This new World Privacy Forum report reviews privacy law applicable to the Precision Medicine Initiative (PMI), and the large medical information and biospecimen database at its center. The HIPAA health privacy rule and its protections for individuals will not apply to PMI research activities. The key privacy concerns raised by the PMI are the lack of applicable law to govern its collection and use of individuals’ health data, the potential waiver of the patient-physician legal privilege that can shield data from disclosure through litigation, and the possibility of law enforcement access to patient records held in the PMI.

FOR IMMEDIATE RELEASE: 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.

The World Privacy Forum submitted comments to the Food and Drug Administration in response to its request for public input on its draft guidance on the cybersecurity of medical devices. The privacy considerations for medical devices is significant. Because there are a large number of stakeholders in the life cycle of cyber medical devices, the stakeholders are subject

This substance of this analysis is about the new EU-US Privacy Shield, with contextual background and an analysis of how this new proposal compares to the old EU-US Safe Harbor agreement. The analysis includes a discussion of winners and losers in Privacy Shield, and discusses its potential future.

The World Privacy Forum commented on an important proposal to make changes to the existing rules regarding the confidentiality of alcohol and drug abuse patient records. The proposal is from the Substance Abuse and Mental Health Services Administration (SAMHSA), part of the US Department of Health and Human Services. These proposed rule changes are important, as the current