Frequently Asked Questions
Why use ART?
Please see Why use ART? page.
What types of errors does ART software catch?
All checks whose input exists in structured format such as in databases or structured documents can be automated. Almost all checks fall under this category. A great source of information on the types of errors that can occur in radiotherapy is ASTRO's RO-ILS.
Is ART software FDA approved?
Software designed by ART meets the definition of a Medical Device Data System (MDDS). (See: FDA MDDS ).
In the past, MDDS were designated as Class III (high risk) devices and required FDA clearance/approval. On February 15, 2011 the FDA issued a regulation down-classifying MDDS from Class III (high-risk) to Class I (low-risk). More recently, on February 9, 2015, the FDA issued guidance informing manufacturers, distributors and other entities that the Agency does not intend to enforce compliance with regulatory controls that apply to MDDS due to the low risk they pose to patients and the importance they play in advancing digital health.
Regardless of the FDA's lack of intent to enforce Class I controls for MDDS, ART is committed to validating all software for its intended use according to established protocols and to documenting such validation.
Would ART sign a HIPAA Business Associate Agreement?
Yes. A Business Associate Agreement between ART and the clinic is necessary for HIPAA compliance.