Patricia Wagner Quoted in “FDA Issues Draft Guidance on Sharing Medical Device Data with Patients”Med Device Online June 15, 2016
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and Litigation practices, in the firm’s Washington, DC, office, was quoted in Med Device Online, in “FDA Issues Draft Guidance on Sharing Medical Device Data with Patients,” by Jof Enriquez.
Following is an excerpt:
Patricia Wagner, a Washington-based attorney with Epstein Becker & Green P.C., told the news outlet that FDA’s draft guidance is “very patient friendly” and “very much aligned” with HIPAA rules to provide access to medical records.
While data sharing could empower patients, FDA cautions manufacturers to take steps “to avoid the disclosure of confusing or unclear information that could be misinterpreted.”