With FDA Guidance in Place, Enforcement is in the Hands of the Providers and Patients

ImageFor months now, I’ve called for the FDA guidance to clarify medical device regulations as they apply to mHealth. While most vendors would shy away from stricter regulations and standards, I believe that FDA regulations are necessary for mobile applications and websites to ensure patient safety and privacy in this emerging space.  This week my calls were answered, with the release of the FDA final guidance for mobile medical applications.

The long-awaited final guidance is a critical milestone for mHealth, and is largely aligned with what was anticipated based on earlier released drafts. But it’s what happens now that guidance is in place that will truly shape the industry. It’s critical for payers, providers and, ultimately, consumers to ensure that they are being broadly implemented.

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Believe It or Not, FDA Regulation IS mHealth’s Friend

Capitol_Building_Full_ViewThe Food and Drug Administration should take action and immediately release the final Mobile Medical Applications guidance document.

As you may have guessed from the title of this post, my opinion is not widely held among my fellow mHealth business leaders. Most think it is counter-intuitive to argue that the FDA must be a key player in the development – and regulation – of the mHealth ecosystem. We all know the real reasons.

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Bringing Mobile Capabilities to the…Desktop?

ImageThe demand for patient-centric tools to mobilize EMR and medical device data in a single viewer is obvious. All the major providers I talk to, including Dignity Health and Ardent Health, already have a plan to go mobile. But now it’s time to put practical plans in place to implement the strategy.

The best way to go mobile is to support all form factors. In parallel with mHealth implementation, providers should bring the look and feel (i.e. touchscreens) of mobile technologies to physicians’ desktops and laptops. After all, that’s what they are still primarily using when they are not on the go.

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CommonWell Health Alliance – Big Stride or Baby Steps?

baby-steps1You’ve all heard my thoughts on mobility as the critical lynchpin for healthcare to achieve true clinical transformation. And, that one of the longest standing and most stubborn barriers to mobility is the lack of true interoperability across systems and devices from multiple vendors in any health system.

So during HIMSS13 back in March, I was interested to hear that some EMR vendors were joining together in the CommonWell Health Alliance to integrate their systems. It was encouraging to see these EMR vendors talk about opening up and becoming more compatible with each other – something that health systems have demanded, but that vendors’ proprietary attitudes and competition for market share have prevented. Like most of the industry, I’ve been curious to see how the Alliance would unfold and if the outcome could be experienced immediately since healthcare organizations cannot afford to wait. The need for action is NOW. Continue reading

Getting at the Heart of Readmissions

heartbeat-thumb-550xauto-83375I will always stay true to my belief that health systems need to take an enterprise-wide approach to mobility. But at the same time, I’m often asked by hospitals CEOs and CIOs how they should prioritize mobility when it comes to different care areas. My first answer is to look at your current challenges and strategic initiatives, and then ask how mobility can help you to get there.  While I always emphasize the benefit of mobility across all departments, cardiology is where I see the potential for mobility to make the most immediate impact – especially when it comes to improving outcomes and reducing readmissions. Continue reading

My Wish List: FDA Mobile Medical App Regulation

iPhone_FDAThe House Energy and Commerce Committee’s recent questions to FDA are seeking much-needed clarification of the agency’s policy of regulating certain mobile medical apps as medical devices. I’m very pleased to see the FDA responding to attempts to clarify the “gray area” of the guidance it issued in July 2011. Following three days of hearings last week on rules for these products – including the impact of FDA oversight and the potential for new taxes – I hope the FDA will take the following patient safety issues into consideration: Continue reading

Are We There Yet?…Almost

Road_14The interoperability challenge has plagued hospitals and health systems for longer than any of us care to admit. The topic still elicits eye-rolls and cringes from everyone from health care reporters to CIOs – and who can blame them? The industry has largely over-promised and under-delivered when it comes to vendors “playing nice in the sandbox,” integrating systems and making data across the continuum available in a simple and cost-effective way. Continue reading

2013 Predictions: Healthcare’s Five Biggest Moves in the Year Ahead

Crystal ballHealthcare may have had an impressive 2012, but the year ahead is going to be an even wilder ride. Obamacare will start ushering 38 million newly insured patients into the system, while we face a shortage of caregivers and primary care physicians. Health systems will continue to buy physicians groups, test out new accountable care and pay for performance models, and try to avoid getting their hands slapped on readmissions and other quality measures. Healthcare IT will continue to both empower and stifle clinicians. It all sounds like a tall order, but from where I sit, we’re also going to see some really positive and exciting moves in 2013:

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