New World Privacy Forum report finds the Precision Medicine Initiative is lacking in legal privacy protections

May 18, 2016

Pam Dixon at (760)-470-2000
or Robert Gellman at (202) 543-7923

The World Privacy Forum finds the Precision Medicine Initiative is lacking in legal privacy protections; HIPAA will not apply, leaving medical data and biospecimen donors open to multiple data complications

San Diego — The World Privacy Forum today published a report finding that the Precision Medicine Initiative has laudable goals, but that many core privacy questions are unaddressed and unanswered.

President Obama’s Precision Medicine Initiative (PMI) is an ambitious program with a goal of gathering the freely volunteered health and biospecimen data of over a million people to facilitate medical research. According to World Privacy Forum’s analysis of the PMI documents and plans, the 1 million planned volunteers may be getting more exposure than they bargained for after they donate their medical records and biospecimens to the volunteer research effort.

“We want the Precision Medicine Initiative to succeed in its goals of large-scale medical research, but not at the expense of exposing data and biospecimen donors to risks they were not told about,” said Pam Dixon, Executive Director of the World Privacy Forum. “The Initiative still has time to solve its privacy problems, but it needs to act now, or risk losing the trust of patients.”

Some key privacy concerns raised by the PMI are:

  • Medical record data and biospecimen data that consumers donate to the PMI are not covered by the core federal health privacy law, HIPAA, while in the hands of the PMI;
  • Patients who share their health records and biospecimens with the PMI could lose the ability to claim a physician-patient privilege in unrelated judicial proceedings;
  • The possibility of law enforcement access to patient records held in the PMI has not been addressed by the PMI, nor have donors been informed of how law enforcement access to the data will be handled;
  • Consumers may have no formal legal right to obtain their own information from the PMI unless a US government agency administers the PMI, something that is not expected.

The World Privacy Forum has recommended that the PMI clarify the legal and administrative privacy protections that apply to its activities before it launches. People who volunteer their medical data and biospecimens must be told what specific legal protections apply and do not apply.

The World Privacy Forum report is available at:



The World Privacy Forum is a non-profit public interest research and consumer education group focused on the research and analysis of privacy-related issues. The Forum was founded in 2003 and has published significant privacy research and policy studies in the area of health, online and technical privacy issues, privacy self-regulation, financial, identity, and data brokers among other many areas.