Cool Technology of the Week

Massachusetts Data Protection regulations require us to encrypt mobile devices. Red Flag rules require us to implement processes to protect against identify theft. ARRA requires notification of prominent media for any inappropriate data disclosures.

This all sounds great, but what if you drop your wallet containing credit cards, identification cards, and maybe even your personal health information?

The answer - a Kevlar and Carbon Fiber wallet with biometric identification.

Tungsten W created such a wallet. Its features include:

*Fingerprint access only

*Bluetooth enabled for notification alerts - automated notification via bluetooth if your wallet strays more than 10 feet from your body

*Protected against RFID electronic theft - the case shields all contents from RFID scanners

A portable, monitored, personal safe you can keep in your back pocket and open via biometrics. That's cool.

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A Functional View of my Brain

As part of the Personal Genome Project, the PGP 10 participate in a variety of projects and diagnostic tests. We've done genome sequencing, published our medical records, and made our stem cells available to the research community worldwide.

Last week, I joined a Functional MRI/Genome study run by Randy Buckner at Harvard. The project is a collaboration among investigators across Harvard and its affiliated hospitals to construct the largest available reference database of brain function for both normal individuals and for individuals with psychiatric illness. Over the past year and a half, they have collected brain imaging data from 1500 volunteers with the help of 20 laboratories spread across Harvard, Massachusetts General Hospital, and McLean Hospital. The goal is to use the database as an openly available reference to understand psychiatric disorders including autism, depression, and schizophrenia with a particular focus on how genetic risk factors for illness alter the brain�s function.

What you are seeing above is what Randy refers to as the �Default Network� of my brain. These are the brain areas that are active when I think to myself. According to Randy, my images are particularly sharp - not because my brain is special but because I moved less than a half millimeter during the study. A dime is about one millimeter thick. Randy's team has speculated that the default network is involved in internal modes of cognition such as when a person is remembering or planning for the future.

Since I'm always planning for the future, you now have a picture of how my brain works. The good news is - I have a brain!

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More Questions, No Answers About the Case of the Deadly Heparin - Some Congressmen Weigh In

In 2008, we started posting on how the "active pharmaceutical ingredient" of heparin made in China under apparently primitive conditions, contaminated accidentally or deliberately, was sold in the US bearing the label of a large American pharmaceutical company. Ultimately, many patients were sickened, or died. A summary of our posts on the topic, in smaller type, is below.

- We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.

- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.

- Most recently, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.

- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

- Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post here.)

- Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible.  (See post here.)

- Hundreds of lawsuits against Baxter have now been filed, so far without resolution.  (See post here.)

- A recent government report which attracted little attention warned of the dangers of pharmaceutical ingredients made in China and subject to virtually no oversight. (See post here.)

Last week, minority (Republican) members of a committee of the US House of Representatives sent a letter to the Commissioner of the US Food and Drug Administration (FDA) raising a number of concerns of its investigation of contaminated heparin from China.  The letter was summarized in http://www.theheart.org/ (here), but so far has not been noticed by any main-stream media outlets.  The main concerns raised in the letter were:

1. The FDA has not adequately followed up specific and credible information linking Chinese heparin firms to counterfeit heparin or contaminated heparin in several different supply chains.
2. The FDA inspected several Chinese heparin firms in 2008 and 2009 for regulatory compliance issues but did not conduct these inspections consistently and adequately for determining the source of the heparin contamination.
3. The FDA has not adequately followed up with the Chinese government about the heparin contamination-source investigation.

Curiously, though, most of the letter detailed concerns about an FDA inspection of a company called Chongqing Imperial Bio-Chem Co, Ltd, which appears to be separate from any of the firms mentioned above which seemed to be involved with the heparin ultimately sold in the US under the Baxter label.  In fact, I have not seen to date any report on the contamination of that heparin, supposedly whose active ingredient Baxter obtained from  a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions.  Nor have I seen any report on the responsibility of any of these parties for the purity and safety of the heparin.  In particular, given that the heparin was sold in containers with the Baxter International label, and hence given that the doctors, nurses and pharmacists involved in its administration likely thought that it was actually made by Baxter, I have not seen any further discussion of that company's responsibility to provide a pure, safe, unadulterated product to its US patients. 

And all this still begs the question that most of the coverage of the deadly heparin also begged. Are American pharmaceutical companies so besotted with the need for cost-savings that they are willing to buy active pharmaceutical ingredients with unknown provenance overseas as if they were a pig in a poke? If so, why do we allow company leadership to potentially sacrifice quality, and sell adulterated drugs just to enrich their bottom lines (and their executives' salaries)?

As a postscript, a report last week in a New York Times blog reminds us of the monetary stakes here:

A drug harvested from pigs� intestines has made a low-profile Chinese couple the nation�s wealthiest overnight. Husband and wife Li Li and Li Tan�s Shenzhen Hepalink Pharmaceutical sold 10 percent of its shares this week in an I.P.O. that values their stake at about $6.2 billion, The Financial Times reported.

The I.P.O. also earned Goldman Sachs a near 200-fold profit on its original $5 million investment.

According to the newspaper, analysts say Hepalink�s high valuation is a result of the company being the only one in China that is accredited by the U.S. Food and Drug Administration [presumably after the above case of the deadly heparin] to export the 'active pharmaceutical ingredient' heparin after it has been harvested.

This amount of money sloshing around suggests that the reason this case remains so persistently anechoic is fear of offending those who have been getting very rich from the products of pigs' intestines.

