I have been doing quite a lot of work lately on setting up redundant network attached servers and cloud storage systems for what is now about 2TB of data. It has been increasingly clear to me that none of the systems I see would be adequate for the panacea that everyone thinks EMR’s are. I predict we are in for a huge wave of data security breeches at best and total data losses at worst. many docs using EMR’s I’ve seen have woefully inadequate data security and backup plans.
Just reported: another day, another privacy breach. New York-Presbyterian Hospital and Columbia University Medical Center “inadvertently” posted the personal information of about 6,800 patients–including names, clinical data and 10 social security numbers–online, reports the New York Times. While the breach was discovered in July (after a patient’s relative saw the information online), the hospital and medical center didn’t announce the problem until yesterday because of an ongoing investigation.
The personal information was accidentally placed on a server, but has since been removed, the hospital said in a statement.
During the breach, exposed data such as names, ages, surgical status, temperature and pulse became accessible to search engines, Myrna Manners, a NewYork-Presbyterian Hospital spokeswoman told the Times. Patient diagnoses were not disclosed, she noted.
I must say this is an example where the old taboo idea of “economic migration” would end it overnight. That is — have managed care simply make these tests not reimbursable (ie if you order the test the lab won’t be paid for it) and the use of these tests will end overnight. HOWEVER– just the opposite happens. Newly introduced tests of clear benefit languish for months or years (ie MIF/AMH in fertility) being refused by managed care and patients forced to pay out of pocked for them. Interestingly the old bad tests are relatively cheap and the new ones routinely more expensive.
According to the study, “given the current economic climate for medical practices, it is the responsibility of clinical laboratory directors … to review their test menu and … remove tests that do not provide clinical value to a particular medical practice, whether such testing is conducted in-house or sent to a reference laboratory.”
Think that’s bad– how about an old test that frequently gives incorrect false positive genital herpes results?
In fact, a recent paper in the American Journal of Obstetrics & Gynecology found that many US labs are using outdated genital herpes tests that often yield false-positive results.
“Commercially available herpes simplex virus antibody assays that were not glycoprotein-G based demonstrated high false-positive rates (14 percent-88 percent) for herpes simplex virus type-2 antibodies in sera that were positive for herpes simplex virus type-1 antibodies but negative for herpes simplex virus type-2 antibodies,” according to the paper. “Herpes simplex virus serologic testing should be performed with only glycoprotein-G–based tests.”
have just returned from the Maker Faire and have seen the future of medical device innovation, invention, and design– Self-design and rapid home prototyping. For those unfamiliar with the jargon basically technology now exists that can allow the creation of a working prototype of a device from idea to an actual working hand-held version in a physician-inventor’s own home. This has the potential to democratize the process and eliminate previous massive cost and technological barriers that kept the process inaccessible except to large industry or those with substantial capital resources.
One person I spoke with was calling this the Next Industrial Revolution. To me this is clearly the inevitable technological evolution of design and device innovation following in the exact path blazed by desktop publishing, digital video and computer based editing for movie creation to name just two examples. –And once again it is fueled by the exponential progress in computer power –here married to a fanatical base of innovators driving the creation of the raw tools that will be the assembly line of the future.
What is Maker Faire? Maker Fair just had its first NY exhibit and is an offshoot of Make magazine. MAKE brings the do-it-yourself mindset to all the technology in your life. Think of it as technology-hackers. Its like wood-shop for the 21st century hacker who is building his own radio controlled spy drone or augmented reality device instead of oven mitts and hotplate coasters. AS they write “this is a magazine that celebrates your right to tweak, hack, and bend any technology to your own will. For example, in our first volume, we show you how to get involved in Kite Aerial Photography, how to make a cheap but effective video camera stabilizer, and how to build a device that reads the hidden information stored on the magnetic stripes on all your credit cards.”
Homelab laser engraver/cutter. can carve any substance with laser power and precision. cuts out 3D models too.
But that’s just the beginning. The sophistication of the home creation kits is mind-blowing.
This is a beagleboard. It contains all the power of an entire computer. It was running what looked like a normal desktop with a video capture and object recognition on a version of linux. It costs less than $500 and can be the basis for home-made computer intelligent devices. All open source as well.
At the Faire take thousands of people with this mindset, demos, kits, and lessons to “celebrate arts, crafts, engineering, science projects and the Do-It-Yourself (DIY) mindset.” And as usual for my tech crossovers— add one doctor to the group.
