A coalition of 15 patient groups said it wants to see the Food and Drug Administration Safety Innovation Act workgroup take its time in crafting a risk-based framework for health IT regulation, in a letter sent to federal officials this week.
The letter piggybacks on a similar letter last month that called on the Obama administration to work with congress on health IT oversight, and suggested that congress also look to revise the Food, Drug and Cosmetic Act "to reflect the explosive growth in and rapidly evolving nature of information technology in healthcare."
The letters were sent to U.S. Department of Health & Human Services Secretary Kathleen Sebelius; Federal Communications Commission Acting Chairwoman Mignon Clyburn; U.S. Food and Drug Administration Commissioner Margaret Hamburg; and National Coordinator for Health IT Farzad Mostashari.
"While proper oversight of health IT is critical to ensuring patient safety, such oversight must be implemented in a balanced way that also fosters innovation and encourages adoption" of interoperable electronic solutions that boost patient safety, the letter reads. "We believe that, by working collaboratively, congress and the administration can produce a statutory framework for regulation of health IT based on risk while supporting innovation and patient safety."
The FDA, the Office of the National Coordinator for Health IT and the Federal Communications Commission jointly published a request for information in theFederal Register last month asking for "broad input" on what elements should be considered for a risk-based regulatory framework to be proposed for health IT.
To learn more:
- read the letter