Is That An App Or A Medical Device In Your Pocket?

August 23, 2011

At a recent Twitter chat of the Health Care Communications & Social Media group ( see the August 21, 2011 chat ) , one of the questions considered by the group prompted a heated discussion over the province of  the U.S. Food and Drug Administration (“FDA”) to regulate phone/iPad applications. For the uninitiated, there have been a slew of new apps that have entered the market, some of them approximating medical devices, while others have merely added to the wellness and personal diary category.  The growing sophistication of the apps into the medical device arena has prompted the FDA to develop a draft guidance to provide oversight and regulatory clarity.

During the Twitter chat mentioned above, some individuals thought the FDA’s action was intrusive and would stifle innovation. Given the potential for economic benefit in the growing health care field, I doubt this concern holds too much water. The fundamental issue at play here is if the app itself is a medical device. In section IV of the draft guidance concerning the rule’s scope, the FDA states that this concerns mobile medical devices defined as those app which:

  • are used as an accessory to a regulated medical device; or
  • transform a mobile platform into a regulated medical device

This was also affirmed by the FDA during its July 19, 2011 Twitter chat on its new draft guidance:FDA mobile device definition

The FDA goes on to say what its rule does NOT cover. I am paraphrasing below, but if you read the scope itself , it provides good examples in defining these exclusions: 

  1. apps that are copies of medical books, texts, or teaching aids (e.g. Physician’s Desk Reference or flash cards)
  2. apps that only log, record, offer evaluations or suggestions on “maintaining general health or wellness”
  3. apps that automate general office operations (billing, inventory, appoitments, insurance transactions, etc.)
  4. apps that are general tools and NOT marketed for a particular medical condition (e.g. an audio recording or note taking pad)
  5. apps that serve as electronic health records or a personal health record system

 A lot of the hubbub during the Twitter chat concerned stifling innovation in this burgeoning space. However, what many in the group did not recognize is that we already rely on the FDA to regulate medical devices, so as technology changes and encompasses apps, so too must the FDA’s purview of these tools.  A cursory look at some apps makes the FDA’s interest valid:

Smartheart: This is being represented by the manufacturer (SHL Telemedicine) as a self-service heart monitor, and as the smallest ECG. It operates by performing an electrocardiogram and allows the user to send the reading to his doctor.

IBG Star Monitor App: This involves an iPhone, an attachable iBGStar device, and the iBGSTar Monitor App. When used in concert together, the system allows patients to test their blood sugar wherever they are, record notes and send the data to their doctors.

diabetes-meter-iphone-app

Fujifilm Synpase Mobility: This app allows doctors to view radiology films in 2D, 3D and to use MIP/MPR as in a clinical setting from Androids, iPhones, and iPads.

Reliance on any of these tools to diagnose or treat patients makes them clearly medical devices, and well within FDA’s control.  What is still up in the air are those “wellness” apps that happen to encroach into the clinical space and are used to diagnose and treat patients. I posed that question during the FDA’s July 19th chat on Twitter concerning their new draft guidance:

Question to FDA regarding pedometer as a clinical device

FDA says: We'll get back to you on the pdeomter question

I’m still waiting. And therein lies the ambiguity that will beset developers as they race to market. Will they have to submit their apps for approval as a medical device? For the wellness apps that could be used as clinical instruments, the guidelines might not be precise enough. In the example I was thinking of I imagined a pedometer as part of an obesity treatment (exercise aid) or as part of an obesity clinical study where exercise logging was a requirement or an outcome. Plus there’s the issue of the long slogging process of device approval, involving clinical trials. Granted the process is important to ensure safety, but I openly wondered if a shorter path is possible.

Question to FDA on shortening the clinical trial process for apps

I am still waiting on that too. While the FDA sorts all this out, you are invited to offer your remarks at the FDA’s website where it is gathering public comments. Join in to get the last word. By the way, the docket number for this is FDA-2011-D-0530-0002 and at Regulations.gov you can enter your comments electronically.

FDA invitation to 1.usa.gov/MobMed


Further thoughts on HCSM

August 23, 2011

This year I’ve been invited to give a few different presentations on healthcare communications and social media (HCSM).  A co-presenter at two of these talks, Dr. Felasfa Wodajo (one of the creators and editors of iMedicalApps.com), kindly offered me the opportunity to further develop some of these ideas and post them on his site.

The post will be going up in two parts.  The first post can be found here, and the second part can be read here.


More Thoughts on Physician Professionalism in Social Media

August 1, 2011

This morning, the Mayo Clinic Center for Social Media published a new blog post of mine.  This post is long, but attempts to wrestle in greater depth with the issues surrounding physician professionalism online.

I hope you will take the time to read it, and comment here (or there).


Taking a Shot at Immunizations Online, Part 4

August 1, 2011

We have arrived at National Immunization Month and many of us health-focused Twitter colleagues have committed ourselves to support this campaign by tapping the promise of social media. We have entitled it the #HCSMVAC Project, which loosely translates into Health Care Social Media Vaccine Project. Our group decided to focus on Kansas City, MO given its historically low vaccine rates and to make the project more manageable. On the whole, the diversity of activities set for August will allow us to shine a brighter light on the need for vaccinations. Below is a summary of the tasks we are pursuing and we hope they serve as inspiration for others to adopt and in generating new ideas. Included in this list are suggestions to avoid the hurdles we encountered.

