Health IT: The Coming Regulation

The Food and Drug Administration has spent decades refining its processes for approving drugs and devices (and is still refining them), so what would happen if they extended their scope to the exploding health software industry? The FDA, and its parent organization, the Department of Health and Human Services, are facing an unpleasant and politically difficult choice.

Sticking regulatory fences into the fertile plains of software development and low-cost devices will arouse its untamed denizens, who are already lobbying Congress to warn the FDA about overreaching. But to abandon the field is to leave patients and regular consumers unprotected. This is the context in which the Food and Drug Administration, the Office of National Coordinator, after consultation with outside stakeholders, released a recent report on Health IT...