Health IT Promises More Timely Drug Information

FDA modernizes information systems, expands access to drug safety and use information.
Mar 02, 2010
Volume 34, Issue 3

Jill Wechsler
Public and private healthcare experts have been struggling for years to establish electronic health-information systems able to track and transfer a broad range of data in patients' medical records. The fragmented nature of existing health information and the inability of health information technology (HIT) systems to communicate with one another has made the task extremely difficult. Add to that concerns about patient privacy and protecting access to personal health information (PHI), and the endeavor becomes even more daunting.

A primary strategy of eHealth advocates is to offer incentives and penalties to spur physician adoption of electronic health record (EHR) systems. Such measures were included in a 2008 Medicare bill as well as in the 2009 stimulus legislation, formally known as the American Recovery and Reinvestment Act (ARRA). The Health IT (HITECH) portion of ARRA authorized $20 billion to promote the adoption of EHR systems by healthcare providers, to support interconnectivity on a regional basis, and to expand the Office of the National Coordinator for Health Information Technology (ONC) in the Department of Health and Human Services (HHS), now headed by Harvard Medical School professor and health policy guru David Blumenthal.

HITECH strengthens privacy and disclosure requirements for eHealth systems as a way to enhance public trust in EHR programs. In the process, the measure threatens to restrict the services that pharmaceutical companies and other third parties can offer healthcare plans and providers such as medication-management and disease-management programs.

In Washington this month
At the same time, the HITECH bill encourages electronic prescribing as one of several criteria that providers must meet to make "meaningful use" of certified EHR systems and thus qualify for Medicare bonus payments, not to mention to avoid future penalties [see sidebar, "Electronic prescribing grows"]. Providers are also required to submit insurance claims electronically; track patients' medications and laboratory results electronically; provide patient access to their health records; and use computerized order systems. There are a lot of complaints about the deadlines and criteria specified in a proposed rule on meaningful use that was issued in late December to implement HITECH. And there's still a need for standards and procedures for certifying that EHR systems perform required functions and are secure and interoperable.

In addition to doling out incentives for EHR adoption, HHS is providing some $2 billion to: help providers adopt HIT that fits standards; assist states and communities in establishing health information exchanges; develop interoperability standards; and examine a range of technical and policy issues that impede HIT adoption. All these efforts aim to support a Nationwide Health Information Network that will provide more information on healthcare costs, quality, and outcomes needed for a more effective healthcare marketplace. EHR systems are important, but will accomplish little, says Blumenthal, unless health data "can flow freely, privately, and securely to the places where they are needed."

FDA struggles

Although the US Food and Drug Administration does not benefit directly from HITECH funding, increased connectivity among healthcare entities promises to support more efficient drug testing and development, along with more timely medical product monitoring and oversight. To take advantage of these developments, FDA first has to update its internal IT operations to improve its capacity for reviewing applications for new drugs and medical products; for receiving and archiving clinical-trial data and regulatory submissions; for tracking manufacturing facilities and product supply chains; and for expanding oversight of the safety of drugs and medical products on the market.

A report from FDA's Science Board in 2007 described the sorry state of the agency's IT infrastructure. The report noted that much clinical-trial data was available only in paper form, and that FDA's decentralized IT operations have created different systems in agency centers without common standards for data exchange. Much of FDA's IT infrastructure was more than five years old and thus unable to support advanced analysis such as that using genomics information related to medical products. FDA has an IT plan for drugs and biologics, as authorized by the Prescription Drug User Fee Act (PDUFA) IV of September 2007, but the plan falls short of addressing broader agency information problems.

The Science Board report renewed efforts to overhaul FDA's information systems. The agency announced in September 2008 a 10-year, $2.5-billion bioinformatics project to modernize agency IT infrastructure for data management, data warehousing, IT infrastructure, and IT security. One aim is to coordinate the many IT modernization activities launched over the years, which range from establishing an electronic document room and an Advanced Submission and Tracking Review system, to creating a risk-based import screening system (PREDICT), and a centralized electronic system to manage advisory committees.

Electronic prescribing grows
However, Congress' Government Accountability Office (GAO) reported in June 2009 that FDA still needs a comprehensive IT strategic plan with specific goals, strategies, milestones, and performance measures to tackle its many information challenges. Agency officials promised to complete such a plan last year, but the plan has been delayed by difficulties in establishing advanced IT systems at the agency's White Oak, Maryland, campus. (Under the President's proposed fiscal year 2011 budget, the White Oak campus will become the sole FDA headquarters). Last August, the Science Board reported that FDA was making progress in creating a more effective IT infrastructure and in harmonizing data standards, but that it still needs standards-based electronic data exchange capacity, more IT expertise to manage these programs, and additional investment in scientific computing systems.

lorem ipsum