Development of a public health information infrastructure for postmarket evidence

Postmarket data on prescription medical product performance has historically been incomplete, underutilized, and mismanaged to inform safety and comparative clinical effectiveness. Congress has tasked the Food and Drug Administration to build a public health information infrastructure for drug safety. It also has allotted $1.1 billion dollars in new spending for comparative effectiveness research. A singular, shared, multi-purpose public health information infrastructure can be built to serve both these needs and others. It can be used by multiple public health agencies under a coordinating framework. A new independent public health authority is best positioned to manage that framework and to negotiate the security, legal, proprietary, and privacy barriers that accompany requests to access large amounts of patient data. Such a design protects privacy, avoids duplication, leverages investment, and promotes sustainability in what is truly a "greenfield" opportunity in the United States. Consequently, the policy window to influence the system design is now. Personal health data is the scarce resource needed to constitute this infrastructure. Citizens have a right and responsibility to re-examine how postmarket data is used to measure safety and comparative clinical effectiveness. A public process to establish new classification schemes that set benefit-risk targets for classes of prescription medical products is needed. Such schemes would differentiate products according to therapeutic need, expected length of treatment, expected patient population, novelty of treatment, and availability of substitutes.

Department dc:contributor.department

Massachusetts Institute of Technology. Engineering Systems Division

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2009

Author dc:creator

• Maro, Judith C

Advisor dc:contributor.advisor

• Nicholas A. Ashford.

• Engineering Systems Division.
• Technology and Policy Program.

Statement dc:rights

• M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission.

Licence dc:rights.uri

• http://dspace.mit.edu/handle/1721.1/7582

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/1721.1/53058

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/53058