Darshan Kulkarni and Edye Edens discuss the critical role of data privacy in clinical trial site acquisitions. While privacy concerns can seem daunting, they don’t have to be a dealbreaker if managed correctly. The key is understanding whether privacy laws like HIPAA apply, ensuring the site is already handling data compliance well, and putting safeguards in place to mitigate risks. Investors should conduct thorough due diligence to assess the site's current privacy practices before the merger or acquisition.

One major misconception is that HIPAA always applies to clinical trial data. In reality, properly anonymized trial data often falls outside its scope, though certain patient records may still be regulated. Beyond HIPAA, state-specific laws such as the California Consumer Privacy Act (CCPA) and disease-specific privacy regulations (e.g., HIV, weight loss treatments) add layers of complexity. Additionally, compliance risks arise when acquiring companies use AI-driven tools, as AI itself is facing lawsuits over privacy violations.

A smart approach to privacy in M&A involves firewalling sensitive data whenever possible—if an acquiring company doesn’t need direct access to regulated data, it should avoid handling it altogether. Investors should also consider risks tied to telemedicine regulations, patient communications (TCPA, CAN-SPAM), and wiretapping laws in certain states. The goal is to minimize exposure while maintaining operational efficiency.

Ultimately, data privacy in clinical trial acquisitions is about proactive risk management. Understanding the regulatory landscape, setting clear boundaries around data access, and ensuring compliance with both federal and state laws can help investors navigate these challenges. If you’re considering acquiring a clinical trial site and want to safeguard your investment, reach out to us to discuss your privacy strategy.

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The FDA you designed your protocol around may no longer exist. In this episode, Darshan Kulkarni breaks down why clinical researchers, regulatory attorneys, and promotional review teams need to pay attention—now.

With mass layoffs, frozen guidances, and a reorganization shaking CDER and CBER to their core, trial timelines, IRB reliance, and even legal interpretations are in flux. Marketing teams are flying blind with the FDA’s communications division gutted and post-Loper Bright challenges looming large.

Darshan outlines urgent next steps:
 ✔️ Rethink your submission timelines
 ✔️ Reassess your SOPs for oversight and reporting
 ✔️ Update your promotional risk strategy—especially in digital

If you're in life sciences and relying on yesterday’s FDA to approve tomorrow’s innovation, it’s time to rethink.

Reach out to the Kulkarni Law Firm—we specialize in compliance during regulatory chaos.

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The FDA is facing unprecedented turmoil—staff cuts, a sweeping reorganization, and political interference are undermining its ability to safeguard public health. Former agency leaders are raising red flags, with one likening the situation to "flat earthers taking over NASA." With vaccine data access becoming politicized, stem cell oversight potentially weakening, and the user fee system in jeopardy, startups and pharma companies must treat this not as a minor policy shift but as a major compliance crisis. If you're not already reassessing your regulatory strategy, you're falling behind.

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In this episode, Kate Woods and Darshan Kulkarni discussed the shift from employer-sponsored health insurance to individual responsibility, a transition accelerated by policy changes and rising healthcare costs. Traditionally, employer-provided insurance has been the backbone of the U.S. healthcare system, but evolving regulations, including the Affordable Care Act (ACA), have made individual plans more accessible. This shift has given employees greater flexibility but also placed the burden of navigating complex insurance options on them, often without sufficient guidance.

One key development in this transition is the rise of Individual Coverage Health Reimbursement Arrangements (ICHRA), which allow employers to fund employees' insurance plans rather than providing direct coverage. While this model expands consumer choice, it also raises concerns about decision fatigue and potential financial risks, especially for younger employees who may prioritize lower premiums over comprehensive coverage. As the workforce becomes more mobile and remote work grows, the demand for personalized, portable health coverage is likely to increase.

