Before reviewing the article in this issue of Medical Writing by Larry Liberti and Tina Wang, The regulatory-HTA decision-making interface: What the medical writer should know (p. 50), I put on my ethicist’s hat. Thus, I tuned my ethics antennae to detect whether there might be some concerns about issues that could result in unintended harm, either to individual patients, or to the collective society to which health technology assessment (HTA) and regulatory authority decisions might apply. I approached the evaluation as an opportunity to ask questions that should be considered, rather than suggest solutions. This may better enable those charged with making critical healthcare decisions to evaluate choices in context, rather than attempt to apply overarching “rules”. This approach, of course, raises the challenge of whether it is appropriate to apply “situational ethics”, or whether there should, indeed, be universal standards that should remain inviolable and absolute. Perhaps, this is where objective algorithms must be melded with subjective human assessments, based on education, experience, expertise, personal values, and instinct. Hopefully, this will stimulate thoughtful questions in the context of HTAs, and medical writers will better understand the scope of medical decisionmaking. In this way, we may raise awareness, and hopefully, prevent – or at least recognise – the potential for harmful unintended consequences of certain HTA-based medical decisions.
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