FDA: Food & Drug (& App?) Administration

We've been considering FDA oversight of medical apps for a while, over at Medgadget.com. Now, the public comment period has concluded on the FDA's draft of how this oversight might look. The story:

The FDA will scrutinize medical apps that act as an accessory to a medical device and those that transform the mobile device into a medical device. A draft guidance issued by the FDA includes an extensive list of applications that will have to undergo review. Examples of apps that fall under the regulatory oversight are:

* Applications that allow the user to view medical images, such as digital mammography or digital images of potentially cancerous lesions on a mobile platform, and those that perform a health analysis or provide a diagnosis by trained health care professionals.

* Applications that allow the user to view patient-specific lab results.

* Applications that connect to a home use diagnostic medical device to collect historical data, or to receive, transmit, store, analyze, and display measurements from connected devices.

Great, right? The apps that do heavy lifting of patient information and connect to real medical devices get regulated, but the fun and educational apps I am working on remain free and open. Still, Harvey Castro, my favorite EM-doc-and-app-developer, was worried:

“Overall, I believe safety is the most important item when it comes to providing patient care,” said Harvey Castro, MD, an app developer (www.deeppocketseries.com) and emergency physician. “Unfortunately, I believe this will hurt small businesses and entrepreneurs by making it cost-prohibitive to enter the market.”

“Applications will be dominated by a few companies capable of paying the high fees to get FDA approval. I will be saddened to see these changes in the future.”

Grand rounds 8.11 call for submissions

Many thanks to AfternoonNapper for hosting this week's edition of Grand Rounds. 

Next week, I host Grand Rounds... but not here! It'll be over at my new Tumblr blog. 

Want to be a part of it? Please mail me at nick -at- blogborygmi.com with the subject Grand Rounds, along with a URL link of your submission and a brief excerpt. Photos are also welcome! 

Submissions are due by 11:59PM, Sunday December 4 (Eastern US time). Then, head over to blogborygmi.tumblr.com on the morning of December 6 for the first Tumbl’d Grand Rounds.

Thoughts on tumblr

Remember how people said there was no real need for a device category between smartphones and laptops? And then Apple sold 40 million iPads?

That's kind of how I felt about Tumblr.

Blogs are obviously great for musings, essays, and a web presence, and Twitter's fine for thoughts and links and pics. Why have something else, in between?

I don't really have a good answer, just like I can't fully articulate why the iPad experience is so much better than a laptop or smartphone. But I'm starting to see the appeal of Tumblr.

Beyond the usual accolades from early adopters / influencers, something that stayed with me was a quote from Tumblr's founder: "No one is proud of their identity on Facebook."

Medscape EM year in review

Medscape's EM editor asked Amal Mattu, Robert Glatter and me to discuss 2011's important papers in emergency medicine. I felt compelled to include an all-around terrible (but still important) paper, and a tidy nice decision-support paper for discharge prescriptions, among others. See what you think about my picks, as well as the great selections from Drs. Mattu and Glatter.

Thoughts on a reading, sharing & archiving solution

Music's pretty much done, right? It's fairly easy to hear any song you've ever liked, anywhere you happen to be. As a bonus, those songs can be stored, shared, tagged, rated, and linked to lyrics and album art.

Movies and TV... their delivery is not quite perfected, but the general outline seems apparent. Already I can watch the WKRP Turkey Drop episode in the kitchen on my iPad's Hulu app, and mirror it to my TV (via Apple's set top box) when I'm ready to sit on the couch. Other shows or films require more effort, though the combination of Netflix, iTunes, and for the remainder, torrents plus the Air Video server app, make it easy enough.

But reading? The written word, for whatever reason, still lags behind. While strides have been made, a simple and universal, Apple-like solution to the problem of reading, sharing and archiving remains elusive.

Airborne toxic event

Longtime readers know my fondness of comparing the healthcare industry to the airline industry (based on similar goals of training, rituals of safety, and differing approaches to error, for starters).

Recently I've learned of a new intersection between medicine and aviation, when Delta chose to air ads to their captive cabin audience purchased by NVIC, the National Vaccine Information Center. The ads talk about staying healthy, maintaining good hygiene, and asking your doctor questions about the different flu shots available -- to stay informed and keep all the options open.

Sounds ... innocuous ... right?

The IOM Weighs In on Health IT Safety

Thanks to a tip from Brian Ahier, I've caught wind of excerpts from the IOM report on Health IT Safety a few days before its scheduled release.

iWatch has the scoop:

But the push [to adopt electronic health records] is occurring so far without any agency really ‘watch dogging’ the safety of health IT — the software, hardware and systems that record and manage patients’ health information. These expensive devices by and large have not gone through any regulatory checks for safety in the way that food, drugs and other medical technology must; most of that oversight is handled by the FDA. But at the moment, no one is required to report instances of harm caused by health information devices and no government agency currently monitors their safety. 

“With all of that money, marketing and public outreach, most simply affirm the value of health IT as an article of faith, rather than investigate it via careful evaluation,” said Ross Koppel, adjunct professor of sociology at the University of Pennsylvania and its School of Medicine, and investigator for RAND Corporation. He is listed as one of the reviewers of the report.

I've read Ross Koppel's work, and seen him speak, and firmly believe he's a brilliant guy. But I disagree that we're accepting health IT's value on faith, because of marketing. We've seen IT transform the way we do business in every other sphere of American life, and many of us have experienced the benefits of easily retrieved patient records and clear, electronic communication between providers. As I've said before -- aside from a few train-wreck implementations, who would go back to paper records, if given the chance? Who would build a new hospital based on anything but an electronic system?

The IOM isn't saying paper's better, but they do recommend caution with, and further study of, health IT:

EHR Cutting & Pasting, in Perspective

I've started to think the medical record is akin to DNA. Maybe 10% (or less) is useful information; the rest is junk. When folks want to find a sequence of significance, risk or reassurance, they've got to search for the good stuff and filter out all the garbage.

But junk DNA is believed to have a purpose. Some regions of junk DNA are highly conserved -- found in organism after organism -- suggesting an important function. In medical charts, conserved regions are also repeated. And they also serve an important function.

It's this repetition that Dr. Bryan Vartabedian called "Cut and Paste medicine" in his excellent recent post. He's concerned that all these computer-generated phrases of historical elements, exam findings and decision-making makes all patients look alike, and hurts continuity of care, as it becomes harder to discern what's actually going with the patient.

It's a reasonable concern. This problem, created by documentation regulations, compounded by declining reimbursements, and exacerbated by quick-fix features of some electronic records, can be solved through technology, too. Just as researchers and geneticists built tools to sift through DNA, to find the small section they're looking for, we need to easily search through records to show the details of patient care relevant to us.