cells of mice with liver disease into iPS cells and subsequently corrected the gene defect that caused the liver disease,” Cantz said.

The Hindu : Health : German researchers turn skin cells into stem cells

Selasa, 26 Juli 2011

NH Hospitals Sue the State Over Medicaid Cuts and One Lays off 180 Employees

One hospital, Elliot is laying off employees and there are 10 hospitals in the lawsuit.  Quite a few other programs are also being disconnected.  Elliott Hospital is due to received 17 million less. 

It was interesting to hear in the video with the CEO saying that it would be better to just forget Medicaid and write off the patient care already given as debt.  BD 

(NECN:  Lauren Collins – Manchester, NH) On Monday, Elliot Hospital was one of ten hospitals in New Hampshire to sue the state over Medicaid cuts.  A day later, “we announced 182 positions that were reduced,” says Elliot Health Systems President and CEO Doug Dean.

“We hope that it was necessary,” says House Speaker Bill O'Brien who finds the layoffs - and the lawsuit - disappointing, but disputes The Elliot's claim that lawmakers are accountable for them. 

“We would have liked to have continued funding of the hospitals at the same level as had been the case in prior budgets just like we would have like to have continued funding in many different areas, but we weren't able to.

NH hospital lays off over 180 people in face of budget cuts

Medical Students and Doctors Protest in Israel Demanding Improvements in the Healthcare System

Once in a while it’s time to take a break and see what is occurring in other countries imageand in this case it’s Israel doctors and medical students wanting improvements in their medical system, sounds familiar with a bit of what we have here.  The medical students said they would not begin their residencies until better conditions prevail.  In a nutshell from reading below it sounds like they want better pay and more staff at the hospitals.  BD 

At least 200 medical students from all departments staged a protest outside of Ichilov Hospital in Tel Aviv on Friday, demanding improvements in Israel's healthcare system and pledging support for the months long battle being waged by doctors and residents across the country .
At least 322 of the 400 students in their sixth year of medical school signed a petition saying they would not begin their residencies next year unless better conditions were implemented, Israel Radio reported.

And, what appeared to begin this week as a “rebellion” by “ignored” medical residents and interns, turned on Thursday into a “reconciliation” between them and veteran physicians in the Israel Medical Association as they met at IMA headquarters in Ramat Gan.

Medical students join doctors', resid... JPost - Health & Science

Positron Emission Tomography (PET) Scan Drug Recalled Due To Radiation–CardioGen-82

The active ingredient is generated by isotopes and the cause it not yet clear and the imageFDA stated it has not ruled out manufacturing facilities in their research.  Doctors should stop using the drug according to the FDA warning.  BD

Positron emission tomography (PET) scan drug CardioGen-82 may cause increased radiation exposure, the Food and Drug Administration announced Tuesday, and the agency is warning doctors to stop using the drug.

The drug, manufactured by Italian company Bracco Diagnostics Inc., is used in positron emission tomography scans to diagnose heart disease. On July 15 the FDA found that two patients who had undergone these scans months earlier had detectable levels of radiation.

Positron Emission Tomography (PET) Scan Drug Recalled Due To Radiation | ThirdAge

FDA Finds U.S. Cetero Research Falsified Records About Drug Studies-Probably Hidden in the Algorithms Used for Reporting

How else does this happen when you look at an algorithmically created report on the studies and then find no physical evidence?  It’s those algos again and some have learned how to work them as they can create a a visual used to be convincing for what ever the occasion calls for.  1900 instances sounds like quite a high number of studies that were not found actually conducted.  image

The article also states that the company may have “fixed” the results and if you read around here at the Quack often enough I talk algorithms created for “desired” and “accurate” results quite a and they should be the same, but not.  When the physician evidence doesn’t match that’s a sure catch right there.  When the FDA comes in they should have a complete open book, or set of algorithms to have the researchers verify.  When you hear reports like this, no wonder we doubt some of the science that is out there today. 

I know coders and developers get pushed to move faster to get a product to market and that is a deadly sin in more ways than one, you don’t push development on the software side until they are comfortable enough to test and re-test to feel confident enough that all bases have been covered as best they can.  Kind of a side topic here we have an awful imbalance too in the US with social algorithms and biotech and funding is harder for research to get so again just a question as to is there yet one more factor with this type of action to move forward as quickly as possible?  The last thing we want is “bad science”.  BD

Good Science, Investments and The Chase for Social Algorithms Has Become a Dangerous Mix-Healthcare and The Creation of Jobs Continue to Suffer

WASHINGTON - Drug companies that had medicines tested by contractor Cetero Research might have to reevaluate results, U.S. regulators warned after the firm was found faking documents and manipulating samples.

The Food and Drug Administration said on Tuesday two 2010 inspections, an internal company investigation and a third-party audit uncovered "significant instances of misconduct and violations" at a Cetero facility in Houston.

