September 20th, 2011 by Medgadget in News
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One of the major areas of research in the medical device industry is how to effectively deliver drugs to their target sites. The gold standard for systemic delivery of drugs is an intravenous (IV) injection, though it is not a great way to deliver meds that address chronic needs because of the pain and inconvenience. There have been exciting developments in transdermal delivery, such as the nicotine and birth control patches, though certain molecules and drugs do not easily diffuse through the epidermal layer to reach the more vascularized layers below.
One potential solution is to Read more »
*This blog post was originally published at Medgadget*
September 20th, 2011 by Felasfa Wodajo, M.D. in News
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The publication in July of the FDA Draft Guidance on mobile medical apps was a major milestone in the evolution of mobile medicine. The blazingly rapid growth in interest among physicians, medical software publishers and device manufacturers has made it clear that the mHealth revolution will be a major turning point, not just in health information technology, but likely in many aspects of physician-patient interactions.
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Last week (Sep 12-13), the FDA is held an important public workshop near its Washington DC headquarters to help it answer some key questions raised within the Draft Guidance and gather feedback from important stakeholders in mobile health. We are proud that iMedicalApps was invited to participate as one of the panelists.
We want to hear from you iMedicalApps readers – what do you want the FDA to consider in regulating mobile medical apps ?
Please add your voice in the comment section below and we will assemble them for submission to the official FDA docket on the Draft Guidance. Hurry because the deadline is just a few weeks away.
The FDA needs input from clinicians and others interested in mobile medicine and has identified two topics in particular as needing further specification:
- How to assess the risks inherent to clinical decision support software and
- How to classify mobile software that works in concert with a medical device.
*This blog post was originally published at iMedicalApps*
September 19th, 2011 by Stanley Feld, M.D. in Health Policy, Opinion
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As we get closer to January 2012, the originally scheduled implementation date for Accountable Care Organizations (ACOs), the time has come to reexamine the showpiece of President Obama’s Patient Protection and Affordable Care Act (PPACA) of 2010.
The final rules for ACO’s are now scheduled for release on January 2012. The implementation was originally scheduled for January 2012. As the original rules are being studied and interpreted the program for ACOs implementation became more confusing. Dr. Don Berwick (CMS Director) has refused to discuss the final rules until they have been published in the Federal Register.
“The ACO program is based on the hubristic assumption that the federal government can design the best organizational structure for the delivery of care, foster its development, and control its operation for the entire country.
The federal government has big-footed health system reform. Although there is no one right way to organize care, the federal government (Dr. Don Berwick and President Obama) thinks it has found one—and exerts top-down, bureaucratic control through PPACA to implement it.”
ACOs are supposed to be organizations that improve coordinated care. If an ACO decreases the cost of care Read more »
*This blog post was originally published at Repairing the Healthcare System*
September 19th, 2011 by KennyLinMD in Health Policy, True Stories
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Flashback to summer of 2008. I’m looking forward to August 5–the day that I’ll no longer be a faceless bureaucrat. The day that the US Preventive Services Task Force (USPSTF) will issue its new recommendations on screening for prostate cancer–recommendations I’ve labored on as a federal employee for the past year and a half.
For much of 2007 I combed the medical literature for every study I could find on the benefits and harms of prostate cancer screening. In November of that year I presented my findings to the USPSTF, a widely respected, independent panel of primary care experts. They discussed and debated what the evidence showed and then voted unanimously to draft new recommendations. I didn’t get to vote, but it has been my job in 2008 to shepherd the draft statement and literature review through an intensive vetting process and to finalize both.
As August 5 approaches, my colleagues in public relations warn me that the last time the USPSTF said anything about prostate cancer screening, the phones started ringing off the hook. I’m not so secretly hoping that the same will happen this time.
And I’m not disappointed! After we release the statement, Read more »
*This blog post was originally published at Common Sense Family Doctor*
September 19th, 2011 by Harriet Hall, M.D. in Health Tips, Opinion
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Here on SBM we have frequently had cause to criticize the media for poor science reporting and for spreading misinformation. Among many other individual offenders, we have criticized Dr. Oz for promoting alternative medicine on his TV show and gullibly promoting guests who pretend to talk to the dead and pretend to heal people with carnival sideshow tricks. We tend to be negative and critical because somebody has to do it, but it’s not pleasant. For once, I have some good things to say.
The September 12 issue of TIME magazine was a Special Nutrition Issue. The cover featured pictures of food and the title “What to Eat Now: Uncovering the Myths about Food by Dr. Oz.” It devotes 7 pages to an article by him entitled “The Oz Diet: No more myths. No more fads. What you should eat — and why.” This is followed by a 5 page article by John Cloud “Nutrition in a Pill? I took 3000 supplements over five months. Here’s what happened.” Both articles have a rational, science-based perspective without any intrusions of woo-woo.
Oz on What to Eat
Oz acknowledges that the science of nutrition is not simple and that much of what we once believed has been discarded in the face of new knowledge. He debunks a number of popular misconceptions about diet. Most of what he says is consistent with scientific evidence and with mainstream diet advice. Read more »
*This blog post was originally published at Science-Based Medicine*
