The Food and Drug Administration (FDA) appreciates the opportunity to provide comments to the National Committee on Vital and Health Statistics (NCVHS) on functional requirements for the National Health Information Network (NHIN).

The following describes functional capacities needed so that FDA systems that promote patient safety and prevent adverse events can be available to patients and providers through the NHIN (Sections I – III).  We limit our comments to FDA systems that would support one or more of the ONC/HITSP Use Cases (this is not a comprehensive list of FDA health information technology activities).   For each necessary function, we describe how the FDA system supports implementation of the relevant Use Case(s).  We will be glad to provide the Committee with further information (including technical information) about these systems.

In addition, in Section IV we note areas in which the contractors’ functionality requirements for the Biosurveillance Use Case should be clarified/expanded to cover the full array of medical products and reports needed for public health surveillance and response.

I.          NHIN Function:  Enable access to current medical product and food safety information at the point of care —  use NHIN to enable prevention of adverse events

Use Case:  Consumer Empowerment, Medication History

A crucial component of the prescriber’s review of medication history with the patient is to check for safety warnings, contra-indications, and/or allergies to medications the prescriber and patient are considering.  To enable this, the NHIN should facilitate provider/patient access to official product information, include access at the point of care.

Specific NHIN Capacity – Enable Access to FDA’s Structured Product Labeling (SPL) Data Base

            The NHIN should enable prescribers, patients, and others to obtain information from the FDA’s Structured Product Labeling (SPL) to improve the safe use of products and prevent adverse events.  Starting with drugs, SPL will contain the most up-to-date and complete prescribing and product information, including the most recent safety alerts and label changes, directly from the FDA.  This information will be free, downloadable, and searchable using standard codes for medical products and ingredients (the relevant codes are currently in the HITSP “selected standards” table).

            For example, this information will give providers and patients access to the most recent warnings and alerts, and allow identification of products that include ingredients to which the patient is allergic.  Availability of SPL began in October 2005 with approved prescription drug products.  Eventually, other FDA regulated products will be added.   By making product information such as contraindications available at the point–of-care, SPL could dramatically improve the safety of prescribing.

II.        NHIN Function:  Enable automated collection of medical product and food safety information from the point of care —  use NHIN to improve identification and understanding of safety issues

Use Case:  Consumer Empowerment, Medication History

FDA’s ability to make relevant safety data available to patients and prescribers depends in part on the quality and quantity of adverse event reports.  FDA is developing a standard electronic formats for reporting adverse events related to all FDA products, starting with drugs.  The NHIN should facilitate direct transmission to the FDA of these standardized adverse event reports.

Specific NHIN Capacity – Transmit Individual Case Safety Reports and Enable Automated Adverse Event Reporting

            The NHIN should be able carry the FDA’s agency-wide standard electronic safety report format (the HL7 ICSR) from any reporting source to the FDA.  This capacity should exist for both voluntary and mandatory reports (see explanation, below), and should apply to reports on events associated with any medical and food product.   ICSR is a national electronic adverse event reporting standard that FDA has adopted and that is based on standards developed by CDC.  It allows standard electronic reporting of adverse events associated with all FDA-regulated products.  ICSR incorporates the data elements reported to FDA through its MedWatch program.

            The ICSR could be generated by  EHR products to significantly improve the quantity and quality of reported data and the timeliness of reporting, by permitting direct electronic transmission of adverse event reports from practitioners at the point-of-care to FDA and other patient safety entities.  The NHIN should be able to accommodate direct transmission of the ICSR to the FDA “edge” system.

III.       NHIN Function:  Facilitate active public health surveillance of medical and food products — use NHIN for quantum improvement in product safety surveillance

Use Cases:

BioSurveillance/ Laboratory Results — lab results data are often crucial to the identification of safety issues with medical products and foods, or identifying defective in vitro diagnostics and other devices

Consumer Empowerment / Medication History – active surveillance would dramatically improve the safety information available to FDA and thus to the public through the SPL (see Section I, above)

Specific NHIN Capacity —  The NHIN should facilitate active public health surveillance related to safety of medical products and foods (not just passive adverse event reporting)

            Active surveillance of medical product and food safety — through specific, targeted, searches —  has the potential to be more effective in identifying safety issues than adverse event reporting.  For example, if FDA or other public health entities could query anonymized data bases (or equivalent distributed systems) to follow prescribing patterns and lab results (e.g.,  determine if products are being prescribed in contraindicated combinations, monitor specific safety outcomes for the initial years of a new product), we could identify safety issues faster and more comprehensively than through passive surveillance (adverse event reporting).

IV.       Scope of public health event monitoring and response functionality

Use Case:  Biosurvellance, Event Detection and Response

The contractors’ functionality requirements appear limited to information about drug products, both with respect to event monitoring and response.  Those requirements also refer to “mandatory” reporting but not voluntary reporting.  As explained below, if the NHIN were limited in this way, it would not support most of FDA’s public health surveillance and response duties.


  • The NHIN should be able to collect safety information and transmit warnings from public health authorities on all FDA regulated products: drugs, devices, biologics, foods, cosmetics, and dietary supplements.  Any of these can be an indicator or source of a public health problem.
  • NHIN functionality should reflect the fact that devices (e.g., medical supplies) and biologics (e.g., blood products, vaccines) , not just drugs, are needed to respond to public health emergencies.
  • The NHIN should accommodate voluntary public health reporting, in addition to mandatory reports.  (The contractors’ functionality requirements mention only mandatory public health reporting.)  Clinicians and CDOs are not legally required to report medical product adverse events to the FDA (only product manufacturers are subject to mandatory reporting).  Thus, if the network were limited to transmission of mandatory reports, it would not accommodate safety information from care providers.