Columbia Drug Study: Elliott Bennett-Guerrero v. Columbia University

An Article on FDA Software Policy and Regulation

Strategic Framework

Report on Hold Harmless Clauses

1989 FDA Software Policy Draft

McKesson Letter of FDA's Proposed Medical Device Data Systems Rule

CPOE Facilitates Errors Study from 2005

Expert Panel Recommendations on Electronic Health Record Certification.

Policy Committee Recommendations on Safety

Policy Suggestions to Obama Transition Team

Congressional Budget Office Estimate on the Cost of Digital Medical Records from 2008

Safety Testing Proposal from 2008 in JAMIA

Proposed FDA Regulation of Medical Device Data Systems

Leapfrog Warnings on Electronic Health Record Technology

Call for Greater Oversight of Electronic Health Records

FDA Says Health Information Technology Has Safety Questions

Internal FDA Report on Adverse Events Involving Health Information Technology

FDA's Notice for a Workshop on How to Oversee Software Used in Medical Devices

Industry Proposal to Create Safe Oversight of Electronic Health Records from 1997

Unintended Consequences in Digital Medical Records Technology -- A 2007 Study from JAMIA