What’s The Medical Significance? As usual I search out emerging technologies not yet used in medicine that have the potential to right now change how we do things. What’s struck me with all I saw was the common theme that anything that was a high tech machine now today can be imagined, designed, researched, 3D modeled, and turned into working prototype all in a home workshop on an inventor’s budget. What’s more this now applies to the physical aspects (ie plastic casing and movable parts) and to the electronics being them embedded operating systems or any myriad of sensors. The theme of the day was that you yourself can see these projects through to this stage and there is a thriving community and ground-swell of momentum to build a grass roots infrastructure to help.
Examples of 3D Prototyping/Desktop Manufacturing:
The left image is a makerbot — you build this machine and then it produces 3d models out of plastic from 3D images on you computer. You can anything from an action figure to a device handle to well– the middle images was made on a higher end system like that shown on the right. here the machine first modeled the bones then applied a tissue layer over it. The system right now can take any 3D dataset from an ultrasound MRI or CT scan and reconstruct 3D tissue or organ models. I’ll follow up in a later post how scientists are using such technologies to literally build artificial organs in the lab– they build the structure then seed it with living cells that create the organ. The maker bot replaces a $100,000 fabricator from a decade ago and costs under $1500– and its all open source.
Could You Cure a Disease With a Device Invention? Does Your Child Think He or She Could? You’d be Surprised? The New Inventor’s Mindset for the 21st Century. You probably grew up thinking devices of all sorts and especially electronics were otherworldly gizmos of incomprehensible complexity of design. The workings of a TV, video camera, or electronic medical diagnostic device where the stuff that only biomedical engineer with a pocket protector and a degree from MIT could have created. Your kids think otherwise. They are comfortable with technology and with programming computers when presented with understandable languages. They can make a webpage. They can edit video and retouch photos. They have a myspace page. They may tinker with remote control toys. Many of them with some practice can create 3D computer graphics. Just recently A Russian amateur filmmaker called Alexander Semenov produced this 2.5 minute bootleg Transformers short with a couple of sub-$1,000 cameras, two hours’ of footage and a month in the home desktop editing suite that many think rivals the effects of a million dollar Hollywood blockbuster.
Understand that the next generation of design and creation tools will use these same sorts of visual programming language and are just as accessible. I walked through the exhibits with a 6 and 9 year old. By the end of the day the 6 year old had soldered an LED lit circuit board to make an electronic toy (parts cost $1), both had piloted radio controlled robots complete with sensors, and had begun to design autonomous robotic creatures– and they had never done this before. I was recently asked to give a talk to a group of 4th graders working on the Lego First competition. This is a robotics competition for kids to build working devices. There are more than 10,000 teams competing this year. This year’s theme is biomedical research. They kids were instructed that they have the tools to invent a device that could solve a medical problem. They don’t believe only MIT engineers solve problems. They expect to. Remember who invented youtube and facebook.
home kit for sensor based mobile search and rescue bot. The same sophistication as a military robot and the same technology as in implantable body rovers being developed.
robotic arm prototype- could model prosthetics
home made kit for scanning tunneling microscope for research uses. A scanning tunneling microscope (STM) is a powerful instrument for imaging surfaces at the atomic level. Its development in 1981 earned its inventors the Nobel Prize in Physics in 1986. For an STM, good resolution is considered to be 0.1 nm lateral resolution and 0.01 nm depth resolution.With this resolution, individual atoms within materials are routinely imaged and manipulated. This is now a do-it-yourself kits for under $200 all open source design and technology
Screening all pregnant women for a rare but fatal genetic disease is too expensive, researchers say in a new report that adds to a recent controversy about whether genetic tests are worth the cost. The research is reported in the new issue of AMJOG and reported in summary here.
While scientists can already screen for SMA, allowing parents to seek an abortion or decide against having children, doctors are split on whether or not to recommend routine screening due to cost concerns.
The new study analysis comes to $5 million for each case of SMA avoided by prenatal screening- and decides its too expensive.
“We found it to be too expensive,” said Dr. Sarah Little of Massachusetts General Hospital, who worked on the study. She added that the value for money was a tiny fraction of what is generally considered acceptable by health economists.
