GUIDANCE ON APPLICATION OF COMMON RULE TO CLINICAL DATA REGISTRIES.

SEC. 511. GUIDANCE ON APPLICATION OF COMMON RULE TO CLINICAL DATA REGISTRIES. Not later than one year after the date of the enactment of this section, the Secretary of Health and Human Services shall issue a clarification or modification with respect to the application of subpart A of part 46 of title 45, Code of Federal Regulations, governing the protection of human subjects in research (and commonly known as the “Common Rule”), to activities, including quality improvement activities, involving clinical data registries, including entities that are qualified clinical data registries pursuant to section 1848(m)(3)(E) of the Social Security Act (42 U.S.C. 1395w–4(m)(3)(E)).