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EHRs Must Find Zebras Among the Horses

October 10th, 2014
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This post is originally published on InformationWeek Healthcare, October 8, 2014

 

EHRs should be adaptive, so that when something like the Ebola outbreak occurs, the overworked ER doc has help catching the one critical piece of information that wasn’t as relevant a year ago.

In my last article for InformationWeekWill Electronic Health Records Ever Be Usable?, I introduced the American Medical Association’s EHR usability priorities, published last month. This time let’s dig a little more deeply into some of these priorities.

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Will Electronic Health Records Ever Be Usable?

October 2nd, 2014
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This post is originally published on InformationWeek Healthcare, September 26, 2014

 

AMA attempts to address the frustration EHRs create, especially for doctors and other healthcare workers.

 

“It’s easy to use, once you know where everything is,” the instructor said during an EHR training session I recently attended. Most EHR companies seem to believe this is an acceptable way to design software.

 

EHR usability has been greatly ignored by vendors, and last week the American Medical Association issued eight usability priorities in an attempt to address the issue. This directive comes as a result of a joint study by the RAND Corporation and the AMA highlighting EHRs as a significant detractor from physicians’ professional satisfaction.
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FDA Mobile Apps Loophole Hazardous For Healthcare

July 23rd, 2014
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This post is originally published on InformationWeek Healthcare, July 23, 2014
 
THE FDA’S RELUCTANCE TO OVER-REGULATE MEDICAL APPS OPENS A PITFALL FOR HEALTHCARE ORGANIZATIONS THAT INNOVATE TOO FAR AHEAD OF THE CURVE.

 

The FDA’s recent guidance on mobile medical apps creates a gray area in which the agency will not automatically require approval for all new mobile medical apps, but may exercise “enforcement discretion,” depending on how the app functions, the risks it introduces to patients/consumers, and its intended use.

 
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What Does the Future Hold for Medtech? (Physicians Will Be More Like Engineers)

July 14th, 2014
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This post is originally published on MD+DI “Medical Device Business,” July 10, 2014
 

When I was asked to think about how physicians will be affected by the changes in the medtech industry over the next 5–10 years, I initially thought “not much.”

 

The field of medicine is a slow-moving beast with substantial inertia. Physicians tend to be quite conservative when treating patients for a number of reasons. Many physicians practice the way they were trained, which may have been a number of years ago, despite the continuing medical education requirements to maintain state licenses. Moreover, physicians may be liable if a bad outcome results from treatment that deviates too far from the current standard of care, so they may be reluctant jump on the latest trends in treatment, no matter how promising they seem. And the very first oath a future physician takes when entering medical school is Hippocrates’s, promising to “do no harm,” which often means “watchful waiting.”

 
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It Takes More than Technology to Change Health Behaviors

April 9th, 2014
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There’s no question that medical apps and software aimed at improving healthcare outcomes are hot items. In a previous post for Popper and Company, I discussed the growth in popularity of medical apps and the FDA’s new approach toward them, showing how new technology can simultaneously empower the patient/consumer and make important health-related information easier to access.

 

But during one discussion at last month’s SXSW Interactive Conference in Austin, experts and innovators alike underscored a more important consideration: How well do any of these inventions interact with patients and consumers?

 

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Five Tips for Folding FDA’s New Medical App Oversight into Your Business Strategy

March 27th, 2014
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In my post for InformationWeek Healthcare (available here), I discussed the implications of the U.S. Food and Drug Administration’s (FDA) final guidance for medical apps. While the September 2013 guidance specified that it would require clearance of any app intended to diagnose, treat, mitigate or prevent a disease, it left an open door to exercise “enforcement discretion” if an app meets the technical definition of a medical device but poses a low risk to the patient.

 

In this post, I will discuss the practical challenges resulting from this guidance, and how the evolving environment of app regulations should be folded into your business strategy.

 

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FDA Creates Medical App Regulation Maze

March 3rd, 2014
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This post is published on InformationWeek Healthcare, March 3, 2014

 

When the US Food and Drug Administration (FDA) issued its final guidance for medical apps, inventors and investors alike pored through the document, seeking answers on what was to be regulated and what wasn’t. While they indeed found more specific information than has been available from the agency, the guidance also showed the agency’s uncertainty over how the world of medical apps is going to evolve.

 

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Robotic Surgery: da Vinci Versus The Ideal

November 25th, 2013
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This post is published on InformationWeek Healthcare, November 25, 2013
 
When the da Vinci Surgical System was introduced in 2000 by Intuitive Surgical, it was heralded for ushering in a new era of robotic surgeries. The robot promised to make operations easier for the surgeon, reducing complications and pain while shortening time under anesthesia and time to recovery for the patient.
 
Now, it appears that the robotic reality is introducing some cracks in these perspectives.
 

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Patient Satisfaction, Medical Outcomes Must Go Together

November 20th, 2013
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This post is published on InformationWeek Healthcare, November 20, 2013
 
Beyond keeping patients well, today’s healthcare providers must keep them happy.
 
Today’s healthcare providers and companies alike are facing a question they’ve never had to confront before: Are patients happy? Logically, practitioners have generally focused more on outcomes and quality of care, such as the rates of post-procedure complications, readmissions, and morbidity and mortality.
 
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Lawmakers Try To Sharpen FDA Focus On Healthcare Apps

October 29th, 2013
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This post is published on InformationWeek Healthcare, October 29, 2013
 
Congress attempts to clarify which health software should be regulated like a medical device with the Sensible Oversight for Technology which Advances Regulatory Efficiency Act.
 
The number of medical apps and software products is mushrooming.
 
Currently, nearly 100,000 mobile medical apps are available, which is double the number from last year. Moreover, those numbers don’t include other software products such as electronic health records (EHR) and clinical decision support (CDS) software.
 
Read full post on InformationWeek Healtchare. 

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