The Cary, North Carolina-based firm does early-phase clinical research and bioanalytics for a number of drugmakers. The pharmaceutical companies can then use those studies as supporting evidence in drug approval applications to the FDA.

FDA finds U.S. drug research firm faked documents - CNBC

Kaiser Permanente Launches Mobile Application–KP Locator for the Iphone

This is great since Kaiser is expanding to more states than just California.  With the imagemultiple locations this makes it easy for patients to find them.  This works for Kaiser as they have so many facilities and makes it simple and I wonder when it will be used for additional mobile platforms.  They have a great Innovation Department and last year I spoke with one of their leaders on how they work.  

Innovation and Learning at Kaiser Permanente – Interview With Chris McCarthy

The PHR, the Kaiser personal health record is not mobile yet but up and coming according to the press release.  Until the application is on other mobile platforms there’s always the Google Maps or Bing, like I use on my Windows Phone to find places, but I am sure what I get does not have the full information the mobile program has, but mention it as it is an alternative in case you don’t have an Iphone.  Earlier this year Kaiser opened their facility in Washington DC which is state of the art and a learning center with big touch screen walls too.  I wonder if any of our lawmakers have checked out the center to see what is new and innovative in healthcare since they debate the topic all the time.  BD

Kaiser Permanente Opens State of the Art Facility in Washington DC-Kaiser Permanente Capitol Hill Medical Center

Center for Total Health

OAKLAND, Calif., July 26, 2011 /PRNewswire/ -- Kaiser Permanente announced today the launch of its first mobile application, KP Locator. The app, available at no charge through the iPhone App Store, is just one element of Kaiser Permanente's growing mobile strategy, which also includes the optimization of My Health Manager, Kaiser Permanente's integrated personal health record on kp.org, for mobile devices later this year. 

The Facility Directory on kp.org is one of Kaiser Permanente's top five online tools with nearly six million visits in 2010. KP Locator combines the power of the robust directory and the iPhone's GPS capabilities to make searching for KP facilities fast and easy for patients on the go. It answers three of the most basic, but vital, user questions thoroughly and simply – where are the Kaiser Permanente locations close to me, how can I contact and get to them, and what departments and services can I access there?

Using Google maps, KP Locator has a simple and intuitive interface familiar to iPhone owners. Users can input a city name or ZIP code to find the KP facilities in their area. Search results can be viewed as pins on a map or a list. Users simply tap the desired facility to view address and phone number information and departments and services available there. Users can add the facility to their favorites list to quickly access the information later, add phone numbers to their contact list, and text or email facility information to someone else. By tapping on the "Directions to here" button on the facility information screen, users can get driving, walking or public transportation directions to the facility. Ultimately, the goal is to provide convenient mobile tools that empower patients to manage their health, no matter the device or operating system.

"Mobile solutions, like KP Locator and the upcoming mobile-optimized version of My Health Manager, mobile.kp.org, are a natural progression in delivering a high-quality care experience," said Phil Fasano, executive vice president and chief information officer, Kaiser Permanente. "Mobile solutions also address the rising costs of health care by giving members access to routine information and services without staff intervention, making interactions more convenient, personal and effective."

The new and future mobile capabilities complement Kaiser Permanente's already significant web presence, providing members with convenient, 24-7 access to their personal health information and to their care teams, and could lead to increased self-management and better health outcomes. Mobile capabilities also allow Kaiser Permanente to engage new member populations that may have a cell phone or other mobile device, but not a home computer.

"Recent analytics reports show that more than 14 percent of visits to kp.org are from mobile devices and smart phones," said Christine Paige, senior vice president for marketing and Internet services, Kaiser Permanente. "As mobile devices become more and more affordable, that number will grow. We want our members who have those devices to have easy access to all of the same high-quality online tools on their mobile devices as they have from standard computers."   

Kaiser Permanente members, from healthy, young adults to Medicare beneficiaries, have enjoyed online access to their lab test results, medications and other important health information since 2007. More than 3.5 million members have signed up to access My Health Manager, which received more than 62 million logins in 2010. The secure personal health record also allows members to order prescription refills and message their doctors, often saving them the inconvenience of having to go to a physician's office or wait on hold to speak with a clinician on the phone.

Kaiser Permanente is known for its leadership in the use of health information technology (health IT) and its groundbreaking electronic health record, Kaiser Permanente HealthConnect®, which is the largest private EHR in the world. KP HealthConnect enables all of Kaiser Permanente's more than 15,000 physicians to electronically access the medical records of all 8.8 million Kaiser Permanente members nationwide and serves as a model for other systems. The health care provider has received numerous awards for its health IT expertise including 35 HIMSS Stage 7 Awards, more than any other health care organization. 

