Virtually everyone who believes that electronic medical records and networked devices can improve healthcare quality and lower costs acknowledges that those technologies will never reach their full potential unless they achieve some level of standardization and interoperability.
But what's the government's role, if any, in trying to harmonize the health IT space?
That question was front and center in Washington yesterday, when officials from the Office of the National Coordinator for Health IT (ONC) and the Food and Drug Administration (FDA) said they're working to find an appropriate balance between hardline regulation and allowing a young, fast-moving market to develop without any intervention.
At the ONC, established in 2004 by an executive order and codified in health IT legislation in 2009, leaders have been wrestling with their role in guiding the industry and recently opted not to pursue mandates for device and application interoperability. For now.
"We decided not to regulate at this time," said Jodi Daniel, director of the ONC's Office of Policy and Planning. "But these problems will not solve themselves."
Daniel urged more active collaboration among the various stakeholders in the health IT field - a large ecosystem that includes healthcare providers, insurers, developers and vendors and patient advocates.
To be sure, the federal government has been working actively on the standards front in health IT. Most notably, the Department of Health and Human Services have been advancing the so-called meaningful use standard, which, now heading into its third year, sets forth criteria that providers must meet to receive Medicare and Medicaid incentive payments for using electronic health records.
How Meaningful Is 'Meaningful Use'?
But the meaningful use certification, though inarguably a prevailing market force in the health IT and care sectors, is a more cautious regulatory step than if the government were to mandate specific technology standards - and ban others - in medical devices and applications.
Government officials express a real fear of issuing more stringent regulations that could codify standards and potentially slow the pace of technological development. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, suggested that a more prudent approach would permit the technology to develop with fewer restrictions, and, once devices and applications reach a reasonable level of maturity, then follow with the standards-setting process.
"The way we kind of approach standards is it follows technology," Shuren said "If not, then standards will always play catch-up."
But it cuts both ways. Some vendors in the IT community have argued that the absence of standards and concerns over interoperability stifle the market - and that demand among providers would be stronger if the policy landscape were more settled.
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