DarshanTalks Podcast

Send us Fan Mail

In this episode of KLF Deep Dive, Darshan Kulkarni explores the growing urgency for in-house counsel to develop AI compliance programs as artificial intelligence becomes embedded in drug discovery, clinical decision-making, patient engagement, and beyond.

Darshan emphasizes that AI can create significant legal risk—even without breaking the law—if companies fail to address issues of transparency, validation, privacy, and governance. As regulators like the FDA and FTC tighten their expectations, companies must proactively implement structured, cross-functional AI compliance programs.

Key Topics Covered:

• AI System Mapping
   Start by identifying all AI systems—internally developed or third-party. Understand who owns them, what data they use, and how they function. Create a living inventory that evolves with your organization.
• Validation & Explainability
   Ensure that your models are transparent, repeatable, and auditable. Document how decisions are made and build mechanisms to detect deviations. Explainability is no longer optional—regulators and litigators expect it.
• Privacy & Governance
   Align your AI systems with HIPAA, GDPR, and state privacy laws. Update privacy notices to disclose AI use and profiling. Legal and privacy teams must collaborate closely with AI developers.
• Monitoring & Decommissioning
   All systems fail or become outdated. Put in place processes to log errors, recalibrate models, and decommission AI tools without disrupting patient care.
• Contracting & Vendor Management
   Negotiate contracts that clearly define data rights, IP ownership, use limitations, and audit rights. Tie these terms back to your insurance coverage and risk allocation.
• Risk Assessment
   Use risk registers to evaluate AI systems for potential misuse, bias, or patient harm. Prioritize mitigation efforts and build policies based on real-world use, not theoretical frameworks.
•  Culture & Training
   AI compliance isn’t a document—it’s a system. Cross-functional teams (legal, medical, IT, marketing) must be trained regularly. Appoint internal champions to maintain risk maps and trigger policy updates.

Conclusion:

If your organization doesn’t know who governs each AI system—or if your contracts don’t cover AI-specific risks—you’re already behind. Now is the time to build an adaptive, defensible AI compliance program that scales with your innovation.

Kulkarni Law Firm helps pharma and health tech companies translate AI risk into operational clarity. Subscribe to KLF Deep Dive for more weekly insights at the intersection of legal risk and life science innovation.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

Darshan Kulkarni and Edye Edens examine the far-reaching implications of the newly passed “Big Beautiful Bill”—a sweeping piece of legislation tied to the Trump administration’s political agenda. While the bill itself does not directly reference clinical research, Darshan and Edye highlight how its provisions—particularly the reduction in Medicare and Medicaid funding—could have serious downstream effects on clinical trial access and site viability.

Edye raises concerns that the legislation may lead to the closure of small physician practices and rural health centers that rely heavily on government reimbursement to operate. These closures could reduce the number of viable clinical trial sites and limit opportunities for underserved populations to participate in research. Additionally, the loss of Medicare coverage for patients may hinder routine care billing within trials, further discouraging sites from participation—especially smaller ones already burdened with administrative complexity and financial strain.

Darshan adds that while academic research institutions often navigate reimbursement issues with dedicated billing teams, many private sites, particularly those with low trial volume, rely entirely on sponsors to cover costs and avoid direct reimbursement processes. He also raises the possibility that trial sites could inadvertently become the de facto providers of clinical care in underserved areas—especially if other care options disappear due to budget cuts.

The conversation evolves into a broader discussion on how health system strain may lead to increased use of telemedicine, as well as the growing reliance on nurse practitioners (NPs) and physician assistants (PAs) to fill care gaps. However, legal limitations—such as whether a PA can serve as a Principal Investigator (PI) if they are not legally allowed to make independent medical judgments—could complicate this trend. The episode closes with a teaser for a future discussion on that very question.

Viewers are encouraged to consider not just the immediate financial and political implications of the bill, but also how changes in access, coverage, and staffing may reshape the clinical research ecosystem in the years ahead.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

In Alvarez v. Lincare, the Eleventh Circuit highlighted a growing risk for pharma marketers and legal teams running Direct-to-Patient (DTP) campaigns. Lincare and Optigen were accused of defrauding the government by:

• Routinely waiving co-pays without documenting financial hardship,
  
  
• Shipping unrequested supplies,
  
  
• Allegedly paying kickbacks to boost business.
  
