Articles and Blogs

On February 6, the Food and Drug Administration (the “FDA” or “Agency”) released a finalized guidance (the “Guidance”) informing the public that the Agency does not intend to enforce any regulatory requirements applicable to several types of devices and software that transfer, store, convert, format and display medical data, specifically including medical image storage (“MIS”) devices,…Read More

On January 20, 2015, the Food and Drug Administration (the “FDA” or “Agency”) published two draft guidance documents designed to fulfill promises it made in the multi-agency Food and Drug Administration Safety and Innovation Act (“FDASIA”) Health IT report. The first draft guidance is intended to promote the innovation of general wellness devices and software…Read More

In November 2014, the ECRI Institute¹ issued a report discussing issues of patient safety and adverse events linked to health information technology (“IT”) products. The report comes in the form of an annual list of top ten health technology safety hazards. According to the ECRI Institute, although many facets of health IT have a positive…Read More

Bipartisan Stark Law Correction Bill Reintroduced On February 5, Reps. Charles Boustany (R-LA) and Ron Kind (D-WI) reintroduced the Stark Administrative Simplification Act (H.R. 376). The legislation corrects the disproportionate penalties a hospital can incur under the Stark Law for having an unwritten, unsigned or lapsed agreement that is otherwise compliant with federal fraud and…Read More

Health care data breaches are not new. The breach announced by health insurer Anthem on February 5, 2015 is notable mostly for its scope. According to Anthem’s statement, hackers utilized a very sophisticated cyber attack to gain access to the information of potentially 80 million current and former Anthem members. The information accessed included names,…Read More

with Drew B. Howk On Monday, February 2, well-respected Federal District Court Judge Jed S. Rakoff awarded costs to the prevailing Defendant in US ex rel. Associates Against Outlier Fraud v. Huron Consulting, Case No. 09 Civ. 1800(JSR). The case had a long history. The Complaint was originally filed in February 2009. It was unsealed ten months later…Read More

This article has been republished with permission from the American Health Law Association. On December 31, the Food and Drug Administration (FDA) issued a guidance stating that it will delay enforcement of certain new product tracing requirements, included in the recently enacted Drug Supply Chain Security Act (DSCSA), until May 1. The delayed requirements were…Read More

Just three months ago, the Department of Justice announced a record year for False Claims Act recoveries totaling more than $5 billion, including $2.3 billion from health care defendants alone. Helping to contribute to these recoveries was another record: over 700 whistleblower cases filed in 2014.

Written by David B. Honig and Steven H. Pratt. On February 2, the Sixth Circuit Court of Appeals ruled on a case from the Southern District of Ohio, US ex rel American Systems Consulting, Inc. v Mantech Advanced Systems International. At issue was whether a court may determine whether a knowingly false statement in a proposal for a…Read More

CMS recently published a notification on its website in response to inquiries regarding the annual reporting requirement for physician-owned hospitals.  In the notification, CMS expressed concerns about the quality of the data collected for the CY 2014 annual report and noted that it would further examine the details of the report prior to publication.  Because…Read More