Protecting Patient Privacy in a Digital World

Protecting Patient Privacy in a Digital World

01.30.13 | By Stephanie Fischer

For biopharmaceutical companies that rely upon volunteers to participate in clinical research on potential new medicines, protecting privacy has always been a priority. Striking the appropriate balance between sharing data to drive medical discoveries and keeping personal health information from being disclosed is critical.

According to recent articles in The Wall Street Journal and New York Times, researchers at the Massachusetts Institute of Technology's Whitehead Institute for Biomedical Research found that by only using the Internet, they could identify people who had anonymously participated in studies and provided genetic samples. Using genealogy websites which publicly post limited genetic information taken from men's Y chromosomes and cross-checking it with other publicly available information, scientists determined the last names of people whose anonymous genetic information was available for science research.

Protection of Patient Safety and Privacy A Priority

Clinical trials are essential to the development of new medicines that save and improve lives, and the biopharmaceutical industry goes to great lengths to protect patient safety and privacy by encouraging programs that are scientifically rigorous and clinically productive. Guided by government regulation and oversight, international standards and industry principles, PhRMA member companies are committed to conducting clinical trials that:

  • Follow standards and practices designed to protect patients, that are constantly evaluated and improved;
  • Respect and protect the safety and privacy of participants, sponsoring clinical studies that fully comply with all legal and regulatory requirements;
  • Adhere to international guidelines and standards designed to share clinical trial data and results, while maintaining the privacy of individual trial participants.

Sharing of Clinical Data Must Be Limited and in Context

Recent calls to release all patient-level trial data pose great risk to patient privacy and could serve as a deterrent to individuals considering participation in clinical trials. Without the participation of thousands of volunteers, clinical trials and the development of new medicines would be significantly delayed - if not impossible.

America's biopharmaceutical companies and other stakeholders in the research ecosystem are committed to ensuring that clinical research is scientifically and ethically rigorous, with the results responsibly communicated in the right context to healthcare professionals, patients, and the public through presentations at medical conferences, articles in medical journals and registration on, the clearinghouse of clinical trials maintained by the National Institutes of Health.

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