What health care and life sciences organizations need to know:

• "Bulk" Has a New Definition: The volume thresholds under the U.S. Department of Justice's (DOJ's) Bulk Sensitive Data (BSD) Transfer Rule are surprisingly low—sharing genomic data on just 100 people can trigger compliance requirements, catching many organizations off guard.
• HIPAA Compliance Is Not Enough: The BSD Transfer Rule creates an entirely new compliance layer that goes beyond existing privacy frameworks, such as the Health Insurance Portability and Accountability Act (HIPAA), applying even when data has been de-identified or anonymized.
• It's About Access, Not Just Transfers: Simply giving a foreign vendor, board member, or investor the ability to view sensitive data can trigger the BSD Transfer Rule—no formal data-sharing agreement is required.

In this episode of Diagnosing Health Care®, Epstein Becker Green attorneys Laura DePonio, Elizabeth McEvoy, and Elena Quattrone walk health care and life sciences organizations through the DOJ's BSD Transfer Rule—from scoping and compliance to enforcement risks and exemptions.

Navigate BSD Transfer Rule Compliance with Confidence:

Our team has developed specific tools and advisory services to help organizations like yours understand their obligations under the BSD Transfer Rule, assess risk, and implement compliant data practices. Check out our free resource center: https://explore.ebglaw.com/resources/doj-bulk-sensitive-data-transfer-rule/

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Epstein Becker Green is a national law firm that focuses its resources on health care, life sciences, and workforce management solutions, coupled with powerful litigation strategies. This video is for informational purposes only and does not constitute legal advice. Viewing this video does not create an attorney-client relationship.

DIAGNOSING HEALTH CARE® is a registered trademark of Epstein Becker & Green, P.C.

© Epstein Becker & Green, P.C. All Rights Reserved. Attorney Advertising.

Value-based enterprises depend on timely, accurate data, yet the rules that govern how that data moves between the Centers for Medicare & Medicaid Services (CMS), accountable care organizations, payors, and providers remain complex and often inconsistent.

On this episode, Epstein Becker Green attorneys Kevin Malone and Karen Mandelbaum unpack the regulatory frameworks shaping data exchange in value-based care. They outline how federal privacy laws, CMS rules, the Health Insurance Portability and Accountability Act (HIPAA), and state requirements intersect; why CMS-sourced data operates under a different regime than Medicare Advantage; and where organizations face the biggest operational hurdles when using, sharing, and governing data across large networks.

Key Takeaways:

• Distinct Legal Frameworks: CMS data is controlled by the Privacy Act, while Medicare Advantage data falls under HIPAA.
• Disclosure Tracking Requirements: CMS data use agreements demand strict tracking and downstream compliance.
• Operational Data Challenges: Silos and uneven data quality remain major barriers to effective value-based care.

Tune in to learn how today's rules shape data access, data quality, and the real-world mechanics of value-based care.

Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc92

Subscribe for email notifications: https://www.ebglaw.com/subscribe.

Visit: http://diagnosinghealthcare.com.

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This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.

By early 2026, substance use disorder (SUD) providers, health plans, clinicians, health information exchanges (HIEs), and vendors must meet new federal privacy standards for SUD treatment records or face Health Insurance Portability and Accountability Act (HIPAA)-level enforcement and penalties.

On this episode, Epstein Becker Green attorneys Lisa Pierce Reisz, David Shillcutt, and Laura DePonio join Nichole Sweeney, General Counsel and Chief Privacy Officer at CRISP, to break down the 42 CFR Part 2 final rule: what's changing, what's staying the same, and what organizations often miss. The group explains how the final rule aligns with (but does not replace) HIPAA, why patient consent remains central, and what new operational risks are emerging.

Key Takeaways:

• Adoption of HIPAA Penalties: Part 2 now adopts HIPAA's enforcement and penalty structure.
• Operational Readiness Challenges: Operational readiness, not technology, is the biggest challenge.
• Expanded Compliance Duties: Payors and HIEs face major shifts in data access and compliance duties.

Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc91.

Subscribe for email notifications: https://www.ebglaw.com/subscribe.

Visit: http://diagnosinghealthcare.com.

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Epstein Becker Green is a national law firm that focuses its resources on health care, life sciences, and workforce management solutions, coupled with powerful litigation strategies.

This video is for informational purposes only and does not constitute legal advice. Viewing this video does not create an attorney-client relationship.

DIAGNOSING HEALTH CARE® is a registered trademark of Epstein Becker & Green, P.C.

© Epstein Becker & Green, P.C. All Rights Reserved. Attorney Advertising.

Why is now the moment for women's health?

On this episode, Epstein Becker Green attorneys Rachel Snyder Good, Beth Scarola, and Laura DePonio sit down with Sheila Biggs, Vice President of Jarrard, to explore how women's health is evolving from a niche focus into a mainstream industry priority. They discuss the forces accelerating growth, the opportunities for change, and the challenges that still need to be addressed across outcomes, access, and patient experience.

This episode unpacks several key topics, including:

• what "women's health" really means today—far beyond fertility and reproductive care;
• how decades of underinvestment created new opportunities for innovation, equity, and growth;
• why investors and policymakers are turning their attention to this space, and what's driving the momentum;
• the biggest gaps still to close in outcomes, access, and patient experience;
• how storytelling and strategy can help reshape the public narrative around women's health; and
• where the industry is headed next—including insights related to the upcoming Women's Health Innovation Summit.

Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc90.

Subscribe for email notifications: https://www.ebglaw.com/subscribe.

Visit: http://diagnosinghealthcare.com.

This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.

Why is now the moment for women's health?

On this episode, Epstein Becker Green attorneys Rachel Snyder Good, Beth Scarola, and Laura DePonio sit down with Sheila Biggs, Vice President of Jarrard, to explore how women's health is evolving from a niche focus into a mainstream industry priority. They discuss the forces accelerating growth, the opportunities for change, and the challenges that still need to be addressed across outcomes, access, and patient experience.

This episode unpacks several key topics, including:

• what "women's health" really means today—far beyond fertility and reproductive care;
• how decades of underinvestment created new opportunities for innovation, equity, and growth;
• why investors and policymakers are turning their attention to this space, and what's driving the momentum;
• the biggest gaps still to close in outcomes, access, and patient experience;
• how storytelling and strategy can help reshape the public narrative around women's health; and
• where the industry is headed next—including insights related to the upcoming [JW1]  Women's Health Innovation Summit.

Tune in to find out what's driving unprecedented momentum across policy, investment, and innovation in the women's health space.

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Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc90.

Subscribe for email notifications: https://www.ebglaw.com/subscribe.

Visit: http://diagnosinghealthcare.com.

This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.

Can food really be the prescription for better health? Discover how the "Food as Medicine" movement is reshaping health care and what it means for patients, providers, and the future of wellness.

On this episode, special guests Noah Voreades of OLIPOP and Ivan Wasserman of Amin Wasserman Gurnani join Epstein Becker Green attorneys Jessika Tuazon and Ada Peters to explore how food is being integrated into health care to prevent and manage chronic diseases.

The episode unpacks the policy priorities of Health and Human Services Secretary Robert F. Kennedy, Jr., the challenges of scaling food-based interventions, and the role of industry and government in driving innovation. Learn about the future of food as a clinical tool, the evolving regulatory landscape, and actionable takeaways for stakeholders navigating this transformative space.

Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc89.

Subscribe for email notifications: https://www.ebglaw.com/subscribe.

Visit: http://diagnosinghealthcare.com.

This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.

Important changes are unfolding in the vaccine space. How have vaccine exemptions posed a significant risk to populations across the country? What are the long-lasting effects of the new administration's federal health agency funding cuts?

On this episode, Epstein Becker Green attorneys Richard Hughes, Spreeha Choudhury, and Will Walters, as well as Anna Larson of EBG Advisors, discuss vaccine-related topics ranging from the measles outbreak and the reduction of the federal workforce to decreased government funding of public health programs.

If you are interested in getting access to Epstein Becker Green's publicly available shared information, please use the following link to subscribe: https://www.ebglaw.com/subscribe.

Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc88.

Visit: http://diagnosinghealthcare.com.

This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.

From removing diversity, equity, and inclusion initiatives to suspending foreign aid and canceling federal funding, it is clear that the current administration is drastically changing the landscape of government-funded research as we know it. What should research institutions be doing now to best prepare themselves for what's to come?

On this episode, Epstein Becker Green attorneys Marylana Saadeh Helou, Emily Chi Fogler, and Elizabeth McEvoy discuss how recent executive actions are impacting federally funded research at ambulatory medical centers, hospitals, universities, and other institutions, as well as how these actions may impact existing or future grants from the government.

Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc87.

Subscribe for email notifications: https://www.ebglaw.com/subscribe.

Visit: http://diagnosinghealthcare.com.

This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.

Since Pam Bondi was appointed U.S. Attorney General, we've seen notable shifts in the U.S. Department of Justice's (DOJ's) criminal enforcement priorities. How significant are some of these changes, and how might they affect your health care organization as we progress through 2025 and beyond?

On this episode, Epstein Becker Green attorneys Sarah Hall, Melissa Jampol, Thomas Jaworski, and Richard Westling discuss what to expect from criminal health care fraud enforcement under Attorney General Bondi's leadership and how it may impact the health care industry.

If you are interested in getting access to Epstein Becker Green's publicly available shared information, please use the following link to subscribe: https://www.ebglaw.com/subscribe.

Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc86.

Subscribe for email notifications: https://www.ebglaw.com/subscribe.

Visit: http://diagnosinghealthcare.com.

This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.

It is critical for health care and life sciences businesses to understand what might and might not change during this transitionary period. How can you advocate for your needs and priorities in a time of such uncertainty?

On this episode, Epstein Becker Green (EBG) attorneys James Boiani, Rachel Snyder Good, Marjorie Scher, and Rob Wanerman discuss the proposed leadership of the U.S. Department of Health and Human Services under the second Trump administration and the top-ticket items for these potential new leaders.

Chevron deference article mentioned in today's show

This podcast was recorded on January 23, 2025. Since then, EBG has put out several important free resources in response to President Trump's executive orders and other executive actions to make sure EBG subscribers have the information they need to navigate any uncertainty. Some examples include:

DEI and Affirmative Action Programs Blitzed, While Executive Order 11246 Is Revoked

Navigating Executive Orders: Insights and What Lies Ahead

The Trump Administration's Immigration Enforcement Policy: What Hospitals and Health Care Providers Must Know for Their Patients, Staff, and Visitors

Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc85.

Subscribe for email notifications: https://www.ebglaw.com/subscribe.

Visit: http://diagnosinghealthcare.com.

This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.