From the August 2019 issue of HealthCare Business News magazine
By: Matthew Michela
Full interoperability and the unimpeded flow of non-proprietary clinical data are essential to innovation and advances in patient care. Still, despite a variety of efforts over the decades, the otherwise technologically advanced U.S. healthcare system has made only sporadic and partial advances toward that goal. Systems remain isolated and data is blocked.
The interoperability and data sharing provisions of the 21st Century Cures Act were intended to finally change this situation.
The Cures Act and health IT
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While the 21st Century Cures Act, passed at the end of 2016, is mostly devoted to funding various medical research, it also contains provisions intended to finally achieve interoperability and prevent data blocking in healthcare.
While Congress passed the Cures Act, specific rule-making is being done by the Office of the National Coordinator (ONC), a staff agency within Health and Human Services (HHS). The ONC coordinates between the vast number of healthcare stakeholders, advancing and publicizing standards through communications and public meetings.
The two issues of interoperability and data sharing somewhat overlap, with interoperability mostly referring to technical capabilities of software and systems to exchange and use data, while data sharing refers more to procedural or bureaucratic barriers to secure data exchange. This spectrum of barriers currently makes exchanging healthcare data extraordinarily difficult. Even with full intent to collaborate, organizations have to overcome the technical barriers — and in many cases, that collaborative intent is missing as hospital systems regard their own clinical data as an asset of some value, and put up arbitrary and unnecessary barriers to access.
Interoperability and innovation
Other areas of the economy, from transportation to manufacturing to going out for the evening, have been transformed by the free flow of data available through application programming interfaces (APIs). Despite a lack of market forces, the Cures Act intends to create the same kind of informational exchange through a range of incentives and fines for noncompliance.
For interoperability, the ONC is creating an environment that supports the development of an entire ecology of APIs. Innovative companies know that they cannot create a new environment of machine learning-based decision support enabled by APIs without appropriate access to de-identified clinical data to train those models. The ONC rules are based on deep analysis of the challenges for data and interoperability from clinical EMRs into health systems with their key applications. It is explicit about the gaps or challenges innovators face in unlocking and operationalizing this data for the benefit of patients.
The key directive in the Cures Act is that clinical data should be shareable “without special effort.” These three words are essential for enabling the free exchange of healthcare data. The ONC believes this means the use of modern, industry-specific standards by all players. There are already many APIs, but their vendor specificity slows their uptake. It often takes many hours of customization for a user to get even a trickle of data, and smaller vendors do not have the resources to achieve even that.