In this paper, we discuss the complex relationship between health
technology assessment (HTA) and the regulation of medical devices and
procedures. The relationship is first examined through a conceptual framework
describing the itinerary from research to three levels of policy making: micro
(standards of medical practice), meso (institutional rules), and macro (health
policies). Four reports from the Quebec Health Technology Assessment Council
(CÉTS) are used to illustrate how HTA activities can influence the
regulatory mechanisms operating at each decision-making level. We then discuss
the skillful balancing act required from HTA agencies to constantly negotiate
the right distance from the regulatory process at which to operate. We propose
that HTA agencies should not be incorporated into any regulatory, auditing, or
monitoring process. Finally, the relationship between health technology
assessment and health care reform is discussed. It is suggested that HTA
activities will contribute most during the data-driven preparation and
consolidation phases of a reform process. The fast pace of events and the
political turmoil characteristic of the implementation phase provide a less
receptive environment for HTA contributions.