Public and private healthcare experts have been struggling for years to establish electronic health information systems that
can track and transfer a broad range of data in patient medical records. However, the inability of the nation's fragmented
health IT (HIT) systems to communicate with one another has made the task extremely difficult, as do concerns about patient
privacy and protecting access to personal health information.
A main strategy of e-health advocates is to offer incentives to spur physician adoption of electronic health record systems
(EHRs), as seen in provisions in a 2008 Medicare bill and the 2009 stimulus legislation. The Health IT (HITECH) portion of
that legislation also encourages electronic prescribing by making that process one of several criteria providers must meet
to make "meaningful use" of certified EHR systems, thus qualifying for $20 billion in Medicare bonus payments and avoiding
future penalties [see sidebar].
The Push for E-Prescribing
The legislation also strengthens privacy and disclosure requirements to enhance public trust in EHR programs. In the process,
though, it threatens to restrict the services that pharma marketers and other third parties can offer healthcare plans and
providers, such as medication reminders and disease management.
Increased connectivity among healthcare entities promises to affect more efficient drug testing and development, along with
more timely medical product monitoring and oversight. To take advantage of these developments, FDA is updating internal IT
operations, partly in response to a 2007 report from the FDA Science Board describing the sorry state of the agency's IT infrastructure.
One goal is to provide information on the safety of regulated products more quickly. To this end, FDA is centralizing adverse
event (AE) analysis through an all-FDA Adverse Event Reporting Systems (FAERS), and is creating a MedWatch Plus single portal
for public AE reporting. Probably the most high profile project is to establish a proactive electronic information system
able to monitor health records on 100 million people by July 2012, as required by the FDA Amendments Act of 2007 (FDAAA).
To meet this deadline, FDA launched the Sentinel Initiative in 2008, and now is establishing a "mini-Sentinel" system that
will tap into medical records held by large health plans and insurers to monitor for certain events and assess evidence of
health conditions associated with drug use. FDA recently signed a $72 million contract with the Harvard Pilgrim Health Care
system to implement a distributed data model that will enable FDA to query databases established by CIGNA, Kaiser Permanente,
and the HMO Research Network, among others. The initiative already has access to information on 60 million patients, according
to project director Richard Platt of Harvard Pilgrim and Harvard Medical School. That's well above the initial FDAAA requirement
of 25 million patients by July 1, 2010. A second phase next year will permit direct FDA access to de-identified health records
from Medicare and other government health programs.
Platt and others discussed the technical, legal, and administrative issues involved in building the Sentinel System at a January
workshop organized by Mark McClellan, former FDA commissioner and now director of the Engelberg Center for Health Care Reform
at the Brookings Institution. FDA commissioner Margaret Hamburg opened the conference by emphasizing her support for better
postmarketing surveillance of regulated products. To have a fully functioning Sentinel System, she urged consensus on methodologies
for proving and disproving causal relationships between a product and an outcome.
Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), described Sentinel as one element in a broader
FDA effort to encourage safe use of medications, revamp the agency's pharmacovigilance system, explore the use of social media
to publicize safety issues, and better understand drug effects in different populations through worldwide collaborations.
Sentinel is "very much a work in progress," Woodcock commented.