4. Legal issues
Legal systems vary worldwide but certain aspects of technology use may draw the attention of legal systems regardless of their cultural basis. At the level of professional practice, ethics and the law are linked because unethical practice is illegal. Illegal practice can lead to criminal or civil proceedings against individual healthcare practitioners and also the institutions and organisations where they work.
In general, legal aspects that are relevant to HTA relate to responsibility and its legal counterpart, liability. HTA bodies need to consider legal issues and a framework for considering them is important in any assessment of a health technology.
Additionally, HTA bodies must be aware that stakeholders who disagree with an assessment’s conclusions may turn to the courts. Therefore, an HTA body that does not take reasonable steps to ensure a high quality assessment may itself be at risk of legal action for failing to perform a responsible assessment.