The purpose of this fact sheet is to establish and clarify standards and expectations associated with the delivery of occupational therapy services via information and communication technologies. Failure of occupational therapists (OTs) and occupational therapist assistants (OTAs) to comply with this regulation will be considered unprofessional conduct.
On September 25, 2013, the Food and Drug Administration (FDA) issued Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (The Guidance). The Guidance is meant to provide clarity and predictability for mobile medical application (app) manufacturers and other interested parties.
CCHP has compiled a summary of 2014 approved telehealth legislation.
On February 9, 2015, the Food and Drug Administration (FDA) updated Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (The Guidance). The Guidance is meant to provide clarity and predictability for mobile medical application (app) manufacturers, and other interested parties. This CCHP fact sheet helps to clarify these recommendations- including 2 easy to understand charts; one which outlines the Mecial device classifications and requirements and one which summarizes the FDA regulatory enforcemtent of Medical Apps.
On February 9, 2015, the Food and Drug Administration (FDA) issued Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration Staff (The Guidance). This CCHP fact sheet summarizes the purpose and intention of The Guidance.
