FDA, HHS at Odds over Digital Medical Records Safety Oversight

As the Obama administration ramps up plans to create a digital medical file for every American by 2014 -- at an anticipated cost of up to $27 billion -- technology's boosters tend to tout its potential benefits to patients and ability to slow runaway medical costs. Yet despite the high political and financial stakes, the Administration has established no national mandatory monitoring procedure for the new devices and software.

That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry. The industry argues that even with flaws, digital systems are an improvement over current paper records. Detailed government regulations announced July 13 spell out how doctors and hospitals can collect stimulus money to help defray the costs of buying digital systems. But safety and quality standards -- which Food and Drug Administration officials had suggested earlier this year could be in the offing -- weren't included. The safety debate has long pitted the FDA, with the duty to make sure medical devices are safe and effective, against the Office of National Coordinator, whose central task is to promote the technology's swift adoption. Under Dr David Blumenthal the office has campaigned tirelessly since last April to sell the medical community and the public on the wisdom of spending billions of tax dollars for digital records. Many industry groups contend that FDA regulation would "stifle innovation" and stall the national drive to wire up American medicine. That view resonates among the dozens of health information technology experts serving as consultants to Blumenthal's office and on advisory groups. Dr Blumenthal also has been skeptical of the need for regulation and argued that even if some miscues occur, digital systems are far less prone to error than paper ones.