Co-Sponsored by the
MSBA Health
Law Section and Food
Drug & Device Law Section.
Breakfast, registration and networking will start
after 7:40 am. The CLE program is
from 8:00 am to 9:00 am.
Program:
Digital health software
is almost everywhere in health care today. FDA is catching up to the marketplace
with their release of several key guidance documents in September.
This presentation discusses changes made to the definition of a medical device
by the 21st Century Cures Act. We will be discussing FDA’s current
thinking regarding the regulation of digital health products including the scope
of software functions that are excluded from the definition of device, software
functions that may be a device but FDA chooses not to regulate and what software
functions remain the focus of FDA regulatory oversight. We also will
briefly touch upon privacy and cybersecurity issues as they relate to digital
health products.
Presenters:
Patricia F. Kaufman , Of Counsel | STINSON LLP
Amy Fowler, RAC,
JD, President | Pathmaker FDA Law
CLE Credits:
1.0 Standard CLE Credit | Event code: 282900
Remote Participation:
Teleconference is available. Please indicate that you will attend
remotely when registering. Instructions will be sent via e-mail a day
prior to the program.
Deadline to
Register: December 18, 2019
Cost:
Health Law and/or Food Drug & Device Law Section Members:
$15.00
MSBA Members NOT in either Sections: $20.00
Non-MSBA
Members: $30.00
Law Students: Free
New Admittees (attorneys admitted
to the Minnesota Bar after January 1, 2019): Free
Join the Health Law Section and/or the Food Drug
& Device Law Section : MSBA members who are not members of either Sections can join
and attend this CLE for FREE. Click here to add
the sections to your membership and then contact Geen Mui to register for this meeting at no
charge.
Want more information about the Health Law
Section?
To register with a check, please mail in this
registration form.
Need to cancel? Please see our cancellation policy.
Questions? Contact Geen Mui |
612-278-6346
The MSBA is committed to creating an inclusive environment in which all
members can participate fully. If you need reasonable accommodations to
participate in this event, please notify Geen Mui via phone or email: gmui@mnbars.org. Please provide
notification at least 72 hours prior to the meeting to allow sufficient time to
make arrangements for accommodations. Thank you.