FDA Releases Final Guidance for Mobile Health Applications

 

 

Monday, September 23, 2013

TOPIC ALERT:

• Mobile Health

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On Monday, FDA issued final guidance for mobile health applications, Reuters reports (Clarke, Reuters, 9/23).

Background

In 2011, FDA requested public comment on how it should regulate smartphones, tablet computers and apps that collect health information or are used to monitor medical conditions (iHealthBeat, 6/26).

According to FDA, the agency has approved about 100 mobile medical apps over the last decade, about 40 of which have received clearance over the past two years (Dolan, MobiHealthNews, 9/23).

Details of Final Rule

According to the final rule, FDA will focus oversight on apps that:

• Were developed to be used as accessories to regulated medical devices, such as apps that allow health care providers to make diagnoses by viewing medical images on smartphones or tablets; or
• Can transform mobile devices into regulated medical devices, such as apps that allow a smartphone to be used as an electrocardiography machine.

Note:  Information is curated from iHealthBeat, a publication of the California Health  Care Foundation (CHCF

The Problem with Meaningful Use and the Affordable Care Act and What’s Pushing EMR Switching?

 

John Lynn (EMR and HIPAA

curated from EMR and HIPAA

Most of us in health care knew that the enactment of the affordable care act was not conceived with the correct goals in mind.

The concept and goal of universal care for all Americans was emphasized at the expense of usability, adoption and ‘buy in ‘ by the health industry.  The health industry was searching for a streamlining and more efficient manner of accessing health care as well as making it more affordable. and uniform.

It has become apparent and more publicly recognized as deadlines fast approach for mandates, insurance exchanges, and expansion to the uninsured.

Are the wheels coming off ? Yes !  Will the Affordable Care Act stand….maybe…but certainly not as it is written.  It has caused a congressional crisis as the Republicans stand fast against President Obama and the Democrats with their wishful thinking and ignoring our debt crisis.

HIT implementation has been accelerated, however at the expense of purchasing unusable and immature EMR programs.

John Lynn of EMR and HIPAA offers the analysis and possible outcomes.

EMR and HIPAA report on ‘switching’.

Hospital Acquisition

EMR User Dissatisfaction

Not Meaningful Use Ready  EMR Switching Encouraged by Meaningful Use

Of course, EMR switching can be a real challenge and every EMR switch is unique. You have to consider what you want to do with your old data. Do you have a way to transfer it to the new EMR? Can you get the EMR data out of the old system? Do you want to transfer all or part of the data? Do you not want to transfer the data to the new EMR, but you still want to keep the old EMR around to access the previous EMR data?

And as time continues the formula for incentives significantly reduces the amount you will receive.  Changing EMRs will again reduce efficiency and increase your costs.  IS IT WORTH IT ?  Doubtful !

Many of the answers to these questions are heavily influenced by your original EMR contract. Sadly, many organizations did a poor job evaluating their EMR contract before they signed it. This can often lead to the old EHR vendor holding the EHR data hostage. It’s not pretty, but there are sometimes workarounds. Just be sure that you don’t make the same mistake with your new EHR vendor.

The Biopsy

 

From  The Biopsy, a Video

The Iconic Health Company as envisioned by FLO, a mobile EMR developed by a first year medical student gives hope to we aged MDs Nothing like fresh blood....they are our hope for the future.

Roheet Kakaday is a shining beacon, as he leads the way to a new concept in EMR, medical record flow and real meaningful use, not the stale unimaginative creation of HHS and CMS.

Not much is right in HIT and EMR despite proclamations of success by HHS and CMS. Despite accolades by data collection agencies, HHS, CMS and government agencies EMR by and large has made the clinical practice of medicine a nightmare, significantly reducing efficiency and patient face-to-face interaction leaving most patients dumfounded when their MD only glances at them during and examination...Many comment about MDs ,now treating the medical record, coming up for air only occasionally.

Yes there is more legible medical record available to consultants and doctors who see the patient after a primary encounter. Eric Topol MD explains this vividly in The Creative Destruction of Medicine..

Read what Roheet has to say about FLO;

“During medical school, we’re supposed to train on how to use hospital’s Epic EMR system. 

I took the training module for it and the moment it loaded, I was bewildered. My monitor had turned into a wormhole and was suddenly displaying software built in the 1990s. I stared for 30 minutes at what was basically a wall of text, trying to find my way around small buttons and clogged sub-screens. I hadn’t even learned how to use Epic yet and I was already frustrated. Perhaps it’s because Epic was a platform built upon billing practices that made it so confusing. Either way, I was done before I had even begun.

I’ve always been a fan of intuitive minimalist design. Everything in its place and a place for everything. I used my experience with that training module to inspire a better design that I think would help make medical work flows a bit easier.

Thus, I rapid prototyped Flo - a gesture-based patient-centric mobile EMR (mEMR) - to satisfy my needs. Flo tries to use our mobile screen space in creative ways instead of sticking to grids, tables, and a plethora of buttons like we’re used to in medicine. Information is displayed on a patient-by-patient basis, thus placing importance on the patient at hand. Swipe, rotate, or tap to get to the information you need. Simple.

This isn’t a robust or complete EMR, as there are a lot of assumptions functioning underneath this model, but, if we could get something like this, I would be so happy.

Let me know what you think.”