EMR presolicitation.doc

Presolicitation Notice – Electronic Medical Record Data THIS IS A PRESOLICITATION NOTICE. THIS IS NOT A REQUEST FOR PROPOSALS. IT IS ANTICIPATED THAT A REQUEST FOR PROPOSAL WILL BE ISSUED ON OR ABOUT 15 DAYS AFTER THIS PRESOLICITATION NOTICE ISSUE DATE.

The United States Food and Drug Administration (FDA) is seeking a qualified contractor to provide Electronic Medical Record (EMR) Data. The FDA anticipates awarding a fixed price contract with an Indefinite Deliver/Indefinite Quantity (IDIQ) portion.

Description: In September 2006, the Institute of Medicine Report entitled, “The Future of Drug Safety: Promoting and Protecting the Health of the Public” was released and outlined numerous activities designed to continue to strengthen the FDA’s drug safety program. In response to this report from the IOM, and under authorization by Title IX of the Food and Drug Administration Amendments Act of 2007 (FDAAA 2007), this effort is intended to develop the capability for advanced analyses of drug and biologics safety data in order to improve the quality of post-market risk/benefit evaluation and enhance the ability of FDA to make timely assessments of drug and biologics safety data. Consequently, FDA is devoting greater resources to the area of postmarketing safety and is expanding the roles and responsibilities of OSE within CDER and OBE within CBER. In furtherance of this effort, FDA seeks continued access to nonfederal, longitudinal patient-level electronic medical record (EMR) data.

FDA seeks to acquire direct access to nonfederal EMR data. This database shall contain searchable patient-level, prescription information along with health history, details of ambulatory care visits, information relating to the full hospitalization record, laboratory test results, and death certificate data, and an ability to link to disease registries, all integrated in the context of an EMR. The majority of these data should be coded in individual fields at the patient level. FDA recognizes that such a data resource may cover patient populations outside the US.

To address postmarketing issues confronting the agency, this database shall provide FDA scientists with the ability to perform hands-on, population-based epidemiologic studies pertaining to drug safety, using nonfederal, nonfederal, commercially available, directly accessible data from longitudinal EMRs that are, by their nature, more detailed than administrative claims data.

The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products. The "Unlimited Access to Longitudinal Patient-Level Electronic Medical Record Data” contract would serve as a mechanism for FDA to respond expeditiously to serious public health or regulatory issues. FDA's authority to fund research projects is set out in section 301 of the Public Health Service Act (PHSA 42 U.S.C. 241).

FDA is not interested in developing this database and expects any qualified organization to own the data as well as the means to access the data. This requisition is not related to the FDA Agency-wide Sentinel system.

1) Objectives:

The specific programmatic goal of this requirement is to gain access to multiple nonfederal, commercially available, EMR data resources that shall:

a. Provide direct, unlimited access to nonfederal, longitudinal, population-based EMR data, including but not limited to the following types of information at a patient level: demographic, health history, diagnoses and procedures, laboratory test results, drug and biologic utilization and administration, and health encounters (e.g. hospitalizations, specialist visits, etc.);

b. Provide FDA personnel with unlimited access to these data in a multi-user environment and in real-time (access shall be provided via Internet or FDA network-based); and

c. Provide FDA personnel with the ability to download (or obtain by other means) large datasets as needed, for the purpose of conducting epidemiological drug and biologics safety studies.

d. Provide technical and clinical support in the area of drug safety research to assist in the utilization of the data resource for epidemiologic studies.