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. Data innovations

The EUnetHTA model on ethical analysis (available at: aims to improve the international transferability, quality and usefulness of HTA to decision-makers by considering ethical issues relating both to the technology evaluated and to the HTA process itself. Thus, the model is not a separate exercise on ethical aspects of a technology, but integrates ethical reflection and value-awareness into the HTA process from start to finish.

A challenge in integrating ethics into HTA has been that although there is a multitude of philosophical approaches to ethics in HTA there is lack of consensus among philosophers, and a lack of methods applicable for non-philosophers.3,10,13,24–26 The model does not purport to solve the philosophical debate but to offer a tool usable by HTA organizations, irrespective of their resources (material, time and knowledge). Thus the model has three elements: a question-based approach26 that covers issues essential for ethical analysis within HTA; a brief explanation of methods that can be used to approach the issues; and a discussion on the integration of ethical analysis into the process of HTA. Key issues and examples of the model are presented below.

Topic selection
Key ethical issues to consider before starting an HTA include analysing whether there are morally relevant reasons for performing an assessment on the topic or not. The value-ladenness of a technology depends on the cultural context where is applied. Assessment resources are always limited and should be used in ways that potentially benefit public health.16 This may not always coincide with commercial or political interests. An upcoming issue is global responsibility: when HTAs can be made internationally transferable, assessing globally relevant topics becomes a priority.

Planning the assessment
The selection of comparison technologies and outcome measures are essentially value-decisions that determine the results of the assessment. Also the moral value of the comparator should be considered, even if it is already widely used. “Hard” outcomes such as mortality should not automatically override relevant patient-reported outcomes,27 and difficult-to-quantify societal and organizational effects should be included.

The set of questions
The set of questions aims to increase standardization, transparency and the international transferability of the assessment. They are especially useful for identifying and cataloguing the relevant ethical considerations, allowing for several methods to weigh and balance the issues.26 The questions highlight the interwoven nature of ethics and HTA, e.g. medical, safety or economic issues also yield important input for ethical analysis.

The model has 16 questions covering the core issues of ethical analysis. These were chosen from a comprehensive list of issues by a consensus procedure so that only issues that were considered both important and internationally transferable were included. These include, for example, principal questions, such as whether the technology can challenge moral, religious or cultural values of a society. The risks of technology with respect to patient autonomy, human dignity or integrity must be addressed, especially considering vulnerable patient populations with special needs for information and support. Issues of basic human rights must be included – will the technology help in realizing these, or threaten them? A key issue is to include all stakeholders in considerations of benefits and harms. This leads to assessing the effects of the technology on the justness, equity or fairness of health care: Who will get access to the technology? What has happened to related technologies before

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