Health Care Counsel Blog
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Headlines that Matter for Companies and Executives in Regulated Industries
As artificial intelligence (AI) becomes increasingly embedded in health care, from diagnostics and clinical decision support to administrative automation, health care providers are increasingly reliant on AI vendors to deliver accurate, safe, and compliant solutions, subject to applicable regulatory requirements and standards of care.
On July 1, the US Department of Health and Human Services’ Office of Inspector General (OIG) released Advisory Opinion No. 25-08, issuing an unfavorable determination regarding a proposed arrangement in which a medical device company would pay licensing fees to a third-party vendor for access to an electronic billing portal used by some of the medical device company’s provider customers.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations (MSOs).
As of mid-2025, private equity (PE) investors remain intensely interested in health care services and technology companies despite higher borrowing costs, heightened regulatory scrutiny, and an increasingly complex state review landscape.
Headlines that Matter for Companies and Executives in Regulated Industries
Health care organizations are under pressure to shore up their cybersecurity response efforts. Much of this pressure is coming from the US Department of Health and Human Services Office for Civil Rights (OCR), which has made clear through recent enforcement actions that conducting a proper risk assessment under the Health Insurance Portability and Accountability Act (HIPAA) Security Rule is not optional.
Headlines that Matter for Companies and Executives in Regulated Industries
On May 27, Blue Cross Blue Shield Healthcare Plan of Georgia, Inc. (BCBSGA) filed a lawsuit in the Northern District of Georgia US District Court, alleging that a group of health care providers, along with their third-party billing agent, manipulated the federal No Surprises Act’s (NSA) independent dispute resolution (IDR) process.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
On July 1, the Virginia Consumer Protection Act (VCPA), as amended by Senate Bill (SB) 754, will provide additional privacy protections for reproductive and sexual health information. The legislation expands the VCPA to expressly prohibit the unauthorized collection and use of this category of information. Businesses that violate the law may be sued by affected Virginia consumers.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Anthem Inc. has agreed to settle a class action lawsuit brought by participants in employee health plans administered by the insurer.
Ambulatory surgery centers (ASCs) have become a large and growing part of the health care industry. ASCs offer same-day surgical care, including diagnostic and preventive procedures, and their popularity has recently grown.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).