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FDA, tech leaders talk regs and innovation at health IT hearing


By Darius Tahir
Posted: June 24, 2014 - 2:30 pm ET
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A Food and Drug Administration official sounded an accommodative tone to entrepreneurs in the healthcare technology space at a roundtable hearing of the House Energy & Commerce Committee Tuesday. His message came in response to ongoing tech industry criticism of government efforts, or lack of efforts, in health technology regulation.

“From an FDA standpoint, we want to engage in smart regulation, (which) means knowing when to regulate, and how to regulate,” said Jeff Shuren, the director of FDA's device center. “We're trying to provide greater predictability, and clarity. And we're trying to get out of the way,” he said, citing the agency's decisions to “deregulate scores of technologies” from apps to medical-device-data-systems.

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A long, bolded list of digital health notables—including Anne Wojcicki, CEO of 23andme; and representatives from IBM, Cleveland Clinic and Intel—also addressed the committee. They spoke of, mostly, optimism about the future of the sector, with some warnings for government about the ways it could hamper progress.

The FDA—besides getting out of the way—can help in one other respect, Shuren said: encouraging interoperability.

“The linchpin is accurate information,” he said. “(We) need accuracy, reliability, (and) meaningful information.”

But interoperability loomed large for many. Jonathan Bush, the CEO of Athenahealth, a cloud-based EHR vendor, spent most of his time criticizing the government's meaningful-use program, saying that there is “no business incentive for interoperability.”

Mark Blatt, the worldwide medical director of Intel Corp., said the government needs to learn lessons from other countries that tried, failed, and spent billions trying to enforce an interoperability scheme. Instead, he suggested, the government needed to “create the business conditions that foster the conditions to interoperability … maybe allowing patients to see their data in real-time, maybe that would promote interoperability.”

Not all panelists saw interoperability purely as a barrier; Sean Hogan, the vice president for healthcare at IBM, mentioned interoperability—along with “evidence-based personalized medicine” and “analytics that support effective clinician and patient engagement”—as his three areas of excitement for healthcare. Instead, his concerns were based on the “consistency and clarity of regulations” and the lack of government funding for research, particularly for the National Institutes of Health.

The idea that regulations were insufficiently clear and consistent was itself a clear and consistent theme of the hearing. Indeed, the contretemps between FDA and 23andme – and perhaps the lack of clarity in that realm – became an issue at the hearing.

“I watched in horror as it happened,” Rep. Michael Burgess, R-Texas, said to Wojcicki, the firm's CEO. “This is the breakthrough we wanted to see. I just hope we haven't taken all the life out of the project.”

Wojcicki responded that she knew the project would always be “challenging” but that FDA had become a valuable collaborator. “FDA has been very responsive to us. If we call on Friday, we'll get a call back Monday.”

“There should be a clear path forward,” she concluded.

FDA was not the only federal agency blamed for a lack of consistency. Bush had a bone to pick with the handling of the ICD-10 transition, which Congress decided to postpone implementation of this year. “We put 200,000 hours into making our doctors ICD-10 compliant,” he said, “and then they just randomly pulled it.”

“There is a culture of wanton and random regulation,” he said during the hearing. In an interview afterward, he elaborated that even slight uncertainty could cause problems. The executive branch, he said, needs to be “conservative in what they decide to do,” and not “capricious.”

Otherwise, businesses have “the incentive to finesse compliance” with regulations, he said.

Follow Darius Tahir on Twitter: @dariustahir


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