The following comments were submitted to CCHIT by Dr Patricia Flatley Brennan, Director of Project HealthDesign:
Thank you for the opportunity to provide feedback on the first draft of the CCHIT Personal Health Record 09 Criteria. The Project HealthDesign team applauds every effort to engage the health IT community and the public in fostering innovation in high quality, secure, effective personal health record systems.
Our comments arise from our assessment of the draft document, and to a large extent echo and expand on discussion that took place at the recent CCHIT Town Call. Our concerns focus on two areas: (1) the potential for premature certification efforts to inhibit innovation and slow access to PHRs for patients and their families; and, (2) the disproportionately small amount of attention paid to user-generated information in the certification draft document.
Inhibiting innovation
While is it plausible that well-specified criteria for certification will provide a target for developers to strive for, the criteria as now presented appear to represent a statement of what is minimally necessary for safety and security. The danger herein is that minimally necessary standards could prove to become the end point in themselves, and developers may reach no further. We are encouraged that the criteria have the potential to be device and platform independent, and encourage more extension of the criteria that attend to a functional, rather than product-based view of personal health records.
Innovation may also be stymied by the costs inherent in participating in a certification process. Although the CCHIT experience with ambulatory EMRs suggests that the cost and effort did not prohibit some 200 vendors, including smaller players, from entering the market, there are many reasons why the ambulatory experience might not work as well for PHR innovators. Thinking of the PHR application innovations developed by the Project HealthDesign grantees, certification costs similar to ambulatory certification is certainly a disincentive for academics and even health care professionals who see opportunities within their own area of practice. $20,000 to $30,000 every two years, for example, would be a deterrent and, indeed, even the certification process might well be prohibitive for a developer who was not a typical IT vendor.
Creating criteria that more extensively encompass the user experience
The current document presents criteria with greater emphasis on managing data originating in health care systems than on the collection and sharing of user-collected information (see Health In Everyday Living – E Primer #3). Although the ability for users to collect and share their own information is often cited as a basic PHR requirement, there are only two certification criteria associated with this functionality – only one of which speaks to user-defined data. The Project HealthDesign grantees learned much about the experience of health in everyday living, and discovered that most people manage their health and heath care using IT technology beyond just computers.
In the Town Call discussion, the point was made that the lack of criteria addressing functionality was intentional on the part of the CCHIT team. CCHIT advisors acknowledged that PHR development is at such an early stage that it is impossible to envision what sorts of applications and technologies might be included in future PHRs. We would certainly agree, and trust that future versions of these criteria are sufficiently robust to handle new kinds of health data and indicators deemed critical to personal health monitoring by lay people themselves.
In summary, we believe that, while markers of quality are important to assure consumer confidence and thus acceptance, the consequence of too many requirements, particularly at this early stage of their development, will be to inhibit creative ideas and deny people access to new, non-clinical tools that help them manage their health and health care. We believe that the health IT community should focus on identifying best practices for managing the elements of personal health information, data security, accessibility and interoperability and not on the certification of free-standing PHRs themselves.
If you have any questions about our comments, please do not hesitate to contact me. To view our grantee programs and learn more about Project HealthDesign, please visit our web site.
Submitted By:
Patricia Flatley Brennan, RN, PhD, FAAN
Chair, Industrial & Systems Engineering, College of Engineering
Moehlman Bascom Professor, School of Nursing
Program Director, Project HealthDesign
University of Wisconsin-Madison
