New Investigations of Boston Scientific, but New CEO Made $33.5 Million for Half a Year's Work

It appears that device-maker Boston Scientific has a new set of troubles.  The Boston Globe just reported:Stepped-up government scrutiny of Boston Scientific Corp. stems from heightened concern over medical safety and disappointment that the company made new missteps after resolving previous problems with the Food and Drug Administration, analysts said yesterday.The Natick medical-device maker, which has been working to settle patent suits and federal investigations dating back years, recently was notified of fresh investigations begun by the Department of Justice and the Securities Exchange Commission into problems that forced it to recall implantable heart defibrillators this month.Boston Scientific said March 15 that it had halted shipments and recalled unsold units of seven brands...

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The ONC Whitepaper on Consent

Last week was a busy one for healthcare IT. In addition to the DEA Interim Final Rule on e-prescribing of controlled substances, the launch of NHIN Direct, and the introduction of new ONC interoperability framework processes, HHS released the Whitepaper on Consent.The entire document and its 3 appendixes are worth reading. The Executive summary contains a great classification of consent models found throughout the world:No consentHealth information of patients is automatically included�patients cannot opt outOpt-outDefault is for health information of patients to be included automatically, but the patient can opt out completelyOpt-out with exceptionsDefault is for health information of patients to be included, but the patient can opt out completely or allow only select data to be includedOpt-inDefault...

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Eczema Drugs Linked to Cancer Risk

There is a scary warning about two common drugs used for eczema. The FDA is recommending warning labels for the skin creams Elidel® and Protpic®. They may cause cancer. I suspect that many of you were told, as we were, that these two creams were the best treatment on the market for our children's eczema, since they were non-steroid based. We switched to these creams when we noticed some loss of pigment on some areas of the leg. "That's from the steroid cream you're using to treat the eczema," our allergist said. Two new (at the time) creams were recommended to us.Now we find out that these creams have caused cancer in animals involved in a study. Human study results will be unknown for 10 years.So we wait?If you are still using either cream, I suggest speaking to your allergist or dermatologist...

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The ONC Interoperability Framework

In my summary of the March HIT Standards Committee meeting I mentioned the new ONC Interoperability Framework and the related RFPs. Here's the detail I promised in my previous blog about ONC. Thanks to Doug Fridsma for this overview and his hard work on it. ONC announced several projects to support Standards and Interoperability Framework and Nationwide Health Information Network (NHIN). Over ten requests for proposals were released in February 2010 under the existing contract vehicle: National Institutes of Health (NIH) Information Technology Acquisition and Assessment Center (NITACC) CIO-SP2 Task Order. The funding will support activities for two years that are designed to develop the standards, tools, interoperability framework, and technical infrastructure to support the overall...

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Meetings and Conferences of Interest

There are a number of upcoming conferences, and sessions within conferences which may be of interest to Health Care Renewal readers. In chronological order, and with apologies for somewhat tooting our own horn,...Annual Meeting, Society of General Internal Medicine Minneapolis, MN, USA, 28 April - 1 May, 2010. Those attending this meeting who read this blog may want to come to the meeting of the SGIM Professionalism Sub-Committee of the Clinical Practice Committee, which I chair, which will be on Friday, 30 April, 7:30-8:30am, Convention Center Room 102C, during the Annual Meeting. We would like to liven up the sub-committee, so please think about attending even if you are not now a member. See the whole meeting program here.Annual Scientific Meeting, Rhode Island Chapter, American...

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E-Prescribing Controlled Substances

Last week, the Drug Enforcement Administration released its long awaited Interim Final Rule on e-Prescribing of Controlled Substances It's 334 pages long, but the most important portion is section � 1311.115 which describes the need for two factor authentication when prescribing controlled substances. Here's the detail(a) To sign a controlled substance prescription, the electronic prescription application must require the practitioner to authenticate to the application using an authentication protocol that uses two of the following three factors:(1) Something only the practitioner knows, such as a password or response to a challenge question.(2) Something the practitioner is, biometric data such as a fingerprint or iris scan.(3) Something the practitioner has, a device (hard token) separate...

