The speed of development may cause legal gaps. These can arise from the difficulties legislators face in assessing the implications and making provision for novel applications in fast-moving areas of technology. This can create uncertainty for everyone concerned.

In introducing new developments where there is no long-term experience and little certainty about outcome or impact, broad ethical consideration is needed to set a long-term strategy to control their use within socially acceptable limits.

 Public debate can be an important resource for defining appropriate standards and provide a reference for the development of governance In this guide ‘governance’ means the accountable use of power or authority to set, monitor, and enforce standards and behaviours within systems or organisations. It can mean both steering people’s behaviour and ensuring that they are held to account. Governance can be given effect through compulsory and non-compulsory measures (legal provision, licensing systems, professional norms, codes of conduct, recommendations etc.,). Governance can be a function of both public and private actors..

The application of digital technologies creates opportunities for data mining. When combined with new biomedical technologies, this may present a challenge to the protection of privacy and autonomy of individuals in several ways. For an individual, it may become difficult to understand the complex flows of data about them, to make informed decisions about how all the information is used or spread, and thus, to exercise autonomy.

Biomedical innovations increasingly rely on access to large and detailed data sets, often from a variety of sources. Combining large amounts of data from different kinds of sources may make the re-identification of the person concerned possible.

 The large volume and variety of data, and opportunities for data mining with many biomedical technologies, call for appropriate protection of information privacy, the need to inform the public, and the need for public debate on the risks and possibilities that modern technologies offer in this context.

Whereas biomedical innovations can reduce the risk of disease or alleviate symptoms they may also require people to accept new conditions in order to receive healthcare. For instance, genetic testing may in the future involve the generation of standardised or complete genomic data sets, and access to certain services may imply that all data is stored. Storage of a person’s genome data implies storage of knowledge that, with increasing scientific understanding, could provide information about predisposition to disease or even to certain behaviours. Withholding or not allowing for the generation of such data may entail opting out of services in a way that could leave an individual without access to the best available standard of care.

 The implications of introducing new technology in medicine may create new conditions for healthcare. This warrants a wide public debate to set fair and appropriate standards.

Biomedical developments have the capacity to blur and challenge normative boundaries. They can translate rapidly from one field of application to another, where different regulations may apply. They can also create ambiguities in the application of regulatory measures, for example over whether a particular use is medical or non-medical, or whether a given use is a therapy or a non-therapeutic enhancement.

For instance, when devices are brought to the market for non-medical purposes, they are not seen as medical devices and may thus fall outside the scope of existing medical device regulation. An example of a technology that produces findings which have an ambiguous status is direct-to-consumer genetic testing, where information about genetic predispositions with health relevance is provided outside the health care context and without proper counselling.

 When new technologies find new areas of application, public debate can help to raise awareness about the uncertainties raised and to find appropriate frameworks for use.

Biomedical innovations can entail risks that may be foreseen or unforeseen. In some developments in biomedicine, there may be substantial areas of uncertainty where the nature of the risks cannot be identified reliably or where there is no clear understanding of how to describe or evaluate them. In such situations, an appropriate response may be to broaden the appraisal of emerging biomedical technologies. This could include taking account of different perspectives, evaluation of alternatives, and consideration of aspects such as irreversibility.

 Public debate can help to bring to the surface different impacts and unforeseen consequences and can reveal differences in the ways they are valued by different people.

The uptake of biomedical developments can lead to profound changes in social norms. Such effects may not have been anticipated when implementing technologies in health care settings. These developments may also have further implications for access to health care for different groups.

For example, the establishment of prenatal diagnosis as a routine examination, in combination with simplified abortion methods, has led to significant reductions in the birth of people with Down’s syndrome in some societies. The increased access of the technology can have a potentially significant effect on the expectations of pregnant women and heighten the risk of marginalisation of those affected by Down’s syndrome. Inequities in access to the benefits of innovation can also compound and exacerbate underlying social and global inequalities and have an insidious effect both on individuals and societies.

 There is good reason to involve the public in debate about biomedical developments that may lead to changes in social norms and where there are risks of increasing inequalities and marginalisation of certain groups.

 Public debate can help to find appropriate and acceptable mechanisms to protect minorities and ensure equality of access to developments in biomedicine.