The discussion also explored the role of AI and digital tools in simplifying healthcare decision-making. AI-powered platforms can assess consumer needs, predict potential risks, and recommend tailored insurance plans. However, while these tools offer convenience and efficiency, they also introduce risks related to bias, transparency, and over-reliance on automated decision-making. Without proper safeguards, employees may make uninformed choices based on incomplete or misleading AI-generated recommendations.

Both Kate and Darshan emphasized the importance of balancing technology with human expertise in healthcare decisions. While AI can streamline processes, it cannot fully replace the nuanced understanding of a skilled advisor. As the healthcare landscape continues to evolve, education, transparency, and regulatory oversight will be critical to ensuring that individuals can make informed choices without unintended consequences.

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When mergers and acquisitions intersect with clinical trials, due diligence becomes a crucial step in ensuring a successful transition. In this insightful discussion, Darshan Kulkarni and Edye Edens explore the key legal and operational considerations when acquiring or merging with clinical research entities, including sponsors, sites, and CROs.

A major focus of the conversation is understanding the risks associated with clinical trial sites. Many private equity investors are actively looking to acquire research sites, but without proper planning, these deals can present significant challenges. One of the biggest concerns is the departure of key personnel—often the very individuals who understand how the site operates. If a site owner exits without a succession plan, the entire operation could be at risk. Investors must assess whether there are trained personnel in place to sustain operations.

Ownership structure is another critical factor. The MSO (Management Services Organization) model is commonly used in healthcare acquisitions, but not all clinical research sites are structured this way. Some investors may assume that site acquisitions function like medical practice acquisitions, which can lead to compliance and operational gaps. Additionally, many site owners have handshake agreements with principal investigators (PIs) rather than formal contracts, posing risks when it comes to continuity and regulatory compliance.

From an operational standpoint, investors and sponsors need to evaluate where a site stands in its progression—its infrastructure, ability to handle feasibility audits, and experience in running trials. Conducting a thorough review of contracts, policies, and procedures is crucial. Beyond the high-level strategic risks, a deeper, on-the-ground audit of compliance and operational readiness is necessary to avoid unforeseen liabilities.

This discussion highlights the complexity of due diligence in clinical trial acquisitions. While this conversation only scratches the surface, it underscores the importance of a comprehensive review process. Investors, sponsors, and site owners must collaborate with legal and compliance experts to navigate these challenges effectively.

For a deeper dive into these issues, watch the full discussion or reach out to Kulkarni Law Firm for guidance.

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Today’s episode is a wake-up call for pharma marketers launching telehealth campaigns. If you're using AI voice assistants or call automation tools in your outreach, you could be stepping into a legal minefield under California’s privacy law (CCPA & CIPA).

Your telehealth campaign reflects your brand—don’t let privacy lawsuits define it. Contact the Kulkarni Law Firm for a legal review of your telehealth tools to ensure compliance and protect your reputation.

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In this episode, Darshan Kulkarni explores an important yet often overlooked question—what happens after a clinical trial ends? While much focus is placed on clinical trials as a care option, the conversation shifts to the opportunities that exist for research-related resources post-trial.

Darshan is joined by:

• Lorri Warren, Program Director of the MedSurplus Alliance at the Task Force for Global Health, which focuses on improving healthcare systems and managing medical product donations.
• Donna Libretti Cooke, a consultant for Kits4Life, who formerly worked at Bayer and helped implement the Kits4Life initiative.
• Greg Folks, Chair of the Kits4Life Advisory Council, who has over 30 years of experience in clinical research, particularly from the site perspective.

The discussion highlights how clinical trial sites often accumulate surplus medical supplies and equipment, which are typically destroyed due to logistical and liability concerns. The Kits4Life initiative, built within the MedSurplus Alliance, aims to redirect these valuable resources to humanitarian efforts rather than letting them go to waste.

Greg shares how the idea stemmed from the realization that research sites were discarding perfectly usable, medical-grade supplies. Donna discusses the legal and compliance challenges faced by pharmaceutical companies in supporting such donations, emphasizing how structured donation agreements and liability protections help overcome these concerns. Lorri provides insights into how the MedSurplus Alliance facilitates these large-scale donations through vetted organizations to ensure compliance and proper distribution.

