Health IT Industry, FDA at Odds Over Regulatory Authority

February 26, 2014 in News

The health care industry and some congressional lawmakers are working to tamper down FDA’s regulatory authority over health IT, the Boston Globe reports (Jan, Boston Globe, 2/24).


In September, FDA issued final guidance for mobile health applications. According to the final guidance, FDA will focus oversight on apps that:

  • Were developed to be used as accessories to regulated medical devices, such as apps that allow health care providers to make diagnoses by viewing medical images on smartphones or tablets; or
  • Can transform mobile devices into regulated medical devices, such as apps that allow a smartphone to be used as an electrocardiography machine (iHealthBeat, 9/23/13).

Following the guidance, Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine) introduced legislation that would clarify FDA’s regulatory framework for health IT and ensure that “low-risk” products are not the focus of oversight.

The Preventing Regulatory Overreach To Enhance Care Technology — or PROTECT — Act of 2014 is the Senate companion bill to the bipartisan House SOFTWARE Act (HR 3303). Specifically, it would clarify the agency’s regulatory process to make sure it primarily focuses on technologies that pose the most health risks.

The bill also would exempt certain health IT software from being charged a 2.3% medical device tax, including:

  • Electronic health records;
  • Scheduling software; and
  • Wellness applications (iHealthBeat, 2/11).

Potential Showdown

Supporters of the increased regulation say the rules are needed to hold vendors accountable and ensure patient safety.

However, opponents say FDA’s oversight could increase costs, stifle innovation and hinder necessary software upgrades (Boston Globe, 2/24).

During a panel discussion on congressional affairs at the Healthcare Information and Management Systems Society’s annual conference, Mitchell Vakerics — legislative counsel for Rep. Renee Ellmers (R-N.C.) — said, “You have the FDA rule that came out in 2013 which basically said they will regulate mobile apps as a medical device if they see fit. So, that is a cause for some concern.” He added, “What we don’t want is the FDA to go too far, stifle an industry and over-regulate it” (Slabodkin [1], Health Data Management, 2/25).

Federal Officials Discuss Upcoming Regulatory Report

At a separate HIMSS panel, federal officials from FDA, the Federal Communications Commission and the Office of the National Coordinator for Health IT said a report to Congress on a risk-based regulatory framework for health IT should be released by the end of March.

The report, which was due to Congress by January 2014, is required under the Food and Drug Administration Safety and Innovation Act (Slabodkin [2], Health Data Management, 2/25).

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