A Legal Framework for Shared Clinical Decision Support

A consortium of leading health IT providers and research organizations is making impressive strides at creating and sharing clinical decision support (CDS) tools and services across organizational boundaries. Yet the success of the effort is dependent on overcoming several legal hurdles, including concerns about intellectual property, liability and data security.

At the recent American Medical Informatics Association meeting in Washington, D.C., representatives of the CDS Consortium described their efforts to create a legal framework for sharing CDS knowledge and services.

Funded since 2008 by grants from the Agency for Healthcare Research and Quality (AHRQ), the CDS Consortium includes researchers from several institutions, including Brigham and Women's Hospital, Harvard Medical School, and Partners HealthCare Information Systems (PHS) along with the Regenstrief Institute, the Veterans Health Administration, The University of Texas Health Science Center at Houston, Oregon Health Sciences University, Kaiser Permanente, Mayo Clinic, NextGen, Siemens Medical Solutions, GE Healthcare, and Duodecim Medical Publications.

Tonya Hongsermeier, M.D., M.B.A., principal informatician in the Clinical Informatics Research and Development group at Partners, said the consortium grappled with the need to create a safe approach to sharing CDS content while ensuring that intellectual property rights of contributing parties are respected. It drafted legal language for both publishers and end-users that takes into consideration attribution and rights granted by the publisher to end-users and warrants that the publisher fully owns the CDS artifacts submitted. Basically, she said, content contributors retain authorship; users may make derivative works with appropriate attribution; and artifacts may not be resold.

The consortium also had to address the issue of liability. The courts have had very little experience dealing with clinical decision support, but it seems to be seen as augmenting but not replacing the judgment or the function of a physician.

“There are multiple points of possible failure,” Hongsermeier noted, including inaccurate content or software that does not perform as designed. Or a customer’s implementation of software could result in defective functioning. Agreement language was drafted to mutually indemnify the parties involved. Publishers agree to hold the consortium harmless against any liability. The CDS content is provided on an “as-is” basis, and the consortium does not warrant its accuracy. The consumers are accountable for ensuring integration with EHRs is accurate.

Lana Tsurikova, a research program manager in the Clinical Informatics R&D group at Partners, talked about some lessons learned in the process of drafting the legal framework. She suggested making initial cost and time estimates and “then triple them.” It is difficult to identify the people at each organization who have the authority to sign the agreements, and it takes time to educate the attorneys involved about the specifics of CDS, she added. Those involved should expect an ongoing investment of time and legal resources as the possibility of future regulation could further impact the complexity in creating sound legal arrangements for knowledge and data sharing.