Part II: The Impact of Cures on Clinical Research
Feb
2
2017
Date: February 2, 2017
Time: 8:00AM - 9:00AM
Location: Webinar
Topics
- 21st Century Cures Act Webinar Series
In addition to the myriad changes the 21st Century Cures Act will have on the drug development and approval process, the Act has important implications for human subjects research ranging from amendments to HIPAA to make it easier to access, share and use health information; to provisions streamlining the IRB review process. The Act will have a significant impact on manufacturers, study sites, investigators, IRBs and study participants. Part II of our series will cover these issues as well as:
- Provisions designed to reconcile long-standing differences between FDA regulations on human subjects protection and the Common Rule
- Provisions related to data use and sharing, subject privacy and the interplay of HIPAA and research
- New priorities for NIH, including precision medicine, the inclusion of underrepresented populations in research and new protections for sensitive research information, such as alcohol and psychoactive drug abuse and behavioral health information
Speakers
Dianne J. Bourque
Speaker
Dianne specializes in counseling researchers and research sponsors in matters related to FDA and OHRP regulated clinical research, and counsels health care clients on the HIPAA Privacy Rule and Security Standards.
Kate F. Stewart
Speaker
Kate F. Stewart is Of Counsel at Mintz and a former in-house counsel who focuses on legal issues affecting health care clients, including digital health and privacy regulations, clinical trial compliance, and transactions for for-profit and nonprofit clients. She represents traditional health care providers, payors, and digital health start-ups.