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

Event Detail

February 2, 2022
12:00 pm - 1:00 pm CT
New Orleans, LA
Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.