Andrew Rusczek, Member of the Firm, presents "Precision Medicine Studies: A Perfect Storm of Legal and Ethical Issues on the Line Between Treatment and Research" for the American Health Law Association's Physicians and Hospitals Law Institute 2022.
Precision medicine may bring promise of better care to patients, but it also brings promise of complex legal and ethical issues to institutions and other providers that care for these patients. This session identifies some of these legal and ethical issues and describe how they can be addressed in the context of precision medicine studies. Andrew addresses the following topics, among others, in the context of precision medicine studies:
- Regulations and requirements of the FDA in relation to investigational devices (including LDTs and “Software as a Medical Device”) and investigational drugs
- Clinical Laboratory Improvement Amendments (CLIA) in relation to laboratories performing genetic analyses
- Applying FDA’s requirements for IRB review and informed consent
- Tort law risks in the context of individualized care
For more information and to register, please visit AHLA.org.