House Set To Tackle Busy HIT Agenda
By Christine Kern, contributing writer
Passage of the SOFTWARE Act as part of 21st Century Cures Package one of several Health IT items on the docket.
The new Congress is poised to address healthcare software regulation, data security, and data privacy issues when it resumes work in January. Modern Healthcare reports Rep. Marsha Blackburn (R-TN) predicted as much at a Bipartisan Policy Center event last week, saying “We have a very aggressive agenda.”
In her remarks, Blackburn confirmed the SOFTWARE (Sensible Oversight for Technology Which Advances Regulatory Efficiency) ACT, which she introduced in 2013, will be part of a 21st Century Cures Package scheduled to be introduced by the House Energy & Commerce Committee in January.
Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) launched the bipartisan 21st Century Cures initiative earlier this year to examine the full arc of the cures process, from discovery, to development, to delivery. Last month, they joined in the 2014 Partnering for Cures event in New York City to promote collaboration and accelerate the pace of cures in America.
Prior to that event, Upton stated said, “21st Century Cures is a top priority at the Energy and Commerce Committee and its success is attributed in large part to the great ideas and support from folks all across the country. I look forward to gathering more ideas at the Partnering for Cures event on Monday as we continue drafting legislation to be introduced in early 2015. Patients and families cannot wait. Diana and I will do our part to ensure that these conversations lead to substantive legislation that will become law.”
Health Data Management explained Blackburn’s proposed bill would establish a risk-based regulatory framework for health IT. It creates three broad categories of software – clinical, health, and medical – and subjects only the last to regulation under the proposed legislation.
The Senate introduced a companion bill, the PROTECT Act in early 2014. Under both pieces of legislation, “clinical software” and “health software” would both be exempted from FDA oversight, focusing attention instead on “medical software” that poses the greatest risk to patient safety.
“The goal of the legislation is to develop a regulatory framework for software used in the healthcare setting, including mobile medical apps, that protects patient safety and provides regulatory clarity and certainty,” Health Data Management quoted Blackburn as telling a Dec. 3 Bipartisan Policy Center forum in Washington, D.C. “We think it’s important enough that we’ve spent about a year and a half working this legislation.”