You can learn more about how patients, clinicians and researchers are using My Health Manager and KP HealthConnect by checking out Kaiser Permanente's YouTube channel: http://www.youtube.com/user/kaiserpermanenteorg.

About Kaiser Permanente

Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America's leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve 8.8 million members in nine states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: www.kp.org/newscenter.

Kaiser Permanente Launches Mobile App to Make Finding Care Facilities Easy and... -- OAKLAND, Calif., July 26, 2011 /PRNewswire/ --

Senin, 25 Juli 2011

How Algorithms Shape Our World–TED Talks Kevin Slavin–Writing the Unreadable And A Good Reason to Get Into the Math

If you read here often enough, no surprise that I would include this presentation as imagethe world “algorithm” and its meaning has held center stage at the Medical Quack for a couple of years, basically carrying the same message, get in to the math.  As Kevin states in his talk “they have teeth”.  Finally someone else who sees reality.  He said there are 2000 physicists on Wall Street now.  They have terminology that matches as well, Black Box Trading, Algo Trading  (Algos are here at the Quack all the tine in conversation relative to healthcare).  When we had the mini crash I took my hand at imagespeculating there too based on my working knowledge and reading about how the whole thing played out.  I was not alone but had few folks kind of like the analogy.

Was a Server Fail Over Taking Place on Wall Street During a “Perfect Storm” of Heavy Transactions?

I like the way he describes how algorithms work, some are made to hide and some are made to seek.  He talks about the Flash Crash and nobody can agree on how it happened.  Nobody had control.  Algorithms get locked in loops with themselves and he uses some good examples like an over priced book on Amazon and how it came about.  What you don’t see are the physics of culture and when will we know when they crash like Wall Street did…in healthcare that is scary but it can and does happen. 

How Algorithms Change the World

He further goes on to talk about how we are “writing the unreadable” and yup we have that in healthcare too with algos that are mismatched, like what FICO is trying to do with using credit score data to determine if you will take your meds.  I like this guy and he talks my language all over the place. 

“It’s a bright future if you are an algorithm” but we can’t say the same for humans right now. 

FICO Analytics Press Release Marketing Credit Scoring Algorithms to Predict Medication Adherence–Update (Opinion)

Now that you have watched this, go out and buy this book, “Proofiness, the Dark Side of Mathematical Deception” from Charlie Siefe of NYU and get acquainted with how you get fleeced today with believing all the numbers and stats put in front of you that are really not real but rather unreadable.  Think about that too when questioning your next medical claim, is it unreadable…ask questions. 

“Proofiness–The Dark Side of Mathematical Deception”–Created by Those Algorithms–New Book Coming Out Soon

So how can our lawmakers function without the Algo men?  They don’t and things get worse.  I made the post below back in October of 2010.  So do you get the idea now with insurers, the financial folks and others creating the “unreadable” and why our current insurance and lawmaking system don’t work and do anything for consumers?  Anyone today proposing massive policy and law changes without the help of that “algo man” is lost as it helps to find out what processes are going to be required before one goes and speaks publicly and has no concept of the work behind such proposed rules and laws and then comes the old proverbial “egg on the face” when someone with some tech knowledge calls you on the carpet. 

More Congressional Testimonies About Health IT–Members of Congress Could Entertain Getting an “Algo Man” on Staff As Wall Street and Health Insurers Have Them–Don’t Leave Home Without One

This post goes back to 2009 where I wrote about insurers suggesting algorithms to provide healthcare solutions, well we don’t want those that are unreadable here totally as we are still humans and our care needs to be at the levels we can interpret. 

Health Care Insurers Suggest Algorithms and Business Intelligence solutions to provide health insurance solution

At the present rate I would be afraid to guess how few lawmakers know what an algorithm is even though they live with them just like us.  They don’t do math so Medicare cuts are guesses and gambles on outcomes without predictive analytics with politicians riding by the seat of their pants and we get the results of their unintended consequences. 

Are We Ever Going to Get Some Algorithm Centric Laws Passed for Healthcare!

Last but not least on this list, one more classic post about these algorithms…we need a Department of Algorithms to begin filing these digitally so we can view and see the concept and verify that all are not unreadable and that we don’t get fleeced.  Harry Markopolos and his testimony about the SEC makes a real strong case here at the link below.  It beats having a department of boneheads:)  BD

“Department of Algorithms – Do We Need One of These to Regulate Upcoming Laws?

Kevin Slavin argues that we're living in a world designed for -- and increasingly controlled by -- algorithms. In this riveting talk from TEDGlobal, he shows how these complex computer programs determine: espionage tactics, stock prices, movie scripts, and architecture. And he warns that we are writing code we can't understand, with implications we can't control.

