FDA considers regulation of 'safety risks' of health IT

The Huffington Post (or HuffPo) isn’t a usual source of eHealth information for this editor (Donna), but this report from their ‘Investigative Fund’ about FDA moving to regulate electronic medical records (EMRs) and HIT companies appears to be a primary report.  “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.”  Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, will be testifying on these errors in remarks prepared for a government hearing on Thursday.  This comes on the heels of up to $27 billion in ‘stimulus’ monies to convert hospital and medical practice paper records to EMRs on everyone by 2014.  The article does present some of the self-regulation point of view as well as the usual industry critics.  Your thoughts, please.  Article.

[Editor’s update 26 Feb:  Brad Thompson’s lead article today in Mobihealthnews following on this presents an experienced regulatory attorney’s point of view.  But the start is dismaying: Dr. Shuren’s rather broad remark “Under the Federal, Food, Drug, and Cosmetic Act, HIT software is a medical device.”  Seven key points made by Thompson:

  • if it impacts health, FDA gets interested
  • their natural reaction is to interpret the scope of their authority very broadly and then tier it, making distinctions based on risk
  • FDA does not care if it’s complex or if their involvement will slow down important technologies.  High complexity+high public health involvement=FDA involvement
  • if FDA is now thinking about regulating EMRs, then FDA will probably have a view on the hardware and software in between the patient and the EMR
  • it’s not far, then, to look at mHealth and possible regulation of smartphones
  • conclusion:  this is the beginning of a conversation, Dr. Shuren is not being dogmatic and is looking for best approaches (this is a tone point that I expect will be debated)
  • the approach will start and end with concern for the patient