I hope that more investigators with intestinal fortitude step in to investigate the out-sourcing of drug production to dubious suppliers before more patients are poisoned.

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Wisdom from Xena: Warrior Princess

My family is a "nerd herd", a "gaggle of geeks", a "den of dorks". We do not watch television, but we do occasionally watch DVDs of cult series such as Babylon 5, The Prisoner, Doctor Who, The Secret Adventures of Jules Verne, and Xena: Warrior Princess.

Last night, we watched an episode in which Xena (Lucy Lawless) described her secret to winning competitions/battles/confrontations - "Act, do not react".

Today, while speaking to my staff about a few challenging projects, I realized the wisdom of this statement.

When I think about challenging projects with difficult to please customers, negative emotions may start to flow. You know what I mean - the emails with subject lines or From addresses that you dread reading. The meetings you do not want to attend. The politics that are impossible to successfully navigate.

Reacting to any situation when you've already biased yourself with negative emotions leads to less than perfect thinking and communication. All that stimulation of the sympathetic nervous system (fight or flight response) leads to a dry mouth, a racing heart, and scattered thoughts.

Instead, if you think about the endpoint you want to reach - a successful project, a better technology, a completed implementation - and take the actions needed to achieve this result, you'll be thoughtful, calm, and reasoned.

Here's an example. Rolling out EHRs to 1700 clinicians including all the capabilities and workflow redesign to achieve meaningful use is a change management challenge. Along the way, there will be naysayers, raised voices, and criticism. There may even be mean-spirited personal verbal jousting.

We know what actions we need to take - implement a practice every week between now and the end of the year. Follow our proven model office configuration. Build the interfaces and interoperability needed for care coordination, patient engagement, and quality measurement. By keeping our focus on the "act" and not the "react" to the few naysayers, we get closer to our goal every day, without emotion or negativity.

So next time you have a difficult project, difficult people, or difficult politics, think about the wisdom of Xena - Act, do not react.

You'll feel better and achieve your goals.

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Medical Transcription outsourcing: Can improve the receivables cycle of a healthcare facility.

Timely Medical Transcription could actually accelerate the flow of receivables of a healthcare facility!

At the end of the day it is the goal of every enterprise whether in the healthcare business or otherwise to shorten the flow of payments cycle and receive payments sooner. In the case of a healthcare facility this becomes imperative for survival.

Once the patient has visited, diagnosed and treated or further references/tests ordered, essentially the healthcare part of the visit ends and the business side starts. Records have to be created of the whole process so that it can be further processed for coding and billing and finally for insurance claims.

The receivable cycle begins with the creation of timely and accurate records. This is where the outsourcing of medical transcription can really speed up the process. By handing over the medical transcription process to a service provider who is an expert in the process, more time and resources are freed up, which can be used to concentrate on the core business of healthcare.

Not only does medical transcription play an important role in the receivables cycle, it also plays an important role in other areas such as:

Patient treatment: The information transcribed from the initial patient-healthcare professional encounter forms a foundation for future treatment, This forms the basis of any follow-up healthcare, has references to the drugs prescribed, allergies and other pertinent information.

Statutory requirements: The information regarding a patient needs to be maintained for a period of 5 years.

Evidence in litigation: In case of malpractice suits medical records form a part of the evidence.

Referrals: In case further treatment is needed based on the present diagnosis these records form the basis of referrals to specialists for further treatment.


The medical transcription service provider needs to be assessed on the basis of the following:

Accuracy: This means the percentage of accuracy of the completed transcripts vis-à-vis what was dictated. A minimum of 99% and above would be acceptable.

Turnaround time: Turnaround time refers to the time taken to revert the transcribed report to the healthcare facility. A Turnaround time of not more than 24 hours for normal reports and 4-12 hours for STAT reports would be considered ideal.

Data security: The service provider being outsourced to should be HIPAA/HITECH compliant. The medical transcription service provider has to have adequate security measures to ensure that the confidential data transmitted back and forth is safe and secure.

Pricing: This is one of the main benefits that a healthcare facility hopes to have, from the outsourcing option. Pricing should be fair and reasonable for the services rendered. Pricing method should also be transparent and simple so that both parties can verify the same at any stage of the process

Technology: The technology used by the medical transcription service provider should not only secure but should also be easy to use, without having to require extensive training.

Once a medical transcription service provider has been evaluated on all these characteristics, the healthcare facility can finalize on a company offering all the benefits and rest easy on the first stage of its’ receivables cycle.

TransDyne offers all the above benefits of outsourcing the medical transcription needs. To avail the advantages of outsourcing medical transcription to TransDyne, click here

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Food Allergy and School Nurses

Parents of food allergic children rely on their school nurses when it comes to keeping their children safe at school. The trouble is that school nurses don't always feel they have the tools to protect children with food allergies.

A recent study reported in The Journal of School Nursing reveals weaknesses in these areas:

emergency plan development
staff education
delegation
developing guidelines for banning foods
planning school trips

The school nurses surveyed indicated a willingness to gain more knowledge in these areas. Their preference was that this be done via video and internet resources through professional organizations.

As more and more children are diagnosed with food allergies, it is imperative that our school nurses have the education and tools they need. Who is filling this need?

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Goodwill Industries

Goodwill Industries - Medical Adaptive / Assistive Technology Program

Provides medical and adaptive equipment and supplies to older adults and to persons with disabilities.

Examples: wheelchairs, walkers, canes, bathroom safety equipment

For more info call: (804) 521 - 4923

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