Saturday, March 23, 2013

FDA and Mobile Health Apps

 

The Sprawling leviathon Food and Drug Administration Complex is struggling to keep up with drug review, and is now facing additional challenge of mobile health regulations in the face of  [Governmental Sequestration.]    [Washington Post Opinions]

Sprawling leviathon Food and Drug Administration Complex struggling to keep up with drug review, now facing additional challenge of mobile health regulations in the face of Governmental Sequestration.

Three days of congressional hearing with the FDA concluded with discussions about the FDA’s role in monitoring and producing guidelines for mhealtlh applications. There were no specific guidelines, nor binding regulations forthcoming at this time.

 

iHealthbeat reported this yesterday, along with other topics.

Telehealth

Flawed HER Designs

Lag of Long Term Facilities in HER adoption

 

HIMSS Hot Topics:

 

 

HIMSS13: Mostashari Says Data & Incentives Matter

HIMSS13: Federal Officials Stress Commitment to Health IT

HIMSS13: Sequester Will Affect Medicare EHR Pay, ONC Budget

11 Experts on Health IT Progress, Frustrations and Hopes for 2013

With 2012 now behind us, we asked 11 leaders in the health IT field to reflect on the progress and missed opportunities of the past year, as well as their hopes for health IT in 2013.

The meeting at HIMSS 2013 produced an intense focused forum for discussions about the progress of digitizing health information.  Most leaders in HIT were present, and many vendors were present on the meeting floor.

Unable to attend in person Digital Health Space monitored several live twitter streams, and also video live streams.  Microsoft’s health division and Dell Systems sponsored an evening meeting for a roundtable discussion of some high points of the meeting.

Hashtags from Dell's HIMSS Meeting:

You can  follow the tweets via the hashtag #DoMoreHIT or the participating tweeps in the conversation: @drandylitt, @ahier, @egpierro, @techguy, @lsaldanamd, @cthielst,@2healthguru, @jloveloc, @norabelcher, @boltyboy, @shahidnshah and @healthcarewen.

Implementation of HIT is turning out to be a “Big Bang”, an issue which challenges our ability to get our hands around it.

Presenters indicated how costly the effort has become, estimating that about $ 25 billion USD is the annual HIT budget at present, just to maintain current systems. At the same time most indicated that this offered employment security for many people at that meeting.  In the midst of the economic crisis it is not yet apparent what or if any of the HIT federal incentives will suffer.  Health now provides employment for a large segment of the U.S. Economy and reductions in health expenditures may be felt in the unemployment rates.

The topic of ‘BIG DATA” emerged as to how it would enter into the equation. Attendees at the Dell sponsored forum were sure Big Data would play a major role. The theory is that analysis of this forthcoming tool will improve outcomes and reduce costs.  The Kaiser model seems to bear that out, but it will take immense effort to convert the rest of American Health Care.  Other countries in Asia, and Europe are significantly ahead of the United States.

Big Data was vaguely defined. It was unclear if analytic systems were really in place to understand it, although it was mentioned that some large integrated systems such as Kaiser were already utilizing “Big Data”.  Most participants agreed that most hospitals and providers were not at all prepared for “Big Data”, that a large challenge is to educate 800.000 providers, and several thousand hospitals.

What organizations can encompass this ? State, county, Public Health, Health Information Exchanges.  The ‘baby” is still in the womb….what will emerge is still unknown.

Finally the topic of personalized medicine was discussed, in connection with advances in genomics. Exponential decreases in the cost of analyzing one genome have occurred due to immense increases in computer power.   We will be discussing personalized medicine and genomic in one of our next blog posts.

At times there are more questions than answers, a good sign of interest in solving our health challenges. 

The choices for organizational hierarchy changes, rapidly expand in number and perhaps we need an IBM Watson to analyze our organizational structures of health care to prepare a diagnosis and then a treatment plan  for our health system ills. How about several second opinions before the operation?

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