AMDIS: Managing the tension between regulations and innovation

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 - Crossroads

BOSTON—The healthcare industry is facing a “critical juncture” of tension between regulations and innovation. John Glaser, PhD, CEO, Health Services, Siemens Healthcare, told health IT leaders at the AMDIS Fall Symposium that they need to “take time out of [their] lives to contribute to the discussion of regulations.”

"It’s a challenge in front of us. There are real conversations in the federal government, held by people who work hard and who want to do the right thing, but don’t always know what their ideas will do,” he said. “Without your voice, they will make calls that will hurt.”

For example, he said, the Office of the National Coordinator for Health IT is weighing whether to regulate the usability of EHR systems. “Do you regulate usability and what in the world does that look like? These are real conversations with real consequences,” he said, noting that such regulation could be premature and stifle innovation.

The past five years have seen a remarkable spike in the federal oversight of health IT, he said. Because the government foots the bill for Medicare and Medicaid, naturally it has an incentive to see a return on its investment. Also, state and federal governments want to avoid policy problems that happen when the market fails.

Due to this “political pressure,” state governments like those of Rhode Island and New York require participation in their health information exchanges and, in Massachusetts, physicians will lose their license in 2015 if they fail to achieve Meaningful Use Stage 2, he said.

In all, it’s a mixed bag of whether regulations hinder or propel innovation.

For example, stepping up regulation of standards for interoperability could aid innovation. However, he said he expects interoperability to be a “highly chaotic messy experience for at least a decade” and that “there isn’t a simple answer to interoperability.”  

To that end, he urged health IT leaders to remain engaged in the regulatory process so they don’t have to spend time undoing bad choices.