Electronic health records (EHRs) have providers and the public buzzing over their benefits, but pharmaceutical companies are excited, too—along with better safety surveillance and more efficient trial recruitment, this electronic information could trim the industry's expenses. If companies gain access, that is.

Currently, EHRs fall within the realm of health providers, with clinicians and insurers also reaping most of the benefits. But, at a higher level, electronic systems could be treasure troves for secondary data use, a term referring to the aggregation of EHRs for research and other purposes. If pharma, for example, can get its hands on the data—medication use, adverse event reports and more—it could be a huge boon to the industry, decreasing the cost of its own data collection efforts, starting with drug targeting and on through post-market surveillance. A recent report by Deloitte—“Modernizing the Pharmaceutical Development Process with EHRs”—estimated that EHRs could cut the costs in an average phase 3 trial by $5 million.

However, access to reap those rewards is limited. In 2009, a PricewaterhouseCoopers survey found that 90% of pharmaceutical companies had zero or only partial access to EHR data from providers. It's largely a result of EHRs' youth; policies surrounding them are still in the early stages, and “it remains unclear how and with whom providers can share or even sell their data,” says Frances Morrison, a researcher with Columbia University's Department of Biomedical Informatics in New York.

The US government has stepped in, at least partly, to look at data sharing. In December 2007, the National Committee on Vital and Health Statistics (NCVHS) made recommendations to the Department of Health and Human Services for what's being called 'data stewardship'. The NCVHS report, though, was a collection of guidelines, and actual implementation—bringing data sets together and opening them up for use— remains largely up in the air.

All this has pharma anxious. Given the billions in stimulus funds put toward EHRs, health care providers will soon be riding a wave of data. Unless things change, the pharmaceutical industry could be left behind, sticking to the smaller data sets and trials it has coasted on for years. “If health care has the data, but pharma doesn't, we get an imbalance in the market,” says Steven Labkoff, a former medical executive with Pfizer, who presented on this topic at a New York Academy of Sciences conference last month.

Concerns remain about privacy and the potential for companies to exploit data for marketing purposes. The NCVHS guidelines were a start, but Labkoff and Morrison agreed that future enforcement seems unlikely, and the public will need to understand the great value there is in accessing EHR data. “Put simply,” Labkoff says, “medicine will not be advanced if there are limits to accessing aggregated data.”