Kevin Slavin: How algorithms shape our world | Video on TED.com

Orange County Oncologist Gets Sentenced to 18 months Prison – Diagnosed With “Co-Dependency”- Couldn’t Stop Fraudulently Billing Medicare

I couldn’t make that title up if I tried as that is what Dr. Justice’s attorney states in this story. He was caught once a few years ago and his hands were slapped and then he did it again.  As you can see from this story and some of the history, we was an actually practicing oncologist and in the last 10 month has been devoting his time to a free medical care clinic in Orange County.  Back in November of 2010 I still found him listed and I point this out to show you how MD rating services are not updated and accurate on the web and this was after he pleaded guilty but had not been sentenced yet.

Prominent Orange County Oncologist Pleads Guilty to Medicare/Insurance Fraud – Over $1 Million

 He’s not a bad doctor but just likes the thrill of excessive billing and the rush of up-coding, that’s all.  

Avvo Physician Rating Service Can’t Get Accurate Information Listed on Doctors - One OC Oncologist Sitting in Jail for Fraud

I do have to say the name is a perfect, Dr. Justice, oxymoron, again you can’t make this stuff up. As you can read he also has a big fine to pay under a civil settlement.  With getting all the numbers and match together today, if it is not fraud, then we have premiums being pain on dead patients too. 

City of Buffalo Has Paid Over $2 Million to Provide Health Insurance for Hundreds of Dead People-Some as Many as 4 Years

We are dealing with all types of addictions today and frankly I think data use and abuse, especially after reading this tale will be the next 12 step addiction program on the map, you think?  We already have one credit agency company, FICO that thinks a credit rating will be able to determine whether or not a patient will take their medications, so again it’s all about those numbers and algorithms we run with today.  BD

Data Addiction and Abuse –The Up and Coming Next 12 Step Program Is On the Horizon–Side Effects Include Lack Of Data Quality, Integrity And Spasmodic Algorithms

SANTA ANA – A federal judge Monday sentenced Dr. Glen R. Justice to 18 months in prison for committing Medicare fraud, rejecting a defense request to allow the oncologist to continue treating indigent patients at a nonprofit clinic.

In a separate civil settlement, Justice will pay Medicare $7.5 million in restitution and penalties once his multimillion-dollar Corona del Mar home is sold.

Prosecutors said unlike sham clinics that have bilked insurers, Justice, 66, ran a legitimate medical office in Fountain Valley where patients received the treatment they needed, although Justice added fraudulent charges to their bills. He also served as director of the cancer center at Orange Coast Memorial Medical Center.

Assistant U.S. Attorney Jeannie Joseph initially recommended probation in a plea agreement struck with Justice, but she requested a year in prison after discovering that Justice continued committing fraud even after signing the plea agreement. She suggested Justice's "expensive lifestyle" as a motive, noting his two yachts and properties around the country.

Justice's attorney David Wiechert explained the doctor's conduct as "irrational for someone who had it all." He said Justice was diagnosed with co-dependency, which caused him to commit fraud the way an addict might abuse drugs.

For the past 10 months, Justice has volunteered at the Lestonnac Free Clinic in Orange. He was offered a full-time job treating cancer patients, where he would have no role in billing.

Oncologist sentenced to 18 months prison | justice, patients, prison - Life - The Orange County Register

FDA Mobile Medical Applications NPRM From the FDA–Register All With Categories and Create New Classification for “Clone Apps”

This is a bit of complicated issue for many as to setting up guidelines and rules that can be used, simply because technology in Health IT is bursting at the seams with new technologies and software being created almost daily.  Back in April the first rules on MMDS for Class 1 devices was announced and there’s still gray here to and with the multitude of apps and what they do today, the medical apps that will or will not be approved by the FDA is certainly leaving a lot of room for discussion. 

FDA Rule Regarding Medical Device Data Systems Takes Effect–MMDS (Medical Device Data Systems) Rule For Class 1 Devices

Dr. Halamka created his opinions and thoughts here at his blog and you can read the entire post here, but again when consuming all of this, he has some questions and issues too so we don’t have a real definitive policy yet.  Some of the obvious apps that are not regulated as he mentions are e-books, etc. in other words reference materials not directly related to a specific patient and there’s tons of those apps floating around out there, more than I care to talk about sometimes.  As he mentions the Continua Alliance definitely has some input here as relates to wireless devices too. 

Global Certification Forum and Continua Health Alliance to Collaborate to Certify Personal Health Records - Wireless Devices

In addition this also puts the FDA in the same spot as private industry in having to make sure they have enough engineers to facilitate approval for apps, so again staffing and availability of personnel, one more consideration to think about, all in house, contract or a bit of both?  A few decisions impact more than just one area here and then the agency has the old battle with Congress in not understanding all the agency does. 