While a genetic test for SMA costs just under $500, more than 12,500 women would have to be screened to prevent one case of SMA, which affects only about 1 in 10,000 newborns.The results bolster guidelines from the American College of Obstetricians and Gynecologists, which recommends that only parents with a family history of SMA get screened.
However, another professional association, the American College of Medical Genetics, was not impressed with the study, which was published in the American Journal of Obstetrics and Gynecology.
“They came to the wrong conclusion because they used the wrong tool to do the evaluation,” said Michael Watson, executive director of the American College of Medical Genetics, which recommends universal screening for SMA.The team used the standard method of calculating cost-effectiveness, which naturally favors screening for diseases such as cystic fibrosis in which patients live long lives and require expensive treatment.
When patients die young, in contrast, they don’t incur a lot of expenses, and so the dollar value of preventing such diseases is smaller. “It’s just not a practical approach,” said Watson, adding that “we could save a ton of money in the US if everybody died.” I have often pointed this out to those who criticize fertility care as being too expensive for the health care system. Cancer care and intensive care units are very expensive. If we only use cost effectiveness analysis then we would only offer preventive health, nutrition, smoking cessation, and vaccinations. Much more cost effective then treating elderly sick people!
As a fertility specialist I deal with the SMA genetic screening test on a daily basis. I advise all infertile couples of the existence of the test and the risks of being a carrier and having an affected child. As is the case with cystic fibrosis and fragile X most couples do want to be screened once they know the test exists. For those who test positive in both male and female some have chosen to have PGD where I test the embryo during IVF to see if it is affected and only replace those that are not. I have had couples use this test to successfully have a healthy child unaffected by SMA. Just recently I saw couples who came specifically for PGD having lost more than one child who died from SMA– and they were unaware that testing existed before.
This reminds of when a west coast state (think it was washington) used a cost effectiveness analysis to decide which medical treatments their public health insurance would cover. Treatments were ranked and they went down the list until the budget ran out. This system was very poorly received.
I hate to rock the boat but as advances in genetic diagnosis are exploding this problem is going to go through the roof. I can now test for far more genetic diseases than tests existed for 10 years ago. Using DNA chip technology I can now screen for over 200 diseases. Is this cost effective? Would you want to have it done? When I thought about having children I wanted to be tested for everything possible! Just last week I had a Yale student on a research elective with me. He could not believe we don’t universally screen everyone for everything possible–yet many patients don’t want any test not 100% needed. Others striving so hard to have a baby want to be tested for everything possible. As the number of diseases we can test for heads north of 1000 in the next years our ability to test has outpaced policy decisions and protocols of what should be done for the couple who never had a child. The bigger issue as we enter the future of Obama health care is where does genetic screening for low risk couples for diabling or fatal diseases (the ultimate preventative care) fit into the economic analysis. How much is too much? I guess it depends on who you ask and who’se paying…
I have just received a breaking news update from Astellas regarding risks of using their antibiotic Vitabiv in pregnant women. This is one of the most strongly worded warnings on use of an antibiotic in pregnancy I have seen recently. I received a generic warning update last week from the American College of Ob Gyn that “some warning regarding a drug in pregnancy” was coming today.
As the letter reads:
The purpose of this letter is to inform you of important safety information for VIBATIV™
(telavancin) for injection, a once-daily intravenous antibiotic indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following organisms.
An informational program for healthcare providers has been established to help minimize the risks associated with the use of VIBATIV; the most important relates to the use of the product during pregnancy. Animal data indicate that use of VIBATIV during pregnancy is associated with reduced fetal weights and increased rates of digit and limb malformations in offspring, although these malformations were infrequent.
Women of child bearing potential should have a serum pregnancy test prior to administration
of VIBATIV. Patients should be counseled on the risks and benefits of VIBATIV. Consideration
should be given to using an alternative course of therapy, if a positive test result is obtained.
The use of VIBATIV should be avoided during pregnancy unless the potential benefit to the
patient outweighs the risk to the fetus. Women of childbearing potential (those who have not
had: complete absence of menses for at least 24 months or medically confirmed menopause,
medically confirmed primary ovarian failure, a history of hysterectomy, bilateral oophorectomy, or tubal ligation) should use effective contraception during VIBATIV therapy. Patients should be
instructed to notify their prescribing physician/healthcare provider if they become pregnant while taking VIBATIV. A pregnancy registry has been established to collect information about the effects of VIBATIV use during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the pregnancy registry by calling 1-888-658-4228.
