U.S. Clinical Trial Website Pairing — a Need for Privacy Safeguards

Fox Trial Finder is a welcomed initiative in ongoing efforts to facilitate clinical trial participation.  In a recent interview with ABC’s Diane Sawyer, Michael J. Fox, who suffers from Parkinson’s disease, said that in addition to his support for stem cell research addressing Parkinson’s, he also supports research looking for a cure on other fronts, including drug therapies and diagnostic tests. (Article Link)  Toward that end, Fox’s Foundation for Parkinson’s Research recently launched an online initiative called Fox Trial Finder.  This website promotes research across the country by pairing patients with clinical trials in their areas, based on the individual’s symptom profile.  The foundation’s webpage notes that 30% of all clinical trials fail to recruit even one subject, and that 85% of clinical trials are delayed because of insufficient subject enrollment – so Fox’s initiative (and others like it that focus on other diseases) may well spur needed research.

One impediment encountered with Fox’s and others’ webpages relates to privacy protection.  As noted in the “Terms and Conditions of Use” for Fox Trial Finder, this service is not protected by HIPAA (the Health Insurance Portability and Accountability Act).  HIPAA regulates the use and disclosure of individually identifiable health information only by “covered entities”, which are health care providers, health plans, and health care clearinghouses.  Others (like Fox Trial Finder) that obtain and use health data are not subject to the privacy protections in the HIPAA privacy rule – and this may give pause to individuals who are contemplating signing up.  Legislative reform in the US, patterned after data privacy laws in Europe, might help address this problem.  In Europe, privacy safeguards for the collection, use, and disclosure of personal information attaches to the data and applies to all data controllers.  A more comprehensive legislative data protection paradigm that protects private health information in anyone’s hands likely would encourage more prospective research subjects to sign up with research study pairings sites like Fox Trial Finder.