Prescription digital therapeutics (PDTs) are evidence-based medical interventions that use software accessed on a tablet or smartphone to prevent, manage, or treat a range of diseases and disorders. PDTs can allow patients to receive high-quality care without being required to travel to a healthcare facility. Cleared by the Food and Drug Administration (FDA) as medical devices, PDTs require a prescription by a clinician for patients to access the treatment. Historically, only healthcare professionals with state authorized prescription authority such as physicians, dentists, and veterinarians, have been allowed to prescribe PDTs. However, as Bradley Thompson recognizes in Prescription digital therapeutics don’t need a physician, there may be a broader group of healthcare professionals that have authority to prescribe PDTs.
As Thompson explains in his article, federal law relating to prescription of medical devices is distinguishable from federal law of prescription drugs. While state laws govern which health professionals and dispensaries are authorized under state law to provide prescription drugs, federal law on prescription medical devices is much broader. Unlike prescription drug law, federal law for prescription medical devices allows medical devices to be sold on “prescription or other order of such practitioner for use in the course of his professional experience.” Thus, Thompson explains that the “other order of such practitioner for use in the course of his professional experience” allows for other health professionals like psychologists to order PDTs. In his view, this interpretation would be consistent with the current use of medical devices by chiropractors using manipulation devices and speech language pathologists using voice level recorders. The full article can be read here.
Aimed Alliance spearheads ACTION for PDTs, multidisciplinary partnership that is working to expand the adoption, coverage, and access to PDTs for individuals with chronic diseases. To learn more about ACTION for PDT’s upcoming work, click here.
Last Updated on December 23, 2021 by Aimed Alliance
