Health care policy issues continue to stream out of Congress and the Administration. The Senate held a markup of various health bills as part of its effort to produce a companion to the House of Representatives-passed 21st Century Cures legislation and CMS released long awaited Medicare Advantage rates.
Today, the President sent Congress the $4 trillion Fiscal Year 2017 Budget Proposal – his last while in office. While the Budget on the whole is dead on arrival in the Republican-controlled Congress, there are provisions worth noting because of their current newsworthiness and possible reemergence in future policy debates. Moreover, proposals directed at addressing the […]
Late last week, Senator Barbara Boxer (D-CA) wrote to the leaders of Johnson & Johnson, GE Healthcare, Siemens USA, Medtronic and Philips USA, to “express serious concerns” about potential cybersecurity vulnerabilities in their medical devices. From the letter, the rationale for selecting these companies is that together they “control more […]
A U.S. Department of Health and Human Services (HHS) administrative law judge (ALJ) recently sustained an earlier HHS Office of Civil Rights (OCR) decision to impose a civil money penalty (CMP) of $239,800 against Lincare Inc. (Lincare) in connection with HIPAA violations discovered after a breach of patient records. This is only the second time […]
Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers should monitor and address cybersecurity risks. The Guidance is the latest manifestation of a federal agency weighing in on the continually […]