A little over a week ago, the Office of the National Coordinator for Health Information Technology (ONC) announced the early retirement of its ten-year Interoperability Roadmap (Connecting Health and Care for the Nation: A 10 Year Vision to Achieve an Interoperable Health IT Infrastructure). This Roadmap, initially published in 2015, outlined a three-phased plan for instituting the regulatory, technical, and operational infrastructure necessary for an interoperable health ecosystem, alongside nine broad governing principles.
In the announcement last week, Deputy National Coordinator Steve Posnack explained the unexpected sunsetting of the document, noting that there is a time when the “future becomes the present” and, consequently the roadmap “no longer drives our work.” Shortly thereafter, ONC instituted a call for stakeholder feedback to inform its new initiative: Health Interoperability Outcomes 2030. This feedback will inform ONC’s publication of a prioritized “aspirational but achievable” outcome statement, expected this autumn. As Deputy National Coordinator Posnack explained: “When we know with certainty what we want to accomplish, what outcomes we seek to achieve, it frees us up to be a bit more creative about how we get there.”
The transparency and intentional effort of public engagement by ONC are to be (roundly) applauded. It certainly is also true that a great deal has been accomplished since 2015 as it relates to health interoperability, most notably the passage last year of ONC’s CURES Act rules. At the same time, retiring the roadmap and starting from square one as it relates to defining “where we are going” as to national health IT strategy and an interoperable health ecosystem, feels like stepping back from a job that is not yet done. Allow me to explain.
THE ROADMAP AND ONC’S FINAL INTEROPERABILITY
The biggest advance as it relates to interoperability followed the 21st Century Cures Act, which was passed in December 2016 and did three primary things as it relates to interoperability. The Act:
- Defined interoperability and data blocking;
- Prohibited the latter; and,
- Directed ONC to promulgate rules to implement these broad principles.
Last year ONC finalized its CURES Act rules, creating a mandatory framework to support an interoperable ecosystem, which hinges on a patient’s right to access and directs the exchange of records. The accomplishment (and sometimes controversy) of these rules should not be overlooked. These rules, in coordination with additional rules from CMS related to patient right of access and interoperability, represented a paradigm shift as it relates to health data use and stewardship.
These rules were not without controversy. After all, you can’t shift paradigms without uprooting and disturbing the status quo, and health data (who has it and can you use – and who doesn’t) is, if not big business, a substantial market advantage. At the same time, making it easier to exchange data, and allowing the circumvention of HIPAA protections by non-covered entities (as may occur if patients are not adequately informed of the consequences of directing the release of their health data, or where developers are not held to data use transparency standards) raises substantial concerns and questions—questions that remain unanswered.
The ONC Final Rules accomplished a great deal (and honestly, I can’t underline or emphasize that enough)– but they did not complete the work that it set out to do: The work of creating a sustainable ecosystem where health data is seamlessly and securely exchanged, with patients at the center of their care and in control of their data. I would argue that the Roadmap (expressly designed to be a “living document” and, as such, updated and revisited over the years) remains as relevant today as it was when it was first published.
Indeed, the Roadmap identified nine guiding principles for this iterative task – the first being to build upon the existing health IT infrastructure. Behind this technical, structural principle is a sound interdisciplinary management principle: don’t go about “recreating wheels.” Save your energy and political capital for the next stage—implementation—because this is where the rubber meets the pavement. After all, the passage of the regulatory framework necessary for this ecosystem is only the first step—now comes the doing.
My feedback to ONC, therefore, is this: Make this a pause (and reset as needed) and not an end to the Roadmap and turn attention to two things:
- Enforcement of the data blocking practices and
- Creating, in coordination with DHHS, OCR, and stakeholders, the enforceable standards that will ensure that patients are informed and able to direct their data in a meaningful and informed manner.