Health Law Diagnosed

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 investing in women's health. She is joined by Lauren Edgerton, Healthcare Director at Piper Sandler, and Kathryne Cooper, Partner at Jumpstart Nova. Lauren and Kathryne discuss the areas of women's health that have seen the most growth in the last few years, how they evaluate a potential investment including their standard criteria, and how you can get involved in investing in women's health care. Our guests also cover topics such as: • What are the unique challenges in raising capital for companies that focus on women's health? • Why do you think women's health has historically been underfunded compared to other sectors, and what can be done to improve funding for women's health? • What advice would you give to women interested in a career in investing in health care?

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.

In this episode, Mintz Health Care Enforcement Defense specialists Karen Lovitch, Brian Dunphy, and Eoin Beirne discuss key trends in the health care enforcement landscape with Health Law Diagnosed host, Bridgette Keller, focusing on their recent edition of the EnforceMintz newsletter, Analyzing Health Care False Claims Act Cases.

The Mintz Health Law team celebrates the start of 2023 by sharing what they are grateful for as they look back on a year of client service, mentorship, and working together as a team.

During this episode, Bridgette Keller speaks with Bre Hitchen, Regulatory & Operations Counsel at Aledade, Inc., about the most important topics on Bre's mind as she works to support Aledade's business teams with regulatory counsel and compliance advice.

During this episode, Bridgette Keller speaks with Kerlann Flowers, Legal Director and Senior Attorney for Hofstra University School of Law's Medical-Legal Partnership (MLP), and Mintz Associate Jean Krebs. They discuss the work of the MLP, how the ongoing pandemic has impacted the MLP and its clients, and, in many respects, made collaboration between medical providers and lawyers more important than ever.

The acceleration in the development and use of, and comfort with, telehealth over the past several years has the potential to counteract historical disparities in access to health care. Listen to hear how Andy Ward, Director of the South Boston Collaborative Center, and Kate Steinle, Chief Clinical Officer of Folx Health, are leveraging telehealth to serve their communities.

Our 6th Annual Pharmacy & Pharmaceutical Industry Summit covered how the confluence of the rapid growth of consumer-centered health care, the lingering effects of the COVID-19 pandemic, a focus on equitable access to care, and the new presidential administration are driving change across the industry. Listen to our team discuss key takeaways from the weeklong summit and how industry trends are impacting business practices.

Health regulatory diligence has the ability to make or break a deal. Listen to hear about our team's firsthand experience in the importance of conducting health regulatory diligence and best practices in preparing for a sell-side transaction.

2021 was a busy year for Mintz's Health Law team, as they helped clients navigate complex health care transactions. Listen to hear the macro trends our team is seeing in the market, as well as their takeaways from the deals they closed.

The Mintz Health Law team celebrates 2022 by sharing their health law–focused resolutions. Listen to how the team is resolving to apply the lessons learned from the pandemic, their industry insight, and their knowledge of state and federal government priorities and actions to help clients and colleagues thrive in 2022 and beyond.

In this episode of the Health Law Diagnosed podcast, Mintz's Susan Berson discusses her career trajectory, the benefits of building a diverse and inclusive workplace, why women may be drawn to health law, and the importance of mentorship and sponsorship.

This past year has been a busy one for the FDA, but it hasn't all been about the pandemic. FDA attorneys Joanne Hawana and Benjamin Zegarelli discuss the agency's ongoing efforts to protect the public from unproven COVID-19 cures while also pushing forward with its most important regulatory priorities, such as digital health, cannabis-derived compounds, and laboratory-developed tests and other diagnostic products.

The ability to provide health care from a remote location has been around for many years, but with the arrival of COVID-19, hospitals, physicians, and other health care providers have had to rapidly rethink their traditional models of health care delivery. This episode explores the many changes to the telehealth regulatory landscape necessitated by the pandemic, including expansions in Medicare and Medicaid reimbursements, the deregulation of certain HIPAA privacy and security rules, the loosening of state licensure requirements, and whether other barriers to telehealth will continue to fall in the months and years to come.

At the end of 2020, the US Department of Health and Human Services Office of Inspector General and Centers for Medicare and Medicaid Services issued final rules modifying and expanding upon the regulatory safe harbors and exceptions to the federal Anti-Kickback Statute and the Stark Law, respectively. In Part 2 of this two-part series, Mintz's Karen Lovitch and Rachel Yount return to examine the changes to the Stark Law regulations, including new defined terms, modifications to existing exceptions, and the government's efforts to ease compliance burdens associated with this strict liability statute.

At the end of 2020, the U.S. Department of Health and Human Services Office of Inspector General and Centers for Medicare and Medicaid Services issued final rules modifying and expanding upon the regulatory safe harbors and exceptions to the federal Anti-Kickback Statute and the Stark Law, respectively. In Part 1 of this two-part series, Mintz's Karen Lovitch and Rachel Yount examine the changes to the Anti-Kickback safe harbors, and how they advance the government's efforts to promote value-based care and reduce the regulatory burdens that impede care coordination.

Mounting anxiety over how to control the spread of infectious disease outbreaks encourages public and political discourse of bioethics. In the third episode of Mintz's Health Law Diagnosed, Mintz's Bridgette Keller talks about the legal, public health, and bioethics concerns inherent in a global pandemic, including allocating scarce medical resources such as COVID-19 vaccine, and how the greatest challenge to vaccine distribution may be the public's hesitancy.

Despite dramatic improvements in the overall health of the population, racial and ethnic disparities in health and in our health care delivery system persist. In the second episode of Mintz's Health Law Diagnosed, Dr. Tom Sequist of Mass General Brigham speaks to Mintz's Brent Henry about what health care providers can do to help break down the barriers that perpetuate our country's health care inequalities.

In the inaugural episode of Mintz's Health Law Diagnosed, Dianne Bourque (Member, Mintz Health Law Practice) discusses why HIPAA is so engrained in our collective consciousness, how it was already equipped to handle public health emergencies, and the important changes made over the last several months to address the COVID-19 outbreak.