The Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act, which aims to exempt low-risk medical software and mobile medical apps from regulation by the U.S. Food and Drug Administration, officially was introduced to Congress Dec. 4.
The bill, introduced by Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah, pictured), is "the beginning of a conversation" on the issue of health IT regulation, Hatch told FierceHealthIT in an email. Although the bill was introduced with less than a month remaining until the 113th Congress adjourns on Jan. 3, Hatch said it will be reintroduced in the 114th Congress, as well.
Hatch said this bill differs from legislation proposed in October 2013 by Rep. Marsha Blackburn--the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act--in that it is slightly more specific.
"Our bill attempts to create specific legal definitions around types of software to exempt them from FDA regulation," Hatch told FierceHealthIT. "Specifically, the bill limits and clarifies the FDA's role regarding regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records and software that aids healthcare providers in developing treatment recommendations for their patients."
Blackburn's bill, which she plans to update and reintroduce in 2015, as well, sought to amend section 201 of the Federal Food, Drug, and Cosmetic Act to regulate medical software and to provide guidance to the FDA about mobile medical app regulations. Currently, it defines three classification levels of software--clinical software, health software and medical software.
Hatch also said his bill, in conjunction with a repeal of the medical device tax, is important to protecting and enabling innovation in healthcare. "Since the tax took effect last year, it has been a drain on American innovation, job growth and our ability to provide groundbreaking medical technologies to patients in need," he said.
Health IT Now Executive Director Joel White called the new proposal "critical" to quality care.
"It is time for our laws to reflect the technological advancements made in our healthcare system over the past four decades," White said in a statement. "It is unacceptable that the laws currently governing health software, mobile apps and devices like cellphones and tablets were designed and passed when ABBA was popular and the Watergate scandal was just unfolding."