Research trials pose challenge to medical privacy
At issue is whether electronic medical records can keep sensitive data accessible to caregivers but out of the hands of everyone else.
By Janet Raloff
Records of people participating in a medical trial can hold a lot of sensitive information — not the least being data on the condition for which they’re receiving treatment. Currently, none of this information is shared with outside physicians, even though it might have allowed those docs to make more accurate diagnoses or prescribe more effective therapies. Particularly now, as doctors and clinics around the nation rush to digitize their patients’ records, controversy has begun erupting about whether medical data from clinical trials should be included in those electronic files.
The issue of how — or even whether — to share a patient’s research data poses a real dilemma, argues Emory University psychiatrist Boadie Dunlop in the Aug. 11 Journal of the American Medical Association. On the one hand, doctors would benefit from knowing if their patients had been receiving medicines, physical therapies or dietary supplements as part of some trial. Or if a patient had a history of drug abuse, mental illness, sexually transmitted diseases or engaging in risky behaviors — all details that might also be included in a research subject’s file.
But if such information got into the wrong hands, Dunlop observes, it might do serious harm, such as compromise an individual’s ability to keep a job, qualify for insurance or even retain shared custody rights to children during a contentious divorce. So for some people, keeping medical data private can be essential to maintaining their economic and social well-being. Some people even choose to take part in trials just to get free medical care that will be shielded behind a high privacy fence, he notes.
In theory, adding clinical-trial data to a patient’s general records shouldn’t be a problem if that digital data could not get into the wrong hands. But Dunlop cited survey data indicating that three-quarters of the public remains unconvinced that digital medical records can be protected from unauthorized access. “Psychiatrists appear to share similar concerns,” he notes, pointing out that “at one institution, 83 percent indicated they would not want their own psychiatric records (if any existed) included in their general electronic medical records.”
Dunlop suggests one solution: Keep information attained by clinical trials within a segment of an individual’s electronic records that’s marked “research” — as opposed to “routine.” Routine data could be dispensed to whoever normally has open access — designated family members, insurers or the family doc. Any research data would be dropped into a digital safety deposit box that required extra keys (and patient confirmation) to access.
Unfortunately, this doctor acknowledges: “Few institutional electronic medical records systems currently have this capability” to maintain differential security locks on a patient’s files. And with the Obama administration’s goal of getting every American’s medical records digitized by 2014, this potential hiccup needs to get sorted out soon, Dunlop says, or the pool of candidates for research trials could diminish considerably.
And that could diminish the quality of medicine for us all.
