On February 23, the FDA announced a new approval pathway designed to support the development of drugs for ultra-rare diseases. Often, treatments for ultra-rare diseases have difficulty meeting the agency’s rigorous approval requirements. The FDA has issued a guidance document
Health Law Informer
Health Law Informer, published by Cozen O'Connor, covers legal developments and regulatory issues affecting the health care sector. Topics include legislative scrutiny of health care transactions, particularly involving private equity; FDA regulatory transparency and drug approval processes; enforcement actions under the False Claims Act and Anti-Kickback Statute related to Medicare Advantage plans; proposed policies on clinical trial requirements for vaccines; and significant changes to HIPAA Security Rule aimed at enhancing cybersecurity protections for electronic protected health information. The blog addresses compliance challenges, health care fraud and abuse, regulatory reforms, and the intersection of health law with bioethics and public health policy.
Blog Authors
Latest from Health Law Informer
FDA Outlines Flexible Requirements to Support Cell and Gene Therapy Innovation
The FDA recently shared information regarding its flexible approach to overseeing chemistry, manufacturing, and control (CMC) requirements for cell and gene therapies (CGT). Due to the unique nature of the characteristics of CGT, regulatory flexibility must be adapted in a…
Pennsylvania Legislature Revives Bill Scrutinizing Health Care Transactions
Throughout the country, state governments have been introducing bills which grant state authorities the ability to closely scrutinize health care transactions – specifically, with an eye toward those involving private equity. In Pennsylvania, the recent closure of the Crozer-Chester Medical…
FDA Transparency Push: CRLs Released
On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug applications (NDAs) or biologics license applications (BLAs)…
Justice Department Continues Pattern of False Claims Act Suits Due to Alleged Kickbacks
On May 1, the federal government brought a False Claims Act (“FCA”) suit against three health insurers, as well as three insurance brokers. The Justice Department’s suit alleges that the insurers paid millions of dollars in kickbacks to brokers in…
HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice
The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is rooted in calls for greater methodological rigor and…
Proposed Changes to the HIPAA Security Rule Will Have a Significant Impact on the Health Care Sector
A few days ago, the U.S. Department of Health and Human Services (“HHS”), through its Office for Civil Rights, issued the proposed rule HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health Information (the “Rule”) “to improve cybersecurity…
Blue Cross Blue Shield Agrees to Pay $2.8 Billion Settlement in Antitrust Case
In October 2024, Blue Cross Blue Shield (“BCBS”) agreed to a $2.8 billion settlement to resolve allegations of anti-competitive practices in the health insurance market – it is reported to be the largest settlement in a health care antitrust case…
California’s Bill Increasing Regulations on Private Equity Health Deals
California is looking to take the lead on regulating private equity deals in the health care space by introducing bill AB 3129, which requires private equity groups or hedge funds to receive the state attorney general’s approval before purchasing…
CMS Announces 120-day Exception Period for No Surprises Act Independent Dispute Resolution
Under the No Surprises Act, “open negotiation” is the period of time during which payers must disclose to providers important information regarding the claim at issue. On June 14, 2024, CMS announced a 120-calendar-day exception period, the open negotiation period…