Moral claims of stakeholders and mitigation strategies
| Moral claim | Derived claims or potential solutions |
| Patients | |
| Confidentiality | Data security measures and trustworthy data governance |
| Informational self-determination | Right to govern/control/information/deletion/copy/correction Right to decide about data use for ReuseForPro Consent |
| Patient involvement in governance | Involve patient representative, for example, on data access and use committee |
| Interest in clinical benefit | ReUseforPro is unlikely to generate direct clinical benefit to data donors—this should be clearly communicated in the informed consent process and this interest should not play an ethical role |
| Share in profits | Weak claim, no ownership rights, data understood as public ressource |
| Accountability and mitigation strategies | Risk minimisation must strive for compensation in the event of adverse consequences |
| For-profit companies in the health sector | |
| Freedom of research | Companies are free in their choosing a research topic |
| Access to patient data | Contractual solutions; data access should be non-exclusive and non-discriminatory |
| Sustainability on the market | Products with added value in a field of high medical need justify high prices Limits in the debate about fair pricing |
| Corporate social responsibility | Checking carefully whether companies live up to what they promise |
| Publicand future patients | |
| Public benefit | Ensure benefit outweighs risks and negative effects, for example, on public trust |
| Trust in the healthcare system | Framework that ensures fair return and minimisation of risks |
| Return to the healthcare system | Make sure return can be expected and will be monitored |
| Effective competition | Oversight that market access and effective competition is guaranteed for smaller and larger players equally |
| Promotion of national companies | Promote companies that pay taxes or are trusted as long as it does not forestall effective competition |
| Healthcare institutions/physicians’ office | |
| Ownership of data | Only extra investment in documentation for secondary use can substantiate claims—for refund or recognition |
| Compensation for additional effort | Reimbursement of time, investment and personnel for additional efforts for documentation |