FCRA

Background:

Expedite the research process for new medical devices and prescription drug, quicken process

for drug approval, reform mental health treatment

Privacy Provision:

• Certain individual biomedical research information exempted from disclosure under FOIA

• Researchers permitted to remotely view PHI (must meet minimum safeguards consistent with HIPAA’s Privacy and Security Rules)

• Information blocking prohibited but HIPAA’s protection of PHI remains

• Certificates of confidentiality for research. Must be issued by NIH for any federally funded research. Research material cannot be used in any legal or administrative proceedings without patient’s consent.

• Compassionate sharing of mental health or substance abuse information with family or caregivers