Stakeholders warned rules would stifle progress
WASHINGTON - Federal regulators announced in September that they have dropped plans to write formal regulations, or "rules of the road," to control the exchange of health information within the nationwide health information network (NwHIN).
At a the Sept. 6 meeting of the Health IT Policy Committee, Farzad Mostashari, MD, national coordinator for health information technology, said public comments from stakeholders responding to a May federal request for information (RFI) on the topic caused regulators to back off the idea.
The Office of the National Coordinator for Health Information Technology (ONC) was considering writing rules to spell out "conditions of trusted exchange," including patient privacy safeguards and technical and business practices.
"We asked in the RFI, 'How can we set up a regulatory validation and if the time is right for establishing, evolving and enforcing such a thing?'" Mostashari told committee members. "Over 140 detailed comments from the public really told a story."
"One concern we heard across every response is that regulation at this time may actually slow the development of trusted exchange if it's implemented prematurely," Mostashari said. "And it was something we have to listen to carefully. Our goal isn't to hobble health information exchange in any way."
Mostashari said the majority of comments warned the timing of such a regulation would be too soon. Mostashari said ONC was somewhat surprised because they anticipated stakeholders would want the regulations to make exchange easier. But commenters said exchange is already taking place.
"More exchange is occurring today, perhaps more than is appreciated," he said.
Mostashari added that ONC has decided to forestall formal rulemaking for now, to replace it with guidance - "an approach that would provide a means for defining and implementing nationwide trusted exchange with higher agility, and lower likelihood of regret."
Jodi Daniel, director of policy and planning at ONC, said regulators don't want to rock the boat. "We got information and we're acting on it; we're listening."
ONC plans to lead by engaging, listening and monitoring consumer and provider attitudes toward the exchange. "We will disseminate a framework of principles for folks to align with," said Daniel. "There are some folks looking for guidance and how to establish trusted exchange."
ONC will also make available best practices, she said.
Committee member Judith Faulkner, CEO Epic Systems Corporation, said guidance would be appreciated. "In many cases, vendors don't even know where to start," she said.
There will be a transitivity problem if vendors don't know that everyone in the exchange has signed on to the same rules of the road, Faulkner added.
Gayle Harrell, another committee member and a Florida state legislator, said she was "delighted" with ONC's decision to back off on regulations. "I would much prefer to let the markets develop," she said, "But I do see need for the guidance for consistency.
However, "It's better in the long-run to have the private groups become arbiters of the rules," she said.
"Our goal isn't to hobble health information exchange in any way."