A Coming Storm: FDA Regulation of Mobile Medical Applications - from The Health Care Blog

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.

Please continue on:  http://thehealthcareblog.com/blog/2012/10/24/a-coming-storm-fda-regulation-of-mobile-medical-applications/

What HHS Might Look Like Under President Romney - The Health Care Blog

By Dan Diamond

The world may not be ready for a Romney presidency.
Or more specifically: world leaders may not have done enough homework.

An interesting Washington Post story this week suggested that because the foreign polls have been so bullish on President Obama — 82% of Germans in one survey expected Obama to be re-elected — lawmakers around the world may be scrambling to adjust to a new team of U.S. diplomats and set of policies.

Is the health sector better prepared?

Given the close race — as of press time on Wednesday, most polls had the presidential race neck and neck — there’s been growing scrutiny of Republican health proposals. For example, the Kaiser Family Foundation and the Urban Institute on Tuesday released another report on the GOP House Budget Committee’s Medicaid plan.

But there’s been much less examination of the people who would steer Romney’s Department of Health and Human Services and the policies they’d carry out.

for more: What HHS Might Look Like Under President Romney

The New Bio-terrorism? Medical Device Hacking

 

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.

see the complete article on The Health Care Blog
 

The Health of Nations, David Katz, MD

If all of us were simply to make better use of our feet, our forks, and our fingers — if we were to be physically active every day, eat a nearly optimal diet, and avoid tobacco — fully 80 percent of the chronic disease burden that plagues modern society could be eliminated. Really.

Better use of feet, forks, and fingers — and just that — could reduce our personal lifetime risk for heart disease, cancer, stroke, serious respiratory disease, or diabetes by roughly 80 percent. The same behaviors could slash both the human and financial costs of chronic disease, which are putting our children’s futures and the fate of our nation in jeopardy. Feet, forks, and fingers don’t just represent behaviors we have the means to control; they represent control we have the means to exert over the behavior of our genes themselves.

Feet, forks, and fingers could reshape our personal medical destinies, and modern public health, dramatically, for the better. We have known this for decades. So why doesn’t it happen?

Because a lot stands in the way. For starters, there’s 6 million years of evolutionary biology. Throughout all of human history and before, calories were relatively scarce and hard to get, and physical activity — in the form of survival — was unavoidable. Only in the modern era have we devised a world in which physical activity is scarce and hard to get and calories are unavoidable. We are adapted to the former, and have no native defenses against the latter.

http://thehealthcareblog.com/blog/2012/10/03/the-health-of-nations/

How the Rest of the World Does It: New Delhi’s Safdarjung Hospital, By ASHISH JHA, MD

I visited Safdarjung Hospital in New Delhi today – an institution with 1,531 beds and 145% occupancy rate. Yes, 145%. You do the math. A lot of bed sharing and asking families to bring in cots. It’s right across the street from the All India Institute of Medical Sciences (AIIMS), the premier public healthcare institution in India. While both AIIMS and Safdarjung are run by the federal government, only AIIMS is renowned for famous specialists, world class facilities, and an international reputation to boot. Safdarjung doesn’t suffer such burdens – its specialists are not well known, facilities are dilapidated, and you probably have never heard of it.

I spent several hours walking around, talking to lots of physicians, visiting ICUs and cath labs. I visited the outpatient department where 7,000 people show up every day, many lining up the night before, to get a ticket by 11 a.m., when registration closes and those who haven’t gotten a ticket are out of luck. In the ER, there was a line of between 50 and 100 people waiting to get rabies shots. This is the hospital where every poor person in Delhi unfortunate enough to get a dog bite is sent. They have the rabies serum. Most other public hospitals do not.

Please see the entire article: How the Rest of the World Does It: New Delhi’s Safdarjung Hospital

Should the States set up ObamaCare Exchanges? point-counter point by John Goodman & Linda Gorman

From The Health Care Blog

Under the Patient Protection and Affordable Care Act (PPACA), state governments are expected to set up health insurance exchanges through which individuals will buy their own health insurance, in many cases with substantial subsidies. Should the states comply?

In the following point-counterpoint discussion, Linda Gorman and I give opposing answers to this important question. Leave your thoughts in the comments.

John Goodman: Yes
If the states abdicate their responsibilities under PPACA, the federal government will step in and act in lieu of the state. Under this scenario, states will relinquish all power to make a bad law better. Letting the federal government implement reform almost guarantees bad outcomes.

Linda Gorman: No
Exchanges are required to perform a variety of duties beyond distributing ObamaCare subsidies, and these duties are likely to add significantly to estimated costs. Some of them will damage a state’s business climate by creating new opportunities for crony capitalism. Some require that currently fashionable, but poorly tested, models be forced on health care providers. Some require that state exchanges have expertise equal to private insurers. Others force states to increase the cost of health insurance for people who currently have coverage.

John Goodman continued:
The states should engage in preemptive reform over the next two years. This means enacting responsible, rational reforms — the kind of reforms that they should have enacted all along, in the absence of federal legislation. Where possible, states should try to make their reforms compatible with the new federal law — but only if compatibility does not sacrifice the major goals of the state’s reform.

There are four arguments in favor of preemptive action at the state level:

Save the Country with Preventive Care, by Joe Flower for The Health Care Blog

What are those costs and how do we cut them? Seventy percent to 75 percent arise from chronic conditions. The majority of those arise from behavior, and almost all of them could be better managed to make cases cheaper by making patients healthier.

Who is spending the money, using the health care resources? This follows a Pareto distribution: 20 percent of the people spend 80 percent of the money; 5 percent of the people spend half the money; 1 percent of the people spend 20 percent of the money.

Who are the 1 percent? Some just got prostate cancer or got hit by a bus. This is their year to be expensive. But a substantial portion of that 1 percent and that 5 percent stay in the same category year after year. So a small percentage of the people use a large percentage of the health care resources by crossing your threshold, showing up in the ED and the hospital over and over with the results of their untreated, unmanaged, untracked chronic disease, addictions and mental problems. And recent studies show that people who have health care coverage (and therefore a regular relationship with a primary care doctor and a health care system) cost the overall system half as much as people without coverage.

Bingo! There’s the treasure, because experience shows that getting aggressive with untreated chronic disease can substantially lower costs. Trying to ignore them is costing us dearly. It’s time to change course.

The Treasure Is There

...Health care’s treasure has been hidden not in some subterranean sealed vault but in plain sight: It is those thousands and millions of cases of poorly treated and untracked chronic disease that flood our EDs every day. We can mine those to reduce health care costs drastically, put our hospitals and health systems on a much more sound economic footing, make people much healthier and, by the way, save the country.

How?

***Six ways. (I really don't care to steal Joe's thunder here...Please visit The Health Care Blog for the whole article.)