Patricia Wagner Quoted in “FDA Guidance on Device Data Sharing Aligns With HIPAA: Attorney”

Bloomberg BNA Medical Devices Law & Industry Report

Patricia M. Wagner, Chief Privacy Officer and Member of the Firm in the Health Care and Life Sciences and Litigation practices, in the firm’s Washington, DC, office, was quoted in Bloomberg BNA Medical Devices Law & Industry Report, in “FDA Guidance on Device Data Sharing Aligns With HIPAA: Attorney,” by Michael Williamson.

Following is an excerpt:

Wagner argued, though, that HIPAA was never meant to prohibit patient data collected by devices from being shared with providers. The FDA shouldn't have said this in the draft guidance because it is “just wrong” and “doesn't make sense,” she told Bloomberg BNA.

Aside from that specific incorrect information, Wagner said she believed the document is “very much aligned” with HIPAA.

“One thing HIPAA provides is a right of access to medical records. This is very much following in line with that standard,” she told Bloomberg BNA.

A version of this article also appeared on Bloomberg BNA’s Health Care Blog.