Re: How can I phrase this?

Subject: Re: How can I phrase this?
From: Lauren <lauren -at- writeco -dot- net>
To: techwr-l -at- lists -dot- techwr-l -dot- com
Date: Mon, 01 Jul 2013 13:16:15 -0700

On 7/1/2013 11:33 AM, Keith Hood wrote:

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




^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
New! Doc-to-Help 2013 features the industry's first HTML5 editor for authoring.

Learn more: http://bit.ly/ZeOZeQ

^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

You are currently subscribed to TECHWR-L as archive -at- web -dot- techwr-l -dot- com -dot-
To unsubscribe send a blank email to
techwr-l-leave -at- lists -dot- techwr-l -dot- com


Send administrative questions to admin -at- techwr-l -dot- com -dot- Visit
http://www.techwhirl.com/email-discussion-groups/ for more resources and info.

Looking for articles on Technical Communications? Head over to our online magazine at http://techwhirl.com

Looking for the archived Techwr-l email discussions? Search our public email archives @ http://techwr-l.com/archives


Previous by Author: Re: How can I phrase this?
Next by Author: Re: How can I phrase this?
Previous by Thread: Re: How can I phrase this?
Next by Thread: TECHWR-L Premium Jobs, Events, and Announcements


What this post helpful? Share it with friends and colleagues:

Sponsored Ads


Sponsored Ads