The White House Precision Medicine Initiative (PMI) might do well to borrow some of the concepts already in use in health information exchange (HIE) and health IT, according to comments released by the American Bar Association's Health Law Section on the proposed privacy and trust principles issued by the Precision Medicine Initiative Interagency Working Group.
In an Aug. 4 letter from William W. Horton, Esq., chair of the Health Law Section to Stephanie Devaney, project manager of the Precision Medicine Initiative, Horton suggests, among other things, that since there is no specific governance infrastructure in the proposed principles, the PMI might consider using the Data Use and Reciprocal Support Agreement (DURSA) model developed for the Nationwide Health Information Network Initiative, which is used in many HIE arrangements.
"The DURSA model involves a multi-party agreement under which each participating party enters into the DURSA, establishing various obligations intended to enable that party to exchange health information with other participating parties in a trustworthy fashion," Horton says. "The DURSA is not a perfect model, and it is by no means recommended that it be adopted without substantial analysis and adaptation to PMI needs and goals. Nonetheless, it is a model of a policy-driven governance structure based on voluntary stakeholder agreement which is worth considering for PMI governance."
Horton also recommends that to create an effective security program, the PMI may wish to use as a model committee the privacy and security "tiger team" from the Office of the National Coordinator's health IT policy workgroups.
These comments have not been approved by the House of Delegates or the Board of Governors of the American Bar Association and, accordingly, should not be construed as representing the position of the American Bar Association.
The PMI, announced in January, aims to increase the use of precision medicine in health IT. A rough draft of the PMI privacy and trust principles was released in July for public comment. The principles offer guidance on transparency, data sharing, governance, access, and other issues.
To learn more:
- read the comment letter (.pdf)