Bradley Merrill Thompson wrote an article titled “Set the FDA Mobile Medical App Guidance Free” on MobihealthNews.com.
Following is an excerpt:
I feel like a dissident trying to convince the government to free a political prisoner. That’s a pretty apt description, considering that the FDA’s Mobile Medical App (MMA) guidance document is being held hostage purely on political grounds.
Earlier this year, a DC advocacy group decided they wanted Congress to adopt an entirely different approach to health IT. The group seems to be concerned that regulatory systems adopted years ago may not make sense for the technology of today. I happen to agree with them in many respects. In fact, this week my law firm will submit to the federal government our white paper entitled: “Enhancing Innovation in e-Health through a Systems Approach to Regulation: A Blueprint for FDA Modernization.” The paper is designed to encourage innovation in e-health, and especially mHealth, and outlines specific changes needed to modernize the FDA regulatory system to effectively address unique aspects of e-health.
But somehow, from the fact that the FDA regulatory system is antiquated and in need of modernization, this DC advocacy group concluded that FDA publishing this summer its final guidance on mobile medical apps is a threat to what they want to accomplish on Capitol Hill. I do not understand that. Their concerns do not seem to be based in the substance of the guidance or the regulatory realities facing mHealth entrepreneurs today.
Nevertheless, in a letter that was obliquely written, the advocacy group, together with other groups they invited to join in, requested that HHS slow down its policymaking. Specifically they asked HHS not to release any new agency guidance on HIT until after January 2014 when HHS is scheduled to make strategic recommendations to Congress called for under section 618 of FDASIA. The apparent target for that requested delay is the publication of this FDA MMA guidance.