FDA to regulate health information technology?

Fred Schulte and Emma Schwartz, the Huffington Post Investigative Fund duo who have made it their business to stay in front of all stories related to the federal push for the adoption of health information technology, now look at the possibility of federal regulation of health IT.

Schulte and Schwartz write that “In the past two years, the agency has received reports of six patient deaths and several dozen injuries linked to malfunctions in the systems,” and officials say those voluntary reports represent just the tip of the iceberg. In case you’re interested, here are the transcripts from the relevant government hearing.

Photo by brianjmatis via Flickr.

… digital medical systems are not risk-free. Over the past two years, the FDA’s voluntary notification system logged a total of 260 reports of “malfunctions with the potential for patient harm,” including 44 injuries and the six deaths. Among other things the systems have mixed up patients, put test results in the wrong person’s file and lost vital medical information.

Schulte and Scwartz summarize the three possible regulatory approaches outlined by officials:

  • Option 1: FDA requires HIT makers to register, submit safety reports and correct problems.
  • Option 2: FDA requires HIT makers to report safety concerns and sets minimum quality guidelines.
  • Option 3: FDA makes HIT “subject to the broader regulatory actions that new medical products must face before they ever reach the market.”

Many manufacturers argue that such regulation could be counterproductive.

The manufacturers of the systems generally have opposed regulation by the FDA, arguing in part that imposing strict controls would slow down the government’s campaign to spur widespread adoption of the technology.

Regulation will not necessarily create a “safer” electronic medical record “and might actually limit innovation and responsiveness when it is needed most,” Carl Dvorak, executive vice president of Epic Systems Corporation, a Wisconsin-based company that builds the systems mainly for hospitals and large medical practices, said in his prepared testimony for Thursday’s hearing. The hearing is being held by an advisory group created by the stimulus law.

Government Health IT also is following the issue and points to some problems the Veterans Health Administration has run into and how it dealt with the lapses.

1 thought on “FDA to regulate health information technology?

  1. Justin

    Certainly even 1 death or injury is one too many. However, over many years of using these kind of systems and 260 cases still seem low. How many cases were these systems used in?

    It’s still a numbers game. To expect 100% perfection or accuracy seems slightly naive.

    [Editor’s note: Off-topic link deleted.]

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