Medical Device Companies

Designated personnel can share patient information with medical device companies when the medical device company needs the information:

• As a healthcare provider, to furnish a medical device in accordance with a prescription
• To bill for a medical device furnished to a patient in accordance with a prescription
• To fulfill their regulatory duties to track FDA "trackable" devices
• If working under the jurisdiction of the FDA, to conduct activities related to the quality, safety or effectiveness of an FDA-regulated product for which they have responsibility.
• To counsel a surgeon on or determine the appropriate size or type of prosthesis for the surgeon to use during a patient's surgery, or otherwise assist the doctor in adjusting a device for a particular patient.
• To provide support and guidance to a patient, or to a doctor with respect to a particular patient, regarding the proper use or insertion of the device.

When a medical device company is not acting in the capacity of a healthcare provider or within the scope of a public health activity related to an FDA-regulated product for which they have responsibility (as outlined in the examples above), patient information must not be shared or released to the medical device company without a valid written authorization. For example, if a medical device company simply sells its products to a healthcare provider for the healthcare provider to use or dispense to individuals it is not providing "health care" and thusly, must not receive patient information.

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