Fortify HIT Contracts with Education and Ethics to Protect Patient Safety, Say Informatics Experts

Washington, D.C., November 11, 2010—An original and progressive report on health information technology (HIT) vendors, their customers and patients, published online, makes ground-breaking recommendations for new practices that target the reduction or elimination of tensions that currently mar relationships between many HIT vendors and their customers, specifically with regard to indemnity and error management of HIT systems. In light of the Obama Administration’s $19 billion investment in HIT, paid out in ARRA stimulus funds, these recommendations are particularly significant in helping to foster greater use of electronic health records and other tools in the transition from paper records, largely understood to be a hindrance to quality patient care.

The recommendations, adopted by AMIA — the association of informatics professionals and a trusted authority in the HIT community — strive to imbue the HIT vendor-customer relationship with transparency, veracity, and accountability through collaborative education focused on the installation, configuration and use of HIT systems, in combination with enterprise-wide ethics education to support patient safety. The recommendations are the result of deliberations by an AMIA Board-appointed Task Force. The position statement will appear in the January/February 2011 print edition of JAMIA, the scholarly peer-reviewed journal of informatics in health and biomedicine, co-published by AMIA and the BMJ Group.

“There was a need to consider, study and analyze questions of appropriate oversight,” said AMIA Board Chairwoman Nancy M. Lorenzi, PhD, Assistant Vice Chancellor for Health Affairs and Professor of Biomedical Informatics, Vanderbilt University. “With as much interest and investment in HIT as there is today, AMIA — an unbiased third party — wanted to take a fresh look at gray areas that currently exist between vendors and their customers to see where new practices could be implemented to better support patient outcomes and protect patients, who these systems ultimately serve. We think these recommendations do an excellent job of addressing fairness and balancing accountability in the HIT marketplace and in the health sector.”

The report, titled “HIT Vendors, their customers and patients: New challenges in ethics, safety, best practices and oversight,” makes specific recommendations on Contract Language, Education and Ethics, Ethical Standards, User Groups, Best Practices, and Marketing. An additional section addresses Regulation and Oversight of the HIT Industry and next steps.

The report’s first author is Kenneth W. Goodman, PhD, FACMI, director of the University of Miami Bioethics Program. Dr. Goodman chaired the Task Force responsible for the report, a group of AMIA members comprising nationwide representatives of academia, industry, and leading healthcare institutions.

“AMIA provided an important forum in which complex and sometimes conflicting positions were candidly discussed, analyzed and balanced,” said Dr. Goodman. “HIT systems are ubiquitous these days and need better oversight. These recommendations demonstrate a high-value commitment to patient safety, quality care, and innovation — healthcare goals sometimes difficult to reconcile. These recommendations,” he added, “can help individual institutions do more to support successful HIT implementation.”
Among the recommendations is contract language specified to protect patient safety and to spell out the shared responsibility that vendors and their customers have for successful implementation. “Hold harmless” clauses in contracts between vendors and purchasers or clinical users, that absolve vendors for errors or defects in their software, are declared unethical by AMIA.

The AMIA position states that “safe and successful HIT systems further require ethics education, which has become a standard part of professional development in the corporate world.” HIT vendors and their clients are urged to adopt enterprise-wide ethics education to parallel what accrediting healthcare organizations require. Standards for corporate conduct and subsequent education about such standards are also recommended. A variety of informational tools, many aimed for post-market use, are cited among best practices to assist institutions and clinical practices in achieving optimal HIT implementation.

AMIA President and CEO Edward H. Shortliffe, MD, PhD, praised the Task Force and its accomplishment. “This group of informatics and industry leaders recognized the need to meld business ethics into successful adoption of HIT. Their recommendations balance the forces that drive the competitive HIT marketplace with the practical needs of clinicians, patients, researchers, public health workers and officials. AMIA stands by their work and hopes these recommendations will be embraced by the HIT community.”

Full text of the AMIA position on HIT vendors, their customers and patients is available online at www.jamia.org as an open-access document. Its co-authors are Eta Berner, EdD, FACMI, professor of health informatics at University of Alabama at Birmingham; Mark A. Dente, MD, GE Healthcare IT; Bonnie Kaplan, PhD, FACMI, lecturer at Yale University School of Medicine, and Bioethics Center Scholar at the Interdisciplinary Center for Bioethics at Yale’s Institution for Social and Policy Studies; Ross Koppel, PhD, professor in the Sociology Department and in School of Medicine at University of Pennsylvania; Donald Rucker, MD, vice president and chief medical officer at Siemens Healthcare U.S.A.; Daniel Z. Sands, MD, MPH, FACMI, director of medical informatics at Cisco Internet Business Solutions Group, and clinical assistant professor of medicine at Harvard Medical School; and Peter Winkelstein, MD, MBA, chief of the Division of General Pediatrics at Women & Children’s Hospital of Buffalo, and chief medical informatics officer at UB/MD, the University of Buffalo Physicians Group.

AMIA, the leading professional association for informatics professionals, serves as the voice of the nation’s top biomedical and health informatics professionals and plays an important role in medicine, health care, and science, encouraging the use of data, information and knowledge to improve both human health and delivery of healthcare services.