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 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."
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.