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Kids and Food Allergy Video

Share this video with your kids, grandparents, teachers, school nurses and friends. It's eye-opening. How about the girl who sat alone in her elementary school cafeteria for 2 years at the peanut-free table?How about the kids who talk about hurt feelings when other kids make jokes about food allergies? What about students who feel scared at school because of food crumbs or M&M's® lying around? Isn't it scary to hear that 18% of food allergy reactions occur at school?We can do better than th...

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Methodist Hospital Campaign Poster Girl, Cocci Study Group in Surprise AZ

Denise's story was featured in the 2009 year-end fundraising campaign letter for Methodist Hospital in Arcadia, the hospital where her journey with cocci began. The hospital is building a new patient tower. I can't find a link on their website to the publication with Denise's story, but here's a link to the Methodist Hospital Foundation site. If you happen to be fortunate enough to have money to give away to a good cause during these stressful economic times, Methodist Hospital is a worthy organization to consider.I just got back from the 54th annual Cocci Study Group held this year in Surprise AZ. My aunt Jackie the nurse went with me to explain much of the medical jargon. As usual, it was very informative. This year was especially interesting since they dedicated a big chunk of the program...

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The Settlement and Conviction Round-Up: Friday Frequent Flier Edition

It's time for one of our periodic round-ups of legal settlements and convictions of health care organizations.  This time, we report on three frequent fliers, in chronologic order of the appearance of the relevant news stories.Robert Wood Johnson University Hospital Hamilton (UMDNJ)We have written multiple times about the woes of the University of Medicine and Dentistry of New Jersey, which lead to a deferred prosecution agreement and operation under the watchful eye of a federal monitor for several years, and resulted in criminal convictions of a former Dean and the state legislative leader he hired.  Scroll through this for far too many details.  Now, the redoubtable Newark Star-Ledger reports:Robert Wood Johnson University Hospital in Hamilton has agreed to pay...

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Hospitals Under the Knife: Sacrificing Hospital Jobs for the Extravagance of Healthcare IT?

A WSJ article on the financial condition of NY hospitals, and specifically a line by NY Mayor Bloomberg, caught my eye:Wall Street JournalMar. 26, 2010Hospitals Under the KnifeNew York City System Aims to Cut 2,600 More Jobs as State Funding DropsBy MICHAEL HOWARD SAUL and SUZANNE SATALINENEW YORK�The nation's largest public hospital system plans to slash its work force�including doctors and nurses�by about 10% over two years as government aid drops and the number of uninsured patients jumps.With its budget deficit set to top $1 billion, New York City's Health and Hospitals Corp. plans to eliminate 2,600 jobs in the fiscal year that begins July 1. That comes on top of 1,300 positions to be eliminated this year."No hospital system in the country is exempt from the crushing economics ...

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Unsolicited Email From a Canadian Nurse Working in Healthcare IT

As a result of my writings I receive feedback from those involved in health IT. I reproduce this email from a Canadian nurse with her permission and without additional comment, because it speaks for itself about the ecosystem of healthcare IT:Dear Dr. S,I've reached your site while doing research about privacy and electronic medical records. I am an RN in Canada and have for the past 5 years been working towards integrating computer systems into health care practices. It has been quite the experience and ended with my being laid off.I've only had opportunity to quickly scan a few of your articles as yet but see a familiar theme. When I started in this area, I was convinced practitioners and patients would reap enormous benefits from computer assisted care.A major shortcoming I experienced...

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Cool Technology of the Week

Many Massachusetts homes have experienced flooding this month, so we're all a bit focused on plumbing.I've had two plumbing issues recently, both involving interesting technology fixes.I live in a 100 year old house with fragile plumbing and electrical infrastructure. Recently, the plumbing on two old pedestal bathroom sinks clogged to the point that no plunger or drain cleaner could clear them. In an old New England house, the bathroom sinks are often plumbed back to back together, making a plumbing snake impossible to use. The only option is to open the wall and replace the offending pipe�or so I thought until I discovered Kinetic...

