tci Medicare Compliance & Reimbursement - 2018 Issue 10

Industry Note: Check Your GDPR Compliance Protocols

If your practice engages in medical research, you may want to review privacy guidelines for international and American subjects before the European Union's General Data Protection Regulation (GDPR) goes live on May 25, 2018. Why: Stiff penalties may ensue for researchers and providers who don't follow the GDPR guidelines, which are significantly more restrictive about safeguarding patients' data than HIPAA, suggests the HHS Secretary's Advisory Committee on Human Research Protections (SACHRP) guidance. "A U.S.-based clinical study could be subject to the GDPR if it uses digital technology, such as wearables, mobile phones, or other personal electronic devices...

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