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FDA Issues Guidance on Clinical and Patient Decision Support Software

USA - December 20 2017 On December 8, 2017, the Food and Drug Administration (FDA) published a notice of availability for the Clinical and Patient Decision Support Software…

Elliot R. Golding, John E. Wyand

FDA Draft Guidance on Clinical and Patient Decision Support Software Issued

USA - December 15 2017 Recently, the US Food and Drug Administration (FDA) published a notice of availability for the Clinical and Patient Decision Support Software -…

Elliot R. Golding, John E. Wyand

House Asks HHS to Develop Health Care Cyber Risk Plan

USA - November 30 2017 Last week, the Chairman on the House of Representatives' Committee on Energy and Commerce, Greg Walden (R-OR), sent a formal letter to the Dept. of…

Elliot R. Golding

National Institutes of Health Extends Effective Date of sIRB Policy

USA - July 17 2017 Recently, the National Institutes of Health (NIH) extended the effective date of its policy on the use of the single Institutional Review Board (IRB…

John E. Wyand

National Institutes of Health Extends Effective Date of sIRB Policy

USA - July 7 2017 Recently, the National Institutes of Health (“NIH”) extended the effective date of its policy on the use of the single Institutional Review Board…

John E. Wyand