An Institute of Medicine (IOM) report, released this week, that calls for establishment of an independent federal entity to investigate patient deaths and serious injuries associated with health IT has garnered mixed reviews.

On the one hand, many healthcare stakeholders applaud the report's call to oversee development of health IT as a way to bolster patient safety. But many are also wondering why these safety issues are raised now, after billions of dollars have already been spent installing health IT systems.

"It seems to me that it is quite remarkable that we're in this situation," Dr. Richard Cook, associate professor at the University of Chicago's department of anesthesia and critical care, said Thursday during a webcast held by IOM to discuss the report. Cook went on to say, "the idea that you have to wait until you've invested $30 billion in something to discover that it isn't working very well is clearly a nonstarter."

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The IOM report, Health IT and Patient Safety: Building Safer Systems for Better Care, concludes that health IT can improve the quality of healthcare delivery, but the current literature is inconclusive regarding the overall impact of health IT on patient safety. The report also said stakeholders must coordinate their efforts to better understand the risks associated with health IT and improve its safe design, implementation, and use.

Among its recommendations: Department of Health and Human Services (HHS) secretary Kathleen Sebelius should publish an action and surveillance plan within 12 months to work with the private sector to assess the impact of health IT on patient safety and minimize risks associated with its implementation and use. Then if the secretary concludes that progress toward improving safety is insufficient within a year, the Food and Drug Administration should regulate these technologies. Alongside HHS' efforts, the FDA should take initial steps to develop a framework for potential regulation of EHRs, health information exchanges, and personal health records so that the agency is ready to act if necessary.

The report also said that HHS should:

-- recommend that Congress establish an independent federal entity for investigating patient safety deaths, serious injuries, or potentially unsafe conditions associated with health IT;

-- ensure that health IT vendors facilitate the free flow of information; and

-- fund a new health IT safety council to evaluate the criteria for assessing and monitoring the safe use of health IT.

But in reaction to the IOM's concerns about IT safety, Cook said, "It is not surprising that such events are now being discovered in health IT. What is surprising is that those creating and promoting these large systems have neither anticipated them or look for them ... Development of [health IT] is marked by an optimism about the effects of IT that are unwarranted and naive, and the willingness to embrace this optimism, to the extent that making largescale investments in these systems and only later asking what their impact might be on patient safety, borders on recklessness."

Ashish Jha, associate professor of health policy and management at Harvard University's school of public health, countered Cook's argument saying that it's difficult to assess what the health IT risks are unless the systems are implemented and being used.

"When nobody has these health IT systems it's really hard to study how they're being used. Now that the implementation has happened, ... now [is] the time to really begin to study this in earnest, and I think our committee's report was very clear that this is the kind of information that we need now to help make the system safer," Jha said.

Cook shot back, "Nothing could be further from the truth; we do that for many, many systems with safe software," Cook said. One does not have to "put things out in the field and then wait to see whether or not they work. Nobody bothered to look, it's that simple," he said.

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