Digital Health Software, Does FDA Intend to Regulate It or Not?

Event Description

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.


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.


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


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:  Please provide notification at least 72 hours prior to the meeting to allow sufficient time to make arrangements for accommodations. Thank you.

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Pre-Registration is Closed

Friday, December 20, 2019

8:00 AM to 9:00 AM

River Room / Town and Country Club Saint Paul, MN United States