6 Steps to get more accurate medical diagnoseswas just printed by US News and World Reports along with Newsday. I was interviewed for this segment and asked to share some of the methods I developed and use to deliver the best possible results for my patients with infertility at Gold Coast IVF in Syosset, NY. I provided tip # 1 — don’t assume just because you have been given a diagnosis that it’s complete or accurate and make sure you have a chance to share all the details of what’s happening to you with the doctor. This is the most vital step to start the diagnostic process to help maximize results.
Thea article describes an all too common problem I see in fertility treatments (and medicine in general) - doctors who jump to conclusions and make diagnoses based on assumptions rather than facts- and then lead the patient down treatment paths that may not be optimal – or even correct!
The article goes on to say some doctors mistakenly decide in 18 seconds! I usually spend more than an hour with a new infertility patient asking and listening to determine exactly what the potential issues are. Unfortunately the article says some decide in just 18 seconds.
My Threshold First Step – Make sure you can tell your whole story- insist on an accurate diagnosis before treatments begin. As it states in the article:
If your doctor appears to be in a rush and interrupts frequently, you’re at greater risk of being misdiagnosed. “Don’t assume that just because someone has given you a diagnosis that it’s necessarily accurate and complete,” says Dr. Steven Palter, medical and scientific director of Gold Coast IVF of Syosset, a reproductive medicine and surgery center. “The patient should communicate to the physician all of their concerns and symptoms. . . . There’s rarely only one treatment option, so the patient should ask what are the risks and benefits, and what options does the doctor have experience with and what they don’t.”
The Six Steps:
Make sure you can tell your whole story
Ask your doctor three questionsafter he or she comes up with a possible diagnosis
The risk of listeriosis in pregnant women and their fetuses is greater than previously thought, researchers said.
Listeria monocytogenes — one of the most dangerous foodborne pathogens in the U.S. — can cause miscarriages and stillbirths, according to Mary Alice Smith, PhD, and colleagues at the University of Georgia in Athens.
Top 10 Healthcare Systems by Revenue (ranked by net patient revenue $ millions)
1. U.S. Veterans Affairs Dept $40,686.5
2. HCA, Inc. $28,374.0
3. Ascension Health $12,720.6
4. Community Health Systems $10,840.1
5. NY Presbyterian Healthcare Sys $8,458.3
6. Tenet Healthcare Corp. $8,348.0
7. Catholic Health Initiatives $7,817.1
8. Catholic Healthcare West $7,596.2
9. Sutter Health $6,874.0
10. Mayo Clinic $6,143.5
Top Ten’s Cumulative Revenue: $137,858.3 (Source: Modern Healthcare, 2009)
I previously wrote about the proposed FTC “Red Flag” regulations that will make doctors responsible for verifying photo IDs and protecting patient identities that no one yet knows how to possibly deal with.
Here’s some immediate practical steps you can take —Seven steps you can take to thwart medical identity theft and minimize its impact on patients:
Verify the patient’s identity. Ask for photo identification and compare it to the insurance card. Make a copy of the ID the patient presents, and flag any characteristics of new patients that could help you to identify that patient later.
Don’t assume information in the medical record is correct. For example, double check the patient’s blood type.If the patient’s type does not match the information you have in your file, then that is a strong indicator that you are dealing with an imposter.
Keep patient records secure, as required by federal law and any specific laws in your state.
Be prepared to honor requests from patients to correct medical records resulting from identity theft, help them determine how and where the medical identity theft occurred, and obtain accountings of any disclosures of their information as permitted by HIPAA.If you are hesitant to remove data from the medical record, create a second file and ‘red flag’ that more than one person may be using the same name.
Watch your employees. Conduct background checks to filter out applicants involved in financial crimes. Beware of employees who inappropriately access patient files and loiter in areas where they should not be.
Have written policies on document destruction. Shred documents before putting them into a dumpster.
Assist victims of medical identity theft. A patient who had his/her identity stolen might be half-way across the country. They are going to be upset but a helpful attitude can go a long way towards assuaging a patient’s anger. Keep a contact list handy and take time to answer their questions.
This is a beagleboard. It contains all the power of an entire computer. It was running what looked like a normal desktop with a video capture and object recognition on a version of linux. It costs less than $500 and can be the basis for home-made computer intelligent devices. All open source as well.
