What activities are considered to be related to the quality, safety, or effectiveness of an FDA-regulated product or activity?
HIPAA Weekly Advisor, June 13, 2005
Want to receive articles like this one in your inbox? Subscribe to HIPAA Weekly Advisor!
The HIPAA regulations permit a covered entity to disclose protected health information to a person subject to the jurisdiction of the Food and Drug Administration with respect to an FDA-regulated product or activity for which that person has responsibility, for the purpose of activities related to the quality, safety or effectiveness of such FDA-regulated product or activity.
The regulations list the following activities and note that this is not an exclusive list:
- To collect or report adverse events (or similar activities with respect to food or dietary supplements), product defects or problems (including problems with the use or labeling of a product), or biological product deviations
- To track FDA-regulated products
- To enable product recalls, repairs, or replacement, or lookback (including locating and notifying individuals who have received products that have been recalled, withdrawn, or are the subject of lookback)
- To conduct post marketing surveillance
For more information see Section 164.512(b), "Uses and Disclosures for Public Health Activities" on the Bricker Eckler Web site.
Editor's note: Attorneys from Bricker & Eckler LLP answered this question. This is not legal advice. Consult your attorney for legal matters.
Want to receive articles like this one in your inbox? Subscribe to HIPAA Weekly Advisor!
Related Products
Most Popular
- Articles
-
- Q/A: Volume requirement for reporting hydration services
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- Catch up on what's new with injections and infusions
- Topic: CMS, OESS post new security compliance review information, checklist
- Capturing all necessary codes for IUD insertion and removal can be challenging
- What does case-mix index mean to you?
- QA:Coding multiple initial infusions
- News and briefs: Oklahoma Osteopathic Association against residency bill change
- HIPAA Q&A: Level of encryption needed for email
- OB services: Coding inside and outside of the package
- E-mailed
-
- Q/A: Volume requirement for reporting hydration services
- Featured blog post: Nurses face felony charges after reporting physician to the Texas Medical Board
- HIPAA Q&A: Level of encryption needed for email
- Catch up on what's new with injections and infusions
- New conflicts of interest create new challenges
- Q/A. One injection code or two?
- What does case-mix index mean to you?
- Joint Commission Center announces handoff communication solutions
- Inside best practice: Reduce patient falls with a stoplight
- Identify modifiable risk factors to prevent patient falls
- Searched