Clinical genomics, big data, and electronic medical records: reconciling patient rights with research when privacy and science collide.

Widespread use of medical records for research, consent, attracts little scrutiny compared to biospecimen research, where concerns about genomic privacy prompted recent federal proposals to mandate consent. This paper explores an important consequence of the proliferation of electronic health records (EHRs) in this permissive atmosphere: with the advent of clinical gene sequencing, EHR-based secondary research poses genetic privacy risks akin to those of biospecimen research, yet regulators still permit researchers to call gene sequence data 'de-identified', removing such data from the protection of the federal Privacy Rule and federal human subjects regulations. Medical centers and other providers seeking to offer genomic 'personalized medicine' now confront the problem of governing the secondary use of clinical genomic data as privacy risks escalate.

Legal and ethical issues in neuroimaging research: human subjects protection, medical privacy, and the public communication of research results.

Humans subjects research entails significant legal and ethical obligations. Neuroimaging researchers must be familiar with the requirements of human subjects protection, including evolving standards for the protection of privacy and the disclosure of risk in "non-therapeutic" research. Techniques for creating veridical surface renderings from volumetric anatomical imaging data raise new privacy concerns, particularly under the federal medical privacy regulation.