  

While most claims were dismissed—not because they weren’t serious, but due to insufficient specifics—the upcoding charges remained. Why? The whistleblowers backed them with actual claim numbers, billing codes, and reimbursement data. That detail made the difference.

If your DTP program involves auto-shipping kits, vague copay waivers, or incentive-based referrals, you could be next. This case shows the DOJ and whistleblowers prioritize programs lacking clear, documented compliance.

Bottom line: Innovation ≠ immunity. Marketing tactics must be clinically justified, legally defensible, and clearly documented.

Need help reviewing your DTP strategy or tightening up compliance documentation?
The Kulkarni Law Firm helps pharma teams bridge innovation and regulation—before enforcement knocks.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

Darshan Kulkarni and Edye Edens break down a recent federal court ruling that challenges the NIH’s decision to halt grant funding for projects focused on LGBTQ+ populations and DEI-related research. The judge ruled that cutting off funding solely on a discriminatory basis—such as the subject matter being DEI or LGBTQ+ related—may itself be unconstitutional. While this has sparked optimism among affected researchers, Edye and Darshan caution that this is just one step in a longer legal process and not a final resolution. Appeals are expected, and the ruling could be reversed or narrowed.

The episode explores broader implications for clinical research and federal grant recipients. They stress that this case is about discriminatory decision-making, not a reversal of all NIH funding cuts. They advise institutions and research sites to remain cautious—don’t make financial or operational decisions based on the assumption that funding will be restored.

Ultimately, this episode highlights a potential shift in how courts may view the intersection of politics, discrimination, and scientific research funding. And it sets the stage for their next discussion on the broader implications of the “Big Beautiful Bill” that’s reshaping the federal research landscape.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

Pharmaceutical speaker programs come in two forms: one aimed at promoting a product, and another focused purely on education. Both must be compliant, but many companies blur the lines—leading to billion-dollar fines. Government bodies like the OIG consider these programs “inherently suspect” unless strict criteria are met.

To stay compliant, speakers must have relevant expertise (not just high prescription rates), and every presentation is vetted by a Medical-Legal-Regulatory (MLR) team. Despite all this oversight, violations are common—and patients can report them under FDA’s Bad Ad program.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

The Seventh Circuit just issued a pivotal decision in U.S. v. Sorenson, reshaping how pharmaceutical and medical device companies should think about direct-to-patient (DTP) advertising and Anti-Kickback Statute (AKS) compliance.

In this case, Sorenson’s company paid marketers to generate patient interest in orthopedic braces reimbursed by Medicare. These marketers gathered patient details and sent unsigned prescriptions to physicians. While most leads went nowhere, the court ruled this did not constitute a referral under AKS, since marketers weren’t influencing medical decisions and doctors retained full judgment.

The takeaway? The court is drawing a line between generating patient interest and influencing prescriber behavior. For pharma marketers, this clarifies that driving patient awareness without steering doctors may reduce AKS risk—at least in the Seventh Circuit.

If your DTP campaigns involve disease awareness, educational tools, or lead gen without prescriber targeting, you're likely on safer ground. But if those leads are used to nudge physicians’ decisions, compliance risks still loom.

Bottom line: Intent and influence are everything. Want help navigating this evolving space? Contact the Kulkarni Law Firm for support with risk-adjusted marketing agreements and compliance reviews.

Subscribe to DarshanTalks for more insights on legal and compliance updates in life sciences.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

Darshan Kulkarni and Edye Edens discuss the potential and pitfalls of using AI—like ChatGPT—to draft informed consent documents in clinical research. With both legal and regulatory expertise, they explore how AI could save time, whether it fits institutional IRB requirements, and the real-world value (or lack thereof) for different types of organizations.

Key Takeaways:

• Drafting vs. Final Use: AI can be useful as a first-draft tool, especially for high-volume sponsors. But using it for final documents without oversight is risky.
  
  
• IRB Templates Matter: Many IRBs (especially academic or VA-affiliated) require strict templates—limiting AI's value unless those are integrated upfront.
  
  
• Regulatory Landscape: AI-drafted consents must meet not just FDA standards, but also OHRP requirements. Compliance and clarity are non-negotiable.
  
  
• Customization Is Key: Most current AI tools are just wrappers over ChatGPT. Real ROI comes from domain-specific models trained for clinical research.
  
  
• Data & IP Risks: Feeding protocols into AI raises confidentiality concerns. Plus, who owns the output remains unclear due to copyright issues with training data.
  
