The recent introductions of commercial online personal health record services could have significant effects on how clinical research is conducted and raise new issues with the storage of private patient health data, according to an article published Wednesday in the New England Journal of Medicine, the New York Times reports.
Kenneth Mandl and Isaac Kohane -- who are both physicians and researchers at Harvard Medical School's Children's Hospital Boston -- write that medical professionals and lawmakers have not yet considered the implications of companies like Google and Microsoft having large amounts of private medical information. According to the authors, the companies have the potential to bring "a seismic change" in how those data are managed and used.
Most patient records currently exist within the health system, and federal regulations mandate how such information can be shared among health organizations and insurers. The regulations also stipulate how much of that information can be used by researchers.
However, in the article, Mandl and Kohane describe the development of a new "personalized, health information economy" in which patients are able to notify their hospitals, physicians and care providers which information to send to their PHRs and decide with whom and how to share that information.
The authors warn that because technology companies like Microsoft and Google are not under the purview of HIPAA medical privacy rules, consumer control of PHRs could open up access to patient information and raise the possibility of marketing and false advertising efforts by outside parties.
Mandl and Kohane said they are enthusiastic about the potential benefits of online PHRs but suggested that stricter patient information privacy standards be required, including an extension of HIPAA medical privacy rules to cover online data-sharing providers, certification standards and patient education programs.
Kohane said, "I'm a great believer in patient autonomy in general, but there is going to have to be some measure of limited paternalism."
Peter Neupert, vice president of Microsoft's health group, "resisted the suggestion of extending HIPAA to newcomers like Microsoft and Google," the Times reports. In an e-mail to the Times he wrote, "Philosophically and politically, I am skeptical of the concept of paternalism."
Neupert said a better approach would be to develop a patient data-records system that educates consumers and requires their consent before the data can be used.
Neupert said, "We have to earn the consumer's trust for our brand," adding, "So I can imagine a scenario where we have a third party verify that our system works the way we assert it does" (Lohr, New York Times, 4/17).
NPR's "Morning Edition" on Thursday reported on the NEJM article. The segment includes comments from:
- Joy Pritts, a medical records expert at Georgetown University; and
- Debbie Witchey, senior vice president of government affairs at the Healthcare Leadership Council (Silberner, "Morning Edition," NPR, 4/17).
Other NEJM Articles
The current issue of NEJM also includes three other articles on health IT. Summaries appear below.
- "Electronic Health Records, Medical Research, and the Tower of Babel," NEJM: In a NEJM sounding board, researchers discuss how "medicine has lagged far behind" other industries "in the electronic exchange" of information. The researchers pushed for the development of data standards to facilitate health data exchange (Kush et al., NEJM, 4/17).
- "Off the Record -- Avoiding the Pitfalls of Going Electronic," NEJM: In the NEJM perspective, Pamela Hartzband and Jerome Groopman, both of Beth Israel Deaconess Medical Center and Harvard Medical School, discuss the "current limitations and potential downsides" to increased use of electronic health records. The authors also make several recommendations for successful EHR implementation (Hartzband/Groopman, NEJM, 4/17).
- "Personally Controlled Online Health Data -- The Next Big Thing in Medical Care?" NEJM: The perspective by NEJM national correspondent Robert Steinbrook discusses various aspects of personally controlled electronic health data, including the debate over patient responsibility, assistance from physicians and health care institutions, and the prospect of improved health care and decreased costs. According to Steinbrook, if personally controlled records become popular, the electronic records maintained by physicians and hospitals will be only one component of a larger Internet-based system that will include national interoperability standards in which patients will increasingly manage their health data (Steinbrook, NEJM, 4/17).