Will the FDA Look at Regulating iPhones? From "When Is an iPhone a Medical Device?"

Check out this website I found at medicaldevicestoday.com

Disclaimer: This post title is a bit of a tease.

You would have to purchase this report (which I didn't author - see link above) to read what Medical Device Today and "The Silver Sheet" says about iPhones being considered 'medical devices' and thus potentially subject to FDA regulation and oversight.

I won't be plunking down $129 bucks for the 16-pager (which I found via a Google search) any time soon, but the questions it raises are thought-provoking:

1. How/When might an iPhone become a medical device?

2. Does incremental data entry and updating turn into a medical/health regulatory issue when 'channeled' through consumer tech like the iPhone?

3. How does the FDA categorize new software and portable communications devices in hospital use, and how might these standards effect manufacturing processes?

4. Who holds the liability card if 'a simple software repair winds up costing a life (per the report advertising lingo)'?

This last one in particular is a decent question. As @epatientdave has pointed out repeatedly, no one provides oversight for software entry and updating after the CPD/ICD/DRG coding phase to make sure the data is 'correct.'

What happens when these mistakes cost life or limb? EMR, EHR, and particularly consumer and patient access through PHRs and portals will bring attention to errors in a newsworthy, world-shaking way.

Note: Even when not costing life or limb, a simple data entry error can cost individuals and systems thousands of dollars.

In the first year after my accident, I waited 9+ EXTRA hours for a bone graft surgery (L iliac crest to R talar neck/dome) at Kernan Hospital (UMMC system) because someone had obtained insurance approval for the procedure on an OUTPATIENT basis rather than on an INPATIENT basis.

The difference that caused this wait time? ONE LETTER.

A simple "OP" typed rather than an "IP" on a form and then duplicated ad infinitum until I arrived for preop prep.

The good news? We eventually straightened out the mistake (same day), after constantly rescheduling my surgery time (and thus my doc's OR schedule) BEFORE my desperate parents had to drop 5k (which of course they didn't have) to get me into surgery that day.

The bad news? I'd waited so long that the preop/IV had to be put into a vein on my foot as a result of dehydration.

Let's just say this level of stress is not the most conducive preop process for a quick post-surgery recovery.

What will be the mHealth tech equivalent of an M&M conference? One idea - follow the Joint Commission's "sentinel report" process, or even the hospital best practice of variance reporting.

If you're an iPhone or HIT developer and you've been in existence for more than a quarter, move beyond recording and fixing bugs to recording and FIXING variances (adverse use cases/outcomes).

If you've got an mHealth app, eHealth platform, or telemedicine tool in the works, code in 'sentinel event' reporting from ground zero development.

I can't think of a better way to demonstrate good faith towards 'meaningful use,' can you?

Posted via web from Jen's posterous

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