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Regulating Automated Healthcare and Research Technologies

New technologies, techniques, and tests in healthcare, offering better prevention, or better diagnosis and treatment, are not manna from heaven. Typically, they are the products of extensive research and development, increasingly enabled by high levels of automation and reliant on large datasets. However, while some will push for a permissive regulatory environment that is facilitative of beneficial innovation, others will push back against research that gives rise to concerns about the safety and reliability of particular technologies as well as their compatibility with respect for fundamental values. Yet, how are the interests in pushing forward with research into potentially beneficial health technologies to be reconciled with the heterogeneous interests of the concerned who seek to push back against them? A stock answer to this question is that regulators, neither over-regulating nor under-regulating, should seek an accommodation or a balance of interests that is broadly ‘acceptable’. If the issue is about risks to human health and safety, then regulators – having assessed the risk – should adopt a management strategy that confines risk to an acceptable level; and, if there is a tension between, say, the interest of researchers in accessing health data and the interest of patients in both their privacy and the fair processing of their personal data, then regulators should accommodate these interests in a way that is reasonable – or, at any rate, not manifestly unreasonable. The central purpose of this chapter is not to argue that this balancing model is always wrong or inappropriate, but to suggest that it needs to be located within a bigger picture of lexically ordered regulatory responsibilities. In that bigger picture, the paramount responsibility of regulators is to act in ways that protect and maintain the conditions that are fundamental to human social existence (the commons). After that, a secondary responsibility is to protect and respect the values that constitute a group as the particular kind of community that it is. Only after these responsibilities have been discharged do we get to a third set of responsibilities that demand that regulators seek out reasonable and acceptable balances of conflicting legitimate interests. Accordingly, before regulators make provision for a – typically permissive – framework that they judge to strike an acceptable balance of interests in relation to some particular technology, technique or test, they should check that its development, exploitation, availability and application crosses none of the community’s red lines and, above all, that it poses no threat to the commons.