A recent False Claims Act (FCA) litigation—Jensen ex rel. United States of America v. Genesis Laboratory—highlights critical compliance risks for laboratories. This case reinforces the need for laboratories to ensure adherence to federal regulations governing medical necessity, lab requisition practices, and the Anti-Kickback Statute (AKS).
On February 20, 2025, the ERISA Industry Committee (ERIC) announced that its legal counsel submitted a letter to the U.S. Departments of Labor (DOL), Health and Human Services (HHS) and Treasury, requesting a stay of enforcement of the September 2024 Mental Health Parity and Addiction Equity Act (MHPAEA) Final Rule. In the letter, ERIC urged the Departments to exercise their authority under 5 U.S.C. § 705 to postpone the effective date of the Final Rule while litigation challenging its validity is ongoing. This request marks a significant development in the legal landscape surrounding mental health parity laws and could have far-reaching implications for employers, health plans, and other stakeholders in the health insurance industry.
Throughout this series, we’ve explored the key elements of successful life sciences transactions—from structuring collaborations and securing funding to protecting intellectual property and navigating regulatory complexities.
Yet, even when companies understand these fundamentals, transactions don’t always go as planned. In our work with biotech, medtech, digital health, and research-driven companies, we’ve seen common missteps that can slow deals down, create compliance risks, or weaken long-term business outcomes.
Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to market. CRAs, which govern the conduct of clinical trials, are essential for detailing which party will comply with the regulatory requirements while facilitating the commercialization of new drugs, devices, and digital health solutions.
Taxpayers may encounter a variety of challenges as the IRS is facing one of its smallest (and least experienced) workforces since the 1970s. Continuing the theme of our previous article authored by Robert Romashko, the following discussion highlights some specific tax diligence areas of concern in the healthcare space. The problems of a very outdated IT system still exist – the IRS still uses fax machines in communications with taxpayers.
On March 7, 2025, the U.S. Department of Health and Human Services (HHS) announced that its Office for Civil Rights (OCR) had initiated four investigations into unnamed medical schools and hospitals over allegations that the schools and hospitals “discriminate on the basis of race, color, national origin, or sex” by continuing to implement “DEI” programs.
This blog post explains what HHS OCR is investigating, what laws are at issue, and what those operating medical schools and hospitals with DEI programs should consider, given this and other federal attention to DEI.
With the SXSW Health and MedTech conference in full swing, it’s a good time to reflect on some fundamental Intellectual Property (IP) strategies that can help safeguard your Life Sciences and MedTech business and maximize its value now and into the future.
IP is often one of the most valuable assets a company can own. Whether you’re preparing to sell a business, enter into a joint venture, or acquire another company, understanding the scope of your IP portfolio is essential. For in-house counsel, founders, corporate executives, and other legal professionals, navigating the complexities of IP ownership and licensing can make or break a deal.
What Investors Look for in Early and Late-Stage Funding Rounds and How Regulatory Compliance Impacts Valuation
For early-stage life sciences and health tech companies, raising capital is about more than demonstrating scientific promise. Investors are increasingly focused on regulatory preparedness, reimbursement strategy, and risk allocation—factors that can significantly impact valuation and long-term viability.
AI, Medical Devices, Digital Health, and the Future of Healthcare Transactions
Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions.
The life sciences industry is built on breakthroughs and partnerships. From early-stage biotech startups to established medtech and pharma companies, success often depends on navigating complex business transactions, securing funding, protecting intellectual property, and aligning with regulatory requirements.
At Husch Blackwell, we’ve worked alongside drug manufacturers, device companies, digital health innovators, academic medical centers, CROs