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Daily Archives: February 6, 2016

FDA Guidance – Postmarket Management of Cybersecurity in Medical Devices

Draft Guidance for Industry and Food and Drug Administration Staff – Postmarket Management of  Cybersecurity in Medical Devices – This guidance document is being distributed for comment purposes only. Document issued on: January 22, 2016.

“FDA is issuing this guidance to inform industry and FDA staff of the Agency’s recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. In addition to the specific recommendations contained in this guidance, manufacturers are encouraged to address cybersecurity throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device. A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats. The exploitation of vulnerabilities may represent a risk to the safety and  effectiveness of medical devices and typically requires continual maintenance throughout the product life cycle to assure an adequate degree of protection against such exploits. Proactively addressing cybersecurity risks in medical devices reduces the patient safety impact and the overall risk to public health…”

Market Valuation of Tax Avoidance and Corporate Social Responsibility

Inger, Kerry Katharine and Vansant, Brian, Market Valuation of Tax Avoidance and Corporate Social Responsibility: Does the Market Discount Corporate Robin Hoods? (January 4, 2016). Available for download at SSRN: http://ssrn.com/abstract=2727952 This study examines whether market valuation of firms’ tax avoidance is tempered by the extent firms engage in Corporate Social Responsibility (CSR) activities. Prior… Continue Reading

OPM to issue new requirements for personnel background investigations by contractors

Via Nextgov: “Contractors that conduct background investigations for the federal government will have to report information security incidents to the Office of Personnel Management within half an hour, are required to use smartcards as a second layer of security when logging on to agency networks and must agree to let OPM inspect their systems at… Continue Reading

The Resilient State: New Regulatory Modes in International Approaches to Statebuilding?

Pospisil, Jan and Kuehn, Florian P, The Resilient State: New Regulatory Modes in International Approaches to Statebuilding? (February 4, 2016). Third World Quarterly, January 2016, DOI: dx.doi.org/10.1080/01436597.2015.1086637; Edinburgh School of Law Research Paper No 2016/03. Available for download at SSRN: http://ssrn.com/abstract=2727994 “Resilience’ has quickly risen to prominence in international security and development circles. In recent… Continue Reading

SCAMPI database – search guide to military operations and history data

“The Joint Forces Staff College Ike Skelton Library is a specialized military library, focusing on research in joint and multinational operations, military history and naval science, operational warfare, and operations other than war. Library staff members regularly scan the weekly news magazines, monthly and bimonthly journals such as Military Review, Armed Forces Journal, and quarterly… Continue Reading