On What Goes on With Goal-Oriented Healthcare Equipment Regulations: An Exploratory Case Study on the Diagnostic Imaging Equipment Industry in Brazil

Abstract

Few economic sectors are more regulated than healthcare. Although excessive healthcare regulation is a bad thing, regulatory compliance may bring with it many benefits, such as market entry, product quality and availability, as well as access to tax rebates and financial incentives. Goal-oriented regulations, in particular, embody in their formulation specific propositions to maximize compliance benefits provided the achievement of public policy goals. In this paper, we develop an in-depth study of goal-oriented healthcare equipment regulations. We use expert knowledge and process-mining techniques to investigate what goes on with regulatory compliance and with the benefits obtained by equipment manufacturers when the healthcare equipment regulation is goal-oriented. We present here a multi-company exploratory case study on the variability of mean times-to-benefit after compliance and on regulatory process improvement, focused on the diagnostic imaging equipment segment and the regulatory context in Brazil. We show that, in some cases, mean times-to-benefit depend on the compliance of different categories of diagnostic imaging equipment with technical requirements found in the applicable norms. Moreover, we present process improvement cases elicited during goal-oriented regulatory process analysis and modeling activities. Our study illustrates the usefulness of applying expert knowledge and process mining techniques together in the healthcare equipment domain. It also suggests that healthcare equipment product-management practices should be concerned not only with analyzing and ensuring regulatory compliance but also with regulation dynamics.

Keywords

• Diagnostic imaging equipment
• regulatory requirements
• goal-oriented regulation
• healthcare processes
• public policy