HCBA Lawyer Magazine Vol. 29, No. 1 | Page 44

CHeCK out MY CliniCAl softWAre tHAt definitelY is not A MediCAl deViCe
Health care law section
Chairs: TJ Ferrante – Foley & Lardner LLP & Kevin Rudolph – Shriners Hospitals for Children
Because of the advancements
in technology in the mobile
medical applications space,
the Cures Act attempted
to carve out certain types
T
of Cds from consideration
he Food and Drug
Administration (FDA)
recently requested
public comment on
the exclusion of certain software
functions from FDA regulation
by virtue of the 21st Century
Cures Act’s (Cures Act) amended
definition of a medical device.
FDA sought feedback on the
risks and benefits of exempting
certain software functions from
consideration as medical devices.
u September 6, 2018
as medical devices.
© Can Stock Photo / pressmaster
One particular area that has
generated confusion is how the
FDA treats clinical decision support
software (CDS).
CDS is software that is intended
to provide decision support for the
diagnosis, treatment, prevention,
cure, or mitigation of diseases or
other conditions. Because of the
advancements in technology in the
Continued on page 43
qSave the Dates
Membership Luncheon at the
Hilton Tampa Downtown
u October 3, 2018
22nd Annual Bench Bar Conference
& Judicial Reception at the Hilton
Tampa Downtown
u November 9, 2018
YLD Annual Golf Tournament,
Temple Terrace Golf & Country Club
u December 6, 2018
Holiday Open House at the
Chester Ferguson Law Center
42
mobile medical applications space,
the Cures Act attempted to carve
out certain types of CDS from
consideration as medical devices.
Section 3060 of the Cures Act
removed certain CDS from the
definition of a device as long as
the CDS:
u January 9, 2019
Diversity Membership Luncheon
at the Hilton Tampa Downtown
u April 13, 2019
Pig Roast/5K
5 Pro Bono River Run, Stetson
University College of Law Tampa Campus
u May 8, 2019
Law Day Membership Luncheon
at the Hilton Tampa Downtown
Learn more about HCBA events at
www.hillsbar.com.
StAy ConneCted
SEPT - OCT 2018
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HCBA LAWYER