FDA and Medical Devices-Who Doesn’t Get This, They Are Looking for Engineers Just Like Technology Companies Are Doing- Get Some Congressional Digital Literacy in Place

Who knows, we could end up with an all or nothing arrangement here:)  I don’t the “nothing” portion though is going to fly.  Ambiguities are mentioned so in this area you have 100 different apps basically doing the same thing too, well maybe not that many but a ton of apps that only “do one thing” which drives me nuts as well as I think aggregated and collaborative efforts here need to be accelerated as a consumer I don’t want to learn more apps than I have to.  The smartphone folks who make the phones are off the hook and that was a big one, so again it’s back to the software and the algorithms. 

A bit of satire here, but I think they all should be FDA approved and this way we can keep the number of apps smaller for those that duplicate what 50 other apps do!  Of course that would lead to several levels of approval, but nothing with that as far as I am concerned and the FDA would not be caught blindsided and would have the opportunity to look at each one and the agency might actually help out consumers with knocking out so many duplicate types of programs that are out there in mHealth, so I say let the FDA look at all of them and the bonus points are better apps with less duplication.  In addition, the FDA would also be able to constitute a list too of who’ selling data here as well…and we all want to know that.  It’s almost like approving a new drug and generics except this time it’s mHealth apps:)

Give the FDA the engineers and software folks they need and have them look at all apps and this way we have no blind sides either and tier the levels of approval maybe.  With the medical records portions of approval, they could use the ONC certification information as being justified for their approval so the 2 agencies could collaborate in unique and new fashion.  Anyway, that’s my thought here. 

I make this comment as many mHealth apps will be working with medical records so it’s a CYA for the FDA to ensure the applications are correctly working with certified EHRs and could offer a nice check and balance.  I say this not to be a hassle for medical record vendors at all, but it may help them too with knowing what apps are being written out there to connect with their data too and be on record with it, in short, good record keeping on data.  At minimum, having a listing of all the current medical record vendors at the FDA will supply data that someday will be creeping in to this arena just as mHealth technology develops and you can’t stop that. 

The more I think about it, the more I like the idea of the name brand and generic thought processes with mHealth medical apps!. We can just call those that duplicate the same information “clone apps” and verity the algorithm structure as performing the same function as the original application on file as long as the same type of data is the end result and no patent interference at this level please as this is just a “working” stamp of approval for entirely different purposes. 

Get the FDA the funding and engineers they need to make it happen and we will have less “crap” software floating around out there.  After reading my comments please continue on to read what Dr. Halamka has to offer from a higher level:)  BD

The FDA will not seek to regulate mobile medical apps that perform the functionality of an electronic health record system or personal health record system.   However, the FDA defined a small subset of mobile medical apps that may impact the functionality of currently regulated medical devices that will require oversight.   Here's a thoughtful analysis by Bradley Merrill Thompson of Epstein Becker Green, which he has given me permission to post:

"Today, FDA published the long-anticipated draft guidance on the regulation of mobile apps—more specifically, what the agency calls “mobile medical apps”.  This draft reflects significant efforts by FDA in a fairly short amount of time, and we applaud that work.  Much of the framework of the FDA guidance is consistent with the work the mHealth Regulatory Coalition (MRC) published on its website earlier this year (www.mhealthregulatorycoalition.org).  While FDA has done a good job getting the ball rolling, there are a number of areas that require further work.  We all (including FDA) recognize that this draft guidance is certainly not the end of the story.

This draft guidance has no doubt generated a ton of questions. So, the timing of the release is perfect! On July 27th, a large group of individuals involved in the mobile health space will be congregating at the Continua/ATA Summit to discuss regulation of mHealth products. Bakul Patel, the mobile health policy guru at FDA, will be there to discuss the details of this guidance, as will the mHealth Regulatory Coalition, which is set to release its own version of proposed mHealth guidance in the coming weeks.  The discussion will surely be lively and informative.  There’s still time to register and I hope to see you there."

Life as a Healthcare CIO: FDA Mobile Medical Applications NPRM

When Are You Ready to Pull the Plug against the Wishes of the Family?

On his blog, End of Life - Thoughts from an MD, Dr. Jim deMaine describes a recent case in which a conflicted family could not reach a treatment decision.  So, the patient with metastatic cancer spent three weeks in the ICU.  Her heart then stopped "and the nurses, much against their wishes, had to perform fruitless CPR. Mary thus died in a traumatic way, ribs broken from chest compressions, suffering the kind of technological imperative that's sarcastically referred to by the staff as 'medical last rites.'"  Dr. deMaine also asks how the case might have reached a better resolution, for example, through unilateral withdrawal.



Minggu, 24 Juli 2011

‪The Gates Foundation on Reinventing the Toilet-Let’s Get Our “Crap” Together and Do It (Video)

I do have to say this is a very well done video about a crappy subject and someone imagehad their thinking cap on to produce the video.  When the video hits the recycle parts it makes me think of Kevin Costner and Waterworld a bit. 

