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Policy Committee Recommendations on Safety

Expert Panel Recommendations on Electronic Health Record Certification.

Strategic Framework

An Article on FDA Software Policy and Regulation

Policy Suggestions to Obama Transition Team

Report on Hold Harmless Clauses

Electronic Health Record Rule on Meaningful Use

Internal FDA Report on Adverse Events Involving Health Information Technology

Economic Stimulus Bill

FDA Says Health Information Technology Has Safety Questions

Call for Greater Oversight of Electronic Health Records

Study on the Failure of Computerized Technology to Perform from Health Affairs

Government Advisors Recommendations on Addressing Safety of Electronic Medical Records

Testing Useability of Electronic Health Records

Leapfrog Warnings on Electronic Health Record Technology

Proposed FDA Regulation of Medical Device Data Systems

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

Safety Testing Proposal from 2008 in JAMIA

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

Call To Action by HIMSS from December 2008

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

CPOE Facilitates Errors Study from 2005

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

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

1989 FDA Software Policy Draft

Study

Health IT Policy Panel's Draft Letter on Patient Safety Recommendations

Health Affairs Study on Problems with Computerized Provider Order Entry

FDA Science and Mission at Risk

Inspector General Report on FDA's Adverse Event Reporting System for Medical Devices

Amended Class Action Complaint Against Syngenta

2008 Settlement Agreement

Galeotti Case

Galeotti Case

Statement from Kaiser Permanente Regarding Coverage of Former Kaiser Permanente Members

Galeotti Case

Internal Kaiser E-Mail on Retroactive Termination Policy

FDA's Letter to Hospitals on Health Information Technology

FDA Testimony 2-25-10 on Safety & Regulation

Illinois Class Action Complaint Against Syngenta

HHS Inspector General Report on Adverse Events

Proposed Certification Rule from ONC

Grassley Feb 24 Letters

GAO

Grassley Letter to Vendors October 2009

Grassley Letter to Hospitals January 2010

GAO Physician Credentialing

Standards for EHRs Interim Regulation

Student Aid and Fiscal Responsibility Act (HR 3221))