Skip to main content
On Demand

Software as a Medical Device in Childhood Mental Health

Total Credits: 1 including 1 AOA Category 1-A Credit(s)

Average Rating:
Not yet rated
State Associations:
POMA - Pennsylvania
Paul Ballas, DO
56 Minutes
Never expires.


Per FDA and IMDRF, the term “Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. While healthcare technology is leaps and bounds ahead of where it was only a few years ago, the need for better access in rural or remote areas of the US is greatly needed. This session will address how software can be used by physicians to complement an existing therapeutic mental health treatment program.

At the conclusion of this session, the participant should be able to: 
- Identify FDA approved software that can be used as a medical device for treating childhood mental health.

Disclosure Statement: Dr. Ballas, faculty for this educational event, is clinical director of regulatory affairs for Floreo, Inc. and is on the physician advisory board for Woebot. All relevant financial relationships listed have been mitigated.

Accreditation Statement: The Pennsylvania Osteopathic Medical Association (POMA) is accredited by the American Osteopathic Association (AOA) to provide osteopathic continuing medical education for physicians. POMA designates this activity for a maximum of 1.0 Category 1-A AOA CME credits and will report CME and specialty credits to the AOA commensurate with the extent of the physician’s participation in this activity.

Grievance Statement: If you are not satisfied with the program, you may file a written grievance by emailing Your complaint will be forwarded to the Education Committee for review.  The committee will determine if the participant should be reimbursed with no credits or deny the complaint and take the issue into consideration for future programs.



Paul Ballas, DO's Profile

Paul Ballas, DO Related Seminars and Products

Paul A. Ballas, DO, “Software as a Medical Device (SaMD) in Childhood Mental Health,” is director of medical affairs with Floreo, Inc., located in Rockville, Maryland and a consultant with Woebot Health, located in San Francisco, California. Board certified in child, adolescent and adult psychiatry, he is an attending psychiatrist at Friends Hospital in Philadelphia. Dr. Ballas is a graduate of Shippensburg (Pa.) University, Case Western Reserve University in Chicago, Illinois, and a 2004 graduate of the Philadelphia College of Osteopathic Medicine. He completed an internship, psychiatry residency, and child and adolescent psychiatry fellowship at Thomas Jefferson University Hospital in Philadelphia.

Dr. Ballas is an employee with Floreo, Inc. and a consultant at Woebot Health. All relevant financial relationships listed have been mitigated.

Alternate Options

PFO – What We Know and What We Don’t Know
Original Program Date: 05/03/2023
Suicide Assessment in a Primary Care Setting
Original Program Date: 05/04/2023
Case Studies in Rheumatology
Original Program Date: 05/04/2023
Management of Benign Prostatic Hyperplasia
Original Program Date: 05/04/2023
The Weekend Warrior and Associated Emergencies
Original Program Date: 05/04/2023
Type 2 Diabetes: So Many Meds, So Many Directions
Original Program Date: 05/04/2023
Adolescent Sports Injuries
Original Program Date: 05/05/2023
PIAA Physical Exam: What You Need to Know
Original Program Date: 05/05/2023
Obesity Management and Weight Loss Medications
Original Program Date: 05/05/2023
Mild Cognitive Impairment
Original Program Date: 05/05/2023
Bias in Evidence-Based Medicine
Original Program Date: 05/06/2023