Not too long algo “crap burgers” were in the news too, so may be will be eating sh** some day:)  The did a good job talking about “poop” and “doodoo”.  According to the video, 4 out of 10 people in the world don’t have a safe way to “poop”.   

Reinvent the Toilet

Toilets are a big deal as we know and India has museum of them as well.  BD

Toilet Museum
Four out of 10 people worldwide don't have a safe way to poop. Find out why we need a toilet revolution. We need new ideas to help reduce disease and find new ways to turn crap into valuable stuff, like fuel, fertilizer, and fresh water.

‪Reinvent the Toilet | Bill & Melinda Gates Foundation‬‏ - YouTube

Walter Reed Army Medical Center To Close It’s Doors Forever This Week–Moving to the Bethesda National Naval Medical Center

The hospital is closing it’s doors and will be combined with the National Naval Medical Center and this is slated to cost around $2 billion, more than what had been imageanticipated as the cost.  Many workers will move and some will find jobs at Fort Belvoir in northern Virginia at a new community hospital.  The State Department will be the new owners and some buildings will be preserved as landmarks. 

Soldiers will now have a new place to go in Bethesda and the hospital was opened back in 1909.  There are talks that part of the area will be turned into a shopping center.  The new facility at Bethesda will include 345 medical-surgical beds, 50 intensive care unit beds and 20 operating rooms.  The official date of closure is September 15h when the move is completed.  BD

(Reuters) - The storied Walter Reed Army Medical Center will retire its ceremonial flags on Wednesday, as it prepares to close its doors after more than a century of treating wounded American fighters and presidents.image

Walter Reed has treated some 18,000 troops that fought in Iraq and Afghanistan as well as U.S. President Dwight Eisenhower, who died there, and Generals John J. Pershing and Douglas MacArthur.

The present facility, together with its current patients, will be moving to a new location in Bethesda, Maryland, throughout August, prior to shutting its doors on September 15.

But the official "casing of the colors" at the 102-year-old institution -- as the ceremony to retire the hospital's flags is known -- will take place on Wednesday.

Historic Walter Reed Army hospital prepares for move | Reuters

How Prime Healthcare Hospital Chain Is Accused of Boosting Profits With Higher ER Admissions

A comparison was done with using big hospital chain Tenet, who admitted 39% of the ER patients while the stats at Prime were 63%, so that’s pretty big difference with just looking at the percentage numbers.  Back in February of this year, Prime imagewas also questioned about some of their billing processes with a large number of Medicare patients showing malnutrition.  I live in the OC and remember the hospitals from a business standpoint before their acquisitions and they were busy but now when you drive by the hospitals you can roll bowling balls through the parking lots that were once crowded and challenging to find a parking space. 

Prime Healthcare Billing Processes Under Question as 25% of Medicare Patients are Showing Malnutrition- Profit Algorithms?

A few months ago Prime Healthcare bought another hospital in San Diego where I commented about another Cadillac ER on the way, as this is where the money is with healthcare with current laws and regulations. 

Alvarado Hospital Recently Acquired by Prime Healthcare To Lay Off One Quarter of the Staff in San Diego

As mentioned above when purchased, it kind of looks like the services that are not profitable are abolished and again you see big vacant parking lots at patients have to go elsewhere.  How does this balance out if all hospitals were to run strictly on profit?  Prime also buys hospitals that are usually in financial straits and thus the pricing I think has been what they chain is willing to pay, but in some instances if Prime didn’t buy them, the hospital would close so 6 of one and half a dozen of another.  image

I read the other day to where Prime has filed suit against the consumer group investigating and reporting on the deficiencies they are finding with the chain.  Kaiser has had issues with the chain for a few years now and the new issue at hand is the fact that patients are being “held hostage” for ER admittance, in other words somewhat coerced into being admitted at Prime instead of going to another hospital to be admitted and perhaps one in network. 

“The chain’s founder and board chairman, Dr. Prem Reddy, once described the emergency room as a “gold mine” of Medicare and Kaiser patients, according to the former medical director of Desert Valley Hospital in Victorville.”

Prime HealthCare and Kaiser Still Duking it Out In Court – Patients are Off the Hook for the Balance Due Bills

The comments go on to say that Prime did not want to miss an opportunity to admit a fully insured patient when the opportunity was there and most hospitals of course like to get paid as any other business but the questions here arise about Prime maybe over stepping their coding and ER admittance procedures.  This will be an interesting case to follow to see how the analytics and numbers all shake out.  BD 

A Southern California hospital chain has boosted its profits by transferring an unusually high number of patients from its emergency rooms to its hospital beds, gaining hundreds of millions of dollars by targeting people with Medicare, a California Watch investigation has found.

