Lessons in Change
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Pharma Tech Outlook: Pharma Tech Magazine

Lessons in Change

Wayne Kubick, CTO, Health Level Seven International

Wayne Kubick, CTO, Health Level Seven International

Coming to the expansive and hyper-dynamic world of healthcare informatics from a similar role in the much smaller domain of pharmaceutical clinical research has led me to adjust my modus operandi. As a 30-year-old ANSI-accredited standards organization, HL7 has well-established rules and processes for almost everything. Yet, while HL7 must keep one foot firmly embedded in the solid v2 standard that still largely drives the current engine of healthcare information exchange, it has also had to grab on to the vigorous comet known as FHIR -- which is transforming many preconceptions in its surge toward interoperability. Here are a few things I’ve learned after 60 days as HL7 CTO.

"HL7’s vision is “a world in which everyone can securely access and use the right health data when and where they need it"

Change Matters Most

While standards are expected to be stable, the information world around us is largely fluid. We need both a solid foundation – provided, for FHIR, by core resources and, for HL7, by essential ANSI requirements – and an agile culture to quickly adapt in a rapidly evolving world. In life sciences, we typically withdraw into the comforting arms of past habit using regulations as an excuse, when, in reality, the predicate rules focused on maintaining safety, quality, traceability and accuracy can often be met without being chained to the past.

Go with the Flow

The transition to digital health is all around us, and yet clinical research is still based on antiquated processes stemming from paper CRFs. It’s time for pharma to learn to work directly with real world digital healthcare data sources – instead of trying to forcibly transform information into a series of complex, legacy silos.

Preserve the Base

HL7 has a dedicated community of volunteers, well versed in HL7 lore as well as a body of older standards in wide use. It’s important to keep nurturing the existing base, which in HL7 includes v2 and CDA, while also defining a future around FHIR. In life sciences, companies need time to adapt to a stable set of existing standards, while also looking forward to the next generation better suited to this changing universe.

Focus on Implementation

Theory and models only get you so far. FHIR has shown that by focusing on implementation – putting things to work in quick release cycles, adapting, and then doing it again –builds up an active, knowledgeable community and results in a better product. An energetic and active community can make even the improbable happen.

Stick to Essentials

There’s always too much to do, so it’s critical to stick to the essentials that align with your goals. That means saying “no” – or at least “not yet” – a lot. Like a dominant sports team striving toward a championship—a clear and simple vision along with a winning record –helps eliminate distractions. HL7’s vision is “a world in which everyone can securely access and use the right health data when and where they need it.” This vision applies not just to standards developers, but also to healthcare providers, payers, government, service providers, researchers – and above all to patients. An altruistic vision that relates to everyone can make anything possible.

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