Chatting
We began by launching a weekly chat on Saturdays at 8am PT on Twitter, entitled #HCSMVAC as our hashtag. People across the country and all over the world began participating, contributing ideas, contacts, and asking all he right questions. These contributions have been enormously helpful in shaping this project. Taking up most of he heavy lifting have been Erica Olenski and Nate Osit, serving as moderators and encouragers.

Web Presence
Nate Osit put us on the map with a web site, where our links to resources are posted to the public. These initiatives include posters that can be circulated in Kansas City, featuring our website link to a Google Map of local immunization clinics. The site will soon feature our FAQs, tackling some of the more salient issues raised in the immunization conversation (e.g. no association between autism and vaccines, etc.) and our videos.

Videos
In preparing three videos for this project, I drew from Dr. April Foreman’s inspiring question: “Imagine a World Without Vaccines.” The videos will be featured on YouTube and on my Twitpic page here:

A World Without Vaccines

Consequences

Supermovie

Links to these videos will appear on our Facebook page too. Everyone is encouraged to tweet and blog referencing the videos. In addition, there are several noteworthy and humorous approaches to immunization awareness that we applaud and will re-link to as well (e.g. Immunize Yo!).

Blogging
Many group members have their own perspective and stories to tell regarding the importance of immunization and they are sharing their accounts. Mike Biovin, pharmacist, medical writer and parent, spoke from the heart regarding his daughter’s autism and why vaccinating her is important. Given the fear that some parents have regarding vaccines and their lack of knowledge about there being no connection to immunizations, Mike’s story is all the more powerful. Likewise, related health care stakeholders, such as Dr. April Foreman are using their sites to blog about vaccine awareness, raising their community’s consciousness.

Tweeting
In preparation for this month’s activities, we developed an FAQ sheet and a tweet sheet from which our members could harvest tweetable messages. We created a Dropbox folder to allow our group to download the resources to their computer and pull tweets for their own use. These messages vary from citing statistics to promoting specific locations where vaccines may be obtained.

Tweet samples
Want to protect your kids from infectious disease? Next stop: the nearest clinic. Find yours in Kansas City http://bit.ly/iNnLJU

Which Missouri city will be the most protected by immunizations? It’s
up to you. Vaccine locations http://bit.ly/iO4v8F #hcsmvac

Diptheria, Tetanus & Pertussis: What You Need To Know http://1.usa.gov/lnZdMX National Immunization Awareness Month #hcsmvac

Posters, Temporary Tattoos and Stickers
As mentioned above, our web site features posters that bear a link to the Google map of vaccine locations in Kansas City. In addition, they bear QR codes that can be read with smartphones that also link to the Google map. We started getting creative and decided to try to adapt the QR codes for temporary tattoos, as Mike Smith showcases here. That is when when we had bitten off more than we could chew. There were several glitches: they printed out too small and weren’t easily read. Accordingly, given how expensive and sensitive the medium is (working with temporary tattoo paper is not fun), we advise opting for a different route: print up the QR codes large enough to be readable stickers. It is easier to find a sticker vendor, cheaper to produce, and to generate a size that can be read, which is about 1.5 inches x 1.5 inches. The graphic below should give you a sense of what works.

Non-Traditional Tactics
While not as successful as the ideas above, Lisa Fields and myself have been testing the waters in trying to prod corporations to jump in with us. My hopes for a “Scoops for Shots” campaign have not convinced Baskin & Robbins to assist, though Lisa may have obtained a Chik-Fil-A contact in Kansas City to do a meal discount promotion for vaccinations. Likewise, our appeals to Pampers fell on deaf ears notwithstanding its “1 Pack, 1 Vaccine” program for UNICEF.

We encourage other creative and fun ideas, such as creating haikus and poems about immunizing, creating personal art that articulates your reasons for getting vaccinated, sharing videos of real stories, like Shea O’Machel’s story.

Community Outreach and Traditional Media
Coincidentally, the Association of American Family Physicians held its conference in Kansas City, MO last week, so we were hoping to spread the temporary tattoos among some of our contacts for wider circulation. The technical debacle in reading the tattoos prevented this from going forward, but we hope to pass along our pdf file of the codes so that stickers can be printed by local doctors, nurses, and other providers. Meanwhile, our team has been reaching out to groups and doctors in the KC area, offering our posters, QR code, videos, etc. in the hope of expanding our network reach. While letters have also been written to local KC newspapers, we have not received any receptivity. We continue to explore other contacts, as Dr. Foreman is pursuing circles within church ministries.

That’s a lot of activity from a purely volunteer group that sprang from Twitter. I can only imagine what formalized institutions with grander resources at its disposal can do. My suspicion is if we ever teamed up, our campaign would really go viral.


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