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.
"There's a challenge, because if you want to create a policy that works to align business incentives and try to make sure that people have a focus that drives interoperability, it's a chicken and egg sometimes," said Dr. Doug Fridsma, chief science officer and director of the ONC's Office of Science and Technology. "We need the technology to be there to support the policy. And then the technology folks say, 'Well, we need the policies that will drive the adoption of these things that we've got.' And so I think for a long time we've been in this sort of conundrum, where we don't necessarily have all the pieces that we need."
Health IT advocates cite a long list of benefits that interoperable technologies could bring to the health care arena - from telemedicine and conducting routine tests remotely with mobile devices, to avoiding harmful drug interactions with comprehensive digital health records that follow a patient from one provider to the next.
What You Don't Know Can Hurt You
For some working in the field, it's a change that can't happen soon enough.
"I think Americans would be surprised if not appalled if they knew the degree to which treatment took place every day in this country in the absence of all the relevant information necessary to care for the patient," said Michael Schatzlein, CEO of the Nashville, Tenn.-based hospital consortium Saint Thomas Health. "I think we're living in a particularly dangerous world right now because we're part paper, part electronic. People cling to the paper because it's familiar and they want it, and sometimes the information is not congruent between electronic and the paper records."
The fact that most Americans aren't rallying behind health IT, as Schatzlein suggests, could be part of the challenge.
Officials and industry leaders note that a key goal of digitizing medical records - and making them portable and interoperable - is to empower patients to take a more active role in their healthcare. If, in time, large numbers of patients were to vote with their feet and opt for providers and insurers that embraced health IT, that would be a more powerful force than any government mandate, Fridsma suggested.
"On the one hand, we can push from a regulatory perspective. But the thing that's far more powerful is when there's a pull. When it's not about the physician any longer, it's about the patients," Fridsma said.
"Patients start making choices: 'I'm not going to go to that doctor because he doesn't give me access to the information in electronic format. I'm not going to get that insurance carrier because they don't give me the ability to download my information.' We have choices that we can make, and we need to start exercising the power of those choices to create that pull because I think that's so much more powerful and that we, from the regulatory perspective, can just sort of make sure that we can provide that extra push once that start to happen."
Read more about regulation in CIO's Regulation Drilldown.
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