This guidance document, published by the U.S. Department of Health and Human Services, is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties on the use of electronic health record data in FDA-regulated clinical investigations.
Use of Electronic Health Record Data in Clinical Investigations
Approved
CIPM, CIPP/A, CIPP/C, CIPP/E, CIPP/G, CIPP/US, CIPT
Credits: 2
Related Stories
Web Conference: The De-identification of Health Records – Risks and Rewards
What are the best practices for safely de-identifying records and providing audits to ensure that personal and sensitive information remains protected? Join our panel of legal, technical and operational experts to hear the latest developments in this important and rapidly developing field....
India stirs privacy concerns with proposed Aadhaar, health records merge
A proposal to combine India's Aadhaar identification system and the country's health system into one database is drawing backlash from privacy advocates. The proposed merger was announced by India's Health Ministry in its National Digital Health Blueprint report, which is now open for public consult...
US health care industry pressing lawmakers for national patient identifier
Health care industry leaders held a congressional briefing to implore the U.S. Senate to fund the creation of a patient identifier, TechTarget reports. The House of Representatives voted in June to approve the funding for identifiers, which was banned and removed from the Health Insurance Portabilit...