News 7/20/11

FDA Issues Guidance on Oversight of Mobile Medical Apps

As many predicted, the FDA finally issues proposed guidance on the regulation of mobile medical apps (press release and actual guidance.) The proposed oversight is open to comments from the public for the next 90 days.

According to the FDA, "The Food and Drug Administration (FDA) is now proposing guidelines that outline the small number of mobile apps the agency plans to oversee—medical apps that could present a risk to patients if the apps don’t work as intended". The subset of mobile apps that the FDA has identified to regulate include those that 1) are used as an accessory to medical device already regulated by the FDA and 2) transform a mobile communications device into a regulated medical device by using attachments, sensors, or other devices. If regulated, devices fall into Class I, II, or III, each with its own regulatory requirements.

My summary and interpretation of apps that will be regulated are:

  • Those that use sensors or connect to a device directly or wirelessly. For providers, these are all the attachments to EKGs and other monitors. AirStrip and Calgary Scientific come to mind and I think both already have FDA approval. For consumers, this would be apps that connect to devices or sensors to store and transmit data. MedApps and Withings come to mind and again, I think they both have FDA approval.
  • Those that use patient-specific data to come up with treatment decisions. WellDoc is the obvious one here and they have FDA approval, at least for diabetes.
  • Those that act as medical calculators. This group includes tools like Epocrates but also lots of cheaper (and in my opinion, easier to use) medical calculators. A lot of these have been built by and are used extensively by residents and medical students. I can’t really imagine most of those small developers filing for FDA approval for a simple app that calculates acid base status or Apgar score. Maybe that’s a good thing because, as much as I prefer those apps, in reality lots of decisions are based on them and they should be regulated.

The FDA excluded certain apps as well, including mobile EHRs and PHRs, copies of medical textbooks or other teaching aids, and apps that track, log and "similar decision tools that generally relate to a healthy lifestyle and wellness." I guess as long as the treatment is lifestyle-related, like losing weight if you’re pre-diabetic, an app can help with specific treatment goals and not be regulated.

More News

A new Bulletin Healthcare Briefings report finds that physician mobile use grew by 45% and that 76% of smart phone-using docs have iPhones.

A study from Johns Hopkins finds that Twitter can be a useful tool in public health. My favorite tweet, which was discovered as the researchers were creating a model to read tweets, was "Got a case of Bieber Fever. Love his new song". The researchers analyzed about 1.5 million health-related tweets and found that the analysis correlated with actual data for things like flu rates and the start of allergy season. That’s very cool and a useful example of what can be done with Twitter’s data. Maybe the government should cough up the $8 billion to buy Twitter?

The British Medical Association issues clear guidance for providers on social networks – "politely refuse" friend requests and be wary of posting things to Twitter.

A design firm contracted by Seattle Children’s Hospital builds what I’d describe as a mobile patient viewer. The mobile app, which looks great, takes data from Cerner and other systems to create aggregated summary views of patients, care teams, and hospital floors. The key, now that the prototype is built, is fitting this into the workflow of the providers so that they can use it and benefit from the improved experience. If you can turn Cerner into this then there is still hope. I’m not sure the app does anything more than view, so you still have to use Cerner to enter all the data.

Here’s a story featuring several of the more interesting health technology startups from the Bay Area. Most are consumer facing, like HealthTap and Simplee. I can’t believe Practice Fusion is up to 100,000 docs.

A telehealth group in Tennessee, Community Health Network, lost or misspent $1.2 million over three years. It’s a pretty interesting story showing fraudulent misuse of public funds. It makes me wonder how much is being lost or misspent out of the HIT money.

According to this report, RIM might stop production of its BlackBerry PlayBook tablet. According to a friend of mine, "I knew it was bad for them when they sent me not one, but two PlayBooks to test."

EXTENSION releases its clinical alerts and notifications platform for Android.

Travis Good is an MD/MBA and is involved with health IT startups.

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