Revised Draft Bill Would Simplify Health IT Regulatory Framework

Lawmakers in Congress are circulating a revised draft bill intended to develop a regulatory framework for FDA's oversight of health IT, FierceHealthIT reports (Bowman, FierceHealthIT, 1/26).

Background on Original Bill

In October 2013, a bipartisan group of House lawmakers introduced the original bill, called the Sensible Oversight for Technology which Advances Regulatory Efficiency, or SOFTWARE, Act.

The measure would have classified software into three categories:

  • Clinical;
  • Health; and
  • Medical.

The measure would have amended the Federal Food, Drug and Cosmetic Act to give FDA guidance on regulating mobile medical apps (iHealthBeat, 1/3/14).

In December 2014, Rep. Marsha Blackburn (R-Tenn.) announced that she would reintroduce the bill in 2015 (iHealthBeat, 12/5/14).

Revised Bill Details

A revised version of the SOFTWARE Act, which is sponsored by Blackburn and Rep. Gene Green (D-Texas), would divide health IT into two categories, rather than three. The two new categories are:

  • Health software, which would remain unregulated; and
  • Medical software, which would be regulated by FDA (FierceHealthIT, 1/26). 

According to Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, health software refers to products that generate data which require interpretation by medical professionals. These products include "low-risk software," such as health and fitness applications, software for self-management of chronic conditions and tools that provide administrative and operational support (Wicklund, mHealthNews , 1/26).

Meanwhile, the draft bill's definition of medical software refers to products that analyze patient data to recommend treatments and do not require interpretation by a health care professional. The draft bill would require FDA to develop a new regulatory program to oversee medical software within two years of the bill's passage.

The draft bill also would define an accessory as a tool that is intended to be paired with another device to extend its functionality. According to the draft bill, such tools should be classified as distinct from medical and health software (FierceHealthIT, 1/26).


Thompson said, "It's a huge step forward in the sense that it is much clearer and in some ways more focused than the earlier version" (Sullivan, Government Health IT, 1/26).

Health IT Now Coalition Executive Director Joel White said the draft bill "will provide greater certainty and clarity to the market, which means more innovations and tools to improve patient outcomes."

Dan Haley, vice president of governmental and regulatory affairs at electronic health record vendor athenahealth, also praised the revised draft for taking "into account the perspectives and inputs of a wide variety of stakeholders" (Gold, "Morning eHealth," Politico, 1/26).

Source: iHealthBeat, Tuesday, January 27, 2015

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