Archive for September, 2021


Survival Guide to Structuring Life Sciences Partnering and M+A Agreements

The life sciences space is ever-growing and dynamic as the industry witnesses more companies and, therefore, more collaboration, licensing and M&A agreements, come into the spotlight. While these deals are exciting opportunities for life sciences companies at all stages, they can also be daunting when it comes to their legal…

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Goodwin Virtual Series: Foundations in Healthcare Compliance for Life Sciences Companies

In the ever-evolving life sciences industry, compliance is top-of-mind for investors, business leaders, the public and the government.  Life sciences companies are subject to increased enforcement efforts and greater public scrutiny, and boards, investors, and other key stakeholders call for more and better compliance controls.  As a result, there are…

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Exactly One Year Later, CMS Reverses Course on Covering Innovative MedTech

In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough Devices Program.”  CMS’s proposal – the Medicare Coverage of Innovative Technology, or MCIT, Pathway – was groundbreaking in…

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Florida Joins List of States Requiring Licensure for Genetic Counselors

Many allied health professionals are subject to state-level licensing requirements that can vary from jurisdiction-to-jurisdiction. What may be required in New York to hold a medical professional license may differ dramatically from what is required in Illinois or Texas, for instance.  One state’s requirements may be onerous and administratively taxing;…

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Five Emerging Concerns for the Health Care Industry as AI & Telehealth Converge

The use of telehealth continues to grow rapidly across the U.S.  Given legislative proposals and the Centers for Medicare & Medicaid Services efforts to expand access to telehealth, we can only anticipate that remotely engaging with healthcare providers is here to stay.   In fact, the National Center for Health Statistics…

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