Tuesday, April 24, 2012

Patient-Centeredness: will "Direct-only" get us there?

I read that the HIT Standards Committee recommended that Direct (SMTP, S/MIME secure email) be the only transport protocol for certification. While on the one hand this sounds like a good step toward parsimony (similar to having only one vocabulary for problems or one Consolidated CDA standard for summary of care records), I think it’s different and has some unintended consequences against the patient-centered view that can be advanced with HIEs.

Those of us who worked on Direct recognized its strength for particular “push” use cases. Many also felt strongly that Direct needed a bridge to the HIE world in terms of protocols (hence the XDR and XDM for Direct Messaging specification). The Direct Project Overview made it very clear that Direct “push” is not intended to solve every use case but to coexist with other forms of exchange including “pull” as well explained in this EHRA whitepaper.

This is easy to understand if we look at how businesses are run, and how people manage their personal data. Email push is highly beneficial and essential in my business and personal life. But it’s not all there is. At work, when people collaborate on projects (as providers ought to  collaborate in patient care), they store information in shared resources. They don’t rely upon the project documents existing in every individual’s email or personal folders! That would lead to waste and confusion. Instead, there are repositories that handle version-controlled documents, source code, etc. Wiki pages rather than emails can be used to record the shared project experience. Emails are great for initial notification, but not for the ongoing management of the information. And even individuals don’t email their photos to everyone in their address book: they share them in a single place (like Facebook) from which trusted friends can pull (view and download) them. Information exchange  via Direct should not “push out of the picture” information sharing that benefits the patient and provider community.

HIT SC’s recommendation of a single protocol for certification is fine as a “minimum requirement.” But I’m very concerned that certifying only Direct, if accepted by ONC, could bias providers toward Direct to the detriment of other types of exchange. CMS’ Incentive Program proposes that meaningful use measures only count transmissions to providers using the standards included in certification (page 13708 of the NPRM). This would have the unintended consequence of discouraging sharing through HIEs (at any level), that use IHE profiles such as XDS, XDR, XCA, etc., as most use these instead of Direct. Those profiles require sufficient metadata to support queries against a patient-centered document registry, so that providers can find what they’re looking for. Direct by itself does not provide or require those metadata, so even if Direct were used to push documents to an HIE, the HIE would be hard pressed to correctly index and file the documents.

I’m not criticizing Direct for what it is. I am saying that it was not designed to handle all exchanges, and that overemphasizing it as the only “meaningful use” method that “counts” will have negative impacts on HIEs that provide a patient-centered aggregate view. Point-to-point transmissions don’t provide such a view since each provider’s view from “push alone” is only a “silo” unless everyone copies everyone else on every document (the dreaded “reply to all” email) – not a good idea! While HIEs aren’t required for MU, they should not be discriminated against either. CMS regulations incenting Direct only (implicitly disincenting HIE) could harm progress toward patient-centricity. That would be like a business rewarding people for sending their documents via email but not rewarding them for sharing controlled versions of those documents in a repository. Between ONC and CMS, I hope this problem can be avoided by focusing on the real objective – providers and patients sharing data electronically, without CMS measures counting only Direct SMTP exchanges as qualifying for meaningful use. “Pull” exchanges from an HIE or “push” exchanges using other protocols (e.g., XDR SOAP) should also count toward MU measures. And I hope that HHS goes beyond “permitting” HIEs for MU, but that they will continue to invest in and work with others (e.g., states) on a national healthcare infrastructure (NwHIN Exchange as it evolves) to enable a patient-centered, cross-provider view of data as a public good.


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  2. I think you make some good points here regarding Direct and HIE. I support DoD and their efforts on Direct Project and can tell you straight up that we are looking at this technology purely for the appropriate use cases, but have seen significant interest from some individuals to shoehorn this capability into use cases where another technology might be a better fit (i.e. NwHIN Exchange). I think Direct is an exciting option that gets people hyped up after being somewhat let down by the slow progressing Exchange. That being said it is a good step towards meaningful exchange between Federal partners and private health organizations, something that for DoD at this point is mostly fax based.

  3. Brian and atif, thanks for commenting.

    Brian, as long as people are using whatever standard it is (Direct or XYZ) with "fitness to purpose" in mind, I'm glad. It's the "shoehorning" that worries me, along with the unintended consequences (silos, lack of patient-centeredness) that may result if that happens.

    NwHIN Exchange and XDS styles of HIE rely upon central services for record location/registry, patient matching, and often document repositories. Direct can be truly point-to-point but increasingly will rely upon some central services of a different sort, like HISPs and Certificate Discovery and Provider Directories.