Category: Uncategorized

A Coming Storm: FDA Regulation of Mobile Medical Applications

Oct 24, 2012• 14

By Ryan Minarovich

I recently had the great fortune of attending Health 2.0 in San Francisco. The conference was abuzz with new medical technologies that are harnessing the power of innovation to solve healthcare problems including many new mobile medical application companies showcasing their potential. As I walked and talked around the exhibit floor, one thing caught my ear, or I should say one thing didn’t catch my ear. Among the chatter about these products, the concern about FDA regulation of this product segment, or even FDA regulation in general was noticeably absent. While many of the application developers are well aware of potential FDA involvement, most would be hard-pressed to outline the impact this would have on their companies and products.

Being labeled a medical device, which is the direction the FDA is leaning, could have a significant impact on business model organization, top-line revenue, and product deployment. For unprepared start-ups, FDA regulation could signal an end for their company. This is in stark contrast to well informed developers who are preparing themselves for the change and would most likely be able to leverage these regulations to their advantage.

Training Future Physicians in Safety and Quality

Oct 24, 2012• 1

By Peter Pronovost, MD

Nearly a year ago, one of my blog posts bemoaned a gap in our training of future physicians—a lack of training in the skills needed to lead projects in patient safety and quality improvement.

I wrote the post after speaking to a group of medical students who were energized about this area of work. Yet, as I reflected on the talk:

“I had to confront the sad reality that most of them will graduate ill-prepared to lead the improvements of quality and safety our health care system needs. They no doubt will know chemistry, biology and physiology, but they may not know about human factors, implementation science or performance measurement—the language of quality improvement. They will know orthopedics and genetics but they won’t know teamwork and systems engineering. They likely know about German scientist Rudolph Virchow, the father of cell theory, yet they do not know John Kotter, the father of change theory whose model for leading change is highly effective and widely used.”

So how can medical students, residents and fellows make quality improvement and patient safety a focus of their clinical careers? On Nov. 10, the Armstrong Institute and the American College of Medical Quality will be hosting the National Workshop on Quality for Medical Education—affordable and open to anyone—that focuses on how medical students, residents and fellows can integrate safety and quality into their clinical careers. What career paths exist? What tools and skills are needed to carry out this work, and where do you get them? What kinds of quality and safety projects are residents and students taking on?

The New Bioterrorism? The Hacked Medical Device

Oct 23, 2012• 1

By Jane Sarasohn-Kahn

A time-and-technology challenged FDA, proliferation of software-controlled medical devices in and outside of hospitals, and growth of hackers have resulted in medical technology that’s riddled with malware. Furthermore, lack of security built into the devices makes them ripe for hacking and malfeasance.

Scenario: a famous figure (say, a politician with an implantable defibrillator or young rock star with an insulin pump) becomes targeted by a hacker, who industriously virtually works his way into the ICD’s software and delivers the man a shock so strong it’s akin to electrocution.

Got the picture?

Welcome to the dark side of health IT and connected health. Without strong and consistently adopted security technology and policies, this scenario isn’t a wild card: it’s in the realm of possibility. This is not new-news: back in 2008, a research team figured out how to program a common pacemaker-defibrillator to transmit a “deadly 830-volt jolt,” according to Barnaby Jack, a security expert.

The Organic Medical Home

Oct 23, 2012• 20

By Rob Lamberts, MD

What comes to mind when you hear the term “medical home?” Perhaps you favor the definition put forth by our government (AHRQ):

The medical home model holds promise as a way to improve health care in America by transforming how primary care is organized and delivered. Building on the work of a large and growing community, the Agency for Healthcare Research and Quality (AHRQ) defines a medical home not simply as a place but as a model of the organization of primary care that delivers the core functions of primary health care.

1. Comprehensive care
2. Patient-centered
3. Coordinated care
4. Accessible services
5. Quality and Safety.

The presence of these five attributes to care should then constitute a medical home, right? It depends on who you get your definition from.

The Wages of Home Care

Oct 23, 2012• 7

By David Glenn

Nearly two million Americans work as home health aides and personal care aides — a number that is projected to climb above three million by 2020.

This is low-paid, low-status, exhausting work. A typical shift might include helping a client bathe, preparing her meals, changing her linens, helping her walk safely to the store, sweeping her floors, and helping administer medications (even though in many cases these aides aren’t licensed to do so). There is also a complex burden of emotional labor: comforting, cajoling, making small talk.

Most home aides are hired and paid by third-party agencies, which are often hugely profitable, in part because domestic workers have lacked minimum-wage and overtime protections under the so-called “companionship exemption” to the Fair Labor Standards Act.

After years of organizing by the National Domestic Workers Alliance, the Paraprofessional Healthcare Institute, and other groups, the Obama administration issued a preliminary regulation late last year that might finally bring an end to that exemption.

Stop Cancer Research?

Oct 22, 2012• 21

By James Salwitz, MD

Now here is a novel idea to save lives and stop the cancer plague; stop trying! Sounds as crazy to me, as it does to you, but this idea actually may have merit. Some smart people are saying that we have spent too much money for little gain, thus it is time to give up and by retreating win more battles in the war on cancer, than by charging ahead.

The Cancer Prevention and Research Institute of Texas (CPRIT) is the second largest cancer research agency in the United States, after the National Cancer Institute, controlling a pot of $3 billion dollars, most of which funds basic science and clinical research. At recent hearings, university scientists and leaders in biotech proposed that CPRIT cut back on the money it is pouring into laboratories. As Professor John Hagan of the University of Texas proclaimed, “If people didn’t get cancer in the first place, CPRIT would accomplish much of its mission.”

