Category: Uncategorized

FDA Issues Final Cybersecurity Guidance for Medical Devices

On October 1 the US Food and Drug Administration (FDA) issued final guidance regarding cybersecurity for medical devices. The FDA guidelines urge device manufacturers to include safety controls on devices to prevent cyber threats and recommend manufacturers outline the necessary steps that will be taken if their devices are found to […]

Two New York Providers Reach Largest HIPAA Settlement with OCR To Date

Earlier this week, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) reached settlements with New York and Presbyterian Hospital (“NYP”) and Columbia University (“CU”) for alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  The entities operate a shared data network […]

New HIPAA Settlements Show OCR’s Focus on Encryption

Last week, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) reached settlements with two separate entities for alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  Specifically, Concentra Health Services (“Concentra”) agreed to pay $1,725,220 following the theft of an unencrypted laptop and the […]

CMS to Congress: “We Do Not Plan to Finalize” Certain Controversial Medicare Part D Proposals – All “Protected Classes” Will Remain Protected. For Now.

Yesterday, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Marilyn Tavenner responded to several Congressional concerns regarding CMS’ recent proposed rule on the Medicare Part D outpatient prescription drug benefit.  We previously reported on that proposed rule here.  In a Letter to Representative Sander Levin, Ranking Member of the House […]

CMS Proposes Rate Adjustments and Policy Changes for Medicare Advantage and Medicare Part D Programs: Draft Rate Notice and “Call Letter” for 2015 Plan Year Released

On February 21, 2014, the Centers for Medicare & Medicaid Services (“CMS”) released its Advance Notice of Methodological Changes for Calendar Year 2015 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies (the “Draft Rate Notice”), as well as its draft “Call letter” for the 2015 […]

FTC Expands HSR Reporting Obligations – Targeting Pharmaceutical Licensing Deals

New Federal Trade Commission (“FTC” or the “Commission”) rules targeting the pharmaceutical industry will soon require Hart-Scott-Rodino Act (HSR) notices for a broader array of licensing transactions, expanding the types of deals that have to be notified to the government to allow the antitrust enforcement agencies to scrutinize whether those […]