Health Law Diagnosed Mintz

In the latest episode of Health Law Diagnosed – Women Leaders in Health Care, a series that brings together women leaders for discussions on timely key issues and reflections on developing a career in the industry, host Bridgette Keller leads a conversation around the emerging role of artificial intelligence (AI) in health care. She is joined by Jane Moran, Chief Information and Digital Officer at Mass General Brigham, Rebecca Mishuris, Chief Medical Information Officer and VP at Mass General Brigham, and Carina Edwards, Chief Executive Officer at Kipu Health.

They discuss the opportunities for enhanced patient-provider interactions and improvements in health care delivery through the use of AI. They delve into how this powerful technology can alleviate administrative burdens by helping with tasks like clinician documentation to streamline workflow, determining evidence-based treatment plans, improving revenue cycle processes, and developing patient acquisition and engagement models.

Our guests also explore the future of AI in health care, covering topics such as:

• How do we deploy this technology to improve what matters while maintaining safety, data privacy, ethics, and transparency?
• How do we use AI to deliver higher quality, equitable care?
• How do we make AI a true inflection point in health care delivery and how patients receive it?

Jane, Rebecca, and Carina also share thoughtful advice for women looking to have a career in health IT, including tips on:

• Leaning into obtaining experience with new AI technology
• Working on gaining a seat at the table
• Raising your hand for things you want on your career path
• Finding a sponsor – women are over-mentored and under-sponsored
• Following your passion and curiosity
• Networking strategically

In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory developed tests (LDTs). LDTs have historically not been subject to significant regulatory oversight, and while the FDA aims to promptly release the final rule on this intricate issue laden with complexities, potential roadblocks may delay its course of action.

Bridgette, Joanne, and Ben discuss this and also cover:
• What is a laboratory developed test (LDT)
• Where LDTs sit from a regulatory perspective
• What industry stakeholders are saying about these rules
• What the proposed rules mean
• Why the FDA is stepping in now

As the Mintz Health Law team welcomes the beginning of 2024, many of its members take a moment to reflect on the exciting growth of the Health Law Practice, opportunities to partner with clients on complex legal issues, and the celebration of numerous milestones.

In this episode, host Bridgette Keller introduces a new series of Health Law Diagnosed titled Women Leaders in Health Care. This new series will bring together women leaders for discussions on timely key issues and reflections on developing a career in the industry.

Leah Pollema, Vice President and General Counsel at InhibRx, and Serene Katranji, Chief Operating Officer, Chief Compliance Officer, and Corporate Counsel at Orchard Laboratories, join Bridgette for this inaugural episode. Together, they share personal stories about their experiences as both mentees and mentors, shedding light on the invaluable impact mentorship has had on their professional journeys.

Serene underscores the fulfillment of opening doors for those facing similar career challenges and the satisfaction of seeing mentees surpass her own achievements. She reflects on the enduring impact of mentors who provided helpful guidance during her career, emphasizing the importance of paying forward the knowledge gained.

Leah adopts a modeling approach to mentoring, highlighting the significance of demonstrating the desired behaviors and skills for her colleagues. Drawing from her experience as a mentee, she fosters a collaborative mentoring environment, prioritizing active participation over passive instruction.

Both women stress the pivotal role of trust in successful mentorship, creating a safe and vulnerable space for mentorship to thrive. Additionally, they actively seek diverse relationships in their mentoring journeys, recognizing the importance of opening doors for others and modeling the way to success. This episode provides valuable insights into the multifaceted nature of mentorship in the world of health care.

California’s newly established Office of Health Care Affordability recently proposed regulations outlining its requirements for advance regulatory review of certain health care entity mergers, acquisitions, affiliations, and other arrangements that result in “material changes” of assets, control, or governance. Health Law attorneys Lara D. Compton, Deborah A. Daccord, and M. Daria Niewenhous join Bridgette Keller to discuss the proposed regulations, their potential impact on transactions, and what health care entities should consider as they prepare for transactions moving forward.

In this episode, Health Care Enforcement Defense specialists Eoin Beirne, Karen Lovitch, and Brian Dunphy discuss key regulatory and policy updates issued by the DOJ and their potential impact on False Claims Act cases, from self-disclosure to privacy regulations.