This radical idea was echoed in a scary article in the September issue of Lancet Oncology, entitled “First do no harm: counting the cost of chasing drug efficacy.” This editorial reviewed data, which shows that between 2000 and 2010 many new cancer drugs produced marginal extensions in survival and simultaneously increased risk of treatment associated death and side effects. The Lancet authors emphasized the vital need as we develop new therapies to carefully measure both benefit and harm before FDA approval and for careful post-marketing follow up after drugs are released to the general population.

Now in reality no one is saying that we should shut down cancer research labs and simply hope for the best. Eventually we will completely cure this disease and basic science, as well as the development of new therapies, is key to that future. Perhaps what we should hear from these words is an idea about a different balance in health and healthcare.

Dr. Yes

Oct 19, 2012• 10

By David Dranove

Last week I attended a conference on health policy at the University of Chicago, where I moderated a panel that examined implementation of the Affordable Care Act. For much of our time, the panel focused on Accountable Care Organizations. Panelists and attendees wondered whether ACOs would meet the same fate as Integrated Delivery Systems of the 1990s. Some in the audience mentioned that when it comes to integration, electronic medical records could be a game changer. EMRs could be used to monitor and reward cost saving decision making, for example. But most ACOs are still figuring out how to use EMRs for clinical decision making; their use in helping managerial decision making remains far off.

As more and more speakers expressed skepticism about the future of ACOs, a physician in the audience offered a truly fresh perspective, one that makes me feel much more optimistic. I never learned this physician’s name, so I will call him Dr. Yes. Before I summarize Dr. Yes’ argument, it is helpful to turn back the clock to the late 1990s, when IDSs were taking the health industry by storm. Perhaps the defining feature of IDSs in the 1990s was the integration of hospitals and primary care physician practices. This strategy failed in large part due to classic agency problems. In a nutshell, an agency relationship can fail because of incentive problems (the principal is unable to effectively motivate the agent) or selection problems (the principal employs the wrong type of agent.) IDSs suffered both. When hospitals acquired physician practices, they converted entrepreneurs into employees who resisted any kind of incentive payments. As employees, primary care physicians did not work as hard or show as much commitment to their practices. Moreover, those physicians most eager to give up their autonomy were those looking to dial down their practices and lead the “quiet life.” In these ways, IDSs experienced both incentive and selection problems, with devastating results.

The Day After

Oct 18, 2012• 6

By Rob Lamberts, MD

There is nothing exciting or glamorous about doing what I am doing: building a new practice from scratch. It’s a slow and often mundane process that takes far longer than it looks like it should. There are a thousand questions I need to answer: Where will my office be? What will my logo look like? Does it matter what my logo looks like? Can I get the video of my presentation done? Why is it taking so long? Which EMR system will I use? Will I use and EMR at all, or will a PHR product suffice? Who will I hire? What will I pay them? When will I start? How many patients will I accept at the start? What will I do about my website? Who should design it? Can I do that myself? Who should run it? What about a phone system? Each day uncovers a new set of questions that need answering, and each day passes with most of them left unanswered.

There are two things I’ve been doing which have kept me from becoming discouraged or overwhelmed by this process. The first thing is something called Centering Prayer, which is well-described in the book Into the Silent Land by Martin Laird. Whether from the tradition of the middle ages or from eastern religious practice, meditation is upheld by many in science as a sound life-practice. What makes centering prayer, a form of meditation out of the Christian Tradition, different from other forms is the way one deals with distractions or worries. I’m not an expert on eastern meditation, but my understanding is that the goal is to clear the mind from any thoughts and worries, coming to a place of peace and rest in the mind. Centering prayer, however, does not push away worries or distraction, it changes the perspective on it.

Walmart Moves Health Care Forward Again

Oct 18, 2012• 64

By Brian Klepper

Walmart’s sheer size makes almost any of their initiatives newsworthy. That said, despite being a lightning rod for criticism on employee benefits and health care, they have introduced initiatives with far-reaching impacts. Their generic drug program began in September 2006 – more than 300 prescription drugs for $4/month or $10 for a 90-day supply – and was widely emulated, disrupting retail drug markets and generating immense social benefit. Imagine the difference it made to a lower middle class diabetic who had been paying more than $120 per month for medications, and suddenly could get them for about $24.

Yesterday Walmart announced that “enrolled associates” – covered workers and their family members – needing heart, spine or transplant surgeries could receive care with no out-of-pocket cost at 6 prominent health systems around the country: Mayo Clinics (Rochester, MN and Jacksonville, FL); Cleveland Clinic (Cleveland, OH); Geisinger Clinic (Danville, PA); Mercy Hospital Springfield (Springfield, MO); Scott & White Memorial Hospital (Temple, TX); and Virginia Mason Medical Center (Seattle, WA).

Walmart’s Center of Excellence (COE) program builds on its own and other organizations’ pioneering efforts with similar programs. Walmart developed a relationship with Mayo Clinics in 2007 for transplant and lung volume reduction surgeries. In March 2010, Lowes reached a similar arrangement with Cleveland Clinic for heart surgeries and, last December, Pepsico announced a global pricing deal with Johns Hopkins for cardiac and joint replacement surgeries.