Final HITECH Rules Released
The long-awaited, much anticipated final rules under the Health Information Technology for Economic and Clinical Health (HITECH) Act amendments to the Health Insurance Portability and Accountability...
View ArticleFDA Explains Decision Not to Seek Rehearing in Caronia
Yesterday FDA explained why it did not seek a rehearing of the Second Circuit’s December 3, 2012 decision in United States v. Caronia. In its decision (previously discussed here), the Second Circuit...
View ArticleCenter for Medicare & Medicaid Innovation
Healthcare providers and payers may be salivating today with the news that the Center for Medicare & Medicaid Innovation (CMMI) – created under the Affordable Care Act and funded at $10 billion –...
View ArticlePresident Obama Signs the Drug Quality and Security Act
On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA) into law. Title I of the Act establishes national standards for compounding pharmacies designed to fill regulatory...
View ArticleSupreme Court Denies Cert in Harkonen
The Supreme Court denied certiorari this week in Harkonen v. United States. Harkonen was convicted of wire fraud related to statements he made in a press release about an FDA-regulated clinical study....
View ArticleD.C. Court of Appeals Upholds FDA Jurisdiction in Regenerative Sciences
Last week, the D.C. Court of Appeals upheld the FDA’s District Court victory in United States v. Regenerative Sciences, LLC, No. 12-5254. The District Court in Regenerative Sciences held that the FDA...
View ArticleFDA Releases Modifications Report
Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) released its much-anticipate report to Congress on when a modification to a 510(k) medical device triggers the need for...
View Article
