The drumbeat to limit the FDA's regulatory authority over various software systems is growing.
Many interested parties are worried that the FDA will act to regulate electronic medical records (EMRs) and electronic health records (EHRs) with the same rigor applied to the software running a radiation therapy machine.
Tracy Jan of the Boston Globe spoke with Dan Haley, vice president for government and regulatory affairs at Athenahealth, a Watertown, Mass., health information firm. "Right now, the FDA has the authority to regulate all of health IT," Haley said. "They say they exercise discretion to pick and choose which technologies they regulate. From our perspective, that is just not a tenable state of affairs."
In her article, Jan wrote: "Backers of FDA regulation say digital records systems sometime contribute to prescribing errors and other patient mix-ups that can have dangerous, even fatal, consequences. Bad or missing data in a patient's computer record, for instance, can lead to catastrophic medication errors."
Read the rest of the story at Qmed.