February 2016

Earlier today, on the InsideMedicalDevices blog, our colleague posted a summary of the FDA’s recent issuance of draft guidance on “Postmarket Management of Cybersecurity in Medical Devices.”  The release of the draft guidance coincided with the conclusion of a two-day public workshop hosted by the FDA entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.”

Concerns about the spread of Zika virus and potential complications associated with infection may soon lead to new research and development opportunities for government contractors and grant recipients.  Similar to developments after the recent Ebola outbreak in West Africa, a need to better understand Zika’s characteristics and develop an effective countermeasure or vaccine has led both domestic and

On January 22, 2016, the FAR Council published a proposed rule that, if adopted, would impose a government-wide prohibition on contracting with companies that limit the ability of employees or subcontractors to lawfully report fraud, waste, and abuse to the government.  Given the proposed rule’s near-universal application and potentially devastating consequences for violators, contractors would

Earlier this week, the Centers for Medicare & Medicaid Services (CMS) finalized a rule implementing a provision of the Affordable Care Act (ACA) that requires a Medicaid enrollee seeking coverage for home health services to first meet face-to-face with a practitioner.  The final rule confirms that the face-to-face encounter requirement “may occur through telehealth, as

California is already home to some of the most complicated and searching political regulations in the country, especially in its efforts to expose “dark money” and other undisclosed political spending.  A newly-amended lobbying regulation and proposed campaign finance law will enhance that reputation.  The practical effect of each is to invite deeper scrutiny of not