Provide names of other journalists involved.
“Heart Gadgets Test Privacy-Law Limits, by Amy Dockser Marcus and Christopher Weaver”
List date(s) this work was published or aired.
28-Nov-12
Provide a brief synopsis of the story or stories, including any significant findings.
This story showed how patients have been left behind as the use of “big data” spreads throughout the health-care system. Companies are increasingly collecting patient-specific data about medical conditions, device performance and safety, and though efforts to put such information to commercial use are nascent, executives know the data is valuable. Meanwhile, privacy laws are not keeping pace with technology and patients are finding they cannot directly access data collected by devices implanted in their own bodies. Data generated by heart implants and other new technologies, including smart phone apps and over-the-counter monitors, are testing the definition of medical records and creating fights over who gets access to the information. In our story, we found a number of patients with heart implants who have been refused direct access to the data streaming from their bodies by the device makers, who say patients must go through a doctor. Current law gives doctors 30 days to hand over traditional medical records even as device companies are able to collect data in nearly real time, and many doctors balk at the prospect of patients accessing their records on their own. For patients without health insurance and no regular care by a doctor, this has led to potentially life-threatening situations.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
The story used data and documents including extensive personal health records of patients, such as hospital and doctor’s bills, the reports generated by their devices, and medical records.
Explain types of human sources used.
Human sources included patients, their personal doctors, cardiologists, device makers, lawyers who sue device makers, privacy-law lawyers, Food and Drug Administration officials, Department of Health and Human Services-Office of Civil Rights officials, National Institutes of Health officials, electrophysiologists who implant the devices, and professional society officials. Because the controversy was new and legal theories and regulations pertaining to the predicament are largely untested, reporting required multiple interviews with many of the sources over months as sources familiarized themselves with the issues.
Results:
Some of the patients have been contacted by the device makers or federal officials following privacy law issues to discuss how to help them gain direct access to their data.
Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
There has been no correction or clarification and no one has challenged the accuracy.
Advice to other journalists planning a similar story or project.
One challenge in reporting this story — an obstacle that probably applies to other health-data stories, too — was developing a working understanding of the meaning and significance of the data in question. Implantable heart devices gather a range of complicated electrical measures that tell trained doctors important things about heart health and workings of the devices — but the meaning of the information to patients, potential commercial users of the data, and even the companies themselves is less clear. Extensive conversations with company officials, industry experts and physicians specializing in heart devices helped tease out the potential value of the data and hone our grasp on how such information might be useful to patients or corporate interests. An interactive feature detailing the significance of various data elements allowed our readers to learn how to interpret some key points. Also, gaining access to the individual patients’ complete health records, including data reports from devices, helped ensure accuracy and fact-check medical, financial and technological matters that were in some cases confusing even to patients and the doctors involved in their care.