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Health highway

President Obama's funds for electronic health records should prompt research — and controversy.

One of the most striking, if little noted, aspects of the recent US stimulus bill is that 53 of its 407 pages are devoted to setting up the administrative framework for a national system of electronic health records (EHRs). At the head of this framework, which encompasses committees on standards, policy and much else, will be a National Coordinator for Health Information Technology, located within the Department of Health and Human Services.

Many will find it even more remarkable that this portion of the stimulus bill builds upon foundations laid by former president George W. Bush, who established the office of the national coordinator by executive order in 2004, and set him the goal of giving every American access to EHRs by 2014. Now, with the stimulus bill, Congress and the Obama administration have not only embraced that goal, but have allocated $19 billion to help reach it.

Better still, from the research perspective, the stimulus bill explicitly envisions scientists being able to use these clinical records for a wide variety of population studies — monitoring the spread of flu, tuberculosis and other diseases, for example, or spotting people who might be good candidates for clinical trials, or looking for signs of adverse reactions after a drug has been released on the market (see page 278).

Many researchers believe that such studies could ultimately produce benefits as least as big as the effects of electronic records on clinical care — but only if some major issues about data access get resolved first.

Imagine, for example, that Mrs Smith checks into the hospital for hip-replacement surgery. Her doctors will be able to call up the electronic records of her personal physician, her physical therapist, her pharmacist and everyone else who provides her with health care. But this scenario poses some knotty questions. Even leaving aside the technical challenge of securing all those far-flung databases against attacks by hackers, who has the right to access any given database? And how much are they allowed to see there — everything, or just those portions of the data they need for their jobs, keeping the rest private? And who decides? Patients? Doctors? Hospitals? Anonymization and pseudonymization, in which identities are masked but all data can still be ascribed to respective individuals, protect individuals while enabling research, but how should such measures best be implemented?

These questions have been contentious even in the United Kingdom, which has deployed an electronic records system through its unified National Health Service. They will be even more contentious in the United States, where the health system is anything but unified, and where privacy concerns run deep.

The scientific questions are just as knotty. For example, will each patient have to give permission each time a researcher wants to access his or her records? That sounds reasonable — and indeed, this is the spirit of the strict data privacy and security provisions of the federal Health Insurance Portability and Accountability Act. But that would make using the records for, say, routine epidemiology prohibitively cumbersome. There needs to be a clear policy allowing for such uses, as long as the researchers have no access to any aspect of the data that reveal a person's identity. But at the same time, the health-records system should provide individuals with an audit trail that shows them who has been looking at their records, and what they have seen there.

Or consider another scenario: a research group that wants to do a study aggregating EHR data over a large area. Will they have to get approval from every Institutional Review Board (IRB) — which oversee all research on human subjects in the United States — in every hospital and university involved? Common sense suggests that one IRB process is enough — and then only if the research uses personally identifiable data. But mechanisms to coordinate the oversight will have to be created.

The national coordinator and his advisory committees will have their hands full with these and many other issues. But the good news is that a management framework is in now place to address them, and to build an EHR system that will have the confidence of professionals and public alike.

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Health highway. Nature 458, 259–260 (2009).

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