The FDA's Final Rule:  What Should I Do Now? & Legal Updates for Pathology and Laboratory Providers

McDonald Hopkins' Elizabeth Sullivan will be presenting as part of panels on "The FDA's Final Rule: What Should I Do Now?" and "Legal Updates for Pathology and Laboratory Providers" at the APF 2024 National Meeting in New Jersey. The first discussion will provide a summary of the the final FDA rule as well as discuss its potential challenges and pitfalls, while the second discussion will cover information on the new developments in 2024 that could affect practices and laboratories and strategies to address these developments.

McDonald Hopkins' National Pathology Industry Practice and Laboratory Industry Practice are two of the largest such legal practices in the country.

Our National Laboratory Industry Practice clients include several hundred hospital laboratories (single hospitals to large systems), independent laboratories and other types of laboratories. We work with clinical, anatomic, molecular/ genomic, toxicology, and specialty laboratories. 

Our National Pathology Practice has clients that include over 500 academic and community-based pathology groups ranging in size from small, single location, to large, multi-location groups. We also work with national, state, and local pathology associations and societies. 

To learn more about McDonald Hopkins' services to the pathology and laboratory industry, use the links below or contact any member of our Healthcare Practice. 

• Healthcare practice
• Laboratory industry services
• Physicians and other health professionals

Our attorneys provide valuable business counseling and legal insight on important, timely topics that impact the pathology and laboratory industry.

• Healthcare providers and preparing for the impact of the FTC Final Rule prohibiting non-compete agreements 
• New Medicare LCDs regarding special stains and IHC stains
•  Independent contractor sales and marketing arrangements in laboratories
•  Recent OIG advisory opinion scrutinizes laboratory purchased service arrangements
• Status of remote pathologist interpretations after PHE: Does it affect your current workflows?
• Webinar: Compliance considerations in digital pathology

	Elizabeth Sullivan Chair, Healthcare Practice Group esullivan@mcdonaldhopkins.com 216-348-5401		Emily Johnson Member, Healthcare Practice Group ejohnson@mcdonaldhopkins.com 312.642.1798
	Jane Pine Wood Counsel, Healthcare Practice Group jwood@mcdonaldhopkins.com 216.348.5428		Patrick Campbell Associate, Healthcare Practice Group pcampbell@mcdonaldhopkins.com 216.348.5405