Re: How can I phrase this?
Good point. They may also need to think of HIPAA requirements. I think those are separate from FDA requirements but I'm not certain. I don't really know if HIPAA applies to equipment like this, but it woulde be a good idea to make certain.
HIPAA is an Act of Congress that requires patient privacy and the FDA is a federal agency that regulates drugs and medical devices.
Relevant to this discussion, HIPAA applies to any document, data, or communication that includes patient information. It would apply to the dispensing of hearing aids and to any information received from the patient regarding personal use of hearing aids. It would likely not apply to a product label or product warning message.
Every company that deals directly with patients has a HIPAA policy and every employee or consultant working for that company must fully understand and agree to the company's HIPAA policy. Any questions concerning a company's HIPAA policy should be directed the company's human resources department. Information provided to the employee or consultant should include contact information for when and how to report HIPAA violations to appropriate authorities.
FDA does have guidelines and rules for hearing aids and labeling.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070782.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070958.htm
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=801
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.420
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