Patients and their families have described feeling trapped by doctors and administrators working at Prime Healthcare Services facilities. They entered the emergency room and were stuck in a "Twilight Zone," as one family member described it, unable to see their own doctor at another facility or faced with treatment that seemed unnecessary.

During a 2006 Orange County Board of Supervisors hearing, Dr. Abdul Khan, a doctor at Huntington Beach Hospital, said that after Prime took over that year, doctors were told to admit insured patients who arrive in the emergency room with maladies as minor as a headache. 

In late 2006, Prime took over hospitals in Anaheim, Huntington Beach and La Palma. The chain took over a Garden Grove hospital in mid-2008. By 2009, those hospitals, on average, admitted 64 percent of Medicare patients to hospital beds – compared with the 44 percent admission rate at those same hospitals in 2005.

More than a dozen other Orange County hospitals also admitted about 45 percent of Medicare patients in 2009.

How Prime Healthcare chain boosted hospital admissions | prime, patients, hospital - News - The Orange County Register

RAM (Remote Area Medical) at Wise, Virginia for the 12th Annual Free Clinic Seeing over 4000 Patients

This was a 3 day event with those who have either no insurance or those without enough insurance to receive both free medical and dental care.  1700 volunteers showed to make all of this possible. 

Remote Area Medical Founder Receives 2010 Inamori Ethics Prize – RAM Returning to Los Angeles April 27th

If you remember back last year, the group was there to offer help in New Orleans and have put on two massive free clinics in the Los Angeles area as well as a couple in northern California in the last couple of years. 

Remote Area Medical Going to New Orleans in August To Help Oil Spill Victims and Others

Here’s a few words from the founder at the Free Clinic held this weekend and some of the doctors who are volunteering their time, it’s not getting any better with healthcare in the US otherwise these folks would not have to be here.  For many in the area and for those who travel to the clinic, it’s the only healthcare they receive.  BD

Remote Area Medical Wise, VA 2011

WISE — Upwards of 4,000 people shrugged off the muggy heat of a Friday simmering its way toward sweltering as the 12th annual Remote Area Medical (RAM) Health Expedition got under way at the Wise County Fairgrounds.

About 1,700 volunteers — roughly 1,000 of them medical professionals — got busy before the crack of dawn on Friday to provide free medical, dental and eye care services to all-comers. Gates opened for patient registration at 6 a.m., and by 7 a.m. all 1,500 dental and eye care slots for the day had been filled, with another 200 to 300 people opting for the medicalservices-only line.

RAM off to blistering start- Kingsport Times-News

More Concern about Catholic Hospital Mergers

As with other mergers in other parts of the country, the Louisville Courier-Journal reports significant concern that that Catholic doctrine could override patients' end-of-life wishes under a pending merger of three Kentucky hospitals (University Hospital, Jewish Hospital & St. Mary's HealthCare, and St. Joseph Health System).  Catholic Health Initiatives would own 70% of the combined operations, and the merged hospitals will follow Catholic health care directives.



Wise on Rasouli v. Sunnybrook

Ontario attorney Gary Wise blogged about Rasouli v. Sunnybrook here.  He describes the decision as "a good example of the Court of Appeal taking pains to not rule on a contentious and divisive issue they would prefer to leave to the Legislature."  That reminds me of Betancourt v. Trinitas Hospital.



Jumat, 22 Juli 2011

Public Employee Benefits Alliance (PEBA) A Texas Purchasing Cooperative Signs Agreement With Satori Medical Tourism

PEBA represents over 150,000 from two Texas Political Subdivision Pools and 68 individual employers and I guess when you have the former CEO of Cigna it seems like it is opening some doors as a couple weeks ago we had the City of Hartford sign up too. 

City of Hartford First Major US City to Offer Medical Travel Benefits to Employees With Approximately 6% in Total Budget Savings

I a guessing that Mexico will be a priority destination just simply due to location but from what I read in the press release it appears that other avenues will be open, unlike the Hartford agreement that specified Puerto Rico. 

Press Release:

SAN DIEGO, CA/AUSTIN, TX – July 21, 2011 – The Public Employee Benefits Alliance (PEBA)/Political Subdivision Healthcare Benefit Purchasing Cooperative has selected through a competitive bidding process Satori imageWorld Medical, an International Provider Network and medical travel company, as an additional network option for PEBA member employees.  PEBA was established in 2006 by a group of Texas Government leaders to develop strategies to manage the rising costs of healthcare benefits. PEBA membership is open to all Texas local governments and includes School Districts, Municipalities and Counties throughout Texas. PEBA negotiates on behalf of the membership affordable, high‐quality healthcare and related benefits and services designed for public entity employers.

Satori World Medical will provide PEBA member employers a full service medical travel program option, also known as medical tourism, international centers of excellence or global healthcare, which can result in 40-80 percent cost savings per procedure. The program offers specialized procedures, such as orthopedic, cardiac, and other major surgeries that can be performed at one of Satori’s network hospitals around the world, and includes the costs of travel and hotel accommodations for the patient and a companion.

