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Wednesday, July 20, 2011

IHE Week and FDA announces mHealth regulatory approach

Another IHE Week, this time preparing Trial Implementation Profiles. I'm on the hook for Reconciliation, and we have another couple dozen comments to go.  One of the surprising responses from commenters is that the profile should REQUIRE that external identifiers for problems, medications and allergies be preserved.  That is going to result in a quite a bit of new text (now I have to explain what changes the identity of an entry).  I'm pleased with this response.  We made it a strong recommendation, but not a requirement because I felt that many EHR vendors would not implement the profile if it were required.  Most systems would need to alter their basic tables to record the external identifier.  But experience with prior implementations indicates that this really is the best way to handle it, and I certainly agree with the sentiment.

I spent a good bit of time with IT Infrastructure on Monday discussing Cross Enterprise Document Workflow (pdf).  This profile is critical for Patient Care Coordination, even though it is coming out of IT Infrastructure.  Here's a brief pitch I'm giving on it tomorrow for another group:
  • In Ambulatory Care, providers are desperate for Workflow Management to track referrals, orders, and manage quality of care.
  • But their workflows are loosely coupled and ill-defined.
  • These need to integrate with well defined, tightly coupled workflows in a departmental system (e.g., imaging).
  • XDW uses industry workflow standards to describe Human Tasks that can be well integrated across both settings.
The replacement of CDA with Human Task as the standard to manage the tasks is more than appropriate, and @rjhorniii has done a great job leading the discussion, and getting me and one of my colleagues to agree on an approach.  You can expect some significant changes to the public comment version to come out of this meeting.

While at the meeting, the FDA came out with a proposed regulatory approach for mHealth devices and applications.  I haven't had a change to do more than skim it once.  I'll look over it in greater detail later.  One of the tweople I follow expressed surprise at the exclusion of Mobile devices being used as an EHR.  His interpretation was that EHRs were not medical devices.  In case you are curious, they also excluded EHRs from the Medical Device Data System rule.  It's not that EHRs aren't medical devices.  It's that FDA carefully classifies things so that something doesn't fall into competing classifications.  They may be issuing separate guidance on EHR systems, so they exclude anything that can be viewed as an EHR from the other rules and guidelines.  That way, when the EHR rule comes out, it will be clear WHICH regulations and procedures apply.