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David Blumenthal says debate rages over EMR standards

National Coordinator for Health Information Technology Dr. David Blumenthal says there is a "raging debate" in Washington over whether the development of electronic medical records should be driven by standards or competition.

Former Secretary of the Treasury Paul O’Neill posed a technical question to keynote speaker Dr. David Blumenthal, the National Coordinator for Health Information Technology.

Blumenthal had extolled the virtues of electronic medical records, also known as electronic health records, during his speech at a gala for the Lucian Leape Institute of the National Patient Safety Foundation. EMRs make him a better physician, he said, recounting personal anecdotes of discovering patients’ allergies through automated EMR alerts and using stored image date to more quickly get a diagnosis for a patient without subjecting them to more radiation and toxic radiation agents.

The question O’Neill asked, however, dealt with the national standardization of EMRs, the digitized record systems of patients’ health that the federal government is spending billions of dollars to get physicians and medical centers to adopt.

“Why is it that we’re reluctant to declare that we are going to design the best prototype that we can with an idea that we will have [iterative versions] as we learn more and we identify more needs?” O’Neill asked. “Why is it that we can’t call to question and get on with what’s a clear and apparent need for a national standard that’s a work in progress?”

“It’s not that it has to be perfect from day one, but your office basically says, ‘We’re going to do this now’?”, O’Neill said before a packed house of doctors and administrators of corporatized health systems.

Several audience members asked the HIT chief questions after his speech, but O’Neill’s received the most head-nodding, with a quiet chorus murmuring “good question.”

O’Neill, who has authored academic papers on patient safety with current Medicare chief Dr. Donald Berwick and Lucian Leape himself, said he had once witnessed a $500 million investment in the proprietary development of a non-interoperable electronic medical records system, which he called a “travesty,” because while that system is locally useful, if a patient travels out of the state, that system is “not worth a damn.” He told the story of asking Bill Gates to develop a prototype for a national EMR, only to be told by Gates, “You know, Paul, it’s a good idea, but our customers would view that as competing with them, so we can’t do it.”

Blumenthal began addressing O’Neill’s long-winded question by pointing out that the former government executive worked in several Republican administrations (only to be corrected by O’Neill that he had also worked in the Kennedy and Johnson administrations).

“The federal government, I think, is capable of setting standards and we are doing it. Standards, for example, of what constitutes interoperability and what capabilities records have to have to be interoperable. We’ve set those standards in regulation. The first phase of it. And we will continue to refine those standards,” Blumenthal said. “There is a raging debate in the computer science world, which I have only lifted the lid on because I’m not a computer scientist, but it goes basically like this: Do we want a world where somebody sets very detailed standards for what computers have to do in order to create interoperability? Or do we want a world that’s a little bit more like the Internet, where a minimal set of standards was created and an enormous, vibrant competition and spontaneous growth occurred?”

Citing the analogy that “you build the interstate highway, but you don’t regulate what drives on it,” Blumenthal admitted that the debate has not yet been settled.

“I hear both sides of that argument, constantly, and even those people who believe in the minimal set of standards aren’t really sure what that minimal set is, but we’re working on precisely that,” he said.

The U.S. medical industry may be subject to more standards than any other industry in the world. There are lists of standardizations for insurance codes for procedures, drugs and devices. There are standards that the FDA uses for drug and device approvals. There are 13,600 diagnoses in the ICD9 procedure book that doctors code all their patient visits with. And there are 6,000 drugs and 4,000 medical and surgical procedures that doctors may prescribe, according to New Yorker contributor Dr. Atul Gawande .

“The volume and complexity of our discoveries has now reached a point where, I would argue, it has exceeded our ability as individual artisans to deliver optimal care reliably, safely and without waste of resources,” Gawande told the National Quality Colloquium for medical error reduction at Harvard University in August.

“We’re struggling with a structure of medicine that was built for a world that had many many fewer and simpler solutions. The structure of medicine is still prone for another era and was designed to be small and artisanal in nature,” he said. “We’re trying to deploy 13,600 different service lines, town by town, to every person alive. There’s no industry in the world that has a task that is remotely like that. To no surprise, we’re struggling.”

One way to overcome at least part of the struggle, as Blumenthal had when he was alerted to a patient’s allergies by an EMR, may be to start using a nationally, or even internationally, standardized system.

“Ignorance remains, but we have a new kind of human failure that has emerged as important and that is what the philosophers call ‘ineptitude,’ meaning that the knowledge is there, but the individual or group of individuals fail to apply that knowledge correctly,” Gawande said

Blumenthal, adamantly pro-EMR, said there is a move afoot to add technical fluency into certification for healthcare providers.

“Boards of certification, all the primary care boards of medicine have adopted principles that will lead them to create requirements for the use of electronic health systems as a research requirement, and even the medical licensing boards are beginning to think about whether the maintenance of licensure should be dependent, to some degree, on using electronic health systems,” he said. “Information is the lifeblood of medicine, and unless physicians and other healthcare professionals are capable of using the most modern technology available for managing information, I think they will have trouble claiming, in the 21st century, the unique competence that entitles them to being licensed and board certified. I think they’ll have trouble holding up their heads as professionals and claiming that they are at the top of their game and capable of providing the best care that technology allows.”


MassDevice Staff

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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