Legal & Regulatory Issues in the Protection of MR Data: The Alphabet Soup (GDPR, HIPAA, FDA)
Yvonne W. Lui1
1New York University School of Medicine, New York, NY, United States

Synopsis

In this presentation, we will review some of the legal and regulatory issues in the protection of MRI data that are pertinent to research in MRI including defining and discussing GDPA, HIPAA, and the role of the FDA. We will begin with an overview of the topic of medical imaging data ownership and what the rules are, the differences between legal definitions depending on location such as between Europe and North America. We will comment on what ownership means and review what HIPAA is, discuss issues of informed consent, issues surrounding deidentification, and the role of the FDA.

In this presentation, we will review some of the legal and regulatory issues in the protection of MRI data that are pertinent to research in MRI including defining and discussing GDPA, HIPAA, and the role of the FDA. We will begin with an overview of the topic of medical imaging data ownership and what the rules are, the differences between legal definitions depending on location such as between Europe and North America. We will comment on what ownership means and review what HIPAA is, discuss issues of informed consent, issues surrounding deidentification, and the role of the FDA.

Acknowledgements

No acknowledgement found.

References

No reference found.
Proc. Intl. Soc. Mag. Reson. Med. 29 (2021)