According to the stimulus law, the ONC “in consultation” with NIST “shall keep or recognize a program or programs for the voluntary certification of health information technology” for compliance with EHR certification criteria adopted by HHS.
In addition, the stimulus law tasks NIST to work with the Health IT Standards Committee to come up with a “conformance testing infrastructure” for standards and implementation specifications for healthcare IT systems. That infrastructure may include “a program to accredit independent, nonfederal laboratories to perform testing.”
Those who may chafe at a federal role in setting standards should blame the Founding Fathers. They wrote into the Constitution that the federal government had the responsibility to “fix the standard of weights and measures.”
NIST and its precursors have been engaged in standards setting since 1901, a role elevated to national importance following a Baltimore fire in 1904 during which assisting neighboring firefighters were unable to hook up their hoses and equipment to city hydrants because of an absence of standardized fittings.
NIST has worked in data standards development in electronic commerce and electronic voting, “but it's just not the organization that is obviously associated with healthcare,” Lide conceded. Still, she said, “We do have a history in health IT since the mid-1990s.”
One NIST-sponsored advanced technology program was a public-private partnership to fund high-risk enabling research, she said. “High risk means a for-profit company could not do this all alone, because they could lose a lot of money. Enabling means it could help across industries.”
“We put roughly $150 million into this and it was matched by industry with $150 million,” Lide said. “Some were very, very successful and others were not successful because it was high risk.”
One project Lide lists in the win column was a computerized surgical simulator.
“It was the first one you could practice doing an IV not on an orange or a fellow medical student,” she said. “You could adapt it, because it's different doing an IV on an infant than on an older person.”
Another NIST project was a computer system that prompted clinicians to enter a diagnosis for every patient. “It's still in use in some systems today,” Lide said.
“It does go to show you NIST has a long history in health IT,” Lide said. “I truly believe that it's because of the work in health IT and in voting that Congress recognized that we could bring benefits to what we're doing” in healthcare IT.
More recently, dating back to 2005, NIST and the ONC operated under an interagency agreement, helping David Brailer, the first head of the ONC, process and categorize public comments in developing the first national “strategic framework” for a federal health IT development program.
Lide said she often served as the Commerce Department's representative to the American Health Information Community, a panel created by former HHS Secretary Mike Leavitt in 2005 to advise him on health IT policy.
In addition, NIST representatives have served on various committees of the federally chartered Healthcare Information Technology Standards Panel and as advisers to the not-for-profit but federally funded Certification Commission for Health Information Technology.
Previously, CCHIT had a lock on testing and certifying health IT systems on behalf of HHS, but it will have to apply along with any other organization that wants to receive federal recognition as qualified to test and certify EHRs under the newly released ONC draft rule, released by Blumenthal in March.
Under a new, temporary testing and certification program in the ONC draft rule, both the testing and the certification functions will remain combined in a single organization selected by the ONC.
After early 2012, however, according to the draft rule, the program to test and certify electronic health-record systems qualifying for stimulus law subsidies will be bifurcated, with testing labs operating independently of certification organizations.
These labs will use testing methods that NIST develops.
A final rule on the selection process is expected before summer.
Guided by criteria in the March draft rule, Lide said NIST is “furiously working” on the final stages of test tools to be used by certification bodies in the preliminary combined testing and certification process.
NIST also is working with the ONC and the Agency for Healthcare Research and Quality on developing criteria to test EHRs on usability, she said. Clunky computer/user interfaces have long been a sore point among clinicians about EHRs.
“We have expertise in-house that are setting standards for usability that are measurable,” Lide said. “We have experts in human factor technology. In the end, we're going to have objective criteria to measure usability. I think that's going to play a large role in adoption. It will be really relevant as we work for the 2014.”