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How Do Families Cope with Food Allergies?

National Jewish Health® has received a $450,000 grant from the National Institute of Health to study how families cope with food allergy.Available data suggest that half of parents with food-allergic children experience a pervasive fear for their child's safety, and a sizable subgroup restrict normal child and family activities because of food allergies. Others do not appreciate the potential severity of a food-allergy reaction and are casual about their precautions and preparations. Check out this information on the grant. Anyone interested in participating in this trial (open to families with children between ages 6-12) can call National Jewish Health® at 303-398-1006 for more informati...

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Now Private Equity Jumps into the Health Care Fray: Will Cerberus Do Better with Caritas Christi than It Did with Chrysler?

And now for an early report on what may be the latest fashion in the ongoing commercialization of US health care in the US.  In the last few weeks we spotted three stories that appear to be closely related.  (And thanks to one of our ever vigilant scouts for finding the first of these.)Psychiatric Solutions and Bain CapitalThe first story was in BusinessWeek in early March:Psychiatric Solutions Inc., the operator of psychiatric facilities in 32 states, said it has been approached by a potential buyer.A special board committee will consider possible responses and Goldman, Sachs & Co. has been hired as a financial adviser, the Franklin, Tennessee-based company said today in a statement.Earlier today, the Wall Street Journal reported the company was in buyout talks with Bain...

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The Girl with 2 Brains

Last Thursday I wrote about the Yin to my Yang exploring the synergy between my left brain and my wife's right brain.My daughter Lara turns 17 next week and she's definitely the girl with 2 brains (or a whole brain).I cannot draw a stick figure (my attempts at drawing a human look more like a dinner fork than the Venus de Milo).My daughter took a blank piece of paper and a pencil then drew the self portrait above. Her greatest academic strength is math. She can visualize problems involving vector forces, geometry, or trigonometric functions then break them into solvable component parts. To me, the hardest part of advanced math and engineering...

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Food Allergy Conference this Week-End in Baltimore

FAAN’s Annual Food Allergy Conference Comes to BaltimoreLearn How to “Respect Every Bite” at this Daylong Educational ConferenceFAIRFAX, Va. (March 17, 2010) – The Food Allergy & Anaphylaxis Network (FAAN) is bringing together parents, physicians, dietitians, caregivers, and others for its 17th Annual Food Allergy Conferences, the first of which will be held in Baltimore and promises to give attendees new insights and strategies about food allergies and anaphylaxis.The daylong conference on March 27 will urge everyone to “Respect Every Bite” and feature topics such as the psychosocial impact of living with food allergies, safety at school, food allergy basics, and a research update from one of the nation’s top allergists. It is the first of FAAN’s four spring conferences, which have long...

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The March HIT Standards Committee Meeting

Today's HIT Standards Committee included important discussions about NHIN Direct and a new Interoperability Framework supported by several ONC RFPs.We began the meeting with a summary of the work in progress.The Clinical Operations Workgroup is focused on vocabulary starter sets and ensuring implementation guidance is available.The Clinical Quality Workgroup is focused on quality measure retooling to ensure meaningful use measures are EHR friendly. The Privacy and Security Workgroup is focused on understanding all the consent standards currently available from different Standards Development Organizations and implementation guide writers.The Implementation Workgroup is focused on creating a starter kit to accelerate EHR adoption and interoperability. Yesterday, I summarized the Implementation...

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The Health Care Reform Bill and Health Care Renewal

I have not written much about the seemingly endless health care reform debate in the US, because much of it has not been relevant to the issues we discuss on Health Care Renewal.  Now that the current phase of the debate is done, and legislation has been passed, let me offer my opinions on the few aspects that do seem relevant to this blog.The Sunshine ActFor Health Care Renewal readers, the most important part of the legislation is that containing the provisions of the Sunshine Act, championed by Senators Grassley and Kohl.  (See this summary on Postscript, the Prescription Project blog.)  The act requires that all drug, device, biologic, and medical supply manufacturers report essentially all payments to physicians or teaching hospitals to the goverment, and on the internet. ...

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