Bill Intended to Clarify FDA Oversight Over Mobile Applications Introduced
Tuesday, October 22, 2013
bipartisan group in the House of Representatives, all members of the Energy
& Commerce Committee, recently introduced a bill entitled the
"Sensible Oversight for Technology which Advances Regulatory Efficiency
(SOFTWARE) ACT." The legislation is intended to provide regulatory clarity
regarding mobile medical applications and other electronic health records and
software. A joint press release after the introduction of the legislation
indicated that "the SOFTWARE ACT tailors the Food and Drug Administration's
(FDA) authority to the realities of the 21st century by focusing their
authority onto the products that pose a potential risk to human health."
The legislation follows a series of Energy & Commerce Committee hearings
earlier this year in which the committee investigated potential regulations and
taxes on smartphones, tablets and mobile applications.