NC H855

Authorizes clinical researchers conducting institutional review board-approved clinical investigations to voluntarily connect to NC HealthConnex (the statewide health information exchange network) to access protected health information about research participants and applicants.

Requires clinical researchers to obtain signed releases from participants or applicants authorizing use or disclosure of protected health information for research purposes in compliance with HIPAA and federal regulations.

Restricts researchers from accessing the network for recruitment, data mining, or extracting multiple patient records; access must be on a per-individual basis only.

Limits use of disclosed protected health information to: verifying applicant eligibility, protecting participant health and safety, tracking therapeutic side effects, and providing continuity of care during and after the clinical investigation.

Requires researchers to be financially independent from the clinical investigation's funding sponsor and comply with HIPAA and 21 C.F.R. Part 50; becomes effective July 1, 2021.