Health data access regulatory initiatives hold promise, but rollout remains unclear

At HIMSS18, CMS Administrator Seema Verma announced two potentially promising initiatives, MyHealthEData and Blue Button 2.0.

It’s 2018. We have the HITECH Act and its outcome: moving most healthcare providers to electronic health records thanks to the Meaningful Use incentive program. We have the 21st Century Cures Act and its promise of interoperability. We have the draft trust framework put forth under the Cures Act. We have the original HIPAA regulations, which together with the HITECH Act amendments, guarantee patients prompt access to their EHR data in the format requested by the patient, at a reasonable cost.

And how has the real world kept up with these existing and developing regulatory frameworks? Not very well.

The wife of the CEO of one of the nation’s largest EHR companies travels to appointments with a shopping bag full of records on CDs and paper. The best an academic medical center can do when discharging the CMS Administrator’s husband before he travels home (out of state) is to offer a CD (which turned out to be incomplete) and a printed discharge summary. The Secretary of HHS has his own tale of woe relating more to pricing transparency than access to records, but the fundamental issue is similar: often, the system is not terribly user-friendly. I’ve gotten the CD treatment myself. Very frustrating.

Healthcare often operates as a black box, and in a value-based care environment — where we expect patients to be partners: both in paying for their own healthcare and in managing their own health and care — we can no longer insist that patients execute these maneuvers while blindfolded, with one hand tied behind the back.

There are many good reasons for patients to have full access to their own records, but these two are more than enough to prompt action: First, the Open Notes Project has demonstrated that giving patients access to the full medical record – not just the patient portal subset of full EHR data – improves patient outcomes. Second, patients have the legal right to their full medical records, delivered in the format of their choosing, so long as that is technically feasible.

As is often the case in the mixed-up crazy world that is healthcare, the technical challenges have been met long ago, but the entrenched behaviors in the marketplace have not allowed patients easy access to their own records.

Thank you, Argonaut Project, for standards; thank you, Cures Act, for a trust framework in the making; thank you, Apple, for demonstrating that it is possible to just do it in the real world, at scale; thank you, CMS and HHS, for promoting the idea, long entrenched in law and regulation and now breaking through to the real world more consistently — that patient access to their own – to OUR own – records is non-negotiable.

We’re left with several questions:

Will health records, in fact, be fully accessible to all Americans who want them?

The federales say that they are leading by example and have expressed pretty clearly that they expect others to follow. But it’s far too soon to tell whether MyHealthEData (clinical data) and Blue Button 2.0 (claims data) will deliver on their promise.

Will anybody really want them?

Some will, most won’t. Why would a healthy person want to see his or her medical records? The thing is, most of us don’t really care – until we do, and then we care a lot, and we want our records immediately. For some of us, folks with chronic conditions (and there are plenty), full access to longitudinal records often means easier self-care and care management.

Haven’t we already seen this movie?

Short answer: Yes. And it didn’t always end well. To quote William Gibson, “The future is already here; it just isn’t evenly distributed.” Open Notes practices have fantastic results: engaged patients, improved satisfaction and outcomes. Many other healthcare providers seem stuck in the past, unable or unwilling to be as open as the Open Notes adopters, believing that transparency and openness come at a competitive cost. (Surprise: It doesn’t.)

Are we there yet?

Nope. So far we have functional APIs and early glimmers of uptake in the marketplace. Patient and market demands and regulatory requirements are likely to drag along even the most recalcitrant payers and providers. However, the regulatory agencies have a wide variety of priorities under the current administration, and while it is encouraging to hear the speeches given by the CMS Administrator at HIMSS18 (and by the Secretary of Health and Human Services at other conferences the same week), it can be difficult to predict how and when the MyHealthEData and BlueButton 2.0 initiatives will be more fully rolled out.

David Harlow is Principal of The Harlow Group LLC, a healthcare law and consulting firm based in Boston.

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