FDA Approves Autism Diagnosis-Aid tool

Obtaining an Autism evaluation and diagnosis is normally a long process,  however thanks to the new FDA approved Cognoa ASD Diagnosis Aid also known as Canvas Dx, the software will allow for more accessible way to gather data for children between the ages of 18 months to 72 months  to determine if the child qualifies for a diagnosis at an earlier stage than the traditional route. Canvas Dx will allow physicians to observe and take in information regarding the patient through the three techniques of inputting information, a parent/caregiver questionnaire, a questionnaire completed by a video analyst after submission of child activity, and an HCP (health care provider) questionnaire completed by a physician. Canvas Dx is prescription use only and must come from a patient’s provider or pediatrician.

Cognoa is a new innovation in Pediatric Behavioral Health. It is the first digital diagnosis aid for Autism. “Cognoa is a pediatric behavioral health company developing diagnostic and therapeutic solutions with the goals of enabling equitable access to care and improving the lives and outcomes of children and families living with behavioral health conditions, starting with autism” (Cognoa). The goal of Cognoa is to reach those with behavioral health issues at an earlier time. Cognoa works with Canvas Dx, which

While this innovation sounds wonderful there are many concerns and questions. The most pressing one being that Canvas Dx is FDA approved, but there are concerns around their HIPAA compliancy. With parents/caregivers submitting personal videos and information regarding their children they would like to know that is not being stored or sold. HIPAA (Healthcare Insurance Portability and Accountability Act) compliancy is the protection of healthcare information. Without HIPAA these practices are allowed to share or sell a patient’s information without informing a patient or their caregivers.

New technology like such is a benefit to the healthcare realm. The ability to provide care in a timelier manner for diagnoses that are time sensitive is a great service. However, HIPAA compliancy is extremely important to patient care and is not something that should be lightly looked over. In today’s society with consumer information being sold and passed around it is only proactive to avoid having your child’s personal health information shared in any capacity. Cognoa’s website nor Canvas Dx has provided information to the privacy of the data, or the use of the data outside of obtaining proper diagnosis, NuPrisma reached out for comments to confirm HIPAA and EPHI compliance, but the company did not provide any feedback on this matter.

When considering Cognoa or any other software where information is shared, users should be aware of the privacy laws their data is being protected under in order to make informed decisions of how exactly their data is being used or shared.

**Nuprisma reached out to Canvas Dx in regard to these questions and concerns and we did not hear any information back.

https://cognoa.com/about/