December 7th, 2011 by admin in Health Policy, Opinion
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We’ve been considering FDA oversight of medical apps for a while, over at Medgadget.com. Now, the public comment period has concluded on the FDA’s draft of how this oversight might look. The story:
The FDA will scrutinize medical apps that act as an accessory to a medical device and those that transform the mobile device into a medical device. A draft guidance issued by the FDA includes an extensive list of applications that will have to undergo review. Examples of apps that fall under the regulatory oversight are:
* Applications that allow the user to view medical images, such as digital mammography or digital images of potentially cancerous lesions on a mobile platform, and those that perform a health analysis or provide a diagnosis by trained health care professionals.
* Applications that allow the user to view patient-specific lab results.
* Applications that connect to a home use diagnostic medical device to collect historical data, or to receive, transmit, store, analyze, and display measurements from connected devices.
Great, right? The apps that do heavy lifting of patient information and connect to real medical devices get regulated, but the fun and educational apps I am working on remain free and open. Still, Harvey Castro, my favorite EM-doc-and-app-developer, was worried:
“Overall, I believe safety is the most important item when it comes to providing patient care,” said Harvey Castro, MD, an app developer (www.deeppocketseries.com) and emergency physician. “Unfortunately, I believe this will hurt small businesses and entrepreneurs by making it cost-prohibitive to enter the market.”
“Applications will be dominated by a few companies capable of paying the high fees to get FDA approval. I will be saddened to see these changes in the future.”
For their part, the FDA said it’s nothing to worry about: Read more »
*This blog post was originally published at Blogborygmi*
October 25th, 2011 by Bryan Vartabedian, M.D. in Opinion
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While most of us fail to see it, doctors are changing. We’re changing as a result of the social and technological innovation. In 2050 what we do and how we do it will be very different from what we did at the turn of the century. We’re evolving from analog to digital. I think it’s important to consider the ‘digital physician’ as a concept worthy of attention. The training and support of this emerging prototype has to meet its different needs and workflows. Perhaps the criteria by which we choose medical students should take into consideration the anticipated skill sets and demands of this next generation. And we need hard information about the digital physician and her habits.
Here are some differences between the digital and analog physician:
The digital physician
- Information consumption is web-based
- Rarely uses a pen. Care and correspondence is conducted through an EMR.
- Socially connected. Comfortable with real time dialog at least on a peer-to-peer level. Recognizes Read more »
*This blog post was originally published at 33 Charts*
October 11th, 2011 by KennyLinMD in Health Policy
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The buzzwords of cutting-edge primary care reform – the medical home, coordination of care, electronic health records – have usually been associated with large integrated health systems such as Intermountain Healthcare, Group Health, and Kaiser Permanente. If you believe the arguments that economies of scale and financial resources give such organizations built-in advantages over the traditional small group practice, you may be inclined to believe that solo practice is going the way of the dodo. Indeed, immediate past AAFP President Roland Goertz, MD, MBA penned an editorial a few months ago, “Helping Small Practices Survive Health System Change,” that, while touting some services that the Academy offers family physicians in these practices, betrayed a decidedly pessimistic outlook on their long-term future.
Not everyone agrees, however. In the September issue of the Journal of Family Practice, Jeff Susman, MD cast solo practices as vital engines of primary care innovation: Read more »
*This blog post was originally published at Common Sense Family Doctor*
June 13th, 2011 by BobDoherty in Health Policy
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This question has to be asked, because health policy gurus are looking to the new Center for Medicare and Medicaid Innovation (“the Innovation Center”), created by the Affordable Care Act, as being the principal driver of innovative delivery system reforms to “bend the cost curve”— but skeptics wonder if it can live up to its billing.
The Innovation Center’s website says all of the right things:
“The Innovation Center has the resources and flexibility to rapidly test innovative care and payment models and encourage widespread adoption of practices that deliver better health care at lower cost.
Our Mission: better care and better health at reduced costs through improvement. The Center will accomplish these goals by being a constructive and trustworthy partner in identifying, testing, and spreading new models of care and payment. We seek to provide: Read more »
*This blog post was originally published at The ACP Advocate Blog by Bob Doherty*
August 17th, 2009 by admin in Better Health Network, Health Policy, Opinion
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By George Lundberg, MD
Just as “all politics is local”, so is all medical care personal. One patient; one physician; one moment; one decision. And in this era of balanced physician and patient autonomy, that decision often is an informed joint decision. Many patients now make serious efforts to learn about their conditions both before and after visits to their physicians. Many physicians welcome such informed patients and willingly discuss comparative effectiveness of the available diagnostic and therapeutic options. However, a frank discussion about the comparative costs and charges for the options, whether they be to the insurance company, Medicare, Medicaid or out-of-pocket for the patient, is usually missing.
Many health economists insist that the medical marketplace does not behave like other markets and believe it is fruitless to expect market principles to usefully inform the medical arena. That bias is true in emergencies,
operating rooms or intensive care units, and with patients who are mentally disabled.
Such behavior does not have to persist in an outpatient setting. In my book Severed Trust: Why American Medicine Hasn’t Been Fixed (Basic Books, 2000, paperback 2002), I presented the concept of “the economic informed consent.”
I believe that every patient who is mentally competent and in a non-emergency situation should be informed of the cost of a proposed diagnostic or therapeutic procedure or product, before it is “ordered.” This includes referral to another (often more specialized and costly) physician, no matter who pays the bill. The costs should all be discussed IN ADVANCE decision. This discussion should include whether it is worth it and
whether there a less expensive good alternative.
A recent NPR/KFF/HSPH survey reported that 55% of Americans believe that their insurance company should have to pay for an expensive treatment, even if has not been proven to be more effective than a less expensive
treatment. This attitude underlies the ruling convention, “if insurance will cover it, do it,” that lies at the root of our problem of health care cost inflation. No one is held accountable.
If we as a country could widely apply the “economic informed consent,” physicians and patients would become educated together. They could both become wiser shoppers for the most cost-effective diagnostic tests,
prescribed drugs, and specialists.
With an “economic informed consent,” physicians and patients can reset attitudes toward a healthy concern for the total costs or charges, stifling the usual knee-jerk response, “if the insurance covers it, do it.” No one
knows whether this approach, diligently applied, would actually cut down on wasteful spending, such as choices that drive huge geographic variations, but we do know that pricing an automobile, an airplane ticket, a dinner or a bottle of wine does affect consumer decisions. Why not try it for medical charges as well? Current sweeping proposals for health system reform all state that there must be “cost control” but offer little likelihood of delivering real cost savings.
Now is the time for the US Health Information Technology Initiative to create inter-operative systems that would provide the data to support widespread use of the “economic informed consent” in a timely fashion and
let the medical marketplace speak. Knowing the cost of a medical decision in advance should become a part of a new “Patient’s Bill of Rights”. In a medical care decision, it is the right of a patient to know “who pays whom
how much for what.” All of us in health care laud “transparency”–let that include economic transparency.
George D. Lundberg MD
President and Board Chair, www.lundberginstitute.org
