The following is a letter sent by us and more than 20 prominent health care colleagues to Dr. David Blumenthal, the National Coordinator for Health Information Technology, within the US Department of Health and Human Services.
August 10, 2009
Dear Dr. Blumenthal:
We would like to request that the same exemplary openness, transparency, and support for innovation set by the HIT Policy Committee is followed by the HIT Standards Committee. We ask that the HIT Standards Committee support an evidence-based approach and open discourse about health IT standards and ensure again, as has been done so well thus far, that the results support innovators easily adding value to our health care system.
We applaud the work of the HIT Policy Committee to date. Just as it has been in the nation's best interests to re-open the EHR technology certification discussion in light of NIST's expertise and an international Conformity Assessment framework, it is in its interests to re-open the health IT standards discussion in light of recent experiences and market activity with health data exchange here and abroad.
While CCHIT and HITSP have accomplished some good work, both have been overly influenced by the same small group of special interests, and have created at least the appearance of conflicts of interest. Representatives from the legacy vendors, traditional health IT interests, and large health system enterprises have dominated the Health Information Technology Standards Panel (HITSP). A good example is HITSP’s June 2008 reorganization of its technical committees. Seventeen co-directors were announced for these six committees. Of the fourteen non-governmental co-directors, eight were current or recent employees of just three large pre-Internet enterprise vendors; three were from large vertically integrated delivery systems; and two were from large insurers. There were no co-chairs from emergent or potentially disruptive/innovative technology companies, or those with open source experience. No one representing Google, Apple, or Microsoft, for example. There were no practicing physicians and no patient advocates.
We are concerned because we hear from some of the people who are experienced in building successful standards in IT that the legacy standards largely promulgated by HITSP thus far will be a massive impediment to smaller more nimble innovators. It is very important that health IT standards not “lock out” the experience of other industries - e.g., financial services, e-commerce, and online publishing - which have evolved broad and deep Web-based infrastructures and marketplaces in which proprietary software and hardware are no longer prominent. In this case, it is vitally important to include the voices of the innovators in health care IT and data exchange, such as Microsoft and Google, Apple's iPhone, MinuteClinic and SureScripts, and their many partners.
At the very least, an evidence-based approach to health IT standards selection would consist of hearings to systematically review the best practices and lessons from health data exchange, particularly with respect to the uses of XML as a format and language for secure and interoperable transfers of summary health data like those contemplated as requirements under Meaningful Use by EHR technologies. The information distilled from this exercise could be placed alongside HITSP's conceptual constructs and enterprise use-cases. (In some instances, HITSP has recommended untested and unproven "standards" that experts have already questioned in terms of their suitability for real world implementation. Certainly, if ONC is considering translating these into national policy, they should be subject to full review in a public forum, followed by adequate testing.)
An evidence-based approach to standards selection would bring the innovators with actual experience to the discussion. An open forum would allow this testimony to help ONC's staff and the Committee members get a much better idea of what works, and what doesn't. This letter's signers and, we believe, others with deep field experience, would welcome the opportunity to testify and share their knowledge.
We understand ONC's and the Standards Committees' time pressures. On the other hand, an approach that ignores the evidence from the marketplace and practitioners outside health IT's "old guard," is simply a means of hurrying to failure, not marching to success. This is why we believe it is urgent that the discussion regarding health IT standards be re-opened immediately.
Thank you for your consideration.
David C. Kibbe, MD MBA and Brian Klepper, PhD
Steve Adams, CEO, RMDNetworks, Inc.
Richard Benoit, Dossia
Edmund Billings, MD, CMO and EVP, Product Development, Medsphere
Warren Brennan, CEO, SMA Informatics, Richmond
Bill Crounse, M.D. Senior Director, Worldwide Health, Microsoft Corporation
"e-Patient Dave" deBronkart, Patient, Co-Chair, Society for Participatory Medicine
Michael Fleming, MD, FAAFP Chief Medical Officer Amedisys, Inc.
Sarah Greene, Managing Editor, Journal of Participatory Medicine
Alan Greene, MD, co-founder, DrGreene.com and President, Society for Participatory Medicine
Adrian Gropper MD, Chief Science Officer, MedCommons
James Allen Heywood, Chairman and Co-Founder, PatientsLikeMe
Stasia Kahn, MD, Founder, Physicians for Connectivity and General Internist, Fox Prarie Medical Group
Vince Kuraitis, Prinicpal, Better Health Technologies, LLC
Glenn Laffel, MD, PhD, Sr. VP Clinical Affairs Practice Fusion
Randall Oates, MD, President, SOAPware, Inc.
Martin Pellinat, CEO, VisionTree Software, Inc.
Rick Peters MD, President + CEO, Rocket Technology Labs, Inc.
Tom Schwieterman, MD, Director of Research and Development, Midmark Corporation
Ravi Sharma, CEO, 4Medica
Rahul D. Singal MD, President and CEO, WorldDoc Inc.
Carl Taylor, Director, Center for Strategic Health Innovation
Mary Eleanor Wickersham, Director of Health Policy, GA Governor's Office, Atlanta