As director of Project HealthDesign, a national program of Robert Wood Johnson Foundation’s Pioneer Portfolio, I respectfully submit these comments on the Nationwide Health Information Network: Conditions for Trusted Exchange Request for Information, issued May 15, 2012. Project HealthDesign is a national program of Robert Wood Johnson Foundation’s Pioneer Portfolio, and was established in 2006 to foster innovation in personal health technology. Since 2006, the program has involved 14 interdisciplinary teams that have worked with hundreds of patients and clinicians to develop and implement systems that allow patients to self-track information about their daily lives and health. We call this information, which ranges from data about an individual’s mood to insights about his or her energy or pain levels, observations of daily living (ODLs).
We applaud ONC’s efforts towards the governance of the Nationwide Health Information Network (NwHIN), and support the end goal of robust data exchange that is both safe and secure. Additionally, we are encouraged to see several conditions for trusted exchange (CTEs) that acknowledge the importance of patients’ roles as direct participants in health information exchange (e.g., S-3: allowing individuals a meaningful choice regarding whether their IIHI may be exchanged, S-8: allowing individuals to request a correction or annotation to individually identifiable health information (IIHI)).
Please consider the following comments on specific CTEs:
Condition S-3: An NVE must ensure that individuals are provided with a meaningful choice regarding whether their data may be exchanged by the NVE
We support this effort to engage individuals by allowing them to opt in or out of data exchange. This condition will also allow individual patients to see themselves as direct participants in the exchange process. However, caution should be taken to understand the individual health and public health consequences for opting in or out of data exchange. Trade-offs will need to be made in prudent ways.
Question 28: Under what circumstances and in what manner should individual choice be required for other electronic exchange purposes?
We encourage you to consider whether it might be appropriate for individuals to opt in or out of data exchange at a more granular level (e.g., opt in to all data exchange except the exchange of data related to behavioral health). However, this approach would require a reliable system for keeping track of individual’s granular preferences, as well as good privacy management strategies that lay people are able to understand.
Condition S-6: An NVE must not use or disclose de-identified health information to which it has access for any commercial purpose.
We agree with this condition. We also recognize the importance of establishing a clear definition of what qualifies as a “commercial” purpose in order to avoid creating obstacles to the use of de-identified data for research and public health purposes.
Question 38: On what other entities would this have an effect?
This provision would serve to increase not only providers’ trust in exchanging their data through an NVE, but also patients’ trust in the exchange.
Condition S-8: If an NVE assembles or aggregates health information that results in a unique set of IIHI, then it must provide individuals with electronic access to their unique set of IIHI.
Question 40: What further parameters, if any, should be placed on what constitutes a “unique set of IIHI”?
No additional parameters should be placed to qualify what constitutes a unique set of IIHI. Any IIHI not accessible to individuals through a singular channel should be made available as described.
Condition S-9: If an NVE assembles or aggregates health information which results in a unique set of IIHI, then it must provide individuals with the right to request a correction and/or annotation to this unique set of IIHI.
Question 42: Are there any circumstances where an NVE should not be required to provide individuals with the ability to correct their IIHI?
No. Allowing individuals the ability to correct their IIHI when incorrect or incomplete (as described in the HIPAA Privacy Rule) will help build patient trust in the data exchange process. We also recommend using an audit trail to document when original data sources have been modified.
Thank you for providing this opportunity to comment on the Request for Information. We appreciate ONC’s leadership in this area and look forward to a set of evolving CTEs that foster safety, security, and meaningful exchanges of data. For more information about our work, please contact me directly or visit projecthealthdesign.org.
Patricia Flatley Brennan, Ph.D., R.N.
Project HealthDesign National Program Director