Amends GS 90-414.4 by adding subsection (e1) permitting clinical researchers to access the Statewide Health Information Exchange Network (HIEN) to access health information of applicants for or participants in a clinical investigation approved by an institutional review board so long as the clinical researcher:
(1) Obtains signed releases from clinical investigation applicants or participants;
(2) Is financially independent of the funding sponsor of the clinical investigation;
(3) Will only access HIEN on an individual basis (no data mining, participant recruiting, or extracting multiple persons’ records);
(4) Agrees to limit use of information from the HIEN to (i) verifying applicant eligibility for a clinical investigation, (ii) protecting the health and safety of a clinical investigation participant, (iii) tracking side-effects from test articles in a clinical investigations, and (iv) providing continuity of care to participants before and after a clinical investigation and to use information in a manner consistent with federal health privacy law.
Defines “clinical researcher,” “clinical investigation,” “institutional review board,” “test article,” and “ sponsor” as they are defined in 21 C.F.R. Part 50, as amended (U.S. Food and Drug Administration, protection of human subjects).
Effective July 1, 2021.