Many doctors are turning to computers these days to help them diagnose and treat diseases. But the technology itself may have to pass a checkup soon. The Food and Drug Administration has dispatched a task force to consider how to regulate medical software and hardware. Many industry wizards are uneasy at the prospect of federal meddling.
The FDA is concerned about the use of computer chips in various biomedical devices, such as a pump that meters insulin dosages for diabetics. And new software that can organize vast databases of symptoms and diseases, to assist doctors in making diagnoses, is becoming available.
The FDA argues that many of these products should be considered medical devices that directly affect patient health, thereby falling under its jurisdiction. One of the difficult problems is defining exactly which classes of hardware and software should be regulated. Some observes fear that FDA clearance would slow product introductions by years, scaring off start-ups and stunting innovation.
"What worries me is that there's no particular expertise in the FDA," says Bruce Buchanon, professor of computer science research at Stanford University and a pioneer of software development for data interpretation in medical diagnosis. "It would be all too easy for them to establish arbitrary and unattainable standards. This could mean prolonged delays in the introduction of products, which would make a significant difference in the quality of health care."
The task force will deliver recommendations early this year. Considering President Reagan's opposition to regulation, an attempt to broaden the FDA's role could be hazardous to the agency's health.