Patricia Wagner Quoted in “FDA Offers Guidance in Support of Sharing Device Data with Patients”

Health Care Business Daily News

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 DOTmed’s Health Care Business Daily News, in “FDA Offers Guidance in Support of Sharing Device Data with Patients,” by Thomas Dworetzky.

Following is an excerpt:

This appeared to be problematic to attorney Wagner. For one thing, the information “from a medical device is accessible by the patient’s healthcare provider and patients can contact their healthcare provider to obtain such information,” the guidance stated, in seeming contradiction of its own consent guidance.

For another, HIPAA was not intended to keep patient device-data from providers, according to the attorney. It is “just wrong” and “doesn't make sense,” she told Bloomberg.