Discussion of several key news items that affect med mal practitioners.
GAO Finds FDA's Safety Tracking System Lacking
A report issued in December by the Government Accountability Office (GAO) (available at: http://1.usa.gov/1QpJXmc), faults the U.S. Food and Drug Administration's (FDA's) management of postmarket drug safety information.
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The combination of increasing operating costs and uncertain government reimbursement funding continues to place health care providers under financial pressure, and in many cases, financial distress. Given the importance of Medicare/Medicaid funding of claims under provider agreements with the federal government, how courts interpret and apply the interplay between the Bankruptcy Code and Medicare Program Act determines the disposition of hundreds of millions of dollars of claims for reimbursement that support the health care system.
As AI becomes embedded in everyday business and legal operations, organizations are confronting a new expectation: simply disclosing AI use is no longer enough. A critical shift is taking place in the legal industry: transparency is no longer just about disclosure; it’s about comprehension.
Clients have pushed back on what they are willing to pay for since long before anyone heard of a large language model. AI is the latest chapter in a long story about legal fees. But it introduces a wrinkle that prior tools did not.
If you want sustainable revenue growth, you cannot treat rainmaking as a personality trait. You must treat it as a professional discipline — one that is intentionally developed through structured partner development based on a proven framework.
Patents are not static assets. They are legal instruments shaped over time by prosecution, continuation practice, post‑grant proceedings, and cross‑border filings. Treating them as fixed objects in a fixed landscape misstates the risk.
