1. Letters to the Editor
Dec 01, 2001
By Applied Clinical Trials Editors
Applied Clinical Trials
Volume 8, Issue 12
Privacy balance sought
September 11, 2001, is a date that will forever be remembered by Americans. Our heartfelt sorrow goes
to all those directly and indirectly affected by the tragic events. Terrorist events are expected to impact
our lives and work in ways not yet foreseen. But for those of us in health care, one issue to watch for will
be changes in privacy policies. Privacy has been one of the most hotly debated issues in health care for
the past several years, as evidenced by the passage of HIPAA, the Health Insurance Portability and
Accountability Act of 1996. The impact of this significant privacy law on clinical trials, and specifically
subject recruitment, is still being assessed.
In recent polls, Americans (including civil libertarians) are conceding that home front security does not
come without a price—relinquishing some of the privacy safeguards we currently hold so tightly is likely to
happen. Is it possible that this concession could spill over to health care? Probably not anytime soon, but
it certainly could. While today this may sound implausible, a recent analogy shows otherwise.
Consider how environmentalists in the 1980s who were pushing for passage of the “right-to-know” law
spurred AIDS activists into right-to-know action for clinical trials. As a result of the right-to-know spillover,
AIDS patients gained unprecedented access to clinical protocols and study data.
Americans like options. We want the freedom to have choices and to make them. But health care privacy
is hindering this. Today, patients may not realize that faster access to the latest medical advances in
health care will not come without some concessions in privacy. Restricting access to databases to screen
patients for a possible study match may deny patients the opportunity of being offered a clinical study
option.
Although few can argue with the intentions of HIPAA to safeguard patient records, let us consider that
(under certain conditions) many lives may be tragically lost, when, in the name of privacy, patients are
denied knowledge of a study’s existence and researchers are denied access to interested patients.
Striking the balance between privacy and advancing medical treatments will be akin to the balance
between personal privacy and homeland security. They are both goals for us to strive for. In either case,
without some concessions in privacy our goals cannot be achieved.
Elizabeth Moench, President
MediciGroup Inc.
King of Prussia, PA