Diagnosing Health Care Podcast

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 create...

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 valu...

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...

Why is  now  the moment for women's health? On this episod e , 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 challeng...

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 integrat...

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...

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 Saade...

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 Rich...

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. Departme...

The recent 2024 elections resulted in a new Trump administration and a Republican-controlled House and Senate. From policymakers to stakeholders across the industry, everyone is wondering what health policy will look like in 2025 and beyond. On this episode, Epstein Becker Green attorneys Ted Kennedy Jr. , Leslie Norwalk , Philo Hall , and Alexis Boaz discuss the results of the 2024 elections and...

One year ago, on October 30, 2023, President Joe Biden signed an executive order laying the groundwork both for how federal agencies should responsibly incorporate artificial intelligence (AI) within their workflows and how each agency should regulate the use of AI in the industries it oversees. What has happened in the past year, and how might things change in the next? On this episode, Epstein B...

Workplace violence in health care settings is on the rise, capturing the attention of both state and federal lawmakers. As awareness grows, so too does legal scrutiny and the push for new regulations and enforcement. In these seemingly critical times, what should health care employers be thinking about and incorporating into their comprehensive strategies to prevent and address workplace violence?...

The game has changed—are you positioned to adapt? Over the past 12 months, the federal government has been heavily regulating private investment in health care entities. Simultaneously, multiple states have enacted or introduced new laws restricting or requiring approval of such investments. The question arises: What do you do if you already have investments in these health care entities?   On thi...

Knock, knock! If the Drug Enforcement Administration (DEA) is already at your door, it may be too late. Enforcement is on the rise, and the microscope is fixed on controlled substances. What can industry stakeholders do to prevent penalties and protect themselves from DEA scrutiny? On this episode, Epstein Becker Green attorneys Melissa Jampol , David Johnston , and Avery Schumacher discuss recent...

Laboratories in the United States are facing a major regulatory landscape shift. The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory developed tests (LDTs). What does this mean for labs going forward? On this episode, Epstein Becker Green attorneys James Boiani , Rob Wanerman , and Megan Robertson lay out the new...

In a recent landmark decision, the U.S. Supreme Court overruled the  Chevron doctrine in the case of Loper Bright Enterprises v. Raimondo . This ruling has significant implications for employers and other entities in the health care and life sciences industries, as it changes the way courts are likely to interpret and apply regulations issued by federal agencies. On this episode, Epstein Becker Gr...

Gender-affirming care has become the latest flashpoint in state legislatures and state and federal courts across the nation. States are divided, with some passing laws that seek to restrict access to gender-affirming care and others aiming to protect access. What is gender-affirming care? What risks does it pose to providers and patients? On this episode, Epstein Becker Green attorneys Jenny Nelso...

After nearly two years of combined efforts from the Federal Trade Commission and the Antitrust Division of the Department of Justice, the agencies jointly issued much-anticipated merger guidelines identifying the procedures and enforcement practices they will apply for evaluating potential mergers. What might these changes mean for hospitals, health systems, and other stakeholders in the health ca...

Under the Biden administration, the Centers for Medicare & Medicaid Services published a health equity framework that drastically changed the playing field for health plans and other risk-bearing entities. In the wake of these changes, how can health plans, accountable care organizations, and other similar stakeholders successfully create and administer social determinants of health interventions...

What trends in state laws and regulations have emerged in the post-public health emergency (PHE) era, and how do these changes impact telehealth stakeholders? At the federal level, many telehealth-related flexibilities have been extended through December 31, 2024, whereas, at the state level, there are wide variations in approach. Many states have continued to push the boundaries of existing teleh...

From wholesale revisions of the merger guidelines to significant amendments to the Hart-Scott-Rodino premerger notification forms, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) have proposed significant changes that, if adopted, will have profound effects on merger review and enforcement for the foreseeable future. What might these changes mean for hospitals, health system...

The U.S. Food and Drug Administration's (FDA's) broad definition of "misbranding" has created some industry confusion, while the Federal Trade Commission's (FTC's) updates to its health products compliance guidance have done the same. In light of these recent actions, what challenges are dietary supplement manufacturers now facing? On this episode, Epstein Becker Green attorneys Jack Wenik , Teddy...

Throughout this series, we've talked about the growth of the direct access testing industry and the types of models developed to support the businesses that are using that type of testing. We've covered reimbursement considerations and physician ordering and specimen collection regulations. How does all of this come together to shape the future of the lab testing industry? On the final episode of...

In July, the Centers for Medicare & Medicaid Services made significant headway in its implementation of the drug pricing provisions of the Inflation Reduction Act (IRA). How can stakeholders respond to, implement, and comply with all these new provisions? On this episode, hear from special guest  Sylvia Yu , Vice President and Senior Counsel of Federal Programs at PhRMA . Sylvia and Epstein Becker...

The Supreme Court's decision in Dobbs v. Jackson Women's Health Organization one year ago overturned 50 years of legal precedent protecting the constitutional right to abortion in the United States, leaving the question of whether and how to regulate abortion to individual states. What has happened since and what is to come?  On this episode, Epstein Becker Green attorneys Amy Dow , Erin Sutton ,...