Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force

Abstract

The current commercial health information technology (HIT) arena encompasses a number of competing firms that provide electronic health applications to hospitals, clinical practices, and other healthcare-related entities. Such applications collect, store, and analyze patient information. Some vendors incorporate contract language whereby purchasers of HIT systems, such as hospitals and clinics, must indemnify vendors for malpractice or personal injury claims, even if those events are not caused or fostered by the purchasers. Some vendors require contract clauses that force HIT system purchasers to adopt vendor-defined policies that prevent the disclosure of errors, bugs, design flaws, and other HIT-software-related hazards. To address this issue, the AMIA Board of Directors appointed a Task Force to provide an analysis and insights. Task Force findings and recommendations include: patient safety should trump all other values; corporate concerns about liability and intellectual property ownership may be valid but should not over-ride all other considerations; transparency and a commitment to patient safety should govern vendor contracts; institutions are duty-bound to provide ethics education to purchasers and users, and should commit publicly to standards of corporate conduct; and vendors, system purchasers, and users should encourage and assist in each others' efforts to adopt best practices. Finally, the HIT community should re-examine whether and how regulation of electronic health applications could foster improved care, public health, and patient safety.

Using FDA reports to inform a classification for health information technology safety problems

“…10 As in other patient safety domains (eg, falls, medication errors) there is no single source of information about HIT problems. A range of information sources, including record reviews, root cause analyses, and observational studies are required (see appendix A, supplementary material at www.jamia.org).…”

“…At present, there is considerable debate in the USA about the FDA's role in regulating HIT. 10 Under the Federal, Food, Drug, and Cosmetic Act, HIT is a medical device. 1 However, the FDA does not currently enforce its regulatory requirements with respect to HIT.…”

Health Informatics 3.0 and other Increasingly Dispersed Technologies Require Even Greater Trust: Promoting Safe Evidence-based Health Informatics

“…One important recent initiative is that the American Medical Informatics Association (AMIA) set up a Task Force on HIT Vendor Values, which has reported recently and been accepted by the AMIA Board [27]. This has recommended that patient safety should be of over-riding value, that patient safety should feature large in contracts, that all parties should collaborate on the adoption of best practice, and that there should be published standards of corporate conduct.…”

“…Similarly, identification of problems and adverse effects once a system is exposed to a volume of use, often in varying situations, is important as is now being recognised by the US Federal Drug Administration [27]. Surveillance and incident reporting, requiring open and impartial communication of putative faults, their logging and analysis, are necessary but still rare, whereas they should become the norm, and are required under the EU directive [16], and they may become even more significant given the innovative nature of Health Informatics 3.0.…”

“…Besides the activities of the EFMI and IMIA working groups on health IT evaluation and the recent AMIA Taskforce on HIT Vendor Values [27], several other groups also launched activities concerning evaluation HIT. We summarize a few of them below to highlight the diversity of the issues to be addressed, and the solutions proposed.…”