Tag: Medical device

Senator Calls on Med Device Leaders to Improve Cybersecurity

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 […]

FDA Issues Draft Guidance on Medical Device Cybersecurity

Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers should monitor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 […]

Congress Takes Step Towards Scrapping Device Tax

Yesterday, the House of Representatives voted 280-140 to pass H.R. 160, a bill that eliminates the 2.3 percent medical device tax. The vote was strongly bipartisan with 46 Democrats joining all Republicans voting in favor of scrapping the tax. The vote came amid the threat of a veto from the […]

General Wellness Products: Will the FDA Regulate Your Medical App or Device?

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than products that present a low risk to users. Cooley recently collaborated with Worrell to develop […]

OIG Releases New Guidance for Board Oversight of Corporate Compliance Programs

Earlier today, the U.S. Department of Health and Human Services Office of Inspector General (OIG), in conjunction with the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA) and the Health Care Compliance Association (HCCA), announced the release of a guidance document titled, “Practical Guidance for Health Care […]

AMA Tackles Conflicts of Interest with Industry

Interactions between health care professionals and industry representatives was a key topic at the American Medical Association (AMA) House of Delegates (HOD) meeting this week. As reported in BNA today (subscription required), the AMA HOD supported a resolution on June 9th that seeks greater consistency among conflicts of interest policies […]