Payers, Providers, and Patients – Oh My!

AI in Health Care Series, Part 3: The EU AI Act

In this episode, hosts Payal Nanavati and Savanna Williams talk to Roma Sharma and Wietse Vanpoucke about the European Union’s Artificial Intelligence Act, which establishes a common regulatory and legal framework for AI within the European Union. This podcast episode features the following speakers:

 

• Roma Sharma is a counsel in Crowell’s Health Care Group, where she advises a variety of health care clients on navigating the use of AI in the industry and complying with federal and state laws and regulations.
• Wietse Vanpoucke is an associate in Crowell’s Brussels office, where his practice focuses on the life sciences and digital health sectors, relying on his deep experience with European and Belgian regulatory affairs and legal procedures.

Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

AI in Health Care Series, Part 2: Artificial Intelligence, HIPAA and Data Privacy

In this episode, hosts Payal Nanavati and Megan Beaver talk to Jodi Daniel and Lidia Niecko-Najjum about how HIPAA and existing data privacy protections are shaping health care organizations’ use of artificial intelligence.  Jodi and Lidia discuss the various regulations at play and also provide practical takeaways.

This podcast episode features the following speakers:

• Jodi Daniel is a partner in Crowell’s Health Care Group and part of the firms Digital Health Practice where she counsels health technology companies, health care providers, health plans, life science companies and others on regulatory issues, including data access and use, privacy and security, interoperability, health information exchange, information blocking, telehealth, and FDA oversight. Jodi is also the managing director of Crowell Health Solutions.
• Lidia Niecko-Najjum is a senior counsel in Crowell’s Health Care Group and is part of the firm’s Digital Health Practice. With over 15 years of clinical, policy, and legal experience, Lidia provides strategic advice on health care regulatory and policy matters, with particular focus on artificial intelligence, machine learning, digital therapeutics, telehealth, interoperability, and privacy and security.

AI in Health Care Series, Part 1: AI Use in Clinical Research Institutions

In this episode, hosts Megan Beaver and Savanna Williams talk to Jason Johnson and Linda Malek about the evolving regulatory landscape related to artificial intelligence (AI) in health care. In particular, Jason and Linda discuss the use of AI by organizations engaged in clinical research including key issues and emerging themes in this field.

 

This podcast episode features the following speakers:

• Jason Johnson is a partner in Crowell’s Health Care and Privacy & Cybersecurity Groups, where he draws on his experience as a former research scientist to advise clients on complex compliance, legal, regulatory, and transactional matters.
• Linda Malek is a partner in Crowell’s Health Care and Privacy & Cybersecurity Groups, where she advises a broad array of health care and life sciences clients on compliance with federal, state, and international law governing clinical research, data privacy, cybersecurity, and fraud and abuse.

The Past, Present, and Future of Private Equity’s Role in Health Care

In this episode, hosts Payal Nanavati and Savanna Williams talk to Paul Pollock and Wayne Pryor about how private equity (PE) got its start in the health care industry, current trends in PE regulation, and where listeners can expect to see PE to continue investing in the industry. 

 

This podcast episode features the following speakers:

• Paul Pollock is a partner in Crowell’s New York office and concentrates his practice on mergers, and acquisitions, and corporate finance, specifically in the health care industry.
• Wayne Pryor is Managing Director in VMG Health’s Financial Due Diligence Division in the Nashville office.  He has over 30 years of experience in the health care industry with a focus on transaction surfaces.  Wayne has worked on over 450 buy-side and sell-side transactions in every sub sector of the industry, ranging from $1 million to $10 billion deals.

Enabling Widespread Adoption of Decentralized Clinical Trials

In this episode, hosts Payal Nanavati, Jodi Daniel, and Cara Tenenbaum talk to Ben Moscovitch, Devon Adams, and Noah Goodson about recent policy developments on decentralized clinical trials (DCTs). They also discuss the Crowell Health Solutions’ white paper* on DCTs, which issues to federal agencies a number of policy recommendations to advance DCT adoption and increase clinical trial diversity.

This podcast episode features the following speakers:

• Jodi Daniel is a Managing Director of Crowell Health Solutions and also is a partner in Crowell’s DC office, who leads the firm’s Digital Health Practice. She previously spent 15 years at the Department of Health and Human Services (HHS).
• Cara Tenenbaum is a Consultant with Crowell Health Solutions, leads Strathmore Health, and has extensive experience in health policy and patient advocacy. She worked at the U.S. Food and Drug Administration (FDA) for six years.
• Ben Moscovitch leads Amazon Web Services (AWS) healthcare and life sciences public policy efforts and focuses on policy reforms to improve health data interoperability and clinical research.
• Devon Adams is a Senior Policy Analyst at the American Cancer Society Cancer Action Network, the nonpartisan advocacy affiliate of the American Cancer Society. He works on policy related to cancer research, device and drug development, precision medicine, and clinical trials.
• Noah Goodson, Ph.D. is the Principal of Strategy & Advisory at THREAD Research. He spends his day supporting pharmaceutical, biotech, and medical device companies in the design and execution of clinical trials.

White Paper: https://www.crowell.com/a/web/vFgM2vJzbE4wsuVyJ5o1py/advancing-adoption-of-decentralized-clinical-trials-rationale-current-state-and-policy-recommendations.pdf

 

The Increasing Focus on Mental Health Parity

In this episode, hosts Payal Nanavati and Megan Beaver talk to Chris Flynn and Alice Hall-Partyka regarding the proposed updates to the regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA). We discuss the current regulatory environment, enforcement, and key takeaways from the proposed rule. For further reading, please see:

New Proposed MHPAEA Rule Builds on NQTL Comparative Analysis Standards

(https://www.crowell.com/en/insights/client-alerts/new-proposed-mhpaea-rule-builds-on-nqtl-comparative-analysis-standards)

Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

Hidden Costs of FCA and AKS Claims

In this episode, hosts Joe Records and Payal Nanavati talk to Rebecca Baskin regarding her recently-published article analyzing the true costs to companies of becoming the subjects of False Claims Act or Anti-Kickback Statue investigations.  We discuss the article’s methodology, findings, and key takeaways. 

 

Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

Industry Views on the Trusted Exchange Framework and Common Agreement

In this episode, hosts Joe Records, Payal Nanavati, and Jodi Daniel talk to three members of the health information industry regarding the Trusted Exchange Framework and Common Agreement (TEFCA) published by the Office of the National Coordinator for Health Information Technology (ONC). This episode features Jay Nakashima (Executive Director of eHealth Exchange), Nichole Sweeney (General Counsel and Chief Privacy Officer of CRISP Shared Services), and Erica Galvez (CEO of Manifest MedEx), who each share their experiences in the health information exchange industry and their expectations of TEFCA.

Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

How to Structure an Affirmative Recovery Program

In this episode, hosts Joe Records and Payal Nanavati talk to Kelly Hibbert and Jed Wulfekotte about how Medicare plan sponsors and Medicaid Managed Care Organizations can structure an affirmative recovery program to prevent and detect fraud, waste, and abuse -- among other things.

 

Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

More Changes to Section 1557 Nondiscrimination Rules

In this episode, hosts Joe Records and Payal Nanavati talk to Michelle Chipetine and Stacie Heller about recent developments regarding the nondiscrimination requirements of Section 1557 of the Affordable Care Act, including new rules proposed by the Biden Administration and litigation around the issue of discrimination on the basis of sex.

 

Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.