Standards Committee Struggles for Balance

Instead of recommending small adjustment to the Standards and Certification Interim Final Rule (IFR), the 10^th meeting of the federal HIT Standards Committee was consumed by a fundamental, philosophical debate of just how specific the group should be in its regulations, and the nature of the regulatory process itself. “We have to balance when to be specific and when not,” said Harvard Medical School CIO John Halamka, vice chair of the committee and co-chair of the Clinical Operations Workgroup. “On the one hand, we could provide little specificity and let the industry settle on its own standards, but if you do that and let 1,000 wild flowers bloom, you get many train tracks with different gauges.”

After some initial discussion, Halamka proposed specifying “families” of standards — rather than exact standards to be used within those families — while requiring a “floor,” or oldest version, that would be considered acceptable.

“We have been told that regulations are very hard to change,” he added, “and run the risk that if we are too specific, the industry will be stuck in concrete and not able to move. We don’t want to ossify technology.”

Throughout the meeting, a number of committee members struggled to find the same balance. “We must be careful about having a family of under-specified issues or guides. If we do that, we will not achieve the kinds of goals many of us hope this once-in-a-generation opportunity can afford,” said Christopher Chute, Chair, Division of Biomedical Informatics, Mayo Clinic College of Medicine. “We will not see sharable information improve care and reduce cost, absent clarity and specificity that can produce real interoperability.”

As the debate progressed, David Blumenthal, M.D, National Coordinator for Health Information Technology, interjected that what the group seemed to yearn for — the ability to put as little as is necessary in “set-in-stone” legislation, while leaving ongoing guidance around specific standards to semi-public or even private entities — might not be possible. Jodi Daniel, director of the Office of Policy and Research at ONC, said she would work with the organization’s general counsel to find out just how much flexibility the rulemaking process, and HITECH legislation, allowed.

A strong proponent of injecting more flexibility into the process was Wes Rishel, a vice president in Garter’s Healthcare Provider Research Practice. Rishel said that when it comes to reporting standards, the committee should be very proscriptive, as otherwise no quality data comparison would be possible; but when it comes to how organizations create that data behind the scenes, the committee should tread very lightly.

“The emphasis on the implementer should be to get the job done. If they use certified interfaces to do it, great, but at the end of the day if they are using something else, but still getting the job done, we should not make them change.”

Rishel admitted that after 44 years in the business, going through the recent regulatory process had still been eye-opening, and he urged caution in requiring too much of too many. “We have to be careful. We are speed-skiing downhill where the slalom pylons are made of cement. We need to find some process for allowing standards to evolve and adapt, and decoupling that from the way hospitals and practices achieve their business goals, while we can still achieve our goals for quality and safety.”