RESNA 27th International Annual Confence

Technology & Disability: Research, Design, Practice & Policy

June 18 to June 22, 2004
Orlando, Florida

Overview of Legal Issues in Assistive Technology Outcomes Measurement

Steven B. Mendelsohn, Todd D. Schwanke,
Roger O. Smith
University of Wisconsin-Milwaukee, Milwaukee, WI


The ATOMS Project is a major trans-disciplinary study aimed at developing techniques and criteria for the definition and measurement of assistive technology (AT) outcomes. A number of key legal questions surround these efforts. This paper briefly discusses the ATOMS Project's efforts to investigate these issues and identifies chief legal issues in AT outcomes research, including: the program contexts in which outcomes data could be legally binding upon individualized service decisions; the issues pertaining to the kinds of information that can permissibly be collected and how it can be utilized; the applicability of legally-established research techniques to AT devices and services; the nature of public and private entities with legally important roles in AT outcomes evaluation; and the fit between traditional measures of effectiveness in medical, rehabilitative, educational or other settings and the kinds of outcomes and outcome data AT can yield.


assistive technology, outcomes, legal, ATOMS Project


AT outcomes data and methods for defining and collecting such data cannot be addressed in isolation. The impact of outcomes research upon public policy, including budgetary and programmatic decisions, is profound, and is recognized by all participants in the AT community. But to say that good outcome data and relevant measurement criteria are universally desired is not to say that there is widespread agreement on what the outcome criteria should be, how outcomes should be measured, or how the data should be interpreted and applied. Careful attention to the legal framework of these discussions will help to ensure, if not agreement on these key points, then at least a higher level of shared and objective knowledge concerning material consequences of certain choices and the legal requirements bearing upon certain decisions. For instance, the legal relationship between outcome research and health insurance coverage of various items as durable medical equipment is well understood.

Everyday, requests by individuals for insurance coverage of various devices are granted or rejected based on the insurer's determination of their "medical necessity". Increasingly, in a world of evidence-based medicine, these determinations of medical necessity will be based on outcomes research that tells us the effect of the devices in question in bringing about appropriate results. Yet, in those situations where the absence of positive outcome data for a given intervention legally justifies its denial, or where the existence of positive data mandates its consideration or provision, numerous questions surround:

The law also impacts data collection methodology, even when selection of data to be collected is not an issue and when its collection is technically feasible. Privacy and confidentiality regulations, particularly those promulgated earlier in 2002 under the authority of the Health Insurance Portability and Accountability Act (HIPAA) will determine the conditions under which health-related information can be collected from individuals, and as to the uses that can be made of such data in aggregated form (1). The laws governing non-medical service systems contain similar requirements and restrictions.


While rigorous, the methodology for legal research is different from that of the social sciences. Here, as a component of the broader and multi-faceted ATOMS Project research agenda, the legal issues study: 1) reviews all documented instances in case law where outcomes data have been used as the basis for funding decisions (e.g., coverage exclusions in health insurance based on adverse outcomes data); 2) analyzes privacy and confidentiality requirements applicable to the collection, aggregation and dissemination of AT outcomes data in all relevant service systems, as set forth in governing laws and regulations; 3) reviews the "scoring" and accounting procedures used by government to evaluate the cost benefit and potential economic impact of proposed policy measures relating to AT; 4) reviews the statutory provisions (e.g., definitions of "reasonable accommodation" or of "undue burden" under Section 504 of the Federal Rehabilitation Act and under the ADA, and provisions of such laws as the Regulatory Flexibility Act and the Paperwork Reduction Act) as they bear on the data collection and outcomes definition processes; 5) describes the role of Office and Management and Budget (OMB) review and approval of all AT outcomes data collection efforts involving the use of federal funds; and 6) addresses other matters of overarching concern in the effort.


Based on this analysis, the following key issues, among others, will be clarified: 1) The procedures required to gain requisite approval for outcome studies, 2) the kinds of data that can be collected and aggregated in various settings, and 3) the dissemination that can permissibly be made of such data will be clear. The kinds of outcomes criteria and data that will be legally cognizable within the decision-making of various medical, educational, vocational and other service systems will be fully understood, so that the selection of instruments can be tailored to the practical need for data. The legally cognizable role of various disciplines and professions in the evaluation process will be fully elaborated. The existence of legal authority or responsibility for the funding and oversight of outcomes measurement will be elucidated.


Most people in general society are allowed to make technology decisions for themselves, based on whatever criteria or information they choose to use. However, the role of public and other third-party funding in the development and distribution of assistive technology creates the need for evaluating the efficacy of AT devices and services. A fairly well recognized body of interconnected legal and methodological issues is confronted in the evaluation of any social, medical or educational interventions, but when the modality in question is AT, some additional complexities and distinctive issues are encountered. These range, 1) from where to invest research and development money in AT to what professional development programs to support, and 2) from what role to give AT among the modalities available in all service systems to how to most effectively apply the potential of AT to the needs of particular individuals. Decisions about AT are being made at every level, everyday. Implicitly or explicitly, each of these decisions is made on the basis of some knowledge or certain assumptions regarding the outcomes that AT can yield. If, as many studies indicate, the AT system in our nation is marked by fragmentation, inconsistency and lack of coordination, this is surely due in large part to how different decision-makers operate with so many widely varying outcome criteria in mind.

Legal analysis cannot bring about uniformity or coordination in the criteria and values brought to bear by the numerous participants in the AT system. The criteria used by end-users and those used by third-party payors are, for example, never likely to be the same. Nevertheless, legal analysis can go a long way in creating a framework for coordination, in helping players to evaluate the relevance and accuracy of their criteria for making AT-related decisions, and in clarifying a host of regulatory, methodological and economic issues that constitute major ongoing barriers to the most effective and expansive use of AT in the lives of Americans with disabilities as tools for achieving their aspirations for independence, participation, and equality.

Some advocates fear that systematic AT outcomes research will not yield results that are positive within the frames of references of the various service systems relied upon for distribution to many end-users. And, indeed, it may prove true that the quality of life benefits of AT will not necessarily equate with quantifiable educational, vocational or medical outcomes in the way that many might hope. Ultimately society, through our law, may have to address the question whether such nonspecific life improvements ought to be supported and encouraged, or whether current legal definitions of acceptable outcomes need revision. Suffice it to say, until we get established consensus around the methods for doing AT outcomes research, the answer to this and other pressing questions cannot be known.


  1. United States, Health Insurance Portability and Accountability Act Of 1996, Pub. L. No 104-191 (1996, August 21).


This work is supported in part by the National Institute on Disability and Rehabilitation Research (NIDRR), grant number H133A010403. The opinions contained in this paper are those of the grantee and do not necessarily reflect those of NIDRR and the U.S. Department of Education.


c/o Roger Smith
ATOMS Project
University of Wisconsin-Milwaukee
PO Box 413
Milwaukee, WI 53201
(414) 229-6803

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