By law, hospitals are required to report medical mistakes that result in a medical malpractice judgment or settlement. When it comes to faulty electronic records and mistakes caused by medical software products, the software companies responsible are not required to report mistakes that put patients at risk. The Department of Health and Human Services declined to impose regulations or make such reporting a requirement recently. It did, however, call for vendors who provide such software to voluntarily report safety events and to create a code of conduct to self-regulate.
Electronic health records are becoming more common throughout the United States. According to HHS, nearly 100,000 health care providers are now using such records. Electronic records offer a number of advantages over paper records, though they are not without their drawbacks. A panel appointed by the Institute of Medicine raised concerns about information being lost and about the practice of hospitals to shield software vendors from potential lawsuits from patients who were harmed by software malfunctions.
The voluntary steps being requested by HHS include the collection and analysis of situations where patients were harmed. It is also asking that the performance of health care software be tracked. Consumer groups may not be appeased by these measures and have asked that electronic health record software be treated like a medical device. That would give the Food and Drug Administration power to regulate the software and would allow injured patients to pursue compensation from software developers if a malfunction or improper design caused an injury. As electronic records gain more widespread use, the problem of faulty software will only increase.
Source: Kaiser Health News, “HHS Stops Short Of Calling For Safety Regulation Of Digital Records,” by Jay Hancock, 21 December 2012