FDA Considers Regulations for Health IT Systems | Executive Gov

After reports emerged of patient deaths and several dozens of injuries linked to malfunctions in the health IT (HIT) systems, the Food and Drug Administration is now considering regulating the new technology for the first time ever.

In a testimony prepared for a government hearing yesterday, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said because the reports are “purely voluntary, they may represent only the tip of the iceberg.”

In an attempt to improve the quality of medical care, reduce costs and decrease medical errors and waste, hospitals and healthcare facilities are spending up to $27 million in stimulus money to purchase electronic medical records systems that rely on digital software. However, the new systems have proven to be anything but problem free. Over the past two years, the FDA’s voluntary notification system logged 260 reports of “malfunctions with the potential for patient harm,” including 44 injuries and six deaths. In addition, the systems have mixed up patients, put test results in the wrong person’s file and lost vital medical information.

“The FDA recognizes the tremendous importance of HIT and its potential to improve patient care,” Shuren said. “However, in light of the safety issues that have been reported to us, we believe that a framework of federal oversight of HIT needs to assure patient safety.”

To fix the problem, the FDA has outlined three possible approaches for tighter scrutiny. In the first scenario, FDA could require makers of the devices to register them with the government and to submit reports on safety issues and correct eventual problems.  The FDA could track this information “to help improve the design of future products.” In the second scenario, the agency could require manufacturers to report safety concerns and set minimum guidelines and standards. In the third scenario, the systems could be included in broader regulatory actions that new medical products must face before they ever reach the market.

Regulations do not guarantee safer electronic medical records and they might even limit innovation and responsiveness, said Carl Dvorak, executive vice president of Epic Systems Corporation, a company that builds systems mainly for hospitals and large medical practices. However, another vendor, Cerner Coporation, favored increased scrutiny. In the recent years, Cerner has reported potential safety concerns because it is the “right thing to do,” a company official said.


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