“We are very pleased to be working with Satori World Medical. Their program adds a great value to our members’ benefit packages by giving PEBA member employers access to International Centers of Excellence around the world at significant cost savings.  Satori’s program is in direct alignment with PEBA’s mission, to provide affordable, high-quality healthcare for our members,” said Susan Smith, Administrative Services of PEBA. 

“Political subdivisions around the country are looking at international healthcare to provide a new value add medical benefit and at the same time lower their healthcare costs,” said Steven Lash, President and CEO, Satori World Medical. “The rising cost of healthcare continues to place a tremendous burden on the public sector and U.S. employees and we are thrilled that we can offer PEBA members an alternative.”

Satori World Medical has done extensive due diligence on hospitals and physicians to find the best the world has to offer. Its network features hospitals that meet or exceed U.S. standards of care, are accredited, and monitored regularly by Satori on the quality of care delivered.

For more information on PEBA, visit http://www.buypeba.org/

Satori World Medical provides access to its global network of board-certified physicians and worldwide centers of excellence through a high-quality integrated medical travel program, which is easily added to any health plan, reducing the costs of surgical procedures by an average of 40-80 percent when compared to the same procedures performed in a U.S. hospital. Its business model is specifically designed to deliver high-quality health care services, share the tremendous cost savings with plan sponsors and their employees and to coordinate all medical and travel services for individuals who need care. For more information about Satori World Medical, call +1 (619) 704-2000 or visit at http://www.satoriworldmedical.com.

FDA Approves First Male Vibrator for Use for Men Suffering From ED–Available By Prescription Only

You read the title correctly, you need a prescription to get the device and the home page states it will be available this summer.  There’s a lot of research and science here and I don’t know if we would consider it a DME article or something else?  In case you are interested, it is made in the USA and comes with a warranty and is as easy to use as an electric toothbrush, according to the website.  image

If one is recovering from a surgical procedure it serves as a therapy device and I guess otherwise it’s use as you want.  The website is done professionally and has a long video to tell you all about it and the science behind the design.  Until they are growing the organs you this or prescription pills as options and Wake Forest is working on the harvesting side of things.  There’s also Horny Goat weed out there too with clinical trials for the food supplement side ED.  BD 

Regenerative Medicine News – Fully Functional Rabbit Penis Created That Works

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Reflexonic LLC landed FDA clearance for the first hand-held, non-pharmaceutical device intended to help men with moderate erectile dysfunction, poor maintenance and rigidity or spinal cord injuries achieve successful erection and ejaculation at home. image

Viberect is the only device in the world that delivers targeted vibration applied to the top and bottom of the penis using medical pads that stimulate the pudendal and dorsal nerves.

image

Reflexonic called on Texas-based medical device consultancy firm Emergo Group to aid it through the regulatory bid, and the companies spent two months writing the 510(k) application, which was submitted in February, according to the press release.

Penis stimulation device touts landmark FDA clearance for erectile dysfunction | Regulatory Roundup | MassDevice - Medical Device Industry News

IBM General Parallel File System Scans 10 Billion Files in 43 minutes–New High Powered Hi-Tech-Could be Great for MRI Imaging

This almost makes me wish a 10 billion files to scan:)  This looks like a good place to store some MRI images.  As we all talk about the exploding amount of data we are all dealing with, we need items as such unless we starting dumping data but of course we know that’s not going to happen.  Who’s the first big client here that’s all over this, DARPA and they are into the math and looking for the right algorithms to have machine learning and interpreting work for them.  BD

image

SAN JOSE, CA, July 22, 2011: Researchers from IBM (NYSE: HYPERLINK "http://www.ibm.com/investor" IBM) today demonstrated the future of large-scale storage systems by successfully scanning 10 billion files on a single system in just 43 minutes, shattering the previous record of one billion files in three hours by a factor of 37.
Growing at unprecedented scales, this advance unifies data environments on a single platform, instead of being distributed across several systems that must be separately managed. It also dramatically reduces and simplifies data management tasks, allowing more information to be stored in the same technology, rather than continuing to buy more and more storage.

"Businesses in every industry are looking to the future of storage and data management as we face a problem springing from the very core of our success – managing the massive amounts of data we create on a daily basis," said Bruce Hillsberg, director of storage systems, IBM Research – Almaden. "From banking systems to MRIs and traffic sensors, our day-to-day lives are engulfed in data. But, it can only be useful if it is effectively stored, analyzed and applied, and businesses and governments have relied on smarter technology systems as the means to manage and leverage the constant influx of data and turn it into valuable insights."

IBM rig doesn't look like much, scans 10 billion files in 43 minutes -- Engadget