The FDA’s crackdown on 23andMe has called attention to the agency’s ability to apply the most stringent form of regulation to emerging technologies that promise to revolutionize health care – but that probably wouldn’t survive having to deal with the staggeringly expensive and slow regulatory approval process the FDA applies to prescription drugs.
Today, bipartisan legislation was introduced in the Senate mirroring similar legislation in the House that would bar the FDA from regulating “clinical software” and devices used by health care providers or “health software” such as apps used by consumers unless either is used for diagnostic purposes. That draws a line between high-risk technologies whose failure could injure patients, while preventing the FDA from needlessly regulating all the other forms of technology used by doctors (computers, health records, etc.) or health apps that simply provide medical information.
Unfortunately, because the FDA would still retain the discretion to determine what constitutes diagnoses, the bill would not prevent the FDA from limiting services like 23andMe, which the agency claims are used for diagnostic purposes. But the bill would prevent needless over-regulation of a growing sector of health IT technologies. The Federal Trade Commission, states and private plaintiffs could still apply general consumer protection laws to these apps, so the bill doesn’t “deregulate” them so much as ensure that non-diagnostic health IT tools are treated the same way all IT tools are treated.
In the House, Rep. Marsha Blackburn’s Software Act has 25 co-sponsors, a mix of Democrats and Republicans. Here are Sens. Debbie Fischer (R-NE) and Angus King (I-ME) introducing the Preventing Regulatory Overreach To Enhance Care Technology Act (PROTECT Act) of 2014, which is also sponsored by Sen. Marco Rubio (R-FL):