  
• Why ROI Falls Short: Companies often reassign internal staff instead of building bespoke solutions. Without a clear use case or strategic planning, results disappoint.

AI shouldn’t replace people—it should support them. Darshan and Edye agree: if you're using AI to generate a first draft of informed consent documents, it could help streamline high-volume workflows. But expecting it to generate a compliant final version is unrealistic. Most current tools feel more like flashy "wrappers" around existing models and often lack a strong ROI. And let’s not forget the hidden risks—like IP concerns and exposing proprietary protocols.

Bottom line? AI has potential, but without strategic investment and oversight, it’s just another overhyped shortcut. Use it wisely, or not at all.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

Imagine you're filling a script when a State Board of Pharmacy inspector walks in—no warning, just a clipboard and serious consequences. Most community pharmacists assume, "That won’t happen to me," but audits are no longer rare—they're the norm.

Controlled substances are under intense scrutiny. Inspectors now expect airtight records, ongoing (not one-time) training, and SOPs that reflect current laws—not ones from 2019. If you’re relying on outdated policies, verbal explanations, or friendly smiles to pass inspection, you’re already behind.

Logs must match dispensing. Staff must follow documented protocols. Lock zones must meet state requirements. Every mismatch? A red flag.

At the Kulkarni Law Firm, we help pharmacies:

• Conduct proactive self-audits using real board standards
  
  
• Build strong, defensible SOPs and training systems
  
  
• Respond to audit deficiencies with authority—not panic
  
  

Darshan Kulkarni, a pharmacist and regulatory attorney, brings practical, no-BS insight into what inspectors really expect and how to be prepared. Because waiting for an audit is like waiting for a hurricane to test your roof—too late.

Be ready. Be confident. Be compliant.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

In this video, Edye Edens and Darshan Kulkarni discuss whether sponsors, sites, CROs, or IRBs should self-report compliance issues. Edye, who focuses on sites, explains that whether or not to self-report is highly situation-dependent. Some situations legally require reporting, while in others, organizations might have room to implement corrective actions without immediate reporting—but they must carefully understand applicable regulations and enforcement trends.

Darshan highlights the distinction between “should you report” and “is it reportable.” Not everything unethical is legally reportable, but stakeholders must assess the risks of not reporting, including potential regulatory, investor, or reputational fallout. He also warns that just because an SOP says “do not report,” that might not align with current regulations or enforcement priorities—and could even expose the organization to greater liability.

The conversation also touches on recent Trump administration statements that encourage self-reporting by offering some protection from prosecution—though Edye cautions that administrations often shift their enforcement priorities, so organizations should not rely solely on these statements as a shield. Both agree that any self-reporting should be accompanied by a robust corrective action plan already underway to show good faith. Otherwise, agencies could still decide to prosecute, especially in egregious cases.

Bottom line:
 Self-reporting can build trust and potentially reduce penalties, but only if handled thoughtfully. Assess the legal requirements, business risks, and your agency’s enforcement climate before deciding to disclose.

Support the show

www.kulkarnilawfirm.com

Send us Fan Mail

In this must-listen episode for pharma marketers and corporate counsel, we break down the recent $14.25M False Claims Act settlement involving Diopsys, a neurodiagnostic company accused of offering free tech to physicians—tech that allegedly led to medically unnecessary tests billed to Medicare and Medicaid.

This wasn’t just bad billing—it was a marketing strategy gone wrong. The DOJ saw it as a kickback scheme, and the case highlights how well-meaning “value-add” services can turn into legal liabilities.

Key takeaways:

• Value can become a liability – Helpful services may violate anti-kickback laws if not vetted legally.
  
  
• Volume-based strategies invite scrutiny – More testing isn’t always better—especially without medical necessity.
  
  
• You’re accountable—even if you don’t bill – Diopsys didn’t submit claims but still paid $14M for allegedly enabling them.
  
  

For legal and compliance teams, this is a compliance case study in what happens when oversight misses the risk signals. From fair market value to OIG advisory opinions—this episode explores what should have been done and how you can avoid the same fate.

Are your support services audit-proof? If you're unsure, this episode is for you. Tune in, stay informed, and stay compliant.

 Questions? Contact the Kulkarni Law Firm to assess your risk before you become the DOJ’s next target.

Support the show

www.kulkarnilawfirm.com