The episode underscores the importance of structured donation systems that allow surplus clinical trial supplies to benefit underserved healthcare communities, turning research into an ongoing care option even after a trial has concluded.

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Edye Edens discusses what it truly means to be site audit ready and dispels the misconception that it requires 100% compliance. No auditor expects perfection—what matters is having strong processes in place to catch and address issues in real time, particularly those with safety or regulatory implications.

Being audit-ready means having the infrastructure to identify whether mistakes are isolated incidents or part of a larger trend requiring corrective action. Just like building credit requires a history of responsible transactions, regulatory credibility comes from demonstrating the ability to detect and resolve compliance issues effectively.

Rather than aiming for unattainable perfection, sites should focus on maintaining a proactive compliance system that ensures high-risk issues are caught early and addressed. 

If you need guidance on achieving true audit readiness, KLF is here to help.

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Citizen biohacking is an empowering movement where individuals take medical innovation into their own hands, often stepping in when traditional medicine falls short. Driven by necessity, love, and a desire for survival, many have solved complex medical problems themselves, leading to groundbreaking discoveries. This trend raises important questions about safety, ethics, and the future of healthcare, with both promise and complexity.

One of the most well-known examples is Lorenzo’s Oil, where Michaela and Augusto Odone developed a treatment for their son Lorenzo, who was diagnosed with a rare and fatal genetic disorder. Their research and persistence led to a groundbreaking treatment that helped slow the disease's progression. Another inspiring story is that of Dr. David Fajgenbaum, who, after being diagnosed with Castleman’s disease, repurposed existing drugs to stabilize his condition, saving his life and offering hope to others. These remarkable examples demonstrate how determination and innovation can lead to life-saving breakthroughs.

However, citizen biohacking raises crucial concerns, such as safety and ethics. Operating outside the traditional medical system, it challenges regulatory bodies to reconsider how innovation is validated and tested. Despite these challenges, citizen biohacking is changing the landscape of medicine, pushing the medical community to think differently, adapt more quickly, and collaborate with unconventional innovators. If you’re interested in exploring these stories and the legal implications of this trend, tune in to our Darshan Talks podcast or reach out to Kulkarni Law Firm for expert guidance. 

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Mergers and Acquisitions (M&A) in the healthcare sector can be highly profitable, but they carry significant legal risks, particularly for private equity investors and board members who hold excessive influence over operations. The case of US XRL Martino Fleming vs. South Bay Mental Health Centers serves as a cautionary tale, highlighting how overstepping operational boundaries can lead to False Claims Act (FCA) violations. Investors, eager to enhance efficiency and profitability, may inadvertently trigger scrutiny by imposing aggressive performance targets or controlling daily operations, which could cross the line into operational control. In this case, allegations of fraudulent billing practices arose due to the investor’s involvement in clinical and administrative operations. Such claims can result in severe financial penalties and irreparable damage to reputation, affecting future investment opportunities.

The key takeaway here is that undue influence by investors can unintentionally create compliance liabilities. It is crucial for private equity firms to maintain a balance between oversight and operational independence. As part of M&A due diligence, integrating compliance reviews is essential. The Department of Justice (DOJ) issued updated guidance in 2023 and 2024, emphasizing the need for these reviews to focus on federal healthcare program regulations. This includes everything from Medicare billing practices to compliance with the Stark Law and Anti-Kickback Statute. Investors must conduct operational audits, understand the limits of control in regulated industries, and set up post-acquisition compliance frameworks to avoid liability. Ultimately, proactive compliance strategies are crucial to safeguarding against FCA violations and ensuring M&A transactions remain successful. Reach out to the Kulkarni Law Firm for tailored legal guidance and subscribe to the DarshanTalks Podcast